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FDA Oversight

The FDA has oversight over clinical trials involving investigational drugs, devices, and biologics, and some trials involving approved drugs, devices and biologics. Contact the IRBMED Office if there is any question regarding whether FDA oversight of a clinical trial is required.

Federal Demonstration Partnership(FDP)

The FDP is a cooperative initiative among federal agencies and institutional recipients of federal funds. It was established to increase research productivity by streamlining the administrative process and minimizing the administrative burden on principal investigators while maintaining effective stewardship of federal funds.

Federal Policy

The federal policy that provides regulations for the involvement of human subjects in research. The Policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any federal department or agency that takes appropriate administrative action to make the Policy applicable to such research. Sixteen federal agencies have adopted the Policy known as the "Common Rule."

Federal Wide Assurance

The Policy for the Protection of Human Subjects requires that each institution "engaged" in Federally-supported human subject research file in "Assurance" of protection for human subjects. The Assurance formalizes the institution's commitment to protect human subjects. The requirement to file an Assurance includes both "awardee" and collaborating "performance site" institutions. The UM's FWA number is 00004969. The expiration date changes regularly as IRBs update their Rosters.

Fetal Material

The placenta, amniotic fluid, fetal membranes, and umbilical cord.


The product of conception from the time of implantation until delivery. If the delivered or expelled fetus is viable, it is designated an infant [45 CFR 46.203(c)]. The term "fetus" generally refers to later phases of development; the term "embryo" is usually used for earlier phases of development. See also: embryo.

Financial Conflict of Interest

An interest of an individual (or his/her immediate family) of monetary value that would reasonably appear to be affected by the research or an individual’s interest in any entity whose financial interests would reasonably appear to be affected by the research. Financial interests include, but are not limited to: salary or other payments for services (e.g., consulting fees or honoraria), equity interests (e.g., stocks, stock options, or other ownership interests), and intellectual property rights (e.g., patents, copyrights, and royalties from such rights).

Finding of Non-Compliance

An occurrence or determination of noncompliance that does not require further confirmation or investigation (e.g., failure to respond to the IRB within established deadlines, allegation of noncompliance determined by the IRB to be true).


Freedom of Information Act

Follow up report

A supplemental report from a sponsor or investigator providing additional information, clarification, or corrections to a previously reported (to IRBMED) Adverse Event.


A study that is no longer open to accrual but still has subjects

Food and Drug Administration (FDA)

The FDA oversees safety of foods, drugs, devices, biologics and cosmetics for human use. The FDA also works with the blood banking industry to safeguard the nation's blood supply.

For-Cause Audit/Review

An audit of research and/or investigators initiated at the request of the IRB or Institutional Official to obtain or verify information necessary to ensure compliance with regulations and institutional requirements and to inform decisions about the conduct of human subject research and/or human subject protection.

Form 483

The FDA-483 is the written notice of objectionable practices or deviations from the regulations that is prepared by the FDA investigator at the end of an inspection. The items listed on the form serve as the basis for the exit discussion with the researcher at which time the PI can either agree or disagree with the items and can offer possible corrective actions to be taken. The PI may also respond to the district office in writing after it has had sufficient time to properly study the FDA-483 (hyperlink). The receipt of and a PI’s response to the Form 483 is submitted to IRB as an ORIO (hyperlink).

Freedom of Information Act (FOIA)

The FOIA is a federal freedom of information law that allows for the full or partial disclosure of previously unreleased information and documents controlled by the US government. The Act defines agency records subject to disclosure, outlines mandatory disclosure procedures and grants nine exemptions to the statute.

Full Board / Committee Review

Review of proposed research at a convened meeting at which a majority of the membership of the IRB is present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting.

Full Feasibility Review

All new clinical trials will undergo a Feasibility Review. When a trial protocol has not undergone prior scientific review by a recognized peer review body, then the trial is subject to a Scientific Review (which also includes the Administrative Review).

Full Review

If the study does not meet the criteria for exempt or expedited review, then it must be submitted for full review.

Fund Acct. No.

The Proposal Approval Form (PAF), which is part of the eResearch Proposal Management system, accompanies the proposal to record the appropriate signatures to indicate approval of the proposed project.


Federal-Wide Assurance