I once witnessed a heated discussion between a director of research and a clinical director in a community health care clinic. The clinical director was questioning a proposed quality improvement study, investigating employee bias around sensitive patient care information and the influence of employee attitudes on the delivery of health care. The clinical director noted that employee answers reflected intensely personal feelings about an underserved population and while it might be termed quality improvement, participation required an Internal Review Board (IRB) assessment and staff consent. Notwithstanding the sensitive nature of the survey and the possible implications for the employee, the director of research argued that it was not “really research” since it involved employees who were paid to participate in such activities as part of their job.
This vignette represents both sides of ethical oversight. Insistence on an IRB assessment could result in sensitive research requiring staff consent see a decrease in participation. Staff could believe that responses to the survey could be detrimental to their job security or functioning. The director of research wanted everyone to participate because he wanted his data and was reluctant to consider the broader implications. The clinical director wanted to protect staff and their personal opinions, to keep them separate from the care they provided in the clinic. While this scenario represents a broader and ongoing controversy in ethical oversight, (Whicher et al, 2015), who is correct and how is this resolved?
This month’s Digest focuses on Ethical Oversight, one of the core principles of COPE. We define it as all activities involved in publishing, from consent to publication, publication on vulnerable populations, and ethical conduct of research with animals and humans to the ethical handling of data. COPE has a variety of resources related to ethical oversight: flowcharts, past cases, and discussion documents, which include the topic of preprints and publication ethics issues in the social sciences. While there is extensive literature discussing specific dilemmas and responses to the ethical oversight process, what are the barriers to the process?
Intense system pressures to write and publish papers has been posed as one possible barrier. These system pressures emerge from journals, publishers, funders and grant providers, academic promotion committees in universities, and internal review boards. While not representative of each system that potentially throws up demands and output requirements, each entity has some piece of ethical oversight responsibility applied to the individual(s) developing and conducting the research and/or writing the manuscript or grant report, who then submit it for publication or dissemination. The goals of the different and influential groups can be at odds with the concept of ethical oversight where the system is driven by forces other than an approach to ethical reasoning that protects the research subject.
In a paper published in 2002, London noted that the system tends to be driven by a concern about procedural correctness rather than a substantive approach to ethical reasoning. These drivers can be applicable in the world of publication ethics. Is this concern for procedural correctness a barrier to ethical oversight or an excuse for not applying ethical reasoning to activities that will be scrutinized by various entities providing oversight, funding, academic promotion, etc? Or is the demand for output, with low quality disregard to how it is obtained, more of a concern?
Ethical oversight fundamentally begins with individuals having an understanding of research ethics as it is applied to their work, their writing, and where they choose to publish. This should be taught and learned through education, value clarification, mentoring, and a shared commitment to publication ethics at all levels of research development, implementation, and dissemination.
The discussion I described earlier was resolved when the director of research agreed to file an IRB application given that he wanted to publish results, noting that most reputable journals require IRB approval before considering any type of research. The clinical director was relieved that this would follow an oversight process that was protective of his staff’s attitudes about a sensitive patient issue. That clinic now requires IRB oversight for any quality improvement research involving staff. This one example represents the endless feedback loop of questions and need for constant clarification about ethical oversight, what it is, and how it influences research and publication ethics.
Geri Pearson
Chris Graf
Co-Chairs, COPE
London, L. (2002). Ethical oversight of public health research: can rules and IRBs make a difference in developing companies? American Journal of Public Health, 92, 1079-1084.
Whicher, D., Kass, N., Saghai, Y., Faden, R., Tunis, S., Pronovost, P. (2015). The views of quality improvement professionals and comparative effectiveness of research on ethics, IRB’s, and oversight. Journal of Empirical Research on Human Research Ethics, 10, 132-44. Doi: 10.1177/1556264615571558.
COPE co-chairs Chris Graf and Geri Pearson
Read COPE Digest newsletter for more advice and resources to support your ethical oversight policies and procedures, the case of the month 'Ethics of non-active management of a control group', details of our webinar on 'Creating and implementing research data policies', a Forum discussion document on Preprints and more.