Regulatory Affairs Certification (RAC) Practice Exam

Who must disclose financial interests during an investigation?

1. All research team members

2. Only the lead investigator

3. Investigators with significant holdings in the sponsor company

4. Anyone who has potential conflicts

The correct answer is: Investigators with significant holdings in the sponsor company

The requirement for financial interest disclosure during an investigation is rooted in the need for transparency to manage potential biases that could affect the integrity of the research. The correct answer highlights that it is the investigators with significant holdings in the sponsor company who are specifically mandated to disclose their financial interests. This focus on significant holdings is critical because these holdings could create substantial conflicts of interest that might influence the outcome of the research or the impartiality of the findings. By disclosing these interests, the validity of the research can be better ensured, and appropriate measures can be taken to mitigate any potential biases. In contrast, while it is indeed good practice for all team members to be transparent about their financial interests, the legal or formal requirement may not extend to all research team members but rather focuses on those whose financial interests could be seen as materially influencing the research process. This approach aids in preserving the ethical standards essential in research and maintaining trust with the public and regulatory bodies.