The ethics of the Flexibility In duty hour Requirements for Surgical Trainees (FIRST) trial have been vehemently debated. Views on the ethics of the FIRST trial range from it being completely unethical to wholly unproblematic. The FIRST trial illustrates the complex ethical challenges posed by cluster randomised trials (CRTs) of policy interventions involving healthcare professionals. In what follows, we have three objectives. First, we critically review the FIRST trial controversy, finding that commentators have failed to sufficiently identify and address many of the relevant ethical issues. The 2012 Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials provides researchers and research ethics committees with specific guidance for the ethical design and conduct of CRTs. Second, we aim to demonstrate how the Ottawa Statement provides much-needed clarity to the ethical issues in the FIRST trial, including: research participant identification; consent requirements; gatekeeper roles; benefit-harm analysis and identification of vulnerable participants. We nonetheless also find that the FIRST trial raises ethical issues not adequately addressed by the Ottawa Statement. Hence, third and finally, we raise important questions requiring further ethical analysis and guidance, including: Does clinical equipoise apply to policy interventions with little or no evidence-base? Do healthcare providers have an obligation to participate in research? Does the power-differential in certain healthcare settings render healthcare providers vulnerable to duress and coercion to participant in research? If so, what safeguards might be implemented to protect providers, while allowing important research to proceed?
- research ethics
- clinical trials
- health personnel
- policy guidelines/inst. review boards/review cttes.
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- research ethics
- clinical trials
- health personnel
- policy guidelines/inst. review boards/review cttes.
Training new surgeons requires that they learn to diagnose, treat and follow both elective and critically ill patients. This process requires that surgical residents spend many hours in the hospital, building up requisite clinical experience. Unfortunately, long shifts may threaten both patient safety and resident well-being, such as fatigue-related surgical errors and motor vehicle accidents, respectively. Indeed, there are many uncertainties about the dangers of such intensive training. What are safe work hours for surgical residents? How can evidence guide the development of policy for medical education? The Flexibility In duty hour Requirements for Surgical Trainees (FIRST) was a pragmatic, non-inferiority, cluster randomised trial (CRT) involving surgical residency programmes in USA.1 It evaluated flexible duty-hour policies allowing longer shifts, compared with standard restricted duty-hour policies, with respect to patient safety and resident well-being. The trial found that flexible duty-hour policies proved to be no worse than standard duty-hour policies for patients or residents, providing evidence-based policy for resident work hours.
Controversy erupted following the publication of the FIRST trial in the New England Journal of Medicine in February 2016. One critic described it as ‘among the most unethical research studies [he has] ever seen’.2 He argued that the flexible duty-hour intervention knowingly exposed residents and their patients to serious risks and, further, that the informed consent of residents was required.3 In contrast, a defender of the FIRST trial claimed that it was, ‘not just ethical but laudable to comparatively evaluate duty-hour policies’.4 He argued that the flexible duty-hour intervention did not pose a greater risk to participants and therefore the trial satisfied the conditions for a waiver of consent for both residents and patients.4
CRTs often involve complex multifaceted interventions and thus present unique ethical challenges when compared with individual randomised controlled trial. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trails is a consensus statement that aims to guide researchers and research ethics committees (RECs) through the ethical challenges characteristic of CRTs.5 The Ottawa Statement is the culmination of a 5-year collaboration between an international and interdisciplinary research team, funded by the Canadian Institute of Health Research. The project involved key informant interviews, a review of published CRTs, interviews with trialists and a survey of RECs.5 Six ethical issues were identified, each of which received an extensive ethical analysis by the research team in consultation with informants and stakeholders. The resultant consensus statement was written in consultation with an independent expert panel. The Ottawa Statement sets out 15 recommendations based on internationally accepted ethical principles to guide researchers and RECs in the design, conduct and review of CRTs. Published in 2012, the Ottawa Statement has since influenced the development of research ethics policy on CRTs internationally.6 7
Nonetheless, we find that the controversy surrounding the FIRST trial points to a lacuna in the current ethical guidance surrounding CRTs; that is, there are ethically salient features of the FIRST trial that are not presently addressed by the Ottawa Statement. Accordingly, we have a tripartite thesis: (1) first, we outline and critically review the FIRST trial and the ensuing controversy, respectively; (2) second, we apply the Ottawa Statement to the FIRST trial to appropriately identify and illuminate relevant ethical issues and (3) third, and finally, we identify ethical issues that are not adequately addressed and thus require further analysis and guidance.
