What is the role and authority of gatekeepers in cluster randomized trials in health research? Effect of the Informed Consent Process on Anxiety and Comprehension of Patients Undergoing Esophageal and Gastrointestinal Surgery Improving Informed Consent of Surgical Patients Using a Multimedia-Based Program?: Results of a Prospective Randomized Multicenter Study of Patients Before Cholecystectomy Informed consent for cataract surgery: Patient understanding of verbal, written, and videotaped information Educational intervention for women undergoing image-guided breast biopsy: results of a randomized clinical trial. Neonatal Research and the Validity of Informed Consent Obtained in the Perinatal Period Informed patient consent to participation in cluster randomized trials: an empirical exploration of trials in primary care Effectiveness and cost-effectiveness of arthroscopic lavage in the treatment of osteoarthritis of the knee: a mixed methods study of the feasibility of conducting a surgical placebo-controlled trial (the KORAL study). “I don’t like that, it’s tricking people too much…”: acute informed consent to participation in a trial of thrombolysis for stroke The informed consent: a study of the efficacy of informed consents and the associated role of language barriers. Enhancement of Surgical Informed Consent by Addition of Repeat Back: A Multicenter, Randomized Controlled Clinical Trial Fitting a routine health-care activity into a randomized trial: an experiment possible without informed consent? When is informed consent required in cluster randomized trials in health research? Informed consent, parental awareness, and reasons for participating in a randomised controlled study The quality of informed consent in a clinical research study in Thailand. Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials. Informed consent and participant perceptions of influenza vaccine trials in South Africa Informed consent for cardiac procedures: deficiencies in patient comprehension with current methods. A novel method to enhance informed consent: a prospective and randomised trial of form-based versus electronic assisted informed consent in paediatric endoscopy Long term clinical trials: how much information do participants retain from the informed consent process? Specific barriers to the conduct of randomized trials Seeking informed consent to cancer clinical trials: describing current practice. THE EFFECTIVENESS OF PATIENT VERBALIZATION ON INFORMED CONSENT Informed consent: how much information is enough? Hospital informed consent for procedure forms: facilitating quality patient-physician interaction. Predictors of comprehension during surgical informed consent. Randomization to standard and concise informed consent forms: development of evidence-based consent practices. Monetary incentives improve recall of research consent information: it pays to remember. Patient-physician communication: informed consent for imaging-guided spinal injections. Internet based patient education improves informed consent for elective orthopaedic surgery: a randomized controlled trial Patients' evaluation of informed consent to postponed information: cohort study Informed consent in pediatric surgery: Do parents understand the risks? Modified informed consent procedure: consent to postponed information Informed consent and patient participation in the medical encounter: a list of questions for an informed choice about the type of anaesthesia. It's not just what you say, it's also how you say it: opening the 'black box' of informed consent appointments in randomised controlled trials. [Informed consent as viewed by patients participating in cardiology drug trial]. Interactive Informed Consent: Randomized Comparison with Paper Consents Parents' understanding of a randomised double-blind controlled trial. A randomised trial of conventional versus BAUS procedure-specific consent forms for transurethral resection of prostate. Study of the Quality of Information Given to Patients Participating in a Clinical Trial Regarding Chronic Hemodialysis Comparison of Closed-Ended, Open-Ended, and Perceived Informed Consent Comprehension Measures for a Mock HIV Prevention Trial among Women in Tanzania Informed consent: do information pamphlets improve post-operative risk-recall in patients undergoing total thyroidectomy: prospective randomized control study An evaluation of informed consent prior to epidural analgesia for labor and delivery. Researchers’ perceptions of ethical challenges in cluster randomized trials: a qualitative analysis Appreciation of the informed consent procedure in a randomised trial of decompressive surgery for space occupying hemispheric infarction A computer-based education intervention to enhance surrogates' informed consent for genomics research. Parental perceptions and attitudes about informed consent in clinical research involving children. The role of the consent document in informed consent for pediatric leukemia trials. Informed consent in a clinical trial of a novel treatment for rheumatoid arthritis. Informed consent in trauma: does written information improve patient recall of risks? A prospective randomised study. Informed consent for biobanking: consensus-based guidelines for adequate comprehension The DiReCT study - improving recruitment into clinical trials: a mixed methods study investigating the ethical acceptability, feasibility and recruitment yield of the cohort multiple randomised controlled trials design Optimising recruitment and informed consent in randomised controlled trials: the development and implementation of the Quintet Recruitment Intervention (QRI) [Ethical approach to informed consent for participation in clinical studies in acute cerebral infarct]. Effect of a Study Map Intended to Support Informed Consent in Transplant Research Quality of informed consent: a new measure of understanding among research subjects. Strengths and weaknesses of a stepped wedge cluster randomized design: its application in a colorectal cancer follow-up study. Pilot study demonstrating effectiveness of targeted education to improve informed consent understanding in AIDS clinical trials Mothers’ perceptions of their child’s enrollment in a randomized clinical trial: Poor understanding, vulnerability and contradictory feelings Randomized, Controlled Evaluation of a Prototype Informed Consent Process for HIV Vaccine Efficacy Trials Framing Procedural Risks to Patients: Is 99% Safe the Same as a Risk of 1 in 100? Impact of Stroke Syndrome and Stroke Severity on the Process of Consent in the Third International Stroke Trial Participants' Recall and Understanding of Genomic Research and Large-Scale Data Sharing Effects of two formats of informed consent on knowledge amongst persons with advanced HIV disease in a clinical trial of didanosine. Informed consent in facial plastic surgery: effectiveness of a simple educational intervention. Can consultation skills training change doctors' behaviour to increase involvement of patients in making decisions about standard treatment and clinical trials: a randomized controlled trial. Recall from informed consent counselling for cataract surgery. Comparison of group counseling with individual counseling in the comprehension of informed consent: a randomized controlled trial Consumer involvement in consent document development: a multicenter cluster randomized trial to assess study participants' understanding A practical guide to informed consent to treatment Web-Based Education Prior to Knee Arthroscopy Enhances Informed Consent and Patient Knowledge Recall: A Prospective, Randomized Controlled Study. Assessing the quality of informed consent in a resource-limited setting: A cross-sectional study Prospective Randomized Controlled Study on the Efficacy of Multimedia Informed Consent for Patients Scheduled to Undergo Green-Light High-Performance System Photoselective Vaporization of the Prostate Medical eligibility, comprehension of the consent process, and retention of injection drug users recruited for an HIV vaccine trial. Testing an Alternate Informed Consent Process Acupuncture trials and informed consent How do patients feel about taking part in clinical trials in emergency care? Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception
This article is part of a series of papers examining ethical issues in  cluster r and omized trials ( CRTs )  in health research . In the introductory paper in this series , we set out six areas of inquiry that must be addressed if the CRT is to be set on a firm ethical foundation . This paper addresses the sixth of the questions posed , namely , what is the role and authority of gatekeepers in CRTs in health research ? ‘ Gatekeepers ’ are individuals or bodies that represent the interests of cluster members , clusters , or organizations . The need for gatekeepers arose in response to the difficulties in obtaining informed consent because of cluster r and omization , cluster-level interventions , and cluster size . In this paper , we call for a more restrictive underst and ing of the role and authority of gatekeepers . Previous papers in this series have provided solutions to the challenges posed by informed consent in CRTs without the need to invoke gatekeepers . We considered that consent to r and omization is not required when cluster members are approached for consent at the earliest opportunity and before any study interventions or data - collection procedures have started . Further , when cluster-level interventions or cluster size means that obtaining informed consent is not possible , a waiver of consent may be appropriate . In this paper , we suggest that the role of gatekeepers in protecting individual interests in CRTs should be limited . Generally , gatekeepers do not have the authority to provide proxy consent for cluster members . When a municipality or other community has a legitimate political authority that is empowered to make such decisions , cluster permission may be appropriate ; however , gatekeepers may usefully protect cluster interests in other ways . Cluster consultation may ensure that the CRT addresses local health needs , and is conducted in accord with local values and customs . Gatekeepers may also play an important role in protecting the interests of organizations , such as hospitals , nursing homes , general practice s , and schools . In these setting s , permission to access the organization relies on re source implication s and adherence to institutional policies Objective This study seeks to evaluate the level of anxiety , recall , and comprehension of the provided information in patients undergoing esophageal and gastrointestinal surgery . Methods Sixty-one patients without cognitive disorders entered a prospect i ve study design ed to assess the effect of a surgical informed consent process . The written informed consent was administered to all patients and was supported by a verbal explanation and a schematic drawing of the operation . The  State Trait Anxiety Inventory test  was used to assess state anxiety and tract anxiety . The test was repeated after the informed consent process . A disease-specific feedback question naire was subsequently administered to assess the actual comprehension of the provided information . Results A significant decrease of the state anxiety scores was documented in most patients ( p < 0.001 ) . This effect was more evident in the elderly ( p = 0.021 ) and in those who used Internet as a previous source of information ( p = 0.032 ) . The mean correct exact answer rate on the disease-specific question naire was 76 % ( IQ range 66.7–85 % ) . No statistically significant relationship was found between the rate of correct answers and the state anxiety scores . Conclusions An exhaustive surgical informed consent process was effective in providing comprehension and decreasing anxiety in patients who are c and i date s to minimally invasive esophageal and gastrointestinal surgical procedures Objective : The term “ informed consent ” explains the process by which a patient , before treatment , is provided comprehensive and impartial information regarding a planned operative procedure so that he/she underst and s the implication s of the procedure before consenting . The goal of the current study was to investigate whether st and ard methods of consenting can be improved using a multimedia-based information program ( MM-IP ) . Patients and Methods : In a prospect i ve multicenter study , 80 patients undergoing laparoscopic cholecystectomy went through the st and ard informed consent process . One group of patients was also given access to a MM-IP . Question naires were completed before surgery . These evaluated how patients perceived their own underst and ing of important aspects of their illness ( ie , disease , therapeutic alternatives , operation , risks ) and satisfaction with the consenting process . Patients ’ anxiety levels were also assessed . These question naires were used to evaluate the effectiveness of the MM-IP for improving the consent process . Results : Seventy-six patients ( 47 women , 29 men , median age 54 years ) were included . There was no significant age or gender variation between the groups ( st and ard n = 41 and MM-IP n = 35 ) . Eighty-two percent of all respondents were satisfied with the st and ard informed consent process . However , perceived underst and ing of the material was significantly improved in the MM-IP group ( P < 0.001 ) . Patients with less formal education profited particularly from the MM-IP .  Preoperative anxiety did not vary between the groups . Conclusion : Use of the multimedia-based program was positively evaluated by patients , and significantly improved patients ’ perceived underst and ing of their disease and its treatment . It is , therefore , valuable in the informed consent process PURPOSE : To determine the effectiveness of verbal , written , and videotaped descriptions of cataract surgery on patients ’ underst and ing of the risks , benefits , and treatment alternatives . SETTING : Veterans Affairs Boston Healthcare System , Boston , Massachusetts , USA . DESIGN : R and omized prospect i ve study . METHODS : Patients eligible for cataract surgery were r and omized into 1 of 4 arms of the informed consent process as follows : Group 1 , conventional verbal information ; Group 2 , conventional verbal information plus second‐ grade reading level brochure ; Group 3 , conventional verbal information plus eighth‐ grade reading level brochure ; Group 4 , conventional verbal information plus American Academy of Ophthalmology DVD Underst and ing Cataract Surgery : Patient Education DVD Featuring an Aid to Informed Consent . After the informed consent process , patients in each group completed a 12‐ question question naire discussing the surgical procedure , its benefits , its foreseeable and unforeseeable risks , and the alternatives to cataract surgery . Scores in each group were calculated as the number of correct responses out of 12 questions . RESULTS : Patients in Group 2 ( mean score 10.8 ± 1.29 [ SD ] ) and Group 4 ( mean score 10.56 ± 1.44 ) scored significantly higher than patients in Group 1 ( mean score 7.68 ± 2.80 ) or Group 3 ( mean score 9.08 ± 1.60 ) . Previous cataract surgery and education level had no significant influence on recall of the informed‐consent process . CONCLUSIONS : Concise informed consent information sheets at lower reading grade levels and videotape presentation optimized patient underst and ing of the risks , benefits , and treatment alternatives to cataract surgery . The cost – benefit of these results is important because better patient underst and ing has the potential to decrease the risk for indemnity payments awarded because of inadequate informed consent . Financial Disclosure : No author has a financial or proprietary interest in any material or method mentioned BACKGROUND The process of informed consent has been examined for patients undergoing various procedures but not breast biopsy . Our study was a r and omized trial that examined the effect of an educational flip chart as part of the informed consent . METHODS A total of 122 patients referred for stereotactic or ultrasound-guided core breast biopsy  were r and omly assigned to receive an informed consent discussion with or without an illustrated flip chart . The chart included information about breast anatomy , pathology , and diagnostic procedures . Outcome measures included objective knowledge , subjective knowledge , anxiety , and satisfaction . RESULTS Analysis showed few significant main effects of the intervention . However , results showed interactions between experimental condition and race/ethnicity , indicating that the intervention was effective in enhancing objective and subjective knowledge for African American but not Caucasian patients . Anxiety after consultation was higher among patients assigned to the flip chart condition , possibly because they were better informed about the risks of the procedure . Patients who underwent biopsy sooner after learning they needed one were more satisfied with their care . CONCLUSIONS The usual care consent process is effective for many but not all patients . Informed consent that employs visual aids may help overcome characteristics of the consent process that are ineffective for some patients BACKGROUND : Consent for participation in clinical research is considered valid if it is informed , understood , and voluntary . In the case of minors , parents give permission for their child to participate in research studies after being presented with all information needed to make an informed decision . Although informed consent is a vital component of clinical research , there is little information evaluating its validity in neonatal intensive-care population s. The objective of this project was to determine the validity of informed consent obtained from parents of infants enrolled in the multicenter r and omized research study , neurologic outcomes and pre-emptive analgesia in the neonate ( NEOPAIN ) . DESIGN / METHODS : Parents of infants who survived to discharge and had signed consent for their newborn to participate in the NEOPAIN study at the University of Kentucky were asked 20 open-ended questions to determine their level of underst and ing about the NEOPAIN study . The NEOPAIN consent form , which had been approved by the University of Kentucky Medical Institutional Review Board ( IRB ) , was used to formulate these questions . Questions addressed the timing of consent , parental underst and ing of the purpose , benefits , and risks of the study , the voluntary nature of the project , and their willingness to enroll in future studies if the opportunity presented . Answers were scored on a Likert scale , with 1 for no underst and ing and 5 for complete underst and ing . RESULTS : Five of 64 parents ( 7.8 % ) had no re collection of the NEOPAIN study or of signing consent . Of those who remembered the study , only 67.8 % understood the purpose of the study , with a higher proportion of the mothers than fathers knowing the purpose of the study ( 73.3 % vs 57.1 % ) , ( p=0.029 ) . Of those who understood the purpose of the study 95 % were able to verbalize the benefits , but only 5 % understood any potential risks . No parents reported feeling pressured or coerced to sign consent for