Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

Is the investigator required to share the names of subjects with the IRB/IEC?

1. Yes

2. No

3. Only under certain circumstances

4. It depends on the protocol

The correct answer is: No

The correct answer indicates that the investigator is not required to share the names of subjects with the Institutional Review Board (IRB) or Independent Ethics Committee (IEC). This is primarily due to the principles of confidentiality and the ethical treatment of research subjects. Protecting the privacy of research participants is a fundamental aspect of research ethics, and disclosing their identities to the IRB/IEC is generally unnecessary for the review of the research protocol. IRBs/IECs are tasked with evaluating the ethical aspects of research studies, including risks and benefits, informed consent processes, and the adequacy of privacy protections. They are equipped to assess these factors without needing to know the identities of the participants involved. Instead, investigators typically provide aggregated data or summaries that allow the IRB/IEC to perform their duties while maintaining the confidentiality of individual subjects. Sharing personal identifying information could potentially lead to privacy violations and might discourage individuals from participating in research studies, which could impede scientific progress. Therefore, maintaining anonymity is fundamental in protecting participants' rights and encouraging ethical compliance.