Re-consent of subjects enrolled in clinical trials initiated prior to March 7, 2012 is not required. From a practical perspective, however, investigators and sponsors may choose to include the required language in consent forms for applicable clinical trials even if study initiation will occur prior to March 7, 2012.
Climate change will have the following effects on Lyme disease: An acceleration of the tick's developmental cycle, a prolonged developmental cycle, increased egg production, increased population density, and a broader range of risk areas.
Most occurrences of Lyme disease in United States are in the Northeast, especially Connecticut. While it is unclear how climate change will impact Lyme disease, several studies in the Northeast have linked tick activity and Lyme disease incidence to climate, specifically abundant late spring and early summer moisture.