{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,15]],"date-time":"2026-04-15T13:44:36Z","timestamp":1776260676379,"version":"3.50.1"},"reference-count":13,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2020,7,14]],"date-time":"2020-07-14T00:00:00Z","timestamp":1594684800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008460","name":"National Center for Complementary and Integrative Health","doi-asserted-by":"publisher","award":["U24AT010961"],"award-info":[{"award-number":["U24AT010961"]}],"id":[{"id":"10.13039\/100008460","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006086","name":"Office of Strategic Coordination","doi-asserted-by":"publisher","award":["U24AT009676"],"award-info":[{"award-number":["U24AT009676"]}],"id":[{"id":"10.13039\/100006086","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Learning Health Systems"],"published-print":{"date-parts":[[2021,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>The need to protect the confidentiality of research data has long been recognized. One means to help protect research data from use in civil or criminal matters in the United States is a Certificate of Confidentiality (CoC). Until recently, investigators applied for a CoC when conducting research that was sensitive, stigmatizing or where the disclosure of private information could possibly result in civil or criminal liability. However, effective October 1, 2017, CoCs are automatically issued for much research supported by the National Institutes of Health (NIH). While automatic issuance reduces administrative burden, it also poses some surprising unanticipated challenges for research in general and pragmatic clinical trials (PCTs) in particular, which are key elements of learning health systems.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We reviewed the new policy on CoCs to identify and analyze issues related to it that are potentially problematic for PCTs.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>We identified three relevant issues: (1) whether the EHR may be populated with research data that may be sensitive or stigmatizing without explicit consent from subjects; (2) incomplete protections for sensitive data in the EHR; and (3) requirements for notifying subjects about the CoC provisions.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Formal guidance from the NIH is needed to address the application of CoCs to the setting of PCTs. In the meantime, it is essential for researchers designing and conducting PCTs, as well as health care systems in which this research is conducted, to be aware of the nuances inherent in CoCs so they can best adhere to their legal obligations regarding them. In the absence of guidance, special attention should be paid to pragmatic research that populates the electronic health record with research data as well as research conducted without explicit consent. Given the large amount of pragmatic research precipitated by the Coronavirus Disease 2019 pandemic, which has been accompanied by major efforts to share data, the need for such guidance is especially urgent.<\/jats:p><\/jats:sec>","DOI":"10.1002\/lrh2.10238","type":"journal-article","created":{"date-parts":[[2020,7,14]],"date-time":"2020-07-14T15:22:50Z","timestamp":1594740170000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Certificates of confidentiality and unexpected complications for pragmatic clinical trials"],"prefix":"10.1002","volume":"5","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7022-8332","authenticated-orcid":false,"given":"Jeremy","family":"Sugarman","sequence":"first","affiliation":[{"name":"Berman Institute of Bioethics Johns Hopkins University  Baltimore Maryland USA"},{"name":"School of Medicine Johns Hopkins University  Baltimore Maryland USA"},{"name":"Bloomberg School of Public Health (JS) Johns Hopkins University  Baltimore Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Judith","family":"Carrithers","sequence":"additional","affiliation":[{"name":"Advarra  Columbia Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,7,14]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"National Institutes of Health. Certificates of Confidentiality\u2014Human Subjects.https:\/\/grants.nih.gov\/policy\/humansubjects\/coc.htm[accessed April 2 2020]."},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.2307\/3564529"},{"key":"e_1_2_8_4_1","unstructured":"United States Congress. 21st Century Cures Act. Pub. L. No. 114\u2010255 2016."},{"key":"e_1_2_8_5_1","unstructured":"National Institutes of Health. Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality NOT\u2010OD\u201017\u2010109 September 7 2017.https:\/\/grants.nih.gov\/grants\/guide\/notice-files\/NOT-OD-17-109.html[accessed April 2 2020]."},{"key":"e_1_2_8_6_1","first-page":"28","article-title":"Certificates of confidentiality following enactment of the 21(st) Century Cures Act","volume":"11","author":"Ekweani E","year":"2018","journal-title":"J Health Life Sci Law"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1177\/0098858818789431"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1177\/1740774515598334"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1177\/1740774515597688"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1177\/1740774515597677"},{"key":"e_1_2_8_11_1","unstructured":"National Institutes of Health. Helping to End Addiction Long\u2010term Initiative (HEAL).https:\/\/heal.nih.gov\/[accessed April 2 2020]."},{"key":"e_1_2_8_12_1","unstructured":"National Institutes of Health. Frequently Asked Questions: Certificates of Confidentiality.https:\/\/grants.nih.gov\/faqs#\/certificates-of-confidentiality.htm[accessed April 2 2020]."},{"key":"e_1_2_8_13_1","unstructured":"National Institutes of Health. Example Informed Consent Language.https:\/\/grants.nih.gov\/policy\/humansubjects\/coc\/helpful-resources\/suggested-consent.htm[accessed April 2 2020]."},{"key":"e_1_2_8_14_1","unstructured":"Wellcome Trust. Sharing Research Data and Findings Relevant to the Novel Coronavirus (COVID\u201019) Outbreak.https:\/\/wellcome.ac.uk\/coronavirus-covid-19\/open-data[accessed June 21 2020]."}],"container-title":["Learning Health Systems"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Flrh2.10238","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/lrh2.10238","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/lrh2.10238","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/lrh2.10238","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,19]],"date-time":"2023-08-19T01:24:29Z","timestamp":1692408269000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/lrh2.10238"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,7,14]]},"references-count":13,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2021,4]]}},"alternative-id":["10.1002\/lrh2.10238"],"URL":"https:\/\/doi.org\/10.1002\/lrh2.10238","archive":["Portico"],"relation":{},"ISSN":["2379-6146","2379-6146"],"issn-type":[{"value":"2379-6146","type":"print"},{"value":"2379-6146","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,7,14]]},"assertion":[{"value":"2020-04-11","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-06-24","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-07-14","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e10238"}}