Abstract
BackgroundFederal regulations in the United States have shaped Institutional Review Boards (IRBs) to focus on protecting individual human subjects. Health services research studies focusing on healthcare institutions such as hospitals or clinics do not have individual human subjects. Since U.S. federal regulations are silent on what type of review, if any, these studies require, different IRBs may approach similar studies differently, resulting in undesirable variation in the review of studies focusing on healthcare institutions. Further, although these studies do not focus on individual human subjects, they may pose risks to participating institutions, as well as individuals who work at those institutions, if identifying information becomes public.DiscussionUsing two recent health services research studies conducted in the U.S. as examples, we discuss variations in the level of IRB oversight for studies focusing on institutions rather than individual human subjects. We highlight how lack of IRB guidance poses challenges for researchers who wish to both protect their subjects and work appropriately with the public, journalists or the legal system in the U.S. Competing interests include the public’s interest in transparency, the researcher’s interest in their science, and the research participants’ interests in confidentiality. Potential solutions that may help guide health services researchers to balance these competing interests include: 1) creating consensus guidelines and standard practices that address confidentiality risk to healthcare institutions and their employees; and 2) expanding the IRB role to conduct a streamlined review of health services research studies focusing on healthcare institutions to balance the competing interest of stakeholders on a case-by-case basis.SummaryFor health services research studies focusing on healthcare institutions, we outline the competing interests of researchers, healthcare institutions and the public. We propose solutions to decrease undesirable variations in the review of these studies.
Highlights
Federal regulations in the United States have shaped Institutional Review Boards (IRBs) to focus on protecting individual human subjects
Summary: For health services research studies focusing on healthcare institutions, we outline the competing interests of researchers, healthcare institutions and the public
We propose solutions to decrease undesirable variations in the review of these studies
Summary
Examples of variation in review of non-human subjects research by IRBs Study 1: Lagu and colleagues contacted subspecialist practices to request an appointment for a fictional obese and hemiparetic patient, for whom “full and equal access to healthcare services and facilities” is required under the Americans with Disabilities Act (ADA) [2]. Because the Rosenthal study was not reviewed, when they were contacted by journalists asking for the identity of hospitals, they had to decide what to divulge on a case-by-case, ad hoc basis They did not benefit from an IRB review that could have guided them prior to requests for information from journalists. Additional institutional guidance could have prepared Rosenthal and colleagues and led them to consider the potential risks to their research subjects if the subjects were publicly identified This in turn would have clarified before publication what information should and should not be divulged to the media. Since no clear guidelines for review of nonhuman subjects research exists, it is often left to the individual researcher to balance these competing interests on an ad hoc basis, as occurred with the Rosenthal study.
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