And I Won’t Tell No One Your Name: Doesn’t Matter, FDA Reminds IVD Industry of IRB Review in Certain Cases

Arnall Golden Gregory LLP
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The authors doubt the Food and Drug Administration was humming the Goo Goo Dolls 1995 hit, “Name,” when it drafted its letter, dated October 18, 2021, to manufacturers of in vitro diagnostics to remind them that the agency requires Institutional Review Boards to evaluate all clinical investigations of medical devices that involve human subjects, including those that use leftover, de-identified human specimens in FDA-regulated studies.1 FDA defines “leftover human specimens” as “remnants of specimens collected for routine clinical care or analysis that would otherwise have been discarded.” Even though, as the song lyric goes, “And I won’t tell no one your name,” to FDA, it doesn’t matter. The agency requires IRB oversight and evaluation. The agency said that this requirement includes data used to support an investigational device exemption, a medical device marketing application, or a submission to include IVD technical or analytical studies that use human specimens.

FDA made clear that its 2006 FDA guidance, “Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identified,” does not exempt any investigations from IRB requirements.2 The agency reiterated there that it would exercise enforcement discretion with regard to the requirements for informed consent in certain circumstances, as described in that guidance:

  1. The investigation meets the IDE exemption.
  2. The study uses leftover specimens; the study may also use specimens obtained from specimen repositories or leftover specimens that were previously collected for other research purposes.
  3. The specimens are not individually identifiable.
  4. The specimens may be accompanied by clinical information as long as this information does not make the specimen source identifiable to the investigator or any other individual associated with the investigation, including the sponsor.
  5. The individuals caring for the patients are different from and do not share information about the patient with those conducting the investigation.
  6. The specimens are provided to the investor without identifiers, and the supplier of the specimens has established policies and procedures to prevent the release of personal information.
  7. The study has been reviewed by an IRB (with limited exemption).

AGG Observations

  • What the recent FDA letter makes clear is that, while FDA might exercise enforcement discretion for informed consent, the requirement for IRB review remains.
  • Even if FDA uses its enforcement discretion, an IRB still has the authority to review, approve, require modification, or disapprove of all research activities covered under its regulations (e.g., an IRB’s authority to observe the consent process).
  • The agency wants to reiterate the dual roles of both FDA and IRBs in the review process.

[1] www.fda.gov/medical-devices/industry-medical-devices/studies-using-leftover-deidentified-human-specimens-require-irb-review-letter-industry (2021).

[2] Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable – Guidance for Sponsors, Institutional Review Boards, and Food and Drug Administration Staff (2006).

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