That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern.
That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or
If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.
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.