Implications of the Revised Common Rule for Qualitative Health Research: Opportunities, Concerns, and Recommendations

Abstract

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.

Do I Need Institutional Review Board Approval? Applying the 2018 Institutional Review Board Revised Common Rule to Athletic Training Educational Research

“…The RCR provides many benefits for researchers and participants that can save time and improve the clarity of the research process. 2,4 If they have not recently done so, researchers should review their IRB requirements to determine how future scholarly activities should be categorized. Many educational research studies conducted pre-2018 would have required a detailed IRB application and lengthier expedited review, whereas now they may only require a brief application to obtain exempt status.…”

“…2,3 The goal of these changes was to increase flexibility for researchers, better inform potential participants about the research process, and allow IRBs to focus on higher risk studies. 2,4 Two key changes affect educational researchers: (1) the addition of categories that are excluded as research and (2) the expansion of what is considered an exempt study.…”

Ethical inclusion: Risks and benefits of research from the perspective of perinatal people with opioid use disorders who have experienced incarceration

“…In 1978, the United States' National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research outlined ethical guidelines for conducting research with human subjects (the Belmont Report). The Belmont Report has guided determinations of ethical research practices through institutional review boards and research ethics committees with its basic moral principles of respect for persons, autonomy, beneficence, and justice [1,2]. While the Belmont Report arose from a recognition of decades of coercive experimentation that preceded the convening, some have suggested that research has now proliferated and become commodified to a point where a reconsideration of guiding ethical principles is needed [3].…”

“…Informed consent is the primary process through which potential participants in research learn about the potential harms as well as the potential benefits they may accrue through research participation. One consequence of the intense regulatory focus on clinical trials is near consensus on the acceptable risks and benefits of receiving experimental therapies, with a concurrent shift away from regulatory scrutiny of social and behavioral science research practices [2]. Institutionalized ethics procedures run the risk of becoming perfunctory, without considering, from the perspectives of those who have been historically underrepresented or excluded, the unique benefits and risks of which potential research participants should be made aware in order to give informed consent [7].…”