Who should be listed on the consent form as the contact to answer questions?
21 CFR 50.25(a)(7) requires contacts for questions about the research, the research subject’s rights, and in case of a research-related injury. It does not specify whom to contact. The same person may be listed for all three. However, FDA and most IRBs believe it is better to name a knowledgeable person other than the clinical investigator as the contact for study subject rights. Having the clinical investigator as the only contact may inhibit subjects from reporting concerns and/or possible abuses. Standard language for subjects in studies being conducted at the University of Minnesota Medical Center, Fairview: “If you have any questions or concerns regarding the study and would like to talk to someone other than the researcher(s), you are encouraged to contact the Fairview Research Helpline at telephone number 612-672-7692 or toll free at 866-508-6961. You may also contact this office in writing or in person at University of Minnesota Medical Center, Fairview-Riverside Campus, #815 P
