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Implications of the Revised Common Rule for Qualitative Health Research

Opportunities, Concerns, and Recommendations

Bibliographic Data

ID4706293
AuthorsJ Owczarzak (0000-0003-2380-5533, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA), Karen C Smith (0000-0003-2140-1690, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA, corresponding author)
Year2022
Volume32
Issue2
Pages385-393
Publication date2022-01-01
Peer ReviewedYes
Open AccessYes
TypeARTICLE
VenueQualitative Health Research (JOURNAL)
Journal identifiersISSN: 1049-7323 • E-ISSN: 1552-7557
PublisherSAGE Publications Inc (PUBLISHER)
DOI10.1177/10497323211061101
PMID34874221
OpenAlexW4200193619
LanguageEN
References cited34

In January 2019, revisions to federal regulations that outline requirements for ethical oversight of human subjects research (The Revised Common Rule) went into effect. These revisions reflect major changes in thinking about risk and protection of research subjects. The Revised Common Rule (RCR) considerably curtails federal oversight of social and behavioral science, with most non-interventional research and "benign" behavioral interventions becoming exempt from mandated Institutional Review Board (IRB) approval, although determination of exemption remains with IRBs. As two qualitative health researchers serving on IRBs, we consider how this contraction of federal oversight dovetails with longstanding criticisms of IRB oversight of qualitative research. We explore the passage of the RCR as a point of potentially important change in procedure and principle in relation to ethical oversight of qualitative health research. We identify challenges and opportunities with these changes at the institutional, professional, and individual levels for ethical and impactful qualitative research

Alternative medicine · Common Rule · Engineering ethics · Informed consent · Institutional review board · Medical education · Pathology · Political science · Psychiatry · Psychological intervention · Public relations · Qualitative research · Research ethics · Social science · Sociology · Ethics in Clinical Research · Healthcare cost, quality, practices · Medicine · Nursing · Psychology · Qualitative Research Methods and Ethics

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