the project and all parents reported they would enroll their child in additional studies if asked . CONCLUSIONS : Valid consent in the antenatal/perinatal population is difficult , if not impossible , to obtain . To maximize validity of consent in the antenatal/perinatal population every effort should be made to include mothers in the consent process . Additional attention during the consent process should be given to possible risks of the study Cluster r and omized trials are increasingly common . Obtaining informed patient consent to participation in these trials raises practical challenges and ethical issues . The aims of this paper were to 1 ) develop a typology of interventions employed in cluster r and omized trials in primary care ; 2 ) assess whether the likelihood of seeking  individual consent to participation  varies by intervension type ; 3 ) assess whether this likelihood has increased over time ; 4 ) assess evidence for under reporting of consent procedures ; 5 ) articulate reasons for not obtaining consent ; and 6 ) make recommendations for future trial investigators . We collected data on trial interventions and consent procedures from reports of 152 recently published trials , and 47 unpublished trials . We develop a typology of interventions based on reasons for adopting a clustered design . We examine proportions seeking individual consent  to participation among trials involving different types of intervention , in different periods , and among published and unpublished trials . Two-thirds of the trials had multifaceted interventions . Trials involving different types of intervention had different propensities to seek consent , largely because of practical obstacles to obtaining consent . Obtaining consent can compromise internal validity . More recent trials are no more likely to obtain consent than past trials . There was no evidence of under-reporting of consent procedures in publications . In conclusion , future trial investigators should consider both practical reasons and scientific arguments for not obtaining individual patient consent for all interventions in their trials . Where feasible , they should allow patients to opt out of the trial . Lay individuals should represent trial participants as part of the process of cluster consent to participation , and lay individuals could also be involved in considering ethical issues during trial planning . A more public debate may clarify the general acceptability of not obtaining consent in certain situations OBJECTIVES To ascertain the acceptability of a r and omised controlled trial comparing arthroscopic lavage with a placebo-surgical procedure for the management of  osteoarthritis of the knee ; and to assess the practical feasibility of mounting such a multicentre placebo-controlled trial . DESIGN Mixed methods study including : focus groups with surgeons and anaesthetists ; focus groups and interviews with potential participants ; interviews with chairpersons of UK Multicentre Research Ethics Committees ( MRECs ) ; surveys of surgeons and anaesthetists ; and a two-centre , three-arm pilot . SETTING UK secondary care . PARTICIPANTS Members of the British Association of Surgeons of the Knee and members of the British Society of Orthopaedic Anaesthetists took part in the focus groups and surveys . Surgeons and anaesthetists from two regional centres in the UK also contributed to focus groups , as did patients from consultant lists in two UK regional centres , and members of Arthritis Care . Chairpersons of six UK MRECs were interviewed . Participants were eligible for the pilot if they were adults ( 18 years or older ) with radiological evidence of osteoarthritis of the knee who might be considered for arthroscopic lavage , and were fit for general anaesthetic ( defined by the American Society of Anaesthesiologists grade s 1 and 2 ) , and able to give informed consent . INTERVENTIONS Participants in the pilot study were r and omised to arthrosocopic lavage  ( with or without debridement at the clinical discretion of the surgeon ) ; placebo surgery ; or non-operative management with specialist re assessment . MAIN OUTCOME MEASURES The acceptability and feasibility of mounting a  placebo-controlled trial for the evaluation of knee  arthroscopic lavage .  RESULTS There was broad acceptance across all stakeholder groups of the need to find out more about the effectiveness of arthroscopic lavage . Despite this there was variation in opinion within all the groups about how research ers should approach this and whether or not it would be acceptable to investigate using placebo surgery . Within the health professional groups , there tended to be a split between those who were strongly opposed to the inclusion of a placebo surgery arm and those who were more in favour . For prospect i ve trial participants who had osteoarthritis of the knee , the acceptability of the trial was discussed from a more individual perspective - reflecting on their personal reasons for or against participating . The majority of this group said they would consider taking part . The pilot study showed that , in principle , a placebo-controlled trial could be conducted . It showed that patients were willing to participate in a trial which would involve a placebo-surgical arm and that it was possible to undertake placebo surgery successfully and to blind patients to their allocation - although once patients knew their allocation , some patients allocated to surgery became more concerned about the possibility of undergoing placebo surgery , and withdrew . The experience of the pilot , however , showed that , despite full MREC approval , the study required major discussion and negotiation before local clinical approvals could be obtained . The fact that ethics approval had been granted did not mean that clinicians would automatically accept that the process was ethical . CONCLUSIONS The study showed that , in principle , a placebo-controlled trial of arthroscopic lavage could be conducted in the UK , albeit with difficulty . Against the background of falling use of arthroscopic lavage the decision was , therefore , taken not to proceed to full-scale trial for this procedure . The study showed that for some health professionals the use of placebo surgery can never be justified . It highlighted the importance of the surgeon-anaesthetist relationship in this context and how acceptance of the trial design by both parties is essential to successful participation . It also highlighted the importance of informed consent for trial participants and the strength and influence of individuals ' ethical perspectives in addition to collective ethics provided by MRECs . TRIAL REGISTRATION Current Controlled Trials IS RCT N02328576 Background : Informed consent is regarded as a contract between autonomous and equal parties and requires the elements of information disclosure , underst and ing , voluntariness and consent . The validity of informed consent for critically ill patients has been question ed . Little is known about how these patients experience the process of consent . Objective : The aim of this study was to explore critically ill patients ’ experience with the principle of informed consent in a clinical trial and their ability to give valid informed consent . Design : 11 stroke patients who had been informed about thrombolytic treatment and had been through the process of deciding whether or not to participate in a thrombolysis trial went through repeated qualitative semistructured interviews .  Results : None of the patients had any clear underst and ing of the purpose of the trial . Neither did they underst and the principles of r and omisation and voluntariness . Reasons for giving or not giving consent were trust , conceptions of benefits and risks and altruism . Several patients found it immoral to involve patients in the consent procedure and argued that this was the doctors ’ responsibility . Others argued that it is a duty to question patients and perceived it as a sign of being treated with respect and dignity . A majority of the patients found the consent process vague and ambiguous . Conclusions : The results indicate that the principle of informed consent from critically ill patients can not be seen as a contract between equal and autonomous parties . Further studies are needed to explore critically ill patients ’ experiences with the process of informed consent BACKGROUND Obtaining informed consent before performing invasive procedures and operations has become a st and ard practice at all medical institutions in the United States . All agree that patients should be both conscious of and in agreement with their medical care . Though patients routinely sign consent forms with numerous risks and complications detailed , there are only a limited amount of reports that study if these patients have a thorough underst and ing of those risks and complications . Confounding the issue of the efficacy of informed consents is the growing population of patients who do not speak English . To obtain objective data on the efficacy of informed consents and the role of language barriers we looked at how well patients who consented to have a laparoscopic cholecystectomy  understood the complications associated with this procedure . METHODS We conducted a r and omized prospect i ve study of all patients seen in the General Surgery Resident Outpatient Clinic who presented for an elective cholecystectomy . Fifty patients agreed to participate in our study . Participants were split into two groups . In the first group ( the control group ) surgical benefits , risks and complications were explained in the usual fashion . In the second group , after hearing the st and ard explanation of surgical risks , complications and benefits , patients watched a PowerPoint presentation with illustrations on laparoscopic cholecystectomy . Patients from both groups then took a ten question assessment based on the presentations that they encountered . Spanish speaking patients were addressed with an interpreter and given a Spanish PowerPoint presentation with a Spanish assessment . The patients ' age , education level , income , and birth country were also studied . RESULTS Fifty-two percent of the patients in the study were born outside of the United States . All of the non-US born patients were Hispanic and their primary language was Spanish . The average age of the studied patients was 38 . Sixty-eight percent of the patients reported an education level no higher than high school . The majority of the studied patients noted an  income of less than $ 40,000 . Differences were seen between patient native to the US and those born outside the United States . US born patients had an 80 % correct response rate versus non-US born patients who had only a 63 % correct response . Differences were seen between US born patient and non-US born patients concerning the topics of the severity of a common bile duct injury , gastrointestinal changes after cholecystectomy and the safety concerning conversion from laparoscopic to open cholecystectomy . No difference was appreciated in the PowerPoint group versus the non-PowerPoint group . CONCLUSION The addition of a PowerPoint presentation did not increase underst and ing of the risks and benefits associated with a laparoscopic cholecystectomy . This study did however highlight the problem of obtaining consent from foreign born patients . Patients who were not US natives showed a decreased underst and ing of the surgical procedure and the severity of the complications in both the control group and the PowerPoint group . Better methods of educating foreign patients should be investigated to truly obtain informed consents from this patient population Objective : In this r and omized , controlled , unblinded trial , we sought to test Repeat Back 's ( RB ) effect on comprehension following informed consent discussion s. Summary Background Data : RB has been suggested as a method to improve patient comprehension when obtaining informed consent . In this technique , patients are asked to recount what they have been told in the informed consent discussion . Despite preliminary data , this practice has not been evaluated in any large scale study . Methods : This study was conducted in 7 Veterans Health Administration Medical Centers where informed consent is obtained using iMedConsent , the VA 's computer based platform . Patients scheduled for elective surgeries were r and omized to RB ( a module added to the iMedConsent package ) or st and ard iMedConsent ( no RB ) .  Comprehension was tested after the informed consent using procedure-specific question naires . Time stamps in the iMedConsent program estimated the time spent completing the informed consent process . Provider and patient satisfaction were measured using 5-point Likert scales . Statistical comparisons of groups were performed using t-tests and & khgr;2 tests . Results : A total of 575 patients were enrolled . In the RB group , providers spent 2.6 minutes longer ( P < 0.0001 ) obtaining informed consent . The mean comprehension score was significantly higher in the RB group ( 71.4 % ) versus the no RB group ( 68.2 % , P = 0.03 ) ; the effect was greatest in carotid endarterectomy patients ( RB = 73.4 % vs. no RB = 67.7 % , P = 0.02 ) . Quality of decision making was rated similarly . Providers were neutral to slightly favorable regarding RB . Conclusions : RB implemented within an electronic informed consent system improved patient comprehension . The additional time required was acceptable to providers . RB should be considered as an enhancement to surgical informed consent . This clinical trial was registered at http://www . clinical trials.gov ( Identifier NCT00288899 ) Due to possible method ological and practical problems , many research ers refrain from using a r and omized controlled trial design to evaluate procedures already embedded in routine health care . We performed a r and omized controlled trial on the effects of routine individual feedback on test ordering behavior of family physicians . The trial started after 4 years of feedback and lasted for 2.5 years . With some adaptations a r and omized trial proved to be possible . In evaluating health-care procedures that can not be blinded in a traditional way , asking full and study -specific informed consent may conflict with the validity of the design . In such studies , an alternative procedure is to be considered . Our trial , with doctors as study subjects , was held on an already accepted routine procedure ( feedback ) . This made it possible to refrain from obtaining study -specific informed consent . Consequently , a Hawthorne effect and contamination of the trial arms through information leakage could be avoided . Justification and general criteria for not obtaining full and study -specific informed consent are worked out . In health-care research on the performance of doctors or on interventions into the quality of care , obtaining a general informed consent in advance is an acceptable alternative approach This article is part of a series of papers examining ethical issues in  cluster r and omized trials ( CRTs ) in health research . In the introductory paper in this series , we set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation . This paper addresses the second of the questions posed , namely , from whom , when , and how must informed consent be obtained in CRTs in health research ? The ethical principle of respect for persons implies that research ers are generally obligated to obtain the informed consent of research subjects . Aspects of CRT design , including cluster r and omization , cluster level interventions , and cluster size , present challenges to obtaining informed consent . Here we address five questions related to consent and CRTs : How can a study proceed if informed consent is not possible ? Is consent to r and omization always required ? What information must be disclosed to potential subjects if their cluster has already been r and omized ? Is passive consent a valid substitute for informed consent ? Do health professionals have a moral obligation to participate as subjects in CRTs design ed to improve professional practice ? We set out a framework based on the moral foundations of informed consent and international regulatory provisions to address each of these questions . First , when informed consent is not possible , a study may proceed if a research ethics committee is satisfied that conditions for a waiver of consent are satisfied . Second , informed consent to r and omization may not be required if it is not possible to approach subjects at the time of r and omization . Third , when potential subjects are approached after cluster r and omization , they must be provided with a detailed description of the interventions in the trial arm to which their cluster has been r and omized ; detailed information on interventions in other trial arms need not be provided . Fourth , while passive consent may serve a variety of practical ends , it is not a substitute for valid informed consent . Fifth , while health professionals may have a moral obligation to participate as subjects in research , this does not diminish the necessity of informed consent to study participation BACKGROUND The informed consent procedure plays a central role in r and omised controlled trials but has only been explored in a few studies on children . AIM To assess the quality of the informed consent process  in a paediatric setting . METHODS A question naire was sent to parents who volunteered their child ( 230 children ) for a r and omised , double blind , placebo controlled trial of ibuprofen syrup to prevent recurrent febrile seizures . RESULTS 181 ( 79 % ) parents responded . On average , 73 % of parents were aware of the major study characteristics . A few had difficulty underst and ing the information provided . Major factors in parents granting approval were the contribution to clinical science ( 51 % ) and benefit to the child ( 32 % ) . Sociodemographic status did not influence initial participation but west European origin of the father was associated with willingness to participate in future trials . 