Who Protects Subjects

The subject has an obligation to learn about the research study they are considering, ask questions of the investigator, and weigh the risk and benefits prior to independently making a choice of whether to take part.

Investigators, sponsors, ethical review boards or IRBs, and regulatory agencies (such as the Food & Drug Administration and Office for Human Research Protections) also help protect the subject. Each group plays a unique role in the protection of subjects, but by working together, they can accomplish what no single group can do alone. The ultimate goal is to afford the best possible protection of any subject who volunteers to take part in a research study.