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.
The disease is caused by a bite of a deer tick (Ixodes scapularis) leading to a bacterial infection (Borrelia burgdorferi) . With the impending changes to the climate, scientists expect to see the reported cases of Lyme disease to increase, as well as the disease to be able to occur in areas it previously had not.