An article published in the Journal of Medical Ethics explored the controversy surrounding the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) trial and the ethics of other cluster randomized trials (CRTs) involving healthcare professionals.
The FIRST trial (ClinicalTrials.gov identifier: NCT02050789) was heavily debated in the medical community on publication, with 1 of many dissenters claiming that the “flexible duty-hour intervention knowingly exposed residents and their patients to serious risks” and asserting that “informed consent of residents was required.” Supporters of the trial, however, have insisted that the intervention posed no risks, and therefore met the requirements for a “waiver of consent” for all study participants.
The authors identified 6 salient requirements for CRTs from the 2012 Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials: research ethics committee review, proper identification of research participants, informed consent procedures, the presence and authority of gatekeepers, benefit-harm analysis, and the protection of vulnerable participants. Per these requirements, the authors assessed the FIRST trial and examined the ethical issues introduced to cluster randomized trials and studies regarding healthcare policy as a whole.
After review from the Northwestern University’s research ethics committee, the FIRST trial was classified as “non-human-subjects research” and “[exempted] from research regulations.” Surgical residents participating in the FIRST trial were accordingly not classified as research participants, and investigators did not obtain informed consent. Authors described these events as possible violations of the ethical recommendations of the Ottawa Statement.
Per the “gatekeeping” requirement, the authors suggested that all CRTs instate gatekeepers for “cluster-level interests”; in the case of FIRST, investigators may have benefitted from individuals hired specifically to protect such “cluster interests” as the reputations of participating hospitals and the trust of patients. In addition, the authors suggested that surgical residents could be classified as “vulnerable participants” and should have been afforded certain protections, such as anonymity, if they refused to participate. Many dissenters argued that even with the availability of a consent form, residents would have still been subject to “coercion” from superiors and colleagues to participate. However, the authors concluded that the “benefits and harms [of the FIRST trial] were adequately justified,” as survey data were sufficiently anonymized and “evidential uncertainty” provided proper rationale for the study.
Although the Ottawa Statement provides a robust framework by which to assess the ethics of CRTs, the authors underscored the need for additional guidelines. In particular, with “policy trials involving healthcare providers and trainees,” the authors emphasized the need for sufficient “equipoise” before proceeding with research in these sensitive areas, and for a clearer delineation of “the duties of health providers [in research]” and their potential status as vulnerable participants. Although CRTs of this nature are critical to improving policy in healthcare, further guidance is needed to ensure that these study designs are ethical and justified.
Horn AR, Weijer C, Hey SP, et al. Thinking clearly about the FIRST trial: addressing ethical challenges in cluster randomised trials of policy interventions involving health providers [published online April 27, 2018]. J Med Ethics. doi:10.1036/medethics-2017-104282