In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research.

45 CFR § 46 Subpart D addresses the process of obtaining assent for research involving children. IRB reviewers should refer to all relevant sections of the 45 CFR § 46 when making a determination regarding the adequacy and appropriateness of informed consent and assent processes.

The following are other issues that the IRB may consider to meet its obligations under 45 CFR § 46.111 and University policies and procedures. This is not an exhaustive list, and the IRB may consider other issues not listed here.

The IRB will examine the soundness of the study design insofar as it impacts the rights and welfare of the human subjects. The responsible conduct of research dictates that if a research study is so methodologically flawed that little or no reliable information will result, it is unethical to put subjects at risk or even inconvenience them through participation in such a study. The IRB may request an expert consultant review or defer to scientific review committees, in order to determine whether a study design places subjects at unnecessary risk. The IRB may approve a study design that involves deception or withholding of information, if the strategies are justified and the protocol provides for a post-study debriefing of the subjects.

The IRB will assess whether the risks to subjects are reasonable in relation to the anticipated benefits, if any, to the subjects, and the importance of the knowledge reasonably expected to result from the research. The IRB will consider only those risks and benefits that may result from the research as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research. The federal regulations do not allow the IRB to evaluate the possible long-range effect of applying the knowledge gained through the research. The IRB is required to review any possible benefits a subject may derive from participation in research, or the benefits of new knowledge that may justify asking a person to undertake the risks of the study.

According to 45 CFR § 46, minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. For the prison population, minimal risk is defined as the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or the routine medical, dental, or psychological examination of healthy persons.