What do federal regulations require an IRB to review concerning research involving human subjects?

Federal regulations require an Institutional Review Board (IRB) to review a variety of aspects concerning research involving human subjects to ensure their safety, rights, and welfare are protected. Among these, the recruitment strategies and materials are particularly important as they directly impact how participants are approached, informed, and consented to participate in the study. This review process helps ensure that subjects are adequately informed about the study’s purpose, procedures, risks, and benefits, as well as their right to withdraw from the study at any time without penalty.

Reviewing recruitment strategies is essential to prevent coercion and ensure that the participation process is ethical and transparent. It allows the IRB to assess whether the methods of reaching potential participants are appropriate, respectful, and do not exploit vulnerable populations. By ensuring that recruitment materials adequately inform potential subjects and maintain ethical standards, the IRB aids in promoting the integrity of the research process and safeguarding human subjects.

While the qualifications of researchers and the financial aspects of the research are significant in other contexts, the core focus of the IRB's review per federal regulations centers on the ethical treatment of human subjects, particularly how they are recruited and informed about the study. This highlights the IRB’s vital role in protecting the interests of research participants within the