The FIRST trial
Motivated by a widely publicised patient death,8 evidence that sleep deprivation leads to poor cognitive function and fatigue-related errors and accidents and ‘growing public opinion that long duty hours compromise patient safety and resident well-being’,9 the Accreditation Council for Graduate Medical Education (ACGME) in USA introduced national regulations to limit resident working hours in 2003. The regulations limited duty-hours to 80 hours per week, capped overnight shift lengths and mandated minimum time off between shifts.1 In 2011, persistent concerns over patient safety and resident well-being led to further restrictions,10 including shorter maximum shift lengths for interns and increased time-off after overnight shifts for residents.11 The ACGME policy changes are based on the idea that alleviating resident fatigue should reduce errors and improve patient safety. Yet, evidence for these claims is weak. Indeed, some have suggested that shorter shifts and longer time off actually may make patients less safe.2 Duty-hours restrictions increase the frequency with which residents ‘hand-off’ patients under their care, ‘which could jeopardise patient safety by forcing residents to leave at critical times’.1 Increased transfers may also undermine the goals of resident training if they are ‘unable to follow patients through critical aspects of their care’.1
The FIRST trial investigators sought to address this knowledge gap and rigorously determine the impact of ACGME duty-hour policies on patient safety and resident well-being. The FIRST trial employed a pragmatic, non-inferiority, cluster randomised design. One hundred and eighteen general surgery resident programmes in USA were randomised, as clusters, to two policy interventions. Programmes assigned to the restricted duty-hours arm were to continue to adhere to the ACGME duty-hour policies. Programmes assigned to the flexible duty-hours arm were granted a waiver by the ACGME for four of the duty-hour reforms that concerned maximum shift lengths and minimum time off between shifts, specifically: (1) allowing interns to exceed duty periods of 16 hours; (2) allowing residents to exceed 28 hours duty periods; (3) not requiring residents to have 8–10 hours off between shifts; (4) not requiring residents to have 14 hours off after 24 hours of continuous duty.5 Nevertheless, residents in the flexible duty-hour arm were required to adhere to the ACGME duty-hour requirements of limiting work to 80 hours per week, mandated day-off every 7 days and on-call duty no more frequently than every third night.
The primary patient outcome was a composite of 30-day postoperative mortality or serious complication.1 Patient data were obtained from information routinely collected by the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP). The primary resident outcomes were satisfaction with quality of education and well-being. Resident data were collected from a survey administered on completion of the American Board of Surgery In-training Examination (ABSITE), mandatory for all surgical residents. The study protocol was reviewed by the Northwestern University’s REC, ‘which determined the trial to be non-human-subjects research’, thus exempting the trial from research regulations.1 The REC based its decision on the supposition that the trial involved only ‘the collection or study of existing data, documents, records’.12
The results of the FIRST trial showed that flexible, ‘less-restrictive duty-hour policies for surgical residents were non-inferior to standard ACGME duty-hour policies’, on the outcomes of patient safety and resident well-being.1 The researchers nonetheless concluded that flexible duty-hours are associated with benefits to ‘nearly all aspects of patient safety… [and] continuity of care’;1 their conclusion was based on the presumption that ‘patient care and resident education can be compromised by interruptions in continuity of care’, suggesting that flexible duty-hour policies are better for patient safety, although at the cost of resident time away from work.1
Debate about the FIRST trial
Following the publication of the FIRST trial, Public Citizen and the American Medical Student Association filed complaints accusing the FIRST trial investigators of ‘egregious ethical and regulatory violations’.3 Broadly speaking, critics and defenders identify three ethical issues, on which they are sharply divided.
