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.
Finder’s Fees – Payments in exchange for referrals of potential participants. Finder’s fees are prohibited and will not be approved by the IRB. Also, payments to the organization or research staff designed to accelerate recruitment that are tied to the rate or timing of enrollment (“bonus payments”) are prohibited.
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. The FWA for Marshall University is #00002704.