89 % of participants felt positive about the informed consent procedure ; however , 25 % stated that they felt obliged to participate . Although their reasons for granting approval and their evaluation of the informed consent procedure did not differ , relatively more were hesitant about participating in future . Parents appreciated the investigator being on call 24 hours a day ( 38 % ) and the extra medical care and information provided ( 37 % ) as advantages of participation . Disadvantages were mainly the time consuming aspects and the work involved ( 23 % ) . CONCLUSIONS Parents ’ underst and ing of trial characteristics might be improved by design ing less difficult informed consent forms and by the investigator giving extra attention and information to non-west European parents . Adequate measures should be taken to avoid parents feeling obliged to participate , rather than giving true informed consent btaining the informed consent of participants in clinical studies is a fundamental requirement for ethical research . ' Based on the principle of respect for persons , potential research subjects are provided with relevant information about a study so that they can make an informed and voluntary decision about participation . Skepticism and controversy exists , however , about informed consent from research participants in developing countries . In addition to concepts about research and individual choice that might be unfamiliar , developing country participants may be plagued by poverty , illiteracy , and limited access to health care services that make it difficult for them to give valid informed consent.2 Most agree that following the provision of adequate and accurate information about a study , valid informed consent requires at least some knowledge of the study details and a voluntary decision to enroll.3 Evaluation of the quality of informed consent therefore should attempt to measure what participants underst and and how freely they made the enrollment decision . A small yet increasing number of studies using quantitative or qualitative methods to evaluate participants ' informed consent or to test informed consent interventions have been reported . Yet , only a few published studies from Thail and , 4 South Africa , s The Gambia,6 Bangladesh,7 and Haiti,8 have used quantitative methods to survey research participants in developing countries about the informed consent process . Although the results of these studies show mixed comprehension , the paucity and small size of these studies make it difficult to say much about the quality of informed consent in developing countries or to compare it to the quality of informed consent in developed countries . This difficulty is compounded by method ological limitations in the studies that have been conducted in both setting s. For example , in some studies the time period between the informed consent process and the administration of the informed consent question naire varied from respondent to respondent , even extending to several months.9 In other studies , crucial domains , such as the degree to which subjects felt pressured to participate in the clinical research , were excluded . 10 To assess the quality of informed consent in a developing country while avoiding some of these method ological limitations , we interviewed 141 individuals immediately after they consented to participate in a r and omized HIV study in Bangkok , Thail and . In Thai culture , individuals often defer to the authority of the health care professional . However , because there has been a considerable volume of clinical research in Thail and including HIV research , Thai citizens may be more familiar with and experienced in research overall than people in other re source poor countries . Very little is known , however , about the quality of informed consent given by Thai subjects in HIV studies . In this study , individuals were surveyed about their experience with the  informed consent process  , their underst and ing of the information they were given about the trial , and the voluntary nature of their decision to join PURPOSE Here we report the results of a r and omized study undertaken to test the efficacy of a supplementary , telephone-based nursing intervention in increasing patients ' awareness and underst and ing of the clinical trials in which they are asked to participate . METHODS During a 12-month period , 180 cancer patients who were approached to participate in a phase II or III clinical trial were r and omized to undergo either of the following : ( 1 ) st and ard informed consent procedures based on verbal explanations from the treating physician plus written information ( controls ) ; or ( 2 ) st and ard informed consent procedures plus a supplementary , telephone-based contact with an oncology nurse ( intervention ) . For purpose s of evaluation , face-to-face interviews were conducted with all patients approximately 1 week after the informed consent process had been completed . RESULTS The two groups were comparable with regard to sociodemographic and clinical variables . Both groups had a high level of awareness of the diagnosis and of the nature and objectives of the proposed treatments . The intervention group was significantly ( P < .01 ) better informed about the following : ( 1 ) the risks and side effects of treatment ; ( 2 ) the clinical trial context of the treatment ; ( 3 ) the objectives of the clinical trial ; ( 4 ) where relevant , the use of r and omization in allocating treatment ; ( 5 ) the availability of alternative treatments ; ( 6 ) the voluntary nature of participation ; and ( 7 ) the right to withdraw from the clinical trial . The intervention did not have any significant effect on patients ' anxiety levels or on rates of clinical trial participation . Patients reported high levels of satisfaction with the intervention . CONCLUSION The use of a supplementary , telephone-based nursing intervention is a feasible and effective means to increase cancer patients ' awareness and underst and ing of the salient issues that surround the clinical trials in which they are asked to participate Background and objectives : There are few insights from sub-Saharan Africa on research participants ’ experiences of the informed consent process , particularly in the context of r and omised controlled trials , where issues of r and omisation and the use of placebos may be confusing concepts for participants . This study investigated the knowledge and perceptions of the informed consent process among individuals participating in influenza vaccine trials in two disadvantaged communities in South Africa . Method : Four to 12 months after completion of the trials , participants were contacted to return to participate in the informed consent study . The semistructured question naire administered to assess recall of trial procedures and the informed consent process covered key issues including : purpose of the study ; awareness that the study was not part of routine treatment ; voluntary nature of participation and freedom to withdraw ; r and omisation ; placebos ; and remuneration . Results : A total of 334 participants ( 93 % of the original vaccine trial sample ; mean age 68 years , median level of education grade 8 , 69 % women ) completed the question naire . Only 21 % were able to recall that they were allocated r and omly to the different treatment arms . Only 19 % of those involved in the placebo controlled study had interpreted the concept of placebo as an inactive medication . Conclusion : Although a good general recall of trial concepts was demonstrated , only a small proportion of the participants correctly interpreted and recalled the concepts of r and omisation and placebos . Informed consent in this and similarly disadvantaged communities may often be inadequate and new ways to improve underst and ing of the research process should be explored BACKGROUND Patients who undergo cardiac catheterization or percutaneous coronary intervention ( PCI ) often have a poor underst and ing of their disease and of related therapeutic risks , benefits , and alternatives . This pilot study was undertaken to compare the effectiveness of 2 preprocedural educational approaches to enhance patients ' knowledge of st and ard consent elements . METHODS Patients undergoing first-time elective , outpatient cardiac catheterization and possible PCI  were r and omly assigned to a scripted verbal or written consent process ( group I ) or a web-based , audiovisual presentation ( group II ) . Preconsent and postconsent question naires were administered to evaluate changes in patients ' self-reported underst and ing of st and ard consent elements . RESULTS One hundred and two patients enrolled at a single institution completed the pre- and postconsent surveys ( group I=48 ; group II=54 ) . Changes in patient comprehension rates were similar between groups for risk and benefit consent elements , but group II had significantly greater improvement in the identification of treatment alternatives than group I ( p=0.028 ) . Independent of intervention , correct identification of all risks and alternatives increased significantly after consent ( p<0.05 ) ; 4 of 5 queried risks were correctly identified by greater than 90 % of respondents . However , misperceptions of benefits persisted after consent ; increased survival and prevention of future myocardial infa rct ion were identified as PCI-related benefits by 83 % and 46 % of respondents , respectively . CONCLUSIONS Although both scripted verbal and audiovisual informed consent improved patient comprehension , important patient misperceptions regarding PCI-related outcomes and alternatives persist , independent of informed consent approach , and considerable challenges still exist in educating patients about contemplated medical procedures . Future research appears warranted to improve patient comprehension Objectives To evaluate the adequacy of paediatric informed consent and its augmentation by a supplemental computer-based module in paediatric endoscopy . Methods The Consent-20 instrument was developed and piloted on 47 subjects . Subsequently , parents of 101 children undergoing first-time , diagnostic upper endoscopy performed under moderate IV sedation were prospect ively and consecutively , blinded , r and omised and enrolled into two groups that received either st and ard form-based informed consent or st and ard form-based informed consent plus a commercial ( Emmi Solutions , Inc , Chicago , Il ) , sixth grade level , interactive learning module ( electronic assisted consent ) . Anonymously and electronically , the subjects ' anxiety ( State Trait Anxiety Inventory ) , satisfaction ( Modified Group Health Association of America ) , number of questions asked , and attainment of informed consent were assessed ( Consent-20 ) . Statistics were calculated using t test , paired t test , and Mann Whitney tests . Results The ability to achieve informed consent , as measured by the new instrument , was 10 % in the control form-based consent group and 33 % in the electronic assisted consent group ( p<0.0001 ) . Electronically assisting form-based informed consent did not alter secondary outcome measures of subject satisfaction , anxiety or number of questions asked in a paediatric endoscopy unit . Conclusions This study demonstrates the limitations of form-based informed consent methods for paediatric endoscopy . It also shows that even when necessary information was repeated electronically in a comprehensive and st and ardised video , informed consent as measured by our instrument was incompletely achieved . The supplemental information did , however , significantly improve underst and ing in a manner that did not negatively impact workflow , subject anxiety or subject satisfaction . Additional study of informed consent is required . Clinical trial registration number Clinical Trials.gov Identifier NCT00899392 Previous studies report mixed results about how much information study participants actually can read , underst and and retain after completing the informed consent process ; fewer studies have examined disparities in the retention and recall of information by patient factors , such as age , education , and race . Not retaining or being able to recall information from the informed consent process has potentially important ethical and legal implication s and consequences for research quality and integrity , especially when found in population s that commonly are underserved or underrepresented in clinical trials . To determine how much basic knowledge participants finishing a five-year , multi-center , double-blinded r and omized , placebo-controlled clinical trial had about the study , participants ( n=1,789 ) were asked at their final follow-up visit three multiple-choice questions : ( 1 ) the study 's purpose ; ( 2 ) the name of the medication under investigation ; ( 3 ) the main side effect of the medication . The associations between knowledge of these fundamental details and participant social and demographic factors were investigated . A majority of participants correctly recalled the study 's purpose ( 64.7 % ) and medication ( 79.6 % ) , but few correctly reported the main side effect ( 31.1 % ) . In spite of relatively high recall for study purpose and medication , disparities by age , education and race exist . Increasing age was significantly associated with higher odds of incorrectly recalling both the study purpose and the name of the study medication . Likewise those with less than a high school education were more likely to incorrectly identify the study 's purpose and the name of the study medication . Black and other non-white race or ethnic groups were more than two and a half times as likely to incorrectly identify the study 's purpose . These findings suggest that even the most basic information may not be understood or retained by important subgroups of patients enrolled in clinical trials . Implementing effective strategies , such as additional time and effort for consent or repetition of study information , may be necessary in order to assure ethical and valid consent Large r and omized trials are required to provide reliable evidence of the typically moderate benefit of most interventions . To be affordable , such trials need to be simple ; to be widely applicable , they need to be close to normal clinical practice . However , current regulations and guidelines have hugely increased trial complexity , effectively becoming barriers to their design and conduct . Key barriers include inadequate funding , overly complex regulations producing needlessly complex trial procedures , excessive monitoring , over restrictive interpretation of privacy laws without evidence of subject benefit , and inadequate underst and ing of methodology . Complex regulations result in multiple ethics approvals for a multi-center study , unnecessary complexity in the study protocol , delays in securing regulatory approval , and cumbersome regulatory procedures , even for drugs widely used in clinical practice . The type of detailed safety monitoring currently needed in trials of new drugs is being applied indiscriminately to all studies including a simpler and basic level of monitoring that constitutes good practice in most trials could be agreed on , with that level being exceeded only in specific instances . More evidence about the pros and cons of alternative approaches to data quality monitoring would help inform this process . Complex procedures in the form of multiple-page consent forms , overzealous monitoring of side effects and adverse events , source data verification , and over-restrictive approaches to protocol amendments , can impede , rather than facilitate , trial objectives . Finally , further education on the nuances and functions of r and omisation would facilitate trial conduct , and reduce the need for burdensome complexity . A radical re-evaluation of existing trial guidelines is needed , based on a clear underst and ing of the important principles of r and omized trials , with the objective of eliminating unnecessary documentation and reporting without sacrificing validity or safety . Research ers should encourage public debate about how best to strike the balance between regulation and cost . Clinical Trials 2008 ; 5 : 40—48 . Clinical trials have come to be regarded as the gold st and ard for treatment evaluation . However , many doctors and their patients experience difficulties when discussing trials , leading to poor accrual to trials and question able quality of informed consent . We have previously developed a typology for ethical communication about Phase II and III clinical trials within four domains : ( a ) shared decision making , ( b ) sequencing information , ( c ) type and clarity of information , and ( d ) disclosure/coercion . The aim of this study was to compare current clinical practice when seeking informed consent with this typology . Fifty-nine consultations in which 10 participating oncologists sought informed consent were audiotaped . Verbatim transcripts were analysed using a coding system to ( a ) identify the presence or absence of aspects of the four domains and ( b ) rate the quality of aspects of two domains : ( i ) shared decision-making and ( ii ) type and clarity of information .  Oncologists rarely addressed aspects of shared decision-making , other than offering to delay a treatment decision ( 78 % ) . Moreover , many of these discussion s scored poorly with respect to ideal content . The oncologists were rarely consistent with the sequence of information provision . A general rationale for r and omising was only described in 46 % of consultations . In almost one third of the consultations ( 28.8 % ) doctors made implicit statements favouring one option over another , either st and ard or clinical trial treatment . Doctors complied with some but not other aspects of a st and ard procedure for discussing clinical trials . This reflects the difficulty inherent in seeking ethical informed consent and the need for communication skills training for oncologists OBJECTIVE To determine if preoperative patient verbalization of the risks and benefits of  anterior cruciate ligament ( ACL ) reconstruction  enhances underst and ing of the risks and benefits of that procedure . DESIGN A r and omized clinical trial . SETTING A referral-based outpatient sport medicine clinic . SUBJECTS Twenty patients from the general population with clinical ly diagnosed ACL tears requiring elective reconstruction surgery were r and omly assigned to 2 groups . Twelve patients who made up a control group received a st and ard surgical consultation , consisting of knee models , diagrams , open dialogue and informed consent to surgery . Eight patients in the experimental group were exposed to the same surgical consultation and were required to accurately verbalize the associated risks and benefits before operation . One month after informed consent was obtained , patients answered 3 questions about the risks and benefits of ACL reconstruction . INTERVENTION ACL reconstruction . MAIN OUTCOME MEASURES A 3- question question naire , addressing 2 risks and 1 benefit of ACL reconstruction . MAIN RESULTS Patients in the experimental group were able to answer all 3 questions correctly . In the control group , 4 patients answered all 3 questions correctly , but 1 patient answered all 3 questions incorrectly , and 7 patients answered 1 question incorrectly . There was a statistically significant difference ( p = 0.03 ) between the control group and the experimental group . CONCLUSION Patients who verbalized the risks and benefits during their surgical consultation demonstrated a significantly greater underst and ing of the risks and benefits of an ACL reconstruction procedure BACKGROUND Recent judicial decisions involving informed consent have led to some medical practitioners altering the way they obtain consent . The aim of this study was to determine the degree to which patients understood the risks associated with a surgical procedure after giving routine consent and whether providing additional detailed verbal and /or written information improved their underst and ing . It was further determined whether the provision of more extensive information altered patients ' anxiety levels . METHODS Patients undergoing femoral popliteal bypass or carotid surgery were r and omized to obtain either routine consent only or routine consent with verbal or written or verbal