Certification for IRB Professionals (CIP) Practice Exam

A waiver of the requirement for documentation of informed consent may be granted when?

1. The only record linking the subject and the research is the consent document, and the principal risk is a breach of confidentiality.

2. There is a significant chance of the subject being harmed in the process.

3. The study has no potential risks for the subjects involved.

4. The research involves only aggregated data with no individual identifiers.

The correct answer is: The only record linking the subject and the research is the consent document, and the principal risk is a breach of confidentiality.

The correct answer is rooted in the principles of ethical research practices, particularly regarding informed consent and the protection of participant confidentiality. A waiver for documentation of informed consent may be granted under the condition that the only record linking the participant to the research is the consent document itself. In this scenario, there is a substantial risk that participants' confidentiality could be compromised if their consent documentation were to be linked to identifiable data. By allowing a waiver in such cases, researchers can minimize the risk of breaches of confidentiality, which is critical to maintaining the trust of participants and ensuring their privacy. This is particularly relevant in studies where sensitive information is collected, as retaining the signed consent document could inadvertently expose participants to potential risks if confidentiality is not properly safeguarded. The other options fail to meet the criteria for waiving documentation of informed consent. For example, the presence of potential harm to subjects or the involvement of aggregated data without identifiers addresses different aspects of ethical considerations but does not inherently lead to a waiver of documentation for informed consent. Hence, focusing specifically on confidentiality and the unique relationship between consent documentation and participant identification is essential for understanding why this option is correct.