I've been on an IRB at various levels and at various types of institutions for well over a decade, so I've followed the news about them and heard of the results of many of their deliberations. Based on that experience, it is not far off the mark to say that many of them are making up their own rules. Sure, they have to deal with unanticipated circumstances. However, I would be rich if I had a nickel for every time I heard of an IRB requiring the gathering of signatures on informed consent forms from subjects in experiments that posed no risk to the subjects except the risk of being identified with the experiment through the signing of an informed consent form--a situation that the OHRP explicitly cites as one in which informed consent forms should not be collected. If that ain't making rules up, I don't know what is. --Christian Nelson On Mar 9, 2008, at 7:05 PM, Lois Ann Scheidt wrote:
Most - if not all - IRBs in the USA are most definitely NOT making up rules.