Institutional Review Boards
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About Institutional Review Boards
An Institutional Review Board (IRB) is a committee of scientists, non-scientists, and community members who are required by federal law to review all research involving humans as study participants.
The IRB’s job is to determine if the research complies with federal and state regulations regarding the protection of human research participants. This includes assuring that:
- The study will be conducted in an ethical manner
- It has scientific merit
- The risks of the research are outweighed by the benefits
An IRB may approve, disapprove, or require revisions to the research it reviews, and it must review all ongoing research at least once each year.
IRBs at Nemours Children's
Nemours has two IRBs. Each is constituted to comply with the membership requirements of the Office of Human Research Protections (OHRP) and the Food and Drug Administration (FDA) and has sufficient expertise to allow them to review most types of human subjects research.
Our IRB members bring a variety of perspectives to the research review process and may include:
- Faculty from a wide range of clinical disciplines and specialties
- Local nonscientific community members
- Legal advisers
- Nurses
- Pharmacists
The IRBs may also seek outside consultation to supplement the collective expertise of its existing members.
Membership details of our IRBs:
Our IRBs work with the Nemours Office of Human Subjects Protection (NOHSP) to represent the interests of special and vulnerable populations, especially children.
All research involving human subjects conducted at Nemours operating entities must be submitted for review and approval by the appropriate Nemours IRB before an investigator may begin the research.
Does It Qualify as Research?
Questions about whether a project is or is not research must be addressed by the IRB. The US Department of Health and Human Services (DHHS) defines research as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge”
Not all projects fit easily into this definition of research. However, all relevant federal regulations and Nemours policy make it clear that the ultimate decision about whether a given project constitutes research rests with the IRB.
Investigators may not act on any IRB decision unless it is documented by the IRB chair or co-chair. Opinions offered outside of the accepted review process may not be used as justification by an investigator to initiate research involving human subjects.
More About IRB Submissions
Independent Accreditation
Nemours is proud to be fully accredited by the Association for the Accreditation of Human Research Protection Programs.
