NIH Seeks Comments on Electronic Confidentiality Certificate System
Published Date: 4/16/2025
Notice
Summary
The NIH wants your thoughts on their updated online system for applying for Certificates of Confidentiality, which help protect sensitive research info. If you’re involved in research, this change affects you by making applications easier and more secure. Comments are open for 60 days, so jump in now to help shape the process—no extra costs involved!
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
CoCs protect research participant identities
Certificates of Confidentiality (under 42 U.S.C. 241(d)) authorize researchers to protect the privacy of human research subjects by prohibiting release of names and identifying characteristics to anyone not connected with the research, except in limited circumstances specified in the statute. NIH issues discretionary CoCs to eligible requesting organizations that provide legally binding affirmations that they will abide by the CoC terms.
Online CoC application for research groups
If your research organization requests a Certificate of Confidentiality (CoC) from NIH, you will use an online CoC Electronic Application System that includes 27 questions and six Institutional Assurance statements to be affirmed by an Institutional Official. NIH received 915 CoC requests from January 2023 through December 2023 and expects a similar number each year; the system has been used since 2015 and NIH is seeking OMB approval for three years.
Time burden to apply: 1.5 hours each
Applying through the NIH CoC online form requires about 90 minutes per response (listed as 90/60 hours) and NIH estimates 915 responses per year for a total estimated annualized burden of 1,373 hours. The notice says there are no costs to respondents other than their time.
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Key Dates
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