Abstract: A central requirement for the ethical conduct of research is the fully informed consent of a competent individual who is free to exercise his or her own will without restriction and free from duress. Research involving an individual who does not meet these prerequisites is ethically problematic. Vulnerable persons, defined by Robert Levine as those who are "relatively (or absolutely) incapable of protecting their own interests," include children, prisoners and adults with impaired cognitive capacity, and the federal regulations require they be afforded additional protections. These protections often include requiring the proxy consent of a legally authorized representative.
Join Judy to discuss the possibility that Institutional Review Boards (IRBs) allow researchers to use proxy consent to protect cognitively impaired adults and children in cases where it is not appropriate, and neglect the requirement that the subject should be asked to provide his or her own assent for participation. The characteristics that make a particular research subject vulnerable will be discussed, along with suggestions for a variety of possible protections that should be extended to vulnerable research subjects depending on the nature of the risks posed and the extent of the individual's capacity.
No pre-registration is required and all are welcome to attend. For more information or to submit advance questions, contact Melissa Miklos by email at firstname.lastname@example.org.
University of Pittsburgh Human Research Protection Office (HRPO)
Location and Address
Biomedical Science Tower - Room S120