and written consent . Patients undertook a pre-operative risk and complication question naire , a pre- and postoperative anxiety and depression evaluation and a follow-up question naire 6 weeks after discharge . RESULTS Thirty-two patients were included in the trial . The comprehension question naire result ed in a correct percentage response of 48 % for the routine information only , 59 % with added verbal information , 59 % with added written information and 55 % with added written and verbal information . Twenty-five per cent of patients stated that they had a poor underst and ing of the risks and complications of the procedure . CONCLUSIONS Additional written or verbal information did not improve a patient 's underst and ing of risks and complications of the procedure . It also did not improve patients ' perceived underst and ing of the operation or its complications . Patients ' anxiety levels were unaltered by the increase in the information they were given . The information provided to patients should be simple , easy to underst and and list any possible major complications to enable the patient to determine whether to undergo or decline a procedure BACKGROUND Informed consent forms should document and reflect the goals of informed consent and shared decision making . We conducted this study to examine the extent to which informed consent for procedure forms meet accepted informed consent st and ards , how well state informed consent statutes correlate with these st and ards , and whether existing forms can enhance the interactions between patients and physicians or other health care providers . HYPOTHESIS Informed consent forms do not meet accepted st and ards . A different format may be more useful for patient-physician interactions . DESIGN A content analysis was conducted of  hospital informed consent for procedure forms from a r and om selection of hospitals in the 1994 American Hospital Association membership directory . Forms were examined for evidence of the basic elements of informed consent ( nature of the procedure , risks , benefits , and alternatives ) and items that might enhance patient-physician interactions and encourage shared decision making . UNIT OF ANALYSIS : From 157 hospitals nationwide , 540 hospital informed consent for procedure forms were examined . MEASUREMENTS AND MAIN RESULTS Ninety-six percent of forms indicated the nature of the procedure , but risks , benefits , and alternatives were found less often . Only 26 % of forms included all 4 basic elements , 35 % included 3 of 4 elements , 23 % had 2 of 4 elements , 14 % had only 1 element , and 2 % had none of the elements . Forms appear to authorize treatment ( 75 % ) or protect hospitals and caregivers from liability ( 59 % ) rather than clarify information about procedures ( 40 % ) or aid patients in decision making ( 14 % ) . Forms from states with statutes that require that all 4 elements be provided were no more likely than other states to include them ( Fisher exact test = 1.000 ) . Fewer than 40 % of forms supported models of shared decision making . CONCLUSIONS The content of most forms did not meet accepted st and ards of informed consent or patient-physician interactions . We propose a form that more fully supports the models of ideal informed consent and shared decision making to enhance the applicability of informed consent in the clinical setting BACKGROUND Patient comprehension during surgical informed consent  remains problematic . Using data from our r and omized trial of methods to improve informed consent comprehension , we performed an additional analysis to define independent factors associated with improved patient underst and ing . STUDY DESIGN Patients scheduled for 1 of 4 elective operations ( total hip arthroplasty [ n = 137 ] , carotid endarterectomy [ n = 178 ] , laparoscopic cholecystectomy [ n = 179 ] , or radical prostatectomy [ n = 81 ] ) at 7 Department of Veterans Affairs ( VA ) medical centers were enrolled . All informed consent discussion s were performed using iMedConsent ( Dialog Medical ) , the VA 's computerized informed consent platform . Using a unique module within iMedConsent , we r and omized patients to repeat back ( RB ) , requiring correct reiteration of procedure-specific facts , or st and ard ( STD ) iMedConsent . Patient comprehension was tested after the informed consent discussion using procedure-specific question naires . Time spent completing the informed consent process was measured using time stamps within iMedConsent . Multiple linear regression identified factors independently associated with improved comprehension . RESULTS We enrolled 575 patients ( 276 RB , 299 st and ard ) ; 93 % were male , 74 % were Caucasian , and 89 % had at least a high school education . Independent factors associated with improved comprehension included race ( p < 0.01 ) , ethnicity ( p < 0.05 ) , age ( p < 0.02 ) , operation type ( p < 0.01 ) , group assignment ( + /- RB ; p < 0.05 ) , and total consent time ( p < 0.0001 ) . Patient comprehension was maximized when informed consent took between 15 and 30 minutes . RB 's positive impact on patient comprehension was weaker in the analysis including consent time . CONCLUSIONS Comprehension during informed consent discussion s may be limited in individuals with potential language difficulty due to ethnicity or education . Total consent time was the strongest predictor of patient comprehension . Affording adequate time for informed consent discussion s and using informed consent adjuncts such as RB may enhance comprehension in such individuals BACKGROUND Consent to participate in research is an important component of the conduct of ethical clinical trials . Current consent practice s are largely policy-driven . This study was conducted to assess comprehension of study information and satisfaction with the consent form between subjects r and omized to concise or to st and ard informed consent forms as one approach to developing evidence -based consent practice s. METHODS Participants ( N=111 ) who enrolled into two Phase I investigational influenza vaccine protocol s ( VRC 306 and VRC 307 ) at the NIH Clinical Center were r and omized to one of two IRB-approved consents ; either a st and ard or concise form . Concise consents had an average of 63 % fewer words . All other aspects of the consent process were the same . Question naires about the study and the consent process were completed at enrollment and at the last visit in both studies . RESULTS Subjects using concise consent forms scored as well as those using st and ard length consents in measures of comprehension ( 7 versus 7 , p=0.79 and 20 versus 21 , p=0.13 ) , however , the trend was for the concise consent group to report feeling better informed . Both groups thought the length and detail of the consent form were appropriate . CONCLUSIONS R and omization of study subjects to different length IRB-approved consent forms as one method for developing evidence -based consent practice s , result ed in no differences in study comprehension or satisfaction with the consent form . A concise consent form may be used ethically in the context of a consent process conducted by well-trained staff with opportunities for discussion and education throughout the study Research participants often fail to recall substantial amounts of informed consent information after delays of only a few days . Numerous interventions have proven effective at improving consent recall ; however , virtually all have focused on compensating for potential cognitive deficits and have ignored motivational factors . In this pilot study , the authors r and omly assigned 31 drug court clients participating in a clinical research trial to a control group that received a st and ard informed consent procedure or to a group that received the same procedure plus incentives for correctly recalling consent information . The incentive group was told they would receive $ 5 for each of the 15 consent items they could answer correctly 1 week later . At the follow-up , the incentive group recalled a significantly greater percentage of consent information overall than the control group ( 65 % vs. 42 % , p<.01 ) . Findings from this study have important implication s for the ethical conduct of human subject research . The incentivized consent procedure may be useful for improving consent recall in research studies , particularly those involving potentially serious side effects . The results also provide an important " proof of concept " regarding the utility of motivational procedures for improving recall of consent information PURPOSE Historically , informed-consent forms have been developed for the purpose of educating patients . However , informed-consent forms can be very difficult to underst and . The hypothesis of this study was that a method using diagrams would improve patient-physician communication without increasing the time required to obtain informed consent over the teach-the-teacher method , as well as over current st and ard informed-consent protocol . METHODS Ninety-nine of 109 patients undergoing spinal injections agreed to participate and completed this prospect i ve , r and omized , controlled study . The patients were r and omly assigned to the control group ( informed consent obtained in the customary manner at the investigators ' institution , with 12 key points of consent and home care discussed conversationally ) , the teach-the-teacher group ( patients had to repeat the 12 key points to the physicians before informed consent was complete ) , and the diagram group ( patients viewed a set of diagrams illustrating the 12 key points before signing the informed-consent form ) . After the procedure , the patients completed a survey to test knowledge recall , anxiety , and pain during the procedure . RESULTS Statistically significant results included a lower survey score for the control group , longer time required for the teach-the-teacher group than the control group , and a negative correlation between age and survey score in the teach-the-teacher group . CONCLUSIONS The diagram method required less time than the teach-the-teacher method , had no negative correlation in survey score results with age , and had improved patient-physician communication over the control group Background Obtaining informed consent is an essential step in the surgical pathway . Providing adequate patient education to enable informed decision making is a continued challenge of contemporary surgical practice . This study investigates whether the use of a patient information website , to augment patient education and informed consent for elective orthopaedic procedures is an effective measure . Methods A r and omised controlled trial was conducted comparing the quality of informed consent provided by a st and ard discussion with the treating surgeon compared to augmentation of this discussion with an online education re source ( www.orthoanswer.org ) . Participants were recruited from orthopaedic outpatient clinics . Patients undergoing five common orthopaedic procedures were eligible to participate in the trial . The primary outcome measure was knowledge about their operation . Satisfaction with their informed consent and anxiety relating to their operation were the secondary outcome measures . Results There was a statistically significant increase in patient knowledge for the intervention arm as compared to the control arm ( p < 0.01 ) . Patients in the intervention arm , had an average score of 69.25 % ( SD 14.91 ) correct answers as compared to 47.38 % ( SD 17.77 ) in the control arm . Satisfaction was also improved in the intervention arm ( p = 0.043 ) . There was no statistically significant difference between the control and intervention arm relating to their anxiety scores ( p = 0.195 ) . Conclusions The use of a patient education website as an augment to informed consent improves patient knowledge about their planned operation as well as satisfaction with the consent process whilst not increasing their anxiety levels . We recommend that all patients be directed to web based education tools to augment their consent . Trial registration Australian New Zeal and Clinical Trials Registry ( ANZCTR ) ACTRN12614001058662 Fundamental bias can be introduced in r and omised trials if patients can not be masked for the allocated strategy and assess subjective outcomes . In such a trial , on the effectiveness of outreach stroke care in addition to st and ard care , we masked patients by modifying the informed consent procedure . Before discharge home we informed patients that we were study ing their needs six months after discharge ; we could not inform about an additional research question because that would affect the results ; this question entailed no risk and would be clarified after follow up ; and the ethics committee approved this study .1 After we got consent we r and omised patients . We informed patients in the intervention group about the outreach care programme and asked them to participate , but we kept them ignorant that we were study ing the programme for effectiveness . Controls received no further information . After follow up , we sent all participants a OBJECTIVE To investigate parent underst and ing of the risks of pediatric ear , nose , and throat surgery after counseling with and without the use of informational aids . DESIGN Prospect i ve , r and omized trial . SETTING Academic tertiary care center . PARTICIPANTS Parents of children undergoing ear , nose , and throat surgery . INTERVENTIONS  Parents  were  r and omized  to receive st and ard informed consent with or without detailed informational aids . MAIN OUTCOME MEASURES Parents completed identical question naires testing their general procedure knowledge and their recall of 9 specific surgical risks both immediately after counseling and on the day of surgery . RESULTS Thirty-four parents enrolled in and completed the study ( 18 in the control group and 16 in the test group ) . The mean time from informed consent to surgery was 6.3 days ( range , 1 - 22 days ) . Parents in the test group scored significantly higher on identifying the 9 risks on both the preoperative question naire ( mean score , 6.00 vs 4.44 ; P = .007 , 2-tailed t test ) and the postoperative question naire ( 6.25 vs 4.17 ; P < .001 ) . There was a negative correlation ( inverse relationship ) between parent education score and risk recall , with parents with lower education levels scoring higher on both the preoperative ( Pearson r = -0.36 ; P = .04 ) and the postoperative ( r = -0.35 ; P = .04 ) surveys . The maternal parent recalled risks significantly better than the paternal parent , with surgical risk recall scores of 5.46 out of 9 vs 3.67 out of 9 ( P = .02 , 2-tailed t test ) . CONCLUSIONS Parents of children undergoing ear , nose , and throat surgery recall far less than 100 % of counseled risks . The use of detailed surgical risk counseling improves measured parental underst and ing of surgical risk . Parental educational level and maternal vs paternal parent may affect risk counseling recall How do you obtain a valid assessment of subjective outcomes in a trial in which the participants can not be blinded to the intervention ? Bias is inevitable from unblinded patients , but trials that have not told patients about treatment in all arms have been heavily criticised . Asking participants to consent to postponed information could be a solution The most powerful tool for study ing the effectiveness of a medical treatment is a r and omised controlled clinical trial with blinded assessment of outcomes . However , blinding is not always possible — for example , in a trial comparing a surgical intervention with non-surgical treatment or the effectiveness of supplemental care compared with conventional care . Blinding needs special attention in such studies in order to prevent bias . When outcomes are assessed by doctors , it is often easy for the assessment to be done by doctors other than those who performed the procedure . However , when studies measure patients ' assessment of outcomes , blinding is much more complicated or even impossible . ! [ ] [ 1 ] Credit : PETER GRAY Unblinded patients who assess outcomes after being informed about the different treatment options during recruitment might bias the results of a study . The likelihood of bias increases when patients have a preference for one of the treatment options . For example , patients may have been told during recruitment that the new or supplemental strategy has been developed because the current strategy has disadvantages . The best way to obtain valid assessment s in such studies remains unclear . Intense debate was generated when research ers tried to mask patients … [ 1 ] : The present study was undertaken to evaluate the impact of a new procedure for eliciting informed consent by patients undergoing minor surgical procedures , in which the choice between general anaesthesia ( GA ) and regional anaesthesia ( RA ) was possible . In this prospect i ve study , two r and omly selected groups of patients were compared : study group ( SG ) , 52 patients , received from the  nurse  before the preoperative interview , a list of seven questions , which they were invited to ask the anaesthetist ; while the control group ( CG ) , 73 patients , did not receive any suggested questions . There were two end points : the proportion that chose RA and the number of questions actually addressed to the doctor at the preanaesthetic interview . Psychological aspects were taken into account by collecting the Hospital Anxiety and Depression ( HAD ) scale before the preanaesthetic interview . Satisfaction with the interview was recorded using a telephone question naire 2 weeks after the operation . The results from the two groups were compared by calculating the odds ratio according to Mantel-Haenszel and by logistic analysis . Altogether , 71.2 % of the patients chose RA without any difference between the groups . The average number of questions asked by each SG patient was higher than for the CG ( 1.67 vs. 0.96 ) . The satisfaction level was similar in the two groups . Our list of questions was design ed to facilitate patient autonomy . It offered an aid to those requesting more information and assisted communication . The method did not change the proportion who chose a specific kind of anaesthesia , but does seem to improve patient participation in the decision-making process R and omised controlled trials ( RCTs ) represent the gold st and ard methodology for determining effectiveness of healthcare interventions . Poor recruitment to RCTs can threaten external validity and waste re sources . An inherent tension exists between safeguarding informed decision-making by participants and maximising numbers enrolled . This study investigated what occurs during informed consent appointments in an ongoing multi-centre RCT in the UK . Objectives were to investigate : 1 ] how study staff presented study information to participants ; 2 ] what evidence emerged as to how well-informed participants were when proceeding to r and omisation or treatment selection ; and 3 ] what aspects of the communication process may facilitate improvements in providing evidence of informed consent . Qualitative analysis of a purposive sample of 23 recruitment appointments from three study