TY - JOUR
T1 - Implications of the Revised Common Rule for Qualitative Health Research
T2 - Opportunities, Concerns, and Recommendations
AU - Owczarzak, Jill
AU - Smith, Katherine C.
N1 - Publisher Copyright:
© The Author(s) 2021.
PY - 2022/1
Y1 - 2022/1
N2 - 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.
AB - 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.
KW - ethics
KW - qualitative research
KW - risk
UR - http://www.scopus.com/inward/record.url?scp=85121343734&partnerID=8YFLogxK
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U2 - 10.1177/10497323211061101
DO - 10.1177/10497323211061101
M3 - Article
C2 - 34874221
AN - SCOPUS:85121343734
SN - 1049-7323
VL - 32
SP - 385
EP - 393
JO - Qualitative Health Research
JF - Qualitative Health Research
IS - 2
ER -