Answer： Here is the information from FDA information sheet for your reference.(http://www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm#Informed%20Consent%20Document%20Content) Who should be listed on the consent 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.