centres and involving several recruitment staff applied techniques of thematic , content and conversation analysis ( CA ) . Thematic analysis and CA revealed variation in appointment content and structure . Appointments were mostly recruiter-led or participant-led , and this structure was associated with what evidence emerged as to how participants understood information provided and whether they were in equipoise . Participant-led appointments provided this evidence more consistently . Detailed CA identified communication techniques which , when employed by recruiters , provided evidence as to how participants understood the choices before them . Strategic use of open questions , pauses and ceding the floor in the interaction facilitated detailed and systematic exploration of each participant 's concerns and position regarding equipoise . We conclude that the current focus on content to be provided to achieve informed consent should be broadened to encompass consideration of how information is best conveyed to potential participants . A model of tailored information provision using the communication techniques identified and centred on eliciting and addressing participants ' concerns is proposed . Use of these techniques is necessary to make potential participants ' underst and ing of key issues and their position regarding equipoise explicit in order to facilitate truly informed consent BACKGROUND In clinical tests , the Informed Consent is critical to preserve the ethics , but due to its high complexity level , it can not be fully understood . This study assesses the Informed Consent as viewed by patients . OBJECTIVE We addressed the issue of what do patients underst and about the studies based on the IC . METHODS We invited participants of outpatient clinical drug trials phase II , III and IV to answer a question naire with 29 questions , such as : why have you accepted to participate ? Did you read the Informed Consent before signing it ? By signing it , were you sure you have fully understood it ? Eighty individuals ( 20 women and 60 men ) showed up , from 106 patients . The variables of each question were considered as often as they appeared . The comparison of the averages among the groups was made by t tests of Student or Wilcoxon ; and for associations , Chi-square or Likelihood Ratio , or Fisher 's exact test . RESULTS Ages averaged 58.7 + /- 9.3 years . Concerning their reasons to taking part in the survey , 66.2 % pointed out their own benefit ; 42.5 % , for science 's sake ; 25.0 % cl aim ed they were doing so at their doctor 's request ; 50 % did not underst and the Informed Consent properly ; and 32.9 % did not read it , but signed it . Among those who were administered placebo after r and omization ( n = 47 ) , 66.7 % did not underst and the meaning of the informed consent . A strong correlation between failure to underst and the meaning of placebo  with literacy level ( p = 0,02 ) was verified , which is an evidence that the smaller is the literacy level , the smaller is the underst and ing level . CONCLUSION The  Informed Consent  is poorly understood by patients and for some of them , trusting a doctor affected their decision in taking part in the clinical trial with drugs . Their literacy level also influenced their underst and ing of the term ' placebo ' Informed consent is the cornerstone of human research subject protection . Many subjects sign consent documents without underst and ing the study purpose , procedures , risks , benefits , and their rights . Proof of comprehension is not required and rarely obtained . Underst and ing might improve by using an interactive system with multiple options for hearing , viewing and reading about the study and the consent form at the subject ’s own pace with testing and immediate feedback . This prospect i ve r and omized study compared the IRB-approved paper ICF for an actual clinical research study with an interactive presentation of the same study and its associated consent form using an iPad device in two population s : clinical research professionals , and patients drawn from a variety of outpatient practice setting s. Of the 90 participants , 69 completed the  online test and survey questions  the day after the session ( maximum 36 hours post-session ) . Among research professionals ( n = 14 ) , there was a trend ( p = .07 ) in the direction of iPad subjects testing better on the online test ( mean correct = 77 % ) compared with paper subjects ( mean correct = 57 % ) . Among patients ( n = 55 ) , iPad subjects had significantly higher test scores than st and ard paper consent subjects ( mean correct = 75 % vs 58 % , p < .001 ) . For all subjects , the total time spent review ing the paper consent  was 13.2 minutes , significantly less than the average of 22.7 minutes total on the three components to be review ed using the iPad ( introductory video , consent form , interactive quiz ) . Overall satisfaction and overall enjoyment slightly favored the interactive iPad presentation . This study demonstrates that combining an introductory video , st and ard consent language , and an interactive quiz on a tablet-based system improves comprehension of research study procedures and risks Recent reports in the media about the NHS inquiry at a North Staffordshire hospital have highlighted concerns about clinical trials involving children , especially about informed consent and the information given to parents . An inquiry led by Professor Griffiths has recommended that the Department of Health produce guidelines for the conduct of clinical trials ( Boseley 2000 , Rumbelow and Johnstone 2000 ) . The UKCC Code of Professional Conduct ( 1992 ) requires that nurses must ‘ act always in such a manner to promote and safeguard the interests and well being of patients and clients ’ . Polit and Hungler ( 1991 ) summarise informed consent as meaning ‘ subjects have adequate information regarding the research ; are capable of comprehending the information and have the power of free choice , enabling them to voluntarily consent to participate in the research or decline participation ’ . While actively recruiting pre-school children for a r and omised controlled trial , the research team became aware that despite adhering to the consent procedure and regular contacts with parents , 14 of the 54 participants failed to complete the trial as requested . Albert and Chadwick ( 1992 ) suggest that effective communication can only take place if a message is successfully and completely transferred from one person to another . It was important that the research team ( two nurses , a registrar and a consultant ) were able to identify and underst and any potential communication problems with the information given about the trial . A retrospective postal audit of all 54 participants was carried out to address the question of why some parents failed to complete the trial and if information given to parents should be adapted . The results of this audit will be presented in this article INTRODUCTION Conventional consent forms often contain incomplete information regarding risks associated with invasive procedures . BAUS has introduced procedure-specific consent forms ( PSCF ) documenting the risks associated with urological procedures . We compared patients ' underst and ing of the risks and benefits of TURP after the consenting process with either conventional documentation or PSCF . PATIENTS AND METHODS One hundred patients were r and omised to be consented with either a conventional or PSCF .  After 3 h , their underst and ing was assessed with a question naire asking patients to document the indication and likelihood of symptomatic improvement , estimate frequency of complications and the risk of future re-operation . Data were compared by Mann-Whitney test . RESULTS Fifty patients were r and omised to each group . There was no significant difference in mean age , grade of doctor obtaining consent or time interval from consent to question naire . Both groups accurately predicted the chance of improved symptoms ( median , 80 % ) . There was no significant difference in patients ' median estimation of risk of complications such as incontinence , erectile dysfunction , or retro grade ejaculation . Patients consented with the PSCF predicted the risk of re-operation more accurately ( median answer , 10 % versus 30 % ; P = 0.007 , Mann-Whitney test ) . CONCLUSIONS Recall of data was sub-optimal in both groups . For most data points there was no significant difference in estimation of risks between groups . Those consented with a procedure-specific consent form predicted risk of re-operation at 10 years more accurately . Procedure-specific consent forms offer an advantage over conventional consent in this study . We feel that the provision of a written structured framework allows better informed consent for TURP Objective : To study the quality of the information provided to and the procedure for obtaining the consent of chronically ill patients participating in a clinical trial . All patients included in a clinical trial concerning a lipid‐lowering treatment over a 1‐year period were asked to participate in the present research ethical study . Material and Methods : Patients ( n=55 ) on hemodialysis or in a prerenal state were selected . About 2 weeks after being recruited , the patients received a question naire concerning different aspects of the information provided . None of those responsible for providing information and obtaining consent were aware of the research ethical study in advance . Results : A total of 44 patients answered the question naire ( response rate 80 % ) . All but one participant perceived the information provided as being very good or fairly good . None felt that they had been forced to participate in the trial . A total of 12 patients stated that they had delegated the decision making to their doctor . Compared to the younger patients , elderly participants more often stated that they had only been informed orally ( p=0.027 ) . Those who stated that they were only informed orally tended to let the doctor decide whether or not they should participate in the trial . Conclusions : The study indicates that , compared to younger patients , elderly patients tended to be informed about the trial only orally and were also inclined to let the doctor decide whether or not they should participate . Providing information both orally and in writing and providing sufficient time for consideration may improve the informed consent process for severely ill patients Verifying participant comprehension continues to be a difficult ethical and regulatory challenge for clinical research . An increasing number of articles assessing methods to improve comprehension have been published , but they use a wide range of outcome measures including open-ended , closed-ended , and self-perceived measures of comprehension . Systematic comparisons of different measures have rarely been reported . This study evaluated the likely direction of bias observed when using open-ended , closed-ended , and perceived ease of comprehension measures among women administered a mock informed consent process in Mwanza , Tanzania . Participants were r and omized to either a closed-ended or an open-ended assessment of comprehension , administered the consent process for a hypothetical HIV prevention trial in Kiswahili , and then administered a comprehension assessment , per their r and omization . They were then asked how easy or hard it was to underst and each of the informed consent components measured in the comprehension assessment . Women in the closed-ended arm had significantly higher overall comprehension scores than in the open-ended arm . Perceived scores were significantly higher when compared to both open-ended and close-ended scores within arms but were similar between arms . Findings highlight the importance of comprehension assessment s in complex clinical trials that go beyond asking participants if they underst and or have any questions . They also indicate the need for continued exploration of objective measures of comprehension in international clinical research setting s , so that points in need of clarification can be efficiently and effectively identified and addressed . Such measures would reduce burdens on both staff and participants that result from well-intentioned but potentially unnecessary time spent explaining in unwarranted detail things already understood Background Informed consent consists of basic five elements : voluntarism , capacity , disclosure , underst and ing , and ultimate decision-making . Physician disclosure , patient underst and ing , and information retention are all essential in the doctor-patient relationship . This is inclusive of helping patients make and manage their decisions and expectations better and also to deal with any consequences and /or complications that arise . This study investigates whether giving patients procedure-specific h and outs pre-operatively as part of the established informed consent process significantly improves overall risk-recall following surgery . These h and outs outline the anticipated peri-operative risks and complications associated with total thyroidectomy , as well as the corrective measures to address complications . In addition , the influence of potential confounders affecting risk-recall , such as anxiety and pre-existing memory disturbance , are also examined . Methods Consecutive adult ( ≥18 years old ) patients undergoing total thyroidectomy at a single academic tertiary care referral centre are included . Participants are r and omly assigned into either the experimental group ( with pamphlets ) or the control group by a computerized r and omization system ( Clinstat ) . All participants filled out a Hospital Anxiety and Depression Scale ( HADS ) and they are tested by the physician for short-term memory loss using the Memory Impairment Screen ( MIS ) exam . All patients are evaluated at one week post-operatively . The written recall question naire test is also administered during this clinical encounter . Results Forty-nine patients are included - 25 of them receive verbal consent only , while another 24 patients received both verbal consent and patient education information pamphlets . The overall average of correct answers for each group was 83 % and 80 % in the control and intervention groups , respectively , with no statistically significant differences . There are also no statistically significant differences between the two groups , in both interview duration , in time between interviews , and in recall tests . No correlation is also apparent between the pre-op HADS score and the recall question naire overall score . Conclusions A pre-operative thyroid surgical information pamphlet alone might not be sufficient to enhance patient test scores and optimally educate the patient on their expected care pathway in thyroid surgery . Supplementation with alternative means of patient education perhaps using emerging technologies needs to be further investigated This investigation was performed to determine the ability of a parturient to recall the pre-anesthesia discussion with her anesthesiologist and to determine if written consent added to this discussion improves recall . Eighty-two women presenting in labor were r and omized to ' verbal ' and ' verbal plus written ' consent for epidural labor analgesia and were contacted 5 to 7 months after a pre-anesthetic interview . Ten objective questions were posed at this time that addressed issues that were ' true risks ' , ' false risks ' , and ' situational ' issues related to the consent process . These responses were scored on a point scale so that a maximal objective recall score of 100 points was possible . Median recall score was 80 ( 70 - 90 ) in the ' verbal ' group and 90 ( 80 - 100 ) in the ' verbal plus written ' group . This difference was statistically significant ( P < 0.01 ) . In addition , three subjective questions were asked of all women at this time . All but six women ( one ' verbal plus written ' and five ' verbal ' group patients ) expressed that written consent would help them ' remember and appreciate the different anesthetic options , risks , and procedures ' . Four of these same women ( one ' verbal plus written ' and three ' verbal ' group patients ) thought a written consent process was ' alarming ' . Two of these same women ( both ' verbal ' group patients ) reported that they felt unable to give informed consent Background Cluster r and omized trials ( CRTs ) pose ethical challenges for investigators and ethics committees . This study describes the views and experiences of CRT research ers with respect to : ( 1 ) ethical challenges in CRTs ; ( 2 ) the ethics review process for CRTs ; and ( 3 ) the need for comprehensive ethics guidelines for CRTs . Methods Descriptive qualitative analysis of interviews conducted with a purposive sample of 20 experienced CRT research ers . Results Informants expressed concern over the potential for bias that may result from requirements to obtain informed consent from research participants in CRTs . Informants suggested that the need for informed consent ought to be related to the type of intervention under study in a CRT . Informants rarely expressed concern regarding risks to research participants in CRTs , other than risks to privacy . Important issues identified in the research ethics literature , including fair subject selection and other justice issues , were not mentioned by informants . The ethics review process has had positive and negative impacts on CRT conduct . Informants stated that variability in ethics review between jurisdictions , and increasingly stringent ethics review in recent years , have hampered their ability to conduct CRTs . Many informants said that comprehensive ethics guidelines for CRTs would be helpful to research ers and research ethics committees . Conclusions Informants identified key ethical challenges in the conduct of CRTs , specifically relating to identifying subjects , seeking informed consent , and the use of gatekeepers . These data have since been used to identify topics for in-depth ethical analysis and to guide the development of comprehensive ethics guidelines for CRTs Background and aim : As non-r and omised studies have suggested that surgical decompression may reduce mortality in patients with space occupying hemispheric infa rct ion , r and omisation may be considered unethical in controlled trials testing this treatment strategy . We studied differences in recall of information and in appreciation of the informed consent procedure between representatives included in the Hemicraniectomy After Middle cerebral artery infa rct ion with Life-threatening Edema Trial ( HAMLET ) and representatives of patients participating in the r and omised trial of Paracetamol ( Acetaminophen ) In Stroke ( PAIS ) . Methods : 1 year after study inclusion , we contacted 30 consecutive representatives who had given informed consent for participation of their relative in HAMLET , and 30 for PAIS .  