An Institutional Review Board (IRB) is charged with protecting the rights and welfare of people involved in research. The IRB reviews plans for research involving human subjects to assure, both in advance and by periodic review, appropriate steps are taken to protect the rights and welfare of human subjects in the research study. To accomplish this purpose, IRBs review research protocols and related materials (e.g., consent forms, recruitment material, investigator brochures) to ensure the rights and welfare of human research subjects are protected.
Institutions that accept research funding from the federal government must have an IRB to review all research involving human subjects (even if a given research project does not involve federal funds). The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) set the guidelines and regulations governing human subjects research and IRBs.
The Office for Human Research Protections (OHRP) provides the above guidance as a guide to help in deciding:
- whether an activity is research that must be reviewed by an IRB
- whether the review may be performed by expedited procedures, and
- whether informed consent or its documentation may be waived.
Please consult with the IRB office for further clarification.