First, critics of the FIRST trial reject the claim that the trial posed an acceptable balance of benefits and harms to participants. Residents in the flexible duty-hour intervention, they argue, were knowingly subjected to increased fatigue, which rendered them susceptible to a ‘greater risk of motor vehicle accidents, percutaneous injuries and exposure to bloodborne pathogens, depression and, possibly, poorer obstetric outcomes’.3 13–20 Because the risk of harms associated with flexible duty-hour policies were purportedly known to be greater than those of restricted duty-hour policies at the outset of the trial, clinical equipoise—an ethical precondition that requires there to be uncertainty within the relevant expert community regarding the comparative benefits and harms of the study interventions21—did not obtain between the policy interventions.4
Defenders of the FIRST trial disagree. They argue that the trial did in fact pose an acceptable balance of benefits and harms, as they contend it was not known at the start of the trial whether the flexible duty-hour intervention posed greater risk to residents or patients.4 Indeed, defenders argue that it was precisely the uncertainty surrounding the evidence for the policies that prompted the need for a large-scale randomised controlled trial. Accordingly, they argue clinical equipoise did obtain at the outset of the FIRST trial.
Second, critics claim that conditions for a waiver of resident consent were not satisfied. A waiver of consent requires that study participation pose no more than minimal risk to research participants and the study would be infeasible if informed consent was required. However, critics argue study participation posed serious risk, including ‘increased risks of medical errors, death and serious morbidity’, and therefore does not meet the first criterion for a waiver of consent.3
Defenders argue, conversely, that the waiver of consent was justified.4 They claim that risks to participants were minimal because the study interventions were ‘unequivocally’ in equipoise.4 Further, requiring informed consent would have led to serious scientific bias potentially rendering the trial invalid. Given the likelihood of a strong preference for flexible duty-hours among surgical residents, the two study arms would have had substantially different recruitment rates, a source of selection bias in CRTs.
Third, critics claim that even if informed consent was sought and obtained from surgical residents, it would have been invalid.3 They argue that any attempt to obtain consent from residents would amount to duress and coercion, owing to the power differential between staff surgeons and their trainees:
‘[O]btaining the voluntary informed consent of all medical resident subjects who would be enrolled in a trial such as the FIRST trial would never be feasible because the prospective resident subjects would be exposed to significant undue influence and coercion.’3
Hence, critics argue that residents ought to be considered a vulnerable population, given the manifest pressure they are under to conform in residency programmes.
Defenders simply reject the claim that socially important trials that inform evidence-based policy are ethically impossible to conduct. Indeed, defenders seem to suggest that such an ethical conclusion and any argument in support of it, serves as its own reductio ad absurdum.
Applying the Ottawa statement to the FIRST trial
In the face of such stark disagreement about the ethics of the FIRST trial, how should researchers and RECs proceed? Plainly, a systematic approach to the ethics of CRTs is required. In CRTs, the units of randomisation are groups, or ‘clusters’, of individuals, such as schools, neighbourhoods, medical practices or hospitals. CRTs thus differ from individually randomised trials, where the individual study participants themselves are randomised to differing study arms. CRTs can be very complex, as they often ‘evaluate multifaceted interventions targeted at clusters, professionals or individual cluster members’.5 Moreover, the unit of randomisation may differ from the unit of intervention, which may in turn differ from the unit of data collection. For example, ‘in a CRT of teaching a new hand-washing technique to help avoid transmitting infection on hospital wards, the unit of allocation may be the hospital, the intervention may be delivered to health professionals and data may be collected about or from patients’.5 This complexity can make identifying and addressing the ethical issues paradigmatic of CRTs challenging.
The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials seeks to diminish these challenges and promote consistency in the ethical analysis of CRTs by providing 15 recommendations for their ethical design, conduct and review, including: (1) guidance on REC review; (2) identification of research participants; (3) informed consent procedures; (4) the role and authority of gatekeepers; (5) benefit-harm analysis and (6) the protection of vulnerable participants.5 In what follows, we assess the utility of the Ottawa Statement by applying its recommendations to the FIRST trial.
