Response 1: If you collect any data from or about the parent s/he must be considered an enrolled subject. We do lot of research here that collects data about prenatal, perinatal and early post-partum periods and in all cases the mother is considered a subject and must be included as such in the consent form and for IRB purposes.  The regs are very clear about this - I think.

Response 1: We require that physicians write the orders. The GCRC nursing staff make sure the IRB approved protocol is being followed. (By Richard E. Kanner)

Response 2: As do we. (by Frederick W. Luthardt)

Response 3: We also require that physicians write orders. Our nursing staff makes sure these are carried out according to the protocol. (By Priscilla N. Adler)

Response 4: As we do. (By Anne C. Knieriem)

Response 5: Being that we are physically located at a VA Hospital, we follow their policy requiring orders for the nurses to follow, especially for procedures, medications, etc. (By Ricardo A. Martinez)

Response 1: My two cents: Women cannot be excluded unless there is "clear and compelling rationale and justification establishes ...". This justification can be safety related as well as scientific. One cannot exclude women just because a study is a pilot study, justification has to be based on the scientific rationale. (By Wajeeh Bajwa)

Response 2: I agree with Wajeeh: Exclusion must be "based on the scientific rationale" - ask the PI to provide this rationale. There have been studies that involve exercise that have included men and women (Nair et al, Welle et al to name two researchers). (By Nancy Needler)

Response 3: I agree. Also, the benefit of doing a pilot study is to iron out design and procedural issues before you are committed to the full study. It seems to me that the investigator should use this time to resolve his problems concerning female subjects, because he may not be able to justify not including females in an RO1 proposal, for example. (By Jane Alexander)