FDA Asks for Input on Human Research Data Collection
Published Date: 9/29/2026
Notice
Summary
The FDA wants your thoughts on how they collect info about medical devices to keep people safe. This affects anyone involved in medical research or device tracking and aims to improve how data is gathered without adding extra hassle. You’ve got until November 30, 2026, to share your comments, so don’t miss out on shaping the future of health safety!
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Written Informed Consent Required for FDA Studies
For clinical investigations regulated by FDA, investigators must obtain legally effective informed consent and document it using a written consent form that is IRB-approved and signed and dated by the subject or the subject's legally authorized representative. The basic elements required in consent are set out in 21 CFR 50.25 and include purpose, procedures, risks and benefits, confidentiality, contact information, and a statement that participation is voluntary.
Large Time Burden on IRBs and Investigators
The FDA estimates about 2,520 IRBs oversee FDA-regulated research and quantifies annual administrative burden: 1,363 hours for reporting tasks, 1,522,104 hours for recordkeeping tasks, and 103,336 hours for third-party disclosures. FDA assumes each IRB meets about 14.6 times per year and uses 40 person-hours per meeting for recordkeeping under Sec. 56.115.
Certificates of Confidentiality Protect Research Privacy
The 21st Century Cures Act requires issuance of Certificates of Confidentiality (CoCs) for federally-funded human subject research that collects or uses identifiable, sensitive information (mandatory CoCs), while CoCs remain discretionary for non-federally funded research. FDA issued guidance on CoCs (November 2020) describing how to request them and the responsibilities they carry.
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Key Dates
Department and Agencies
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Previous: 2026-19848, Submission of Information Collection for OMB Review; Comment Request; Generic Clearance for the Collection of Qualitative and Quantitative Feedback on Agency Service Delivery
The Pension Benefit Guaranty Corporation (PBGC) wants to keep collecting feedback from the public about how well they deliver their services. They’re asking for permission to continue this through October 31, 2026, and want your comments by October 29, 2026. This helps PBGC improve without costing extra money or time for most people.
Next: 2026-19850, Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503
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