IRB & eConsent

What do the rules and sources say?

• Revised Common Rule (45 CFR 46). Under 45 CFR 46.114(b), U.S. institutions engaged in cooperative research must rely on a single IRB for the U.S. portion of the study. Exceptions apply where law requires more than one IRB or where the federal agency documents that a single IRB is inappropriate. The compliance date was January 20, 2020 (OHRP sIRB exceptions; Federal Register, Nov 22, 2019). Full text: eCFR 45 CFR 46.
• FDA rules (21 CFR 50 and 56). Part 50 covers informed consent and Part 56 covers IRBs for FDA-regulated clinical investigations (eCFR Part 50; eCFR Part 56).
• Harmonization still pending. In September 2022, FDA proposed rules to harmonize with the Common Rule, including a single-IRB requirement for FDA-regulated cooperative research (FR 2022-21089; FR 2022-21088).
• FDA informed consent guidance (Aug 2023, final). "Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors" supersedes FDA's 1998 "A Guide to Informed Consent" (FDA; 88 FR 55703).
• eConsent Q&A (Dec 2016, final, joint FDA/OHRP). "Use of Electronic Informed Consent – Questions and Answers" covers electronic systems and processes, including multimedia, for both HHS-regulated research and FDA-regulated investigations. It finalized the March 2015 draft (Federal Register, Dec 15, 2016; HHS/OHRP). Topics include identity verification, IRB review of eConsent materials, documentation and electronic signatures.
• 21 CFR Part 11 (electronic records and signatures). FDA's final guidance "Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers" (Oct 2024) covers electronic systems, IT service providers, DHTs and Part 11 e-signatures. It supersedes the 2007 "Computerized Systems Used in Clinical Investigations" guidance (FDA; Federal Register, Oct 2, 2024). Regulation text: eCFR Part 11.
• Decentralized trials (Sept 2024, final). "Conducting Clinical Trials With Decentralized Elements" covers remote visits, local health care providers, DHTs, consent, safety monitoring, shipping investigational products and electronic systems. It finalized the May 2023 draft (Federal Register, Sept 18, 2024; HHS guidance portal).

What does it mean for startups?

• Two rulebooks. Federally funded research follows the Common Rule (45 CFR 46). Studies of FDA-regulated products follow 21 CFR 50/56. Many wearable and AI studies fall under both, so map that out early.
• Single IRB is the default for multi-site federally funded studies. Budget for a commercial or central IRB and reliance agreements.
• eConsent is allowed and well-defined. Build to the 2016 Q&A (identity verification, comprehension checks, versioning, giving participants a copy). Pick a vendor whose e-signatures meet Part 11 and get its validation documentation.
• Wearable trials are DCTs. The 2024 DCT guidance and the 2023 DHT guidance together set FDA's expectations for remote data, device provisioning and data integrity.
• Your vendors' compliance is your problem. The 2024 Part 11 Q&A addresses IT service providers directly, so sponsors should qualify their cloud and app vendors.

Sources

1. eCFR 45 CFR 46 — https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46
2. OHRP single IRB exceptions — https://www.hhs.gov/ohrp/regulations-and-policy/single-irb-exception-determinations/index.html
3. FR Nov 22, 2019 — https://www.federalregister.gov/documents/2019/11/22/2019-25358/hhs-policy-for-the-protection-of-human-research-subjects
4. eCFR 21 CFR 50 / 56 / 11 — https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50 , /part-56 , /part-11
5. FDA proposed rules Sept 2022 — https://www.federalregister.gov/documents/2022/09/28/2022-21089/institutional-review-boards-cooperative-research ; https://www.federalregister.gov/documents/2022/09/28/2022-21088/protection-of-human-subjects-and-institutional-review-boards
6. FDA Informed Consent guidance 2023 — https://www.fda.gov/regulatory-information/search-fda-guidance-documents/informed-consent
7. eConsent Q&A 2016 — https://www.hhs.gov/ohrp/regulations-and-policy/guidance/use-electronic-informed-consent-questions-and-answers/index.html ; https://www.federalregister.gov/documents/2016/12/15/2016-30146/use-of-electronic-informed-consent-questions-and-answers-guidance-for-institutional-review-boards
8. Part 11 Q&A 2024 — https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-systems-electronic-records-and-electronic-signatures-clinical-investigations-questions
9. DCT guidance 2024 — https://www.federalregister.gov/documents/2024/09/18/2024-21078/conducting-clinical-trials-with-decentralized-elements-guidance-for-industry-investigators-and-other

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