Q – When should a participant be re-consented?
A – The IRB will consider, on a case-by-case basis, whether and when periodic re-consenting of individuals is required to assure that a participant’s continued involvement is voluntary. The IRB may require that the investigator re-consent subjects after taking into account the study’s anticipated length and the condition of the individuals to be included (e.g., participants with progressive neurological disorders, participants who may become incarcerated, an altered risk/benefit ratio, etc.). Additionaly, the IRB will consider whether and when to require a reassessment of decision-making capacity.
