IRBs are no different from other boards in how their psychological structure could lead to personality clashes and conflicts. However, unlike many organizations, when IRBs ignore such conflicts, the outcome might be a less-effective human subjects protection program or regulatory problems.
The consent form is the IRBs document, but the sponsor may say, If youre not willing to include this language, this disclaimer, then we wont open the trial at your institution, Joffe explains. Then the IRB can think of creative ways to put it in there without distracting from the message they want to convey in the consent form.
IRB members and others in the research community sometimes have misconceptions about the use of the expedited review process, including the idea that an expedited review is different from a review by the full IRB.
A basic tenet of research involving human subjects is those who agree to be participate must give their informed consent after being informed about the known and unknown risks inherent in their participation. One category of risk is the possibility of injury.
Drug and biotech companies that have paid government scientists for consulting services soon will receive a request from a House subcommittee to voluntarily release financial details of such agreements.