FDA: Food and Drug Administration – Regulates products, drugs, devices biologics and food/color additives (collectively known as FDA-regulated test articles).
Regulates clinical investigations involving participants, where “clinical investigation” is defined as:
- Any use of a drug, other than the use of an approved drug in the course of medical practice.
- Any use of a medical device other than the use of an approved medical device in the course of medical practice.
- Any activity in which data will be submitted to or held for inspection by FDA.
Participant is defined as:
- An individual who is or becomes a participant in a clinical investigation, either as a recipient of the test article or as a control. A participant may be either a healthy human or a patient.
- Or in the case of a medical device: A human who participates in a clinical investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A participant may be in normal health or may have a medical condition or disease.
FWA: Federal Wide Assurance – A formal agreement, which outlines an institution’s commitment to conduct its research projects in an ethically sound manner and to protect the welfare of the human subjects. Federal policy requires this for all institutions ‘engaged’ in federally supported human subjects research.
[45 CFR 46, section 103(a)]
This replaces the OHRP MPA (Multiple Project Assurance).
OHRP and ORCA are working together so that the FWA number assigned to a VAMC will function for both OHRP and the VA.