At a third institution, the concern was whether or not the IRB was properly conducting the required continuing, annual review of research. The institution demonstrated to OPRR that some 2,000 research protocols involving human subjects had, indeed, received continuing review in accord with DHHS regulations. Institutional Review Boards Let me turn briefly to the specific responsibilities of the Institutional Review Board. This is particularly important when subjects are likely to be vulnerable to coercion or undue influence. IRBs watch out especially for research involving children, prisoners, pregnant women, individuals with mental disabilities, individuals who are economically disadvantaged, and individuals who are educationally disadvantaged.
Federal regulations provide extra protection for vulnerable subjects in several ways.
If an IRB regularly reviews research that involves a category of vulnerable subjects, consideration must be given to including as IRB members one or more individuals who are knowledgeable about, and experienced in working with, the vulnerable subjects. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, IRBs must see that additional safeguards are included in the study protocol. Specific, detailed protections are actually written into DHHS regulations pertaining to pregnant women, fetuses, human ova fertilized in vitro, prisoners, and children involved in research. Once research is initiated, IRBs have continuing responsibilities. Authority to observe or have a third party observe the consent process and the research.