Recall of trial details and appreciation of the informed consent procedure were investigated using st and ardised question naires and compared between the two groups . Results : All 30 PAIS representatives and 28 HAMLET representatives were interviewed . Participation of their relative in a clinical trial was remembered by 86 % of HAMLET and 40 % of PAIS representatives ( p<0.001 ) . HAMLET representatives remembered more trial details ( effect of the treatment under study ( 61 % vs 3 % , p<0.001 ) ; r and omised treatment allocation ( 71 % vs 0 % , p<0.001 ) ) . With respect to appreciation of the informed consent procedure , we found no differences between the groups : in each trial , four representatives ( 14 % vs 13 % ) had considered the question of r and omisation unacceptable . Conclusions : Participation of patients in a r and omised controlled trial of surgical decompression for space occupying infa rct ion is generally considered acceptable by their representatives , and recall of trial details is better than in a trial in which less vital issues are at stake BACKGROUND Many research studies conducted today in critical care have a genomics component . Patients ' surrogates asked to authorize participation in  genomics research  for a loved one in the intensive care unit may not be prepared to make informed decisions about a patient 's participation in the research . OBJECTIVES To examine the effectiveness of a new , computer-based education module on surrogates ' underst and ing of the process of informed consent for genomics research . METHODS A pilot study was conducted with visitors in the waiting rooms of 2 intensive care units in a Midwestern tertiary care medical center . Visitors were r and omly assigned to the experimental ( education module plus a sample genomics consent form ; n = 65 ) or the control ( sample genomics consent form only ; n = 69 ) group . Participants later completed a test on  informed genomics consent .  RESULTS Underst and ing the process of informed consent was greater ( P = .001 ) in the experimental group than in the control group . Specifically , compared with the control group , the experimental group had a greater underst and ing of 8 of 13 elements of informed consent : intended benefits of research ( P = .02 ) , definition of surrogate consenter ( P= .001 ) , withdrawal from the study ( P = .001 ) , explanation of risk ( P = .002 ) , purpose of the institutional review board ( P = .001 ) , definition of substituted judgment ( P = .03 ) , compensation for harm ( P = .001 ) , and alternative treatments ( P = .004 ) . CONCLUSIONS Computer-based education modules may be an important addition to conventional approaches for obtaining informed consent in the intensive care unit . Preparing patients ' family members who may consider serving as surrogate consenters is critical to facilitating genomics research in critical care We interviewed 64 parents by question naire after completion of a clinical trial involving their children for their perceptions and attitudes about informed consent . The results show that only a small minority realized that drug trials are design ed to assess not only efficacy but safety as well . More worrisome was the majority of parents who felt that drug trials conducted by hospitals are of no or low risks . Moreover , a significant minority offered the view that the strict informed consent procedures we followed were unnecessary because they would do what the doctor advised . Even more worrisome was the small percentage of parents who realized that a signed consent form was primarily meant to protect their rights , and only one-third of the parents knew of their right to withdraw their child unconditionally from the trial at any time . These findings suggest that there may be significant attitudinal barriers to parental underst and ing of the informed consent process PURPOSE To examine both the use of the consent document during the informed consent process for pediatric leukemia clinical trials , as well as relationships between the use of the document and parental underst and ing of essential elements of informed consent . METHODS Participants included 140 parents of children diagnosed with pediatric leukemia . Informed consent conferences in which r and omized clinical trials were discussed were observed , audiotaped , and coded for specific behaviors . Parents were also interviewed within 48 h of their participation in informed consent conferences . RESULTS Observations revealed that 74 % of cases included explanation of consent documents during consent conferences . Parents who reported that they read the consent document were more likely to underst and differences between the clinical trial and off study therapy and were more likely to underst and the right to withdraw . Reading of the consent document was not associated with underst and ing of voluntariness . In comparison to racial/ethnic majority parents , racial/ethnic minority parents were less likely to report that they read the consent document , underst and voluntariness or the right to withdraw , and were less likely to be able to distinguish between the clinical trial and off study therapy . Low SES was associated with a lower probability of reading the consent document and being able to distinguish between clinical trials and off study therapy . CONCLUSIONS Attention to the importance of reading the consent document and improving communication during consent conferences is likely to enhance underst and ing of essential elements of informed consent OBJECTIVE To evaluate the informed consent process for a clinical trial of intravenous doxycycline for rheumatoid arthritis . METHODS Participants completed a self-administered question naire about the consent process at baseline and 16 weeks following enrollment in a clinical trial . RESULTS Respondents ( n = 30 ) affirmed voluntary participation in the parent trial . Participants acknowledged hope and altruism as reasons for entering the trial more than expectation of personal benefit or outside influences . Many respondents did not underst and r and omization ( 14/30 ) , placebos ( 15/30 ) , or risks of study medications ; 11/30 respondents believed that the study drug was completely safe . CONCLUSION Respondents generally understood the experimental nature of the trial and confirmed their participation was voluntary . However , gaps existed in participants underst and ing of trial design , raising the question of whether they were adequately informed about the research study prior to enrollment . Further education of potential participants in clinical trials may be required to achieve valid informed consent Informed consent is vital to good surgical practice . Pain , sedative medication and psychological distress result ing from trauma are likely to adversely affect a patient 's ability to underst and and retain information thus impairing the quality of the consent process . This study aims to assess whether provision of written information improves trauma patient 's recall of the risks associated with their surgery . 121 consecutive trauma patients were r and omised to receive structured verbal information or structured verbal information with the addition of supplementary written information at the time of obtaining consent for their surgery . Patients were followed up post-operatively ( mean 3.2 days ) with a question naire to assess recall of risks discussed during the consent interview and satisfaction with the consent process . Recall of risks discussed in the consent interview was found to be significantly improved in the group receiving written and verbal information compared to verbal information alone ( mean question naire score 41 % vs. 64 % ) , p=0.0014 using the Mann-Whitney U test . Patient satisfaction with the consent process was improved in the group receiving written and verbal information and 90 % of patients in both groups expressed a preference for both written and verbal information compared to verbal information alone . Patients awaiting surgery following trauma can pose a challenge to adequately inform about benefits conferred , the likely post operative course and potential risks . Written information is a simple and cost-effective means to improve the consent process and was popular with patients Purpose : Federal regulations and best practice guidelines identify categories of information that should be communicated to prospect i ve biobank participants during the informed consent process . However , uncertainty remains about which of this information participants must underst and to provide valid consent . Methods : We conducted a Delphi process to define “ adequate comprehension ” in the context of biobanking consent . The process involved an iterative series of three online surveys of a diverse panel of 51 experts , including genome scientists , biobank managers , ethics and policy experts , and community and participant representatives . We sought consensus ( > 70 % agreement ) concerning what specific details participants should know about 16 biobank consent topics . Results : Consensus was achieved for 15 of the 16 consent topics . The exception was the comprehension needed regarding the Genetic Information Nondiscrimination Act . Conclusion : Our Delphi process was successful in identifying a concise set of key points that prospect i ve participants must grasp to provide valid consent for biobanking . Specifying the level of knowledge sufficient for individuals to make an informed choice provides a basis for improving consent forms and processes , as well as an absolute metric for assessing the effectiveness of other interventions to improve comprehension . Genet Med 17 3 , 226–233 Background The ‘ cohort multiple R and omised Controlled Trial ’ ( cm RCT ) design has been proposed as a potential solution to poor recruitment into clinical trials . The design r and omly selects participants eligible for experimental treatments from a pre-enrolled cohort of patients , recruiting participants to multiple trials from a single cohort . Controls remain unaware of their participation in specific trials . Methods We undertook a mixed methods study to determine the ethical acceptability , the proportion of patients in a routine service consenting to cohort participation  , the proportion of these who would consent to being hypothetically r and omly selected to receive new treatments , and the views of clinicians on the acceptability of the design . We su bmi tted our cm RCT design for ethical review and recruited participants from people with anxiety and depression attending a community mental health service of twenty-one clinicians . We recorded the proportion of patients who were offered participation in the DiReCT study and the proportion that consented to research er contact , medical record sharing , and who accepted to be r and omly allocated to active treatment procedures in future hypothetical unspecified clinical trials . We used a thematic framework analysis to analyse clinician interviews . Results We obtained a favourable ethical opinion from the UK Health Research Authority . Clinicians approached 131/752 ( 17 % ) potentially eligible participants for consent . Of these 131 , 84 ( 64 % ) initially consented to be contacted by a research er and all but one consented to being r and omised into future trials . We confirmed consent for 71 ( 54 % ) of participants approached by clinicians , of whom 69 ( 53 % ) consented to being r and omised into hypothetical future trials , 9 % ( 69/752 ) of all potentially eligible patients . The interviewed clinicians described issues impacting on their ability to recruit participants in terms of clinical concerns for patient wellbeing , work pressure , their views of both general research and the specific DiReCT study , and how they viewed patients ’ responses to being offered participation in the study . Conclusions The cm RCT system offers the potential to improve the recruitment into clinical trials and is acceptable ethically and to many patients . Overcoming the multiple factors driving the difficulties clinicians experience in patient recruitment is likely to require the application of significant implementation science-informed effort Background Pragmatic r and omised controlled trials ( RCTs ) are considered essential to determine effective interventions for routine clinical practice , but many fail to recruit participants efficiently , and some really important RCTs are not undertaken because recruitment is thought to be too difficult . The ‘ QuinteT Recruitment Intervention ’ ( QRI ) aims to facilitate informed decision making by patients about RCT participation and to increase recruitment . This paper presents the development and implementation of the QRI . Methods The QRI developed iteratively as a complex intervention . It emerged from the National Institute for Health Research ( NIHR ) ProtecT trial and has been developed further in 13 RCTs . The final version of the QRI uses a combination of st and ard and innovative qualitative research methods with some simple quantification to underst and recruitment and identify sources of difficulties . Results The QRI has two major phases : underst and ing recruitment as it happens and then developing a plan of action to address identified difficulties and optimise informed consent in collaboration with the RCT chief investigator ( CI ) and the Clinical Trials Unit ( CTU ) . The plan of action usually includes RCT -specific , as well as generic , aspects . The QRI can be used in two ways : it can be integrated into the feasibility/pilot or main phase of an RCT to prevent difficulties developing and optimise recruitment from the start , or it can be applied to an ongoing RCT experiencing recruitment shortfalls , with a view to rapidly improving recruitment and informed consent or gathering evidence to justify RCT closure . Conclusions The QRI provides a flexible way of underst and ing recruitment difficulties and producing a plan to address them while ensuring engaged and well-informed decision making by patients . It can facilitate recruitment to the most controversial and important RCTs . QRIs are likely to be of interest to the CIs and CTUs developing proposals for ‘ difficult ’ RCTs or for RCTs with lower than expected recruitment and to the funding bodies wishing to promote efficient recruitment in pragmatic RCTs OBJECTIVE We sought to evaluate the application of the French law for the protection of persons participating in research studies in biology and medicine . Specifically , we examined comprehension and consequences of informed consent procedures  in the field of stroke , characterized by an emergency setting , cognitive impairment and poor prognosis . PATIENTS AND METHODS Patients ( or proxies ) included in recent years in clinical studies conducted in our Neurology Department for evaluating treatment of acute phase cerebral ischemia were interviewed to determine their knowledge of the disease , its treatment , the study protocol and the legal regulations , and the affective and psychological consequences of the informed consent procedure . RESULTS Among 72 patients included in 7 studies ( [ fibrinolytic agent : 3 ( n = 43 ) , anticoagulant agent : 1 ( n = 4 ) , neuroprotective drugs ( n = 25 ) ] , [ 7 r and omized studies , 6 double-blind versus placebo , 5 with a 6-hour inclusion time interval ] ) , 15 died during the acute phase , 5 were lost to follow-up , 4 refused to participate and 7 gave very partial answers . Consent was signed by the patient in 15 % of cases , the spouse in 50 % , a descendant in 23 % . These persons were aware of the spontaneous risk of death ( 85 % ) or definitive functional impairment ( 95 % ) . Half of them thought a specific treatment existed , 11 % had some idea of the mechanism of action of the proposed treatment while 67 % learned about this mechanism from the information provided . Although they had received information , only 25 % of the patients had knowledge of placebo and 7 % of therapeutic risk . 37 % expected complete recovery from the treatment , 44 % partial recovery , and 13 % were very disappointed by the outcome . 81 % felt they were free to make their own decision . Although 86 % did not know there was a law protecting them , 82 % were in agreement with the requirement for their consent while 17 % would have preferred to delay consent . Most wished to be given the opportunity to discuss the study again , after the acute phase , and to receive the results of the study . CONCLUSION This study shows that most French stroke victims and their closest relatives are unaware of the law protecting persons in biomedical research and have poor knowledge of medical data after being given appropriate information . Even so , the quality of information increases the quality of the patient-physician relationship . Patients want to be free to make their own decision to consent to biomedical research , but their desire was more for good information than for the power to make their decision alone . Being asked to give informed consent in order to participate in a clinical study accentuates the affective and psychological consequences of stroke , a factor which should be taken into consideration during follow-up Context — Research participants ' informed consent is integral to the protection of human subjects ; studies exploring the enhancement of st and ard informed consent processes have had mixed success in increasing patients ' underst and ing of complex research protocol s. Objective — To determine the effect of a “ study map , ” a flow diagram of a research protocol , on research participants ' underst and ing of research purpose and procedures . Design — This study was an experimental posttest-only design using 30 research participants enrolling in a study of decision making and recovery among living kidney donors . Participants were r and omly assigned to the st and ard care group ( verbal description with consent documents ) or the experimental group ( st and ard of care plus study map ) . An instrument measured perceived and objective underst and ing , and the differences between groups were determined by an independent t test . Discussion — The high level of comprehension in the control group made detecting improvements in underst and ing difficult . Objective knowledge and perceived underst and ing were positively related , suggesting the importance of periodically confirming comprehension with research participants during the informed consent process . Future research should examine the effect of study maps in patients with lower educational levels . Results — Knowledge levels were high in all participants ( mean objective = 3.7 on a 5-point scale , SD= 1.02 ; mean subjective = 9.3 on a 10-point scale , SD= 1.29 ) . There was a significant relationship between objective knowledge and perceived underst and ing ( r = 0.56 , P = .001 ) ; however , the study map itself had no significant effect on objective or perceived underst and ing BACKGROUND The informed consent of participants is ethically and legally required for most research involving human subjects . However , st and ardized methods for assessing the adequacy of informed consent to research are lacking . METHODS AND RESULTS We design ed a brief question naire , the  Quality of Informed Consent ( QuIC ) , to measure subjects ' actual ( objective ) and perceived ( subjective ) underst and ing of cancer clinical trials . The QuIC incorporates the basic elements of informed consent specified in federal regulations , assesses the therapeutic misconception ( the belief that all aspects of a clinical trial are design ed to directly benefit the subject ) , and employs the language and structure of the new National Cancer Institute template for informed consent documents . We modified the QuIC after receiving feedback from pilot tests with cancer research subjects , as well as validation from two independent expert panels . We then sent the QuIC to 287 adult cancer patients enrolled on phase I , II , or III clinical trials . Two hundred seven subjects ( 72 % ) completed the QuIC . To assess test-retest reliability , a r and om sample of 32 respondents was selected , of whom 17 ( 53 % ) completed the question naire a second time . The test-retest reliability was good with intraclass correlation coefficients of.66 for tests of objective underst and ing and .77 for tests of subjective underst and ing . The current version of the QuIC , which consists of 20 questions for objective underst and ing and 14 questions for subjective underst and ing , was tested for time and ease of administration in a sample of nine adult cancer patients . The QuIC required an average of 7.2 minutes to complete . CONCLUSIONS The QuIC is a brief , reliable , and valid question naire that holds promise as a st and ardized way to assess the outcome of the informed consent process in cancer clinical trials OBJECTIVES To determine the advantages and disadvantages of a stepped wedge design for a specific clinical application . STUDY DESIGN AND SETTING The clinical application was a pragmatic cluster r and omized surgical trial intending to find an increased percentage of curable recurrences in patients in follow-up after colorectal cancer . Advantages and disadvantages of the stepped wedge design were evaluated , and for this application , new advantages and disadvantages were presented . RESULTS A main advantage of the stepped wedge design was that the intervention rolls out to all participants , motivating patients and doctors , and a large number of patients who were included in this study . The stepped wedge design increased the complexity of the data analysis , and there were concerns regarding the informed consent procedure . The repeated measurements may bring burden to patients in terms of quality of life , satisfaction , and costs . CONCLUSION The stepped wedge design is a strong alternative for pragmatic cluster r and omized trials . The known advantages hold , whereas most of the disadvantages were not applicable to this application . The main advantage was that we were able to include a large number of patients . Main disadvantages were that the informed consent procedure can be problematic and that the analysis of the data can be complex Abstract Assessing and improving informed consent underst and ing is equally important as obtaining consent from participants in clinical trial research , but developing interventions to target gaps in participants ’ informed consent underst and ing remains a challenge . We used a r and omized controlled study design to pilot test an educational intervention to improve actual informed consent underst and ing of new enrollees in the Adult AIDS Clinical Trial Group ( AACTG ) . Question naires were administered to 24 enrollees to assess their baseline underst and ing on eight elements of informed consent associated with AIDS clinical trials . Enrollees who scored 18/21(85 % ) or less were r and omly assigned to in-person , targeted education ( intervention ) , or delayed education ( control ) . Two follow-up assessment s were administered . Repeated measures ANOVA was performed to determine intervention effectiveness in improving actual informed consent underst and ing over time . Actual underst and ing improved at the immediate post-intervention time point with a significant score difference of 2.5 when comparing the intervention and delayed groups . In addition , there was a significant score difference of 3.2 when comparing baseline to three-month follow-up for the two groups , suggesting a statistically significant intervention effect to improve actual underst and ing of the basic elements of informed consent . The findings demonstrated that one-time targeted education can improve actual informed consent underst and ing one week after the intervention , but retention of these concepts may require periodic monitoring to ensure comprehension throughout the course of a clinical trial Background Little is known about the views of mothers when their children are invited to participate in r and omized clinical trials ( RCTs ) investigating medicines and /or invasive procedures . Our goal was to underst and mothers ’ perceptions of the processes of informed consent and r and omization in a RCT that divided uncooperative children into three intervention groups ( physical restraint , sedation , and general anesthesia ) for dental rehabilitation . Methods This is a qualitative study based on semi-structured interviews with mothers accompanying children under 3 years old presenting severe early childhood caries . Their responses were analyzed using content analysis . Results We identified one major theme from 15 mothers ’ responses – “ Underst and ing of , attitudes toward , and feelings about consenting to participate in a RCT involving advanced behavior guidance techniques and about r and omization ” – that was derived from the following subcategories : confusion in defining techniques , questions after signing the consent form , lack of knowledge about the techniques , acceptance or question ing of the drawing , sharing responsibility with the child during the drawing , and feelings of faith in God , fear , powerlessness to choose , and relief from or an increase in pressure . Conclusions Despite mothers ’ misunderst and ing , vulnerability , and contradictory feelings , they were willing to overlook their thoughts in order to complete their children ’s dental treatment Procedures must be developed to ensure that valid informed consent is obtained from participants in HIV vaccine efficacy trials . A prototype informed consent process was evaluated among 4,892 persons at high risk for HIV infection in the HIV Network for Prevention Trials Vaccine Preparedness Study ( VPS ) , a prospect i ve cohort study of HIV seroincidence in eight U.S. metropolitan areas . Twenty percent of VPS participants were selected at r and om to undergo the prototype informed consent process at VPS month 3 . Participants ' knowledge of 10 key HIV vaccine trial concepts and willingness to participate in HIV vaccine efficacy trials were assessed and compared at baseline and semiannually thereafter for 18 months . Knowledge of HIV vaccine trial concepts was low at baseline . Participation in the prototype process was associated with substantial and sustained increases in knowledge ( relative risks for the 10 items , 1.04–2.26 ) , which were of similar magnitude across HIV risk groups , race/ethnicity , and educational levels . It is recommended that the prototype informed consent process be adopted for future HIV vaccine efficacy trials as well as for clinical trials in other research areas Purpose A patient 's willingness to consent to a procedure may be influenced by various factors , including the patient 's rapport with the physician , nonverbal cues he or she receives during the discussion of risks , and other elements of the discussion of risks . Previous reports address these influences , but the effect of the actual wording used to describe risks is unclear . The purpose of this study was to better underst and how framing the risk involved in a procedure affects a patient 's likelihood to consent to the procedure . Method In a 1997 study at the Clevel and Clinic Foundation , the authors r and omly assigned 116 patients to view one of two short videos describing angioplasty and its associated risks . Sixty-three participants viewed the first video , which framed the procedure as 99 % safe , and 53 viewed the second , which framed the likelihood of complication as 1 in 100 . Participants were then asked to rate their consent to two hypothetical treatment scenarios on a four-point Likert-type scale ( 1 = definitely , 4 = definitely not ) . Results When asked to consent to a treatment scenario that would relieve chest pain but offer no survival benefit , respondents who viewed the first video were more likely to consent than were those who viewed the second ( p < .001 ) . There was no significant difference in the two groups ' likelihoods to consent when the potential health benefit was to reduce the risk of future heart attack . Conclusion This study 's finding provides evidence that how a physician describes a procedure 's risks when obtaining a patient 's informed consent significantly influences the likelihood of consent . This fact should be considered when teaching communication skills , including interviewing and patient education skills , so that patients will be more likely to make health care decisions that are consistent with their own values and beliefs Background : Obtaining informed consent for a patient ’s participation in a r and omized trial of treatment for use in a medical emergency may be achieved in a variety of ways . We sought to assess the process of consent and to evaluate the influence of the patient ’s neurological deficit on the method used to obtain consent in the first 300 patients recruited into the Third International Stroke Trial ( IST-3 ) . Methods : IST-3 is the first large-scale r and omized controlled trial of intravenous thrombolysis in acute ischaemic stroke . The clinician could use one of four procedures to recruit the patient : written consent , witnessed consent , assent , or a waiver of consent . The patient ’s neurological deficits were recorded at baseline . We analysed the relationship between the neurological deficits at baseline and the consent procedure . Results : The method of consent used was written consent in 71 subjects ( 24 % ) , witnessed verbal consent in 30 subjects ( 10 % ) , assent by a relative in 197 subjects ( 66 % ) , and waiver of consent in 2 subjects ( 1 % ) . Patients with severe neurological deficits  ( as measured either by their stroke syndrome or their lower predicted probability of being alive and independent at 6 months ) were more likely to be recruited by assent . Patients able to give written consent had less severe strokes . Conclusions : Patients with non-lacunar hemispheric stroke syndromes or with a more severe neurological deficit were less likely to give written consent . Excluding such patients from acute stroke treatment trials would eliminate many otherwise eligible subjects , who have a poor predicted outcome without treatment and yet might benefit from acute treatments such as thrombolysis . Flexible consent procedures developed for IST-3 have made it feasible to recruit the target population As genomic research ers are urged to openly share generated sequence data with other research ers , it is important to examine the utility of informed consent documents and processes , particularly as these relate to participants ' engagement with and recall of the information presented to them , their objective or subjective underst and ing of the key elements of genomic research ( e.g. , data sharing ) , as well as how these factors influence or mediate the decisions they make . We conducted a r and omized trial of three experimental informed consent documents ( ICDs ) with participants ( n = 229 ) being recruited to genomic research studies ; each document afforded varying control over breadth of release of genetic information . Recall and underst and ing , their impact on data sharing decisions , and comfort in decision making were assessed in a follow-up structured interview . Over 25 % did not remember signing an ICD to participate in a genomic study , and the majority ( 54 % ) could not correctly identify with whom they had agreed to share their genomic data . However , participants felt that they understood enough to make an informed decision , and lack of recall did not impact final data sharing decisions or satisfaction with participation . These findings raise questions about the types of information participants need in order to provide valid informed consent , and whether subjective underst and ing and comfort with decision making are sufficient to satisfy the ethical principle of respect for persons To determine subjects ' perception of the purpose of informed consent , 113 subjects were recruited from a dose-controlled clinical trial of didanosine ( ddI ) . Subjects were surveyed regarding how they made decisions regarding their medical care in general , about how they obtained information about this trial in particular , and several aspects of the informed consent procedure . Subjects were then r and omly allocated to receive information about the trial by either a written only format or a written and verbal format 1 week before commencement of the trial . An eight-item instrument assessed knowledge of ddI prior to and subsequent to receiving information . Most subjects obtained information about HIV-related issues from their specialist ( 70 % ) or general ( 51 % ) medical practitioner . A large proportion of subjects ( 88 % ) reported that they believed their specialist medical practitioner always acted in their best interest . The majority of subjects ( 79 % ) believed that subjects should be allowed the choice between participating in the clinical trial and receiving the drug outside the trial mechanism . Of the subjects , 96 % believed that informed consent was necessary in clinical trials ; however , their opinions of the purpose of informed consent varied widely . Although they signed the informed consent , 44 % of the subjects stated that they did not underst and ' all ' of the information that was provided . We found that the provision of information by written mode alone , or written and verbal modes were both associated with significant increases in knowledge levels and that there was a significant interaction in the degree of change between the two methods , with the written plus verbal method showing the most improvement over time . There was an interaction between degree of improvement in knowledge of didanosine in subjects who received written information versus those who received written and verbal knowledge and time ( pre- versus post-consent ) and a significant main effect for time . All subjects were relatively well-informed about the drug and stated that specialist and general medical practitioners were their major source of knowledge for all aspects of their HIV health care OBJECTIVE To evaluate the effectiveness of oral communication about the risks of facial cosmetic procedures compared with oral and written communication . DESIGN A prospect i ve r and omized study conducted in an ambulatory surgery center . One hundred twenty consecutive patients were included ; they presented for consultation for rhinoplasty , rhytidectomy , or laser resurfacing . Patients were r and omly assigned to 1 of 2 groups : ( 1 ) those receiving oral discussion of the risks of the procedure and ( 2 ) those receiving oral and written communication about the risks . Two weeks after the initial consultation , patients were surveyed for recall of the risks . RESULTS The group that received a pamphlet had a better risk recall than the group that did not ( 2.5 vs1.5 of 5 risks ; P<.001 ) . The recall rate in the following groups that received a pamphlet was also better : ( 1 ) university-educated patients ( P = .02 ) , ( 2 ) patients who underwent rhinoplasty ( P<.001 ) , ( 3 ) patients who underwent laser resurfacing ( P = .02 ) , and ( 4 ) female patients ( P<.001 ) . CONCLUSIONS Written disclosure of the risks of cosmetic procedures enables patients to retain and underst and more clearly those potential risks . They are , therefore , able to give an informed consent to the proposed procedure . This study also identifies patient groups who may require more intensive presurgical teaching . The medicolegal implication s are apparent BACKGROUND Informed consent is required for both st and ard cancer treatments and experimental cancer treatments in a clinical trial . Effective and sensitive physician-patient communication about informed consent is difficult to achieve . Our aim was to train doctors in clear , collaborative and ethical communication about informed consent and evaluate the impact of training on doctor behaviour , stress and satisfaction . PARTICIPANTS AND METHODS Participants were 21 oncologists from 10 Australian/New Zeal and ( ANZ ) centres and 41 oncologists from 10 Swiss/German/Austrian ( SGA ) centres . Oncologists were r and omized to participate in a 1-day workshop or not .  Patients were recruited before and after the training . Doctors were asked to su bmi t 1 - 2 audiotaped consultations before and after training . Doctors completed outcome measures before and after completing the post-training cohort recruitment . RESULTS Ninety-five consultation interactions were audiotaped . Doctors strongly endorsed the training . ANZ intervention doctors demonstrated a significant increase in collaborative communication ( P = 0.03 ) . There was no effect of training on other doctor behaviours .  Trained doctors did not demonstrate reduced stress and burnout . Patient outcomes are presented elsewhere . CONCLUSIONS Training can improve some aspects of the process of obtaining informed consent . Methods to increase the impact of training are required and may include longer training and more intensive follow-up The authors investigated the effect of giving written material on information recall from informed consent counselling for cataract surgery . Fifty English-speaking patients who underwent non-urgent cataract extraction at Flinders Medical Centre , South Australia , were prospect ively enrolled .  Systematic counselling for cataract surgery was provided , with a written copy of the content given to a r and omly selected group of patients ( n = 24 ) . All subjects completed a question naire after counselling and again at two weeks after surgery to test their satisfaction with , and recall of , information provided . Patients were found to be satisfied with the amount of information they received and most were able to recall details about the cataract surgery procedure . However , many could not recall success rates or complication rates and only a minority could list any complication . The provision of written information did not significantly alter recall ( p>0.05 ) . Recall was significantly better immediately after counselling than two weeks after surgery ( p<0.05 ) . Younger patients also had significantly better recall ( p<0.05 ) . Patients were happy with the information they had been given but did not remember enough from the informed consent process to satisfy legal requirements Background Studies on different methods to supplement the traditional informed consent process have generated conflicting results . This study was design ed to evaluate whether participants who received group counseling prior to administration of informed consent understood the key components of the study and the consent better than those who received individual counseling , based on the hypothesis that group counseling would foster discussion among potential participants and enhance their underst and ing of the informed consent . Methods Parents of children participating in a trial of nutritional supplementation were r and omized to receive either  group counseling or individual counseling prior to administration of the informed consent . To assess the participant 's comprehension , a structured question naire was administered approximately 48 - 72 hours afterwards by interviewers who were blinded to the allocation group of the respondents . Results A total of 128 parents were recruited and follow up was established with 118 ( 90.2 % ) for the study . All respondents were aware of their child 's participation in a research study and the details of sample collection . However , their underst and ing of study purpose , r and omization and withdrawal was poor . There was no difference in comprehension of key elements of the informed consent between the intervention and control arm . Conclusions The results suggest that the group counseling might not influence the overall comprehension of the informed consent process . Further research is required to devise better ways of improving participants ' underst and ing of r and omization in clinical trials . Trial Registration Clinical Trial Registry - India ( CTRI ) : Background Despite widespread agreement on the importance of informed consent in clinical research , uncertainty remains about the adequacy of current consent procedures and documentation . Methods The objective of the study was to compare an informed consent document developed by a consumer group of potential study participants to one developed by the study investigators . The study was a cluster r and omized , controlled study embedded in a ‘ parent ’ r and omized controlled trial of 1092 participants with Gulf War veterans ’ illnesses recruited in 1999–2000 at 20 US medical centers . Centers were r and omized to the investigator-developed or participant-developed consent document . The primary outcome measure was an Informed Consent Question naire-4 ( ICQ-4 ) , a vali date d four-item scale measuring self-reported participant underst and ing scored from 0 to 1 . Secondary outcomes included the Client Satisfaction Question naire-8 and measures of study refusal and adherence to the parent trial protocol . Results There were no significant differences between consent documents on the ICQ-4 score overall or at any of the time points . Mean ( 95 % CI ) treatment differences ranged from 0.020 ( 0.015 , 0.055 ) ( better underst and ing ) at entry to 0.021 ( 0.054 , 0.012 ) ( worse underst and ing ) at three-months for the participant versus the investigator document group . There were also no significant differences in satisfaction , adherence to the protocol , or in the proportion of patients who refused to participate in the trial . Limitations The consumer group may not have been representative of the study participants and they did not suggest dramatic changes to the consent document . The outcome assessment question naire was not vali date d prior to the trial 's initiation . Conclusions Consumer modification of the consent document did not lead to either benefit or harm in underst and ing , satisfaction , or study refusal and adherence rates . This study did demonstrate , however , that embedding consent studies in a clinical trial is feasible and can address important questions about informed consent without disrupting the primary study A year ago BMJ Publications released a 350 page tome that many people will regard as the last word on informed consent to treatment.1 What is missing from this otherwise comprehensive compendium is a practical guide for clinicians at the coalface . In an effort to overcome this deficit we have generated a menu of alternative styles of informed consent . The first five options relate to consent for treatment within r and omised controlled trials , and the final six are options for use in routine clinical practice . We are confident that our menu will help frontline clinicians and patients in practice . It may also help medical ethicists in theory . # # # # Summary points Many alternative styles of informed consent to treatment exist , along with much theory , a few principles , and different st and ards of consent within and outside r and omised trials , but concise practical advice about the available alternatives is not readily accessible We have assembled a menu of options to help frontline clinicians and patients to select whichever form of consent meets their particular needs and circumstances # # # Human sacrifice r and omised controlled trial consent “ The research ethics committee that approved this trial on your behalf would like you to know that future generations might ( or might not ) appreciate it if you would put your life at risk by joining this trial . Although we will keep your individual trial results confidential ( especially if they run contrary to our hypothesis ) and you are free to insist on conventional treatment or withdraw at any time , let 's face it — you are a human guinea pig . The investigators responsible for the study may have conducted a systematic review of relevant previous studies to see whether one of the alternative treatments has already been shown to be superior , but this sort of evidence is beyond the interest and competency of our local research ethics committee , which is primarily interested in protecting BACKGROUND Preoperative patient education is an important part of the informed consent process , and a perceived lack of information can lower patient satisfaction . We sought to evaluate the effect of a web-based multimedia patient education tool on the perioperative experience of patients undergoing first-time knee arthroscopy for a meniscal tear . METHODS Adult patients undergoing knee arthroscopy for the first time for a primary diagnosis of a meniscal tear were consecutively enrolled into the study from January 2014 through June 2014 . Patients were equally r and omized to a control group , who received st and ard preoperative counseling , or the intervention group , who completed a twenty-minute web-based multimedia tutorial in addition to st and ard counseling . The web-based tutorial covered relevant anatomy , pathology , and general perioperative instructions , and it was completed prior to the preoperative visit . Patients completed surveys that evaluated their preparedness for surgery and knowledge recall at the preoperative visit , on the day of surgery , and after the first postoperative visit . RESULTS Sixty-four patients were enrolled , and fifty-five patients ( 86 % ; twenty-nine in the control group and twenty-six in the intervention group ) with complete data sets were included in the analysis . Preoperatively , the intervention group felt significantly more informed about the surgery and more clearly understood the risks and benefits of , and alternatives to , the surgery ( all p < 0.001 ) . Postoperatively , the intervention group reported being significantly more satisfied with the perioperative education that they had received and felt more informed about their surgery and rehabilitation ( p ≤ 0.05 ) . Patients in the intervention group were significantly more likely to correctly answer questions regarding their surgical details at the first postoperative visit ( p ≤ 0.03 ) . CONCLUSIONS Patients who completed the web-based tutorial had improved preoperative knowledge and preparedness as well as enhanced postoperative knowledge recall regarding their surgical procedure . The tutorial received high user satisfaction scores with low user burden scores and was an effective tool for enhancing the patients ' perioperative experience Background The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in re source -limited setting s. We sought to evaluate this process among human research participants in r and omly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences , Makerere University . Methods Data were collected using semi-structured interviewer-administered question naires on clinic days after initial or repeat informed consent procedures for the respective clinical studies had been administered to each study participant . Results Of the 600 participants interviewed , two thirds ( 64.2 % , 385/600 ) were female . Overall mean age of study participants was 37.6 ( SD = 7.7 ) years . Amongst all participants , less than a tenth ( 5.9 % , 35/598 ) reported that they were not given enough information before making a decision to participate . A similar proportion ( 5.7 % , 34/597 ) reported that they had not signed a consent form prior to making a decision to participate in the study . A third ( 33.7 % , 201/596 ) of the participants were not aware that they could , at any time , voluntarily withdraw participation from these studies . Participants in clinical trials were 50 % less likely than those in observational studies [ clinical trial vs. observational ; ( odds ratio , OR = 0.5 ; 95 % CI : 0.35 - 0.78 ) ] to perceive that refusal to participate in the parent research project would affect their regular medical care . Conclusions Most of the participants signed informed consent forms and a vast majority felt that they received enough information before deciding to participate . On the contrary , several were not aware that they could voluntarily withdraw their participation . Participants in observational studies were more likely than those in clinical trials to perceive that refusal to participate in the parent study would affect their regular medical care Purpose The aim of this study was to evaluate the efficacy of a multimedia informed consent ( IC ) presentation on the underst and ing and satisfaction of patients who were scheduled to receive 120-W green-light high-performance system photoselective vaporization of the prostate ( HPS-PVP ) . Material s and Methods A multimedia IC ( M-IC ) presentation for HPS-PVP was developed . Forty men with benign prostatic hyperplasia who were scheduled to undergo HPS-PVP were prospect ively r and omized to a  conventional written IC group  ( W-IC group , n=20 ) or the M-IC group ( n=20 ) . The allocated IC was obtained by one certified urologist , followed by a 15- question test ( maximum score , 15 ) to evaluate objective underst and ing , and question naires on subjective underst and ing ( range , 0~10 ) and satisfaction ( range , 0~10 ) using a visual analogue scale . Results Demographic characteristics , including age and the highest level of education , did not significantly differ between the two groups . No significant differences were found in scores reflecting the objective underst and ing of HPS-PVP ( 9.9±2.3 vs. 10.6±2.8 , p=0.332 ) or in subjective underst and ing scores ( 7.5±2.1 vs. 8.6±1.7 , p=0.122 ) ; however , the M-IC group showed higher satisfaction scores than the W-IC group ( 7.4±1.7 vs. 8.4±1.5 , p=0.033 ) . After adjusting for age and educational level , the M-IC group still had significantly higher satisfaction scores . Conclusions M-IC did not enhance the objective knowledge of patients regarding this surgical procedure . However , it improved the satisfaction of patients with the IC process itself Injection drug users ( IDUs ) at high risk for human immunodeficiency virus ( HIV ) infection are being identified as a population for HIV vaccine trials . We studied willingness of drug users to enroll and their comprehension of consent procedures in the context of a Phase II trial at one site . Of 175 people screened for enrollment and whose data sets were complete , 119 ( 68 % ) were IDUs . Of the 71 who were eligible , 39 ( 55 % ) were IDUs . Exclusion of IDUs was usually for medical reasons . Using a 17-item true/false test , comprehension of the informed consent procedure was high ( median score , 16 of 17 for IDUs and non-IDUs ) ; only three subjects ( all of whom were IDUs ) were excluded from enrollment due to lack of comprehension . Follow-up rates were similar for IDUs and non-IDUs . These data suggest that recruitment of IDUs into HIV vaccine trials is feasible , that IDUs can comprehend and complete the informed consent procedures , and that they return for follow-up visits Background : One of the main problems in conducting clinical trials is low participation rate due to potential participants ' misunderst and ing of the rationale for the clinical trial or perceptions of loss of control over treatment decisions . Objectives : The objective of this study was to test an alternate informed consent process in cardiac rehabilitation participants that involved the use of a multimedia flip chart to describe a future r and omized clinical trial and then asked , hypothetically , if they would participate in the future trial . Methods : An attractive and inviting visual presentation of the study was created in the form of a 23-page flip chart that included 24 color photographs displaying information about the purpose of the study , similarities and differences between the two treatment groups , and the data collection process . We tested the flip chart in 35 cardiac rehabilitation participants .  Participants were asked if they would participate in this future study on two occasions : immediately after the description of the flip chart and 24 hours later , after reading through the informed consent document . Participants were also asked their perceptions of the flip chart and consent process . Results : Of the 35 participants surveyed , 19 ( 54 % ) indicated that they would participate in the future study . No participant changed his or her decision 24 hours later after reading the full consent form . The participation rate improved 145 % over that of an earlier feasibility study where the recruitment rate was 22 % . Most participants stated that the flip chart was helpful and informative and that the photographs were effective in communicating the purpose of the study . Discussion : Participation rates could be enhanced in future clinical trials by using a visual presentation to explain and describe the study as part of the informed consent process . More research is needed to test alternate methods of obtaining informed consent Participants are often not informed by investigators who conduct r and omised , placebo-controlled acupuncture trials that they may receive a sham acupuncture intervention . Instead , they are told that one or more forms of acupuncture are being compared in the study . This deceptive disclosure practice lacks a compelling method ological rationale and violates the ethical requirement to obtain informed consent . Participants in placebo-controlled acupuncture trials should be provided an accurate disclosure regarding the use of sham acupuncture , consistent with the practice of placebo-controlled drug trials Background There is little in-depth research into how patients feel about  emergency medical trials  , and what influences these feelings . Objectives To investigate patients ’ feelings on taking part in  emergency medical research , particularly trials conducted without prospect i ve consent . Methods Seventeen in patients , all recently admitted with a medical emergency , were interviewed . Questions focused on feelings on taking part in hypothetical trials , particularly trials conducted with deferred consent . Results Five main themes were identified . Level of trust in the medical profession — high levels of trust tended to correlate with willingness to participate in trials . Previous bad healthcare experiences tended to diminish trust . Concerns for personal well-being— patients identified a conflict between aversion to unknown side effects and desire for access to newer and potentially better treatments . Some would be less inclined to participate in research if they were severely unwell , some more so . Altruism — many cited the importance of helping to advance medical knowledge and of ‘ giving back to the health service ’ . Concerns over autonomy — some felt that deferred consent was a violation of personal autonomy . Uncertainty — many patients seemed to struggle to underst and the more complex concepts discussed . Conclusions Patients are broadly trusting , and open to participating in emergency medical trials , but want to be kept as informed as possible throughout the process . Willingness may be improved by providing more complete explanations , although this may be limited by the complexity of relevant concepts . Good communication and improved public underst and ing of clinical trials would likely increase acceptance of emergency care research Background : Informed consent in clinical research is m and ated throughout the world . Both patient subjects and investigators are required to underst and and accept the distinction between research and treatment . Aim : To document the extent and to identify factors associated with therapeutic misconception in a population of patient subjects or parent proxies recruited from a variety of multicentre trials ( parent studies ) . Patients and methods : The study comprised two phases : the development of a question naire to assess the quality of informed consent  and a survey of patient subjects based on this question naire . Results : A total of 303 patient subjects or parent proxies were contacted and 279 question naires were analysed . The median age was 49.5 years , sex ratio was 1 and 61 % of respondents were professionally active .  Overall memorisation of the oral or written communication of informed consent was good ( 69–97 % ) , and satisfaction with the process was around 70 % . Therapeutic misconception was present in 70 % of respondents , who expected to receive better care and ignored the consequence of r and omisation and treatment comparisons . This was positively associated with the acuteness and severity of the disease . Conclusion : The authors suggest that the risk of therapeutic misconception be specifically addressed in consent forms as an educational tool for both patients and investigators
We have identified efforts by research ers to investigate interventions which seek to improve information delivery and consideration of information to enhance  informed consent .
The interventions used consistently improve patient knowledge , an important prerequisite for informed consent .
This is encouraging and these measures could be widely employed although we are not able to say with confidence which types of interventions are preferable .
Our results should be interpreted with caution due to the high levels of heterogeneity associated with many of the main analyses although we believe there is broad evidence of beneficial outcomes for patients with the pragmatic application of interventions .
BACKGROUND Achieving informed consent is a core clinical procedure and is required before any surgical or invasive procedure is undertaken .
However , it is a complex process which requires patients be provided with information which they can underst and and retain , opportunity to consider their options , and to be able to express their opinions and ask questions .
There is evidence that at present some patients undergo procedures without informed consent being achieved .
OBJECTIVES To assess the effects on patients , clinicians and the healthcare system of interventions to promote informed consent for patients undergoing surgical and other invasive healthcare treatments and procedures .
AUTHORS ' CONCLUSIONS Informed consent is an important ethical and practical part of patient care .