Can A Clinical Investigator Review Her Own Protocol?

Is it possible for a clinical investigator to serve as a member of the Institutional Review Board (IRB)? Yes, it is allowed, but it’s important to note that IRB regulations (specifically, 21 CFR 56.107(e)) impose certain restrictions on their involvement. Specifically, these regulations prohibit any IRB member from participating in the initial or ongoing review of a research study if they have a conflicting interest in that study. However, they may still play a role in the IRB by providing requested information to support the board’s decision-making process. This measure is in place to maintain the integrity and impartiality of the IRB’s review process.

The role of a clinical investigator in a clinical trial encompasses several crucial responsibilities. Firstly, their primary objective is to conduct rigorous research that generates findings applicable beyond the specific trial, ultimately contributing to the broader body of medical knowledge. Equally important is their duty to safeguard the rights and well-being of the human participants involved in the study. This entails adherence to ethical guidelines, obtaining informed consent, and ensuring that participants are treated with the utmost respect and care throughout the trial process. By fulfilling these dual responsibilities, clinical investigators play a pivotal role in advancing medical science while upholding the highest standards of ethical conduct.