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When they do, investigators and Institutional Review Boards might assume that there is no reason to communicate any information regarding the study to participants. Yet, this approach ignores the possibility that there may be value in providing information to participants, even when the study does not pose significant risks and researchers are not obtaining their consent.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Members of the NIH Collaboratory Ethics and Regulatory Core working group used ethical analysis to determine whether there are reasons to provide information to research participants, other than notifying them of significant risks or obtaining their consent. Study team members then provided examples of trials which illustrate the feasibility and different options for providing information to participants in the context of trials conducted with a waiver of research consent.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Communicating information to participants can promote one or more of six goals: respect for persons, participant understanding of the research, participant understanding of their contributions, participant ability to voice any concerns, participant engagement, and trust and trustworthiness. Providing information can also raise potential concerns about feasibility and cost, which need to be balanced against these reasons to inform participants. Depending on the study, a variety of methods can be used to communicate information; for example, letters, email, flyers, posters, as well as brief conversations with clinicians.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Even when researchers are not obtaining participants' consent, communicating information can promote one or more of six important goals. Providing information to participants should thus be the default for trials conducted under a waiver of research consent.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/lrh2.70014","type":"journal-article","created":{"date-parts":[[2025,4,21]],"date-time":"2025-04-21T06:10:12Z","timestamp":1745215812000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Disentangling informing participants from obtaining their consent"],"prefix":"10.1002","volume":"9","author":[{"given":"Patricia Pearl","family":"O'Rourke","sequence":"first","affiliation":[{"name":"Harvard Medical School, Harvard University  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4767-2512","authenticated-orcid":false,"given":"Joseph","family":"Ali","sequence":"additional","affiliation":[{"name":"Berman Institute of Bioethics, Johns Hopkins  Baltimore Maryland USA"},{"name":"Bloomberg School of Public Health, Johns Hopkins  Baltimore Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judith","family":"Carrithers","sequence":"additional","affiliation":[{"name":"Advarra Inc  Columbia Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Magnus","sequence":"additional","affiliation":[{"name":"Stanford Center for Biomedical Ethics Stanford University  Stanford California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin S.","family":"Wilfond","sequence":"additional","affiliation":[{"name":"Treuman Katz Center for Pediatric Bioethics and Palliative Care, Children's Hosptial, University of Washington  Seattle Washington, DC USA"},{"name":"Seattle Children's Research Institute, Children\u2019s Hospital, University of Washington  Seattle Washington, DC USA"},{"name":"University of Washington School of Medicine, University of Washington  Seattle Washington, DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sheana","family":"Bull","sequence":"additional","affiliation":[{"name":"Community and Behavioral Health, Health Impact Laboratory Colorado School of Public Health  Aurora Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura M.","family":"Dember","sequence":"additional","affiliation":[{"name":"Renal\u2010Electrolyte and Hypertension Division, Department of Medicine, Hospital of University of Pennsylvania  Philadelphia Pennsylvania USA"},{"name":"Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania  Philadelphia Pennsylvania USA"},{"name":"Center for Clinical Epidemiology and Biostatistics; Perelman School of Medicine University of Pennsylvania  Philadelphia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gail","family":"D'Onofrio","sequence":"additional","affiliation":[{"name":"Emergency Medicine and Medicine Yale School of Medicine  New Haven Connecticut USA"},{"name":"Yale School of Public Health, Yale University  New Haven Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie","family":"Goldman","sequence":"additional","affiliation":[{"name":"Department of Psychosocial Oncology and Palliative Care Dana\u2010Farber Cancer Institute  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P. 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