Is REC review required?
According to the Ottawa Statement, researchers must submit a CRT for approval by an REC.5 There is broad agreement in international ethics guidelines that research involving human participants must be reviewed and approved by an REC.6 Research may be defined as a systematic investigation designed to produce generalisable knowledge.5 REC review is critical for the protection of the liberty and welfare interests of research participants, as it ensures that ethical principles, and the research regulations to which they give rise, are upheld.
It is plain that the FIRST trial constitutes research. It employed a rigorous design to produce generalisable evidence. Further, it sought to inform future policy by determining whether flexible duty-hour policies were no worse than standard duty-hour policies with respect to patient safety and resident well-being. The FIRST trial also clearly involved human participants (discussed below). As the FIRST trial is research involving human participants, the Ottawa Statement requires that it be reviewed by an REC. While US regulations are not the focus of this article, it does seem that the REC of record failed to recognise that the FIRST trial involved study interventions directed at surgical residents (and not merely the use of existing data).
Identifying research participants
Identifying research participants in CRTs is often complex. For instance, a single study may involve randomising hospitals, intervening on health providers and collecting data from patients. According to the Ottawa Statement, a research participant is any cluster member who is (1) the recipient or (2) the direct target of a study intervention (including the control condition), (3) with whom researchers interact for study purposes or (4) about whom identifiable private information is collected.5 Each of these criteria is individually sufficient for being identified as a research participant; in other words, if a cluster member meets just one of these criteria, she is a research participant. A direct implication is that CRTs may include research participants at multiple levels, who become participants due to either study interventions or data collection procedures. Researchers and RECs have an obligation to identify research participants accurately so their interests can be protected.
Based on these criteria, it is clear that surgical residents in the FIRST trial were research participants. While the intervention in the FIRST trial was a policy change adopted at the level of surgical residency programmes, residents were nonetheless the direct targets (criterion two, above) of the change in duty-hours. The FIRST trial investigators also interacted with surgical residents with surveys appended to their annual ABSITE examinations (criterion three), which were used to obtain data about their well-being and perceptions of the quality of their education (criterion four). As research participants, surgical residents are entitled to the protections of research regulations and REC review.
More controversially, according to the Ottawa Statement, patients in the FIRST trial are not research participants.22–24 Patients were not the intended or direct recipients of the study intervention. The policy interventions might have affected patients indirectly in various ways, insofar as the inventions affected surgical residents. But, importantly, the duty of loyalty that a resident owes to her patient was not undermined by the policy interventions; an enrolled resident would continue to exercise her professional judgment on behalf of her patient’s best interests, regardless of her duty-hour assignment. Furthermore, researchers did not interact with patients for research purposes. Finally, patient data analysed in the trial were routinely collected by the ACS NSQIP and anonymised prior to analysis. Accordingly, patients may not require all of the protections offered by research regulations and REC review.
Obtaining informed consent
According to the Ottawa Statement, there is a general presumption that informed consent must be obtained from research participants.5 As patients in the FIRST trial are not research participants, their informed consent is not required.
The surgical residents in the FIRST trial are, however, research participants. Is their consent required? Some have argued that health professionals have an ethical obligation to participate in research to improve patient care, allegedly obviating the need for their consent.25 However, if indeed such an obligation does exist, it can at most provide health professionals with a reason to participate in research: it cannot compel them to participate in all research categorically or without discrimination. Hence, such an obligation clearly does not free researchers from the ethical requirement to seek the consent of prospective research participants.26 Thus, unless conditions for a waiver of consent are satisfied (more on this below), the consent of health professionals is required.5
An REC may approve a waiver of consent when: (1) the trial is infeasible without a waiver of consent and (2) the interventions and data collection procedures pose no more than minimal risk.5 Feasibility depends on a variety of factors, including cluster size, proximity of cluster members, complexity of consent processes, research infrastructure and research funding. In the FIRST trial, entