in the recent millennium , the constant trend of change in the demands of the community as well as transforming the trend of knowledge production has highlighted the necessity for researchers to adopt a more comprehensive approach .
increasingly , many academic disciplines are utilizing qualitative research ( qr ) as the qualitative method investigating the why and how of the process of a developed concept ( 1 , 2 ) .
qualitative research is sometimes defined as interpretive research , and as interpretations can be incorrect or biased , the findings may be controversial ( 3 ) . however , qualitative research is not only useful as the first stage of quantitative research , but can also play a key role in  validating it or in providing a different viewpoint on the same social phenomena ( 4 ) .
qualitative studies tend to use methods that result in text production rather than numerical outputs .
given that the researcher is considered to be the research instrument , and the plan of inquiry needs to be developed and altered as the study progresses , a qualitative researcher can not depend upon traditional approaches to address certain concerns such as bias and credibility .
therefore , learning from a series of mistakes is often considered an integral part of qualitative research ( 5 , 6 ) . in this study ,
a literature review was carried out in international electronic databases including pubmed , web of sciences , cumulative index to nursing and allied health literature ( cinahl ) , scopus , ebsco , embase and science direct without any time limitation , using the search terms  qualitative research  , 
these keywords were also searched on national electronic databases including scientific information database ( sid ) , iran medex and medical articles library ( medlib ) using the same strategy .
authors of the present article endeavor to shine a light on the ethical issues affecting researchers and propose strategies to face the ethical challenges of qualitative studies , so as to provide applicable and trustworthy outcomes
. this could be the basis for the formulation of specific ethical guidelines in this regard .
up to the 1970s , qualitative research was solely employed by anthropologists and sociologists . during the 1970s and 1980s ,
however , it was favored by various disciplines and experts of different branches of science and humanity such as health care , psychology , nursing , management , political science , education , and communication studies ( 2 , 7 ) .
qualitative research has been conducted in the field of nursing in order to identify , describe and explain related concepts , experiences and phenomena and to develop the nursing knowledge .
, qualitative research has been performed to achieve the concepts of patient care and other main perceptions in the nursing profession .
qualitative studies provide nurses with sensitivity to the lived experiences of individuals from different nursing care aspects ( 4 , 8) .
in the case of nurses who perform qualitative research , ethical issues are raised when the nurse - patient relationship in the research area leads to some degree of therapeutic communication for the participants ( 9 ) .
thus , nurse researchers must be aware of the impact of the questioning on the participants , and in order to decrease such harmful effects on human subjects , the  reflexive approach  is recommended ( 10 ) . in qualitative studies researchers
are often required to clarify their role in the research process ( 11 ) . in the qr procedure
the researcher is involved in all stages of the study from defining a concept to design , interview , transcription , analysis , verification and reporting the concepts and themes .
therefore , whenever instruments are involved in qualitative research , a human being will be an integral part of the process ( 12 ) .
it is argued that humans have increasingly become the  instrument of choice  for naturalistic research due to certain characteristics : they are highly responsive to environmental stimuli , have the ability to interact with the situation , pull together different pieces of information at multiple levels simultaneously , and perceive situations holistically ; moreover , they are able to process findings the instant they become available , can present immediate feedback , and feel unusual responses .
nevertheless , researchers need to improve the abilities that make them appropriate human instruments and consequently , their interpersonal skills are of major importance in natural settings and study processes ( table 1 ) ( 13 , 14 ) .
the relationship and intimacy that is established between the researchers and participants in qualitative studies can raise a range of different ethical concerns , and qualitative researchers face dilemmas such as respect for privacy , establishment of honest and open interactions , and avoiding misrepresentations ( 19 ) .
ethically challenging situations may emerge if researchers have to deal with contradicting issues and choose between different methodological strategies in conflict arises .
in such cases , disagreements among different components such as participants , researchers , researchers discipline , the funding body and the society may be inevitable ( 20 , 21 ) . some important ethical concerns that should be taken into account while carrying out qualitative research are : anonymity , confidentiality and informed consent ( 22 ) . according to richards and schwartz findings ( 22 ) , the term 
confidentiality conveys different meanings for health care practitioners and researchers . for health care practitioners , confidentiality means that no personal information is to be revealed except in certain situations . for researchers , however , the duty of confidentiality is less clear and involves elaboration of the form of outcome that might be expected from the study ( 22 , 23 ) .
the researcher must endeavor to minimize the possibility of intrusion into the autonomy of study participants by all means .
when highly sensitive issues are concerned , children and other vulnerable individuals should have access to an advocate who is present during initial phases of the study , and ideally , during data gathering sessions .
it is sometimes even necessary that the researcher clarify in writing which persons can have access to the initial data and how the data might be used ( 24 , 25 ) .
informed consent has been recognized as an integral part of ethics in research carried out in different fields . for qualitative researchers , it is of the utmost importance to specify in advance which data will be collected and how they are to be used ( 26 ) .
the principle of informed consent stresses the researcher s responsibility to completely inform participants of different aspects of the research in comprehensible language .
clarifications need to include the following issues : the nature of the study , the participants potential role , the identity of the researcher and the financing body , the objective of the research , and how the results will be published and used ( 27 ) .
informed consent naturally requires ongoing negotiation of the terms of agreement as the study progresses ( 26 ) .
many people consider it necessary to participate in research that their peers , community and/or society may benefit from .
therefore , qualitative health researchers need to clarify that the research they carry out will benefit science and can contribute to the improvement of health policy ( 5 ) .
the qualitative method is utilized to explain , clarify and elaborate the meanings of different aspects of the human life experience .
therefore , researchers can interpret people s experiences because they are involved in human activities .
the principle of  no harm to participants ought to be considered by researchers , who should be aware of the potential harms that might be inflicted upon study subjects .
obviously , sometimes a conflict between the right to know ( defended on the basis of benefits to the society ) and the right of privacy ( advocated based on the rights of the individual ) may happen ( 27 , 28 ) .
there are several effective strategies to protect personal information , for instance secure data storage methods , removal of identifier components , biographical details amendments and pseudonyms ( applicable to names of individuals , places and organizations ) ( 27 ) .
researchers have the responsibility of protecting all participants in a study from potentially harmful consequences that might affect them as a result of their participation .
it is getting increasingly common for research ethics committees to seek documented proof of consent in a written , signed , and ideally , witnessed form .
researchers can only do their best to protect their respondent s identity and hold the information strictly confidential as there would be no guarantee for it otherwise ( 29 ) .
furthermore , in investigations of sensitive topics where written consent puts the informants at risk , audio recorded oral consent would be more appropriate ( 30 ) .
therefore , researchers should seriously consider the potential impact they may have on the participants and vice versa , and details of such interactions should be clearly mentioned in research proposals ( 23 ) .
overall , the role of the researcher as ( a ) stranger , ( b ) visitor , ( c ) initiator , ( d ) insider - expert or other should be well defined and explained ( 3 ) . as brenner quoted kvale state that , preparing an ethical protocol can cover issues in a qualitative research project from planning through reporting ( 30 ) . in qualitative research ,
data are collected with a focus on multifaceted interviews and narratives to produce a description of the experiences .
the researchers , therefore , play the role of a mediator between the experiences of the respondents and the community of concerned people ( 28 , 31 ) .
the post - interview comment sheet could assist the researcher to note the feelings of informants , as well as interpretations and comments that occurred during the interview ( 32 ) .
data collection needs to be as overt as possible , and findings should be recorded .
although there is no guarantee of absolute confidentiality , openly recording field notes assists participants to decide what they wish to have on the record . in health care research , the problem may be even more exaggerated as the researcher is sometimes the health provider as well ( 33 ) . in comparison with other research methods , ethnography has singular characteristics .
when a researcher aims to study the culture of certain people , living amongst them is inevitable .
this method of collecting data is a subject of debate from an ethical point of view .
participants should always be aware of the information that has been obtained and is being recorded , and consent to it .
sometimes this can not be achieved easily and conflicts may happen , as in studies of cultural and ethnic characteristics ( 18 ) .
the physical presence of the researchers within the culture requires them to be responsible for their role and potential consequences on the field .
for instance , when criminals or a group of war veterans suffering from a disease are the subject of a study , the risks involved in living amongst them should be considered .
ethnographers must be vigilant about any distractions stemming from close interactions that can be potentially harmful to participants in the long run ( 33 , 34 ) .
researchers can benefit from supervision sessions directed at learning , mentoring and skill development , all of which can foster their ability to carry out research without risking their health . adequate professional supervision ( which may be outside of the university ) can be of service to researchers in dealing with the potential stress associated with the study ( 35  37 ) . in order to gain explicit data ,
these steps include participant observation , ethnographic record , descriptive observation , taxonomic analysis , selected observation , componential analysis , discovering the cultural theme , cultural inventory , and finally writing ethnography ( 38 , 39 ) .
researchers should always be aware of the precise reason for involvement in a study in order to prevent undesirable personal issues .
the probability of exposure to vicarious trauma as a result of the interviews needs to be evaluated .
interviewers should be properly scheduled to provide the researcher with sufficient recovery time and reduce the risk of emotional exhaustion , while allowing ample time for analysis of the objective and emotional aspects of the research .
it is also necessary for the researcher to be familiar with signs of extreme fatigue and be prepared to take necessary measures before too much harm is done ( 40  42 ) .
the relationship and intimacy that is established between the researchers and participants in qualitative studies can raise a range of different ethical concerns , and qualitative researchers face dilemmas such as respect for privacy , establishment of honest and open interactions , and avoiding misrepresentations ( 19 ) .
ethically challenging situations may emerge if researchers have to deal with contradicting issues and choose between different methodological strategies in conflict arises .
in such cases , disagreements among different components such as participants , researchers , researchers discipline , the funding body and the society may be inevitable ( 20 , 21 ) . some important ethical concerns that should be taken into account while carrying out qualitative research are : anonymity , confidentiality and informed consent ( 22 ) . according to richards and schwartz findings ( 22 ) , the term 
confidentiality conveys different meanings for health care practitioners and researchers . for health care practitioners , confidentiality means that no personal information is to be revealed except in certain situations . for researchers , however , the duty of confidentiality is less clear and involves elaboration of the form of outcome that might be expected from the study ( 22 , 23 ) .
the researcher must endeavor to minimize the possibility of intrusion into the autonomy of study participants by all means .
when highly sensitive issues are concerned , children and other vulnerable individuals should have access to an advocate who is present during initial phases of the study , and ideally , during data gathering sessions .
it is sometimes even necessary that the researcher clarify in writing which persons can have access to the initial data and how the data might be used ( 24 , 25 ) .
informed consent has been recognized as an integral part of ethics in research carried out in different fields . for qualitative researchers , it is of the utmost importance to specify in advance which data will be collected and how they are to be used ( 26 ) .
the principle of informed consent stresses the researcher s responsibility to completely inform participants of different aspects of the research in comprehensible language .
clarifications need to include the following issues : the nature of the study , the participants potential role , the identity of the researcher and the financing body , the objective of the research , and how the results will be published and used ( 27 ) .
informed consent naturally requires ongoing negotiation of the terms of agreement as the study progresses ( 26 ) .
many people consider it necessary to participate in research that their peers , community and/or society may benefit from .
therefore , qualitative health researchers need to clarify that the research they carry out will benefit science and can contribute to the improvement of health policy ( 5 ) .
the qualitative method is utilized to explain , clarify and elaborate the meanings of different aspects of the human life experience .
therefore , researchers can interpret people s experiences because they are involved in human activities .
the principle of  no harm to participants ought to be considered by researchers , who should be aware of the potential harms that might be inflicted upon study subjects . obviously , sometimes a conflict between the right to know ( defended on the basis of benefits to the society ) and the right of privacy ( advocated based on the rights of the individual ) may happen ( 27 , 28 ) .
there are several effective strategies to protect personal information , for instance secure data storage methods , removal of identifier components , biographical details amendments and pseudonyms ( applicable to names of individuals , places and organizations ) ( 27 ) .
researchers have the responsibility of protecting all participants in a study from potentially harmful consequences that might affect them as a result of their participation .
it is getting increasingly common for research ethics committees to seek documented proof of consent in a written , signed , and ideally , witnessed form .
researchers can only do their best to protect their respondent s identity and hold the information strictly confidential as there would be no guarantee for it otherwise ( 29 ) .
furthermore , in investigations of sensitive topics where written consent puts the informants at risk , audio recorded oral consent would be more appropriate ( 30 ) .
therefore , researchers should seriously consider the potential impact they may have on the participants and vice versa , and details of such interactions should be clearly mentioned in research proposals ( 23 ) .
overall , the role of the researcher as ( a ) stranger , ( b ) visitor , ( c ) initiator , ( d ) insider - expert or other should be well defined and explained ( 3 ) . as brenner quoted kvale state that , preparing an ethical protocol can cover issues in a qualitative research project from planning through reporting ( 30 )
in qualitative research , data are collected with a focus on multifaceted interviews and narratives to produce a description of the experiences .
the researchers , therefore , play the role of a mediator between the experiences of the respondents and the community of concerned people ( 28 , 31 ) .
the post - interview comment sheet could assist the researcher to note the feelings of informants , as well as interpretations and comments that occurred during the interview ( 32 ) .
data collection needs to be as overt as possible , and findings should be recorded . although there is no guarantee of absolute confidentiality , openly recording field notes assists participants to decide what they wish to have on the record . in health care research
, the problem may be even more exaggerated as the researcher is sometimes the health provider as well ( 33 ) . in comparison with other research methods ,
ethnography has singular characteristics . when a researcher aims to study the culture of certain people , living amongst them is inevitable .
this method of collecting data is a subject of debate from an ethical point of view .
participants should always be aware of the information that has been obtained and is being recorded , and consent to it .
sometimes this can not be achieved easily and conflicts may happen , as in studies of cultural and ethnic characteristics ( 18 ) .
the physical presence of the researchers within the culture requires them to be responsible for their role and potential consequences on the field .
for instance , when criminals or a group of war veterans suffering from a disease are the subject of a study , the risks involved in living amongst them should be considered .
ethnographers must be vigilant about any distractions stemming from close interactions that can be potentially harmful to participants in the long run ( 33 , 34 ) .
researchers can benefit from supervision sessions directed at learning , mentoring and skill development , all of which can foster their ability to carry out research without risking their health . adequate professional supervision ( which may be outside of the university ) can be of service to researchers in dealing with the potential stress associated with the study ( 35  37 ) . in order to gain explicit data , ethnographers need to know the role of instrument details .
these steps include participant observation , ethnographic record , descriptive observation , taxonomic analysis , selected observation , componential analysis , discovering the cultural theme , cultural inventory , and finally writing ethnography ( 38 , 39 ) .
researchers should always be aware of the precise reason for involvement in a study in order to prevent undesirable personal issues .
the probability of exposure to vicarious trauma as a result of the interviews needs to be evaluated .
interviewers should be properly scheduled to provide the researcher with sufficient recovery time and reduce the risk of emotional exhaustion , while allowing ample time for analysis of the objective and emotional aspects of the research .
it is also necessary for the researcher to be familiar with signs of extreme fatigue and be prepared to take necessary measures before too much harm is done ( 40  42 ) .
it is argued that qualitative research that deals with sensitive topics in depth can pose emotional and other risks to both participants and researchers .
clear protocols for dealing with distress should be in place so that both parties involved in research can use them if necessary .
it is not usually easy to predict what topics are likely to lead to distress , and researchers should therefore receive sufficient training in predicting traumatic situations .
preventive measures for researchers who carry out sensitive qualitative studies should include official arrangements for a peer support program consisting of a list of researchers who are involved , or a constellation of researcher support activities aiming at improving psychological fitness in the form of a professional confidence building module .
other such measures include offering adequate supervision to provide opportunities for self - development and self - care , and facilitating the process of self - reflection and self - monitoring .
strategies for emotional distancing need to be considered and adopted if the research topic or participants have the potential to be emotionally challenging .
an appropriate planning should be in place before the commencement of the fieldwork , and it must be perfectly clear how the study should be conducted and what level of relationship development is necessary .
measures must also be taken so that levels of self - disclosure , objective displays of emotion during the interviews , and strategies to end the relationships are well defined and communicated .
one of the most prominent tasks of qualitative researchers is to minimize the flaws in observation and endeavor to gain truthful knowledge .
therefore , it is necessary for researchers to continuously update their investigation skills in terms of methodology and find novel techniques to better carry out studies in the field of health and sociology . as explained before ,
qualitative research is carried out in natural settings , which requires researchers to work in close collaboration with other members of the team and under direct supervision to discuss and resolve issues as they arise .
therefore , development of practical strategies and communicating them to researchers can be of great benefit and assist them in conducting more perceptive qualitative studies .
it is noteworthy that such research should be directed towards making a difference in people s lives , improving care delivery in different settings and at all levels , and providing a framework for health sciences without any ethical disturbances . as a result of the extensive body of research in the field of medical sciences ,
research ethics committees are formed to provide independent advice to participants , researchers , funders / sponsors and healthcare organizations on the extent to which research proposals comply with universally endorsed ethical standards . in the history of social and medical science , there have been a few research studies that seriously injured people , and many more in which their welfare was not sufficiently protected .
to return to the matter of privacy , the researcher should not rely solely on the informant to identify possible intrusion , but needs to work at anticipating it in advance .
confidentiality does not necessarily preclude intrusion , as anonymity by itself is not enough to protect a person s privacy or prevent disclosure of personal issues .
investigators should refrain from soliciting private information that is not closely related to the research question .
considering the aforementioned challenges , it is recommended to conduct further research in order to provide meticulous and explicit ethical protocols , guidelines and codes with respect to qualitative studies .
 considering the nature of qualitative studies , the interaction between researchers and participants can be ethically challenging for the former , as they are personally involved in different stages of the study . 
 therefore , formulation of specific ethical guidelines in this respect seems to be essential . 
 the present paper aimed to discuss the necessity to develop explicit guidelines for conducting qualitative studies with regard to the researchers role . for this purpose , 
 a literature review was carried out in domestic and international databases by related keywords.health care providers who carry out qualitative research have an immense responsibility . 
 as there is no statistical analysis in qualitative studies , the researcher has to both evaluate what he or she observes and to interpret it . 
 providing researchers with the necessary skills and applying stringent supervision can lead to better extraction of reliable information from qualitative studies . 
 this article presents a debate in order to illustrate how researchers could cover the ethical challenges of qualitative studies and provide applicable and trustworthy outcomes.researchers face ethical challenges in all stages of the study , from designing to reporting . 
 these include anonymity , confidentiality , informed consent , researchers potential impact on the participants and vice versa . 
 it seems of paramount importance that health care providers , educators and clinicians be well informed of all the different aspects of their roles when acting as qualitative researchers . 
 hence , these adroit roles need to be well defined , and the use of practical guidelines and protocols in all stages of qualitative studies should be encouraged . 
Introduction
An overview on qualitative research in health care
Role of researchers in qualitative studies
Ethical challenges in qualitative studies:
The researcher-participant relationship
Research design
Data gathering and data analysis
Conclusion