Who usually determines whether a research study is non-exempt human subjects research in an institution?

In the context of human subjects research, the determination of whether a study is non-exempt typically falls within the responsibilities of the Institutional Review Board (IRB) administrator. The IRB administrator is essential in managing the review process and ensuring that research studies comply with ethical guidelines and federal regulations related to human subjects.

The IRB administrator has the expertise and knowledge required to evaluate research proposals against established criteria for exemption and non-exemption. This process involves assessing whether the proposed research involves human subjects and determining if it meets the criteria for exemption or if it requires a more rigorous review process.

While the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) set regulations and guidelines that govern human research, they do not directly determine the status of individual studies within institutions. Similarly, the Human Research Protection Program (HRPP) staff may support the IRB administrator, but the ultimate responsibility for the determination rests with the IRB administrator. This role is critical for the protection of research participants and maintaining compliance with ethical standards in research practices.