Explain the study orally to the potential topic, provide all relevant information (purpose, procedures, risks, benefits, alternatives to participation), and give the potential participant ample opportunity to ask questions or raise concerns. Do not read the consent document verbatim, but paraphrase information that verifies understanding and allows questions to be asked throughout the process. For some studies, it would be appropriate to involve family members or close friends in the process. Because the above guidelines are flexible with respect to what is considered valid documented consent, some regulations require strict security requirements. As IRBs, we found that, for this reason, certain types of studies require a signed personal signature as the only acceptable method of documentation. These include FDA-regulated studies that fall under 21 CFR 312 (drugs and biologics) and 21 CFR 812 (devices) and therefore require Part 11 compliance, as well as HIPAA-regulated studies that require individual approval for use/disclosure in research (45 CFR 164). Ensure subjects sign the currently approved consent form by printing the stamped copy of iRIS (not mandatory, but highly recommended). An effective informed consent process includes: The term “opt-out” is sometimes used in research with children to describe situations where the reviewer can expect a parent to allow a child to participate. For example, researchers who collect survey and behavior data from children at school give parents information about the study in the mail and ask parents to return a form if they do not want their child to participate. Sometimes this practice is referred to as the opt-out procedure, which is inconsistent with the regulatory requirement to obtain and obtain parental permission. If the IRB determines that the conditions for waiving parental authorization can be met, it may waive the parental permission requirement under 45 CFR 46.408(c) or 45 CFR 46.116(c) or (d). Even if the regulations do not require it, an IRB may require that parents have the opportunity to refuse permission, even if the IRB has waived the regulatory requirement to obtain parental permission. The IRB must review and approve all changes to the approved consent process, including changes to the content as described in the items listed in 45 CFR 46.116 or its Appendix, and may determine whether it is necessary to repeat the process (45 CFR 46.103(b)(4)).
The IRB should consider whether the changes could affect the subject`s understanding of the nature of the study or their willingness to participate. If this is the case, these changes must be made to the declaration of consent. Even in the absence of significant protocol changes or informed consent, regular iteration or confirmation of consent is often a good idea, especially if the study takes place over a long period of time or is particularly complex. Minor changes, such as correcting insignificant typographical errors in the consent document, would generally not reach a level that requires duplication of the consent process. [Note: The previous version of the response to this FAQ contained the following sentences. “Remuneration should in no way be seen as a means of compensating for risks; That is, it should not be considered as an advantage that must be weighed against the risks of the study. The level of compensation should not be so high that a potential subject takes risks that he or she would not take without the compensation. The first sentence was deleted because this FAQ focuses on possible undue interference with the consent process (45 CFR 46.116) and not on the IRB`s considerations under 45 CFR 46.111. However, OHRP continues to assert that IRBs should not consider compensation as a means of offsetting risk. The second sentence has been deleted to clarify that subjects` remuneration may include compensation for risks associated with their participation in research and that remuneration may be an acceptable reason for consenting to participate in research.