FDA and Other Agencies Flashcards
(16 cards)
Unlike the Common Rule, the FDA doesn’t govern all human subject research. What does it govern?
only clinical investigations of FDA-regulated products
What’s considered an FDA regulated product?
Drugs, Biologics, and Devices
When are IND’s required?
When a study evaluates an unapproved drug or biologic. Also required when changing the use of an approved drug in a way that affects safety or labeling.
When are IDE’s required?
When a significant risk device is involved. Non-significant risk (NSR) device studies don’t need FDA IDE approval, but the IRB must make the NSR determination
Do Non-significant risk (NSR) devices need FDA IDE approval?
No, but the IRB must make the NSR determination.
Can FDA-regulated research use broad consent?
No - the FDA does not recognize Broad Consent.
Under what conditions can informed consent be waived in FDA-regulated research?
Only in emergencies or under specific FDA provisions
What’s the difference between Emergency use and Expanded Access?
Emergency Use: Like breaking the glass on a fire extinguisher — one-time, urgent use. Unplanned, urgent, IRB notification after.
Expanded Access: Like a compassionate use lane — non-research but regulated access to an investigational product. Planned, IRB and FDA approval required.
Are Emergency Use, Expanded Access, and HUDs considered research?
No. If the primary intent is treatment, not generalizable knowledge, then it’s not considered research — even if FDA regulations apply.
Does the FDA follow 45 CFR 46.116(e) and (f)?
No. The FDA does not adopt 46.116(e) and (f) — their rules for waiver of consent are much narrower (emergency use only, with very limited exceptions).
True or False: Not all FDA-regulated research is considered a clinical investigation.
False. Not all research is a clinical investigation under FDA, but all FDA-regulated research is clinical investigation.
True or False: IRBs have the final say on whether a drug or device is SR/NSR.
False: FDA has the final say, even after the IRB makes a determination.
Can FDA-regulated pediatric research be approved if it doesn’t meet Subpart D Categories 1–3? (Note: there is a category 4)
No — unlike HHS, the FDA does not allow a “407-like” review pathway. The research must fit Categories 1–3. Category 4 that HHS allows is the following:
Research not otherwise approvable but presents an opportunity to understand, prevent, or alleviate a serious problem affecting children’s health or welfare
The DoD applies the Common Rule, but with added requirements. What are those added requirements mostly concerning?
minimizing coercion and ensuring oversight layers. More Specifically:
Scientific review required, Extra training, voluntary service member protections, no research on POWs
The Department of Justice applies the Common Rule, but is stricter in what areas?
confidentiality and no undue influence in correctional settings.
More Specifically: Special rules for prisoner research, stricter confidentiality, no impact on parole or release
In addition to following the common rule, what are the potential additional requirements under NIH research?
Certificates of Confidentiality required for certain studies, sIRB policy, data sharing policies
