sensitive aspects of subject's behavior, sensitive surveys, or that take place in settings where subjects have a reasonable expectation of privacy. The IRB or OSP staff will also not consider any research exempt that involves survey or interview procedures involving children or observations of public behavior of children, except for observations of public behavior when the principal investigator does not participate in the activities being observed. Furthermore, in most cases, the IRB or OSP staff will not consider any research exempt that involves a test article regulated by the FDA.
At the time the protocols are deemed to be exempt, researchers will be reminded of the responsibility to report all modifications to protocols and unanticipated problems involving risks to subjects or others in accordance with the policies and procedures herein regarding protocol modifications and unanticipated problems.
According to 45 CFR § 46.111, the IRB shall approve research after determining that all of the following requirements are satisfied:
Risks to subjects are minimized: (i) By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subject's subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted. The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.
Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by, 45 CFR § 46.116.