Definitions of Research Compliance Terms

Federal Policy – Another short reference, along with the phrase “Common Rule,” for the Federal Policy for the Protection of Human Subjects in Research.

Federal Wide Assurance (FWA) – An agreement or contract between the institution and OHRP, on behalf of the Secretary, DHHS, stipulating the method(s) by which the organization will protect the welfare of research subjects in accordance with the regulations. The Assurance, approval of which is a condition of receipt of DHHS support for research involving human subjects, spells out the organization’s responsibilities for meeting the requirements of 45 CFR 46. The FWA replaces all other previous forms or assurances (i.e., MPA, SPA, etc.).

Fetus – 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.)

510(K) Device – A medical device that is considered substantially equivalent to a device that was or is being legally marketed. A sponsor planning to market such a device must submit notification to the FDA 90 days in advance of placing the device on the market. If the FDA concurs with the sponsor, the device may then be marketed. 510(k) is the section of the Food, Drug and Cosmetic Act that describes premarket notification; hence the designation "510(k) device."

Food and Drug Administration (FDA) – An agency of the Federal government, established by Congress in 1912 and presently part of the Department of Health and Human Services (HHS). FDA regulations apply only to research involving FDA-regulated products. The FDA has the authority to suspend clinical trials and/or disqualify clinical investigators not in compliance with FDA regulation. HHS regulations, however, apply to all human subject research.

Full Board Review – Review of proposed research at a convened meeting at which a majority of the membership of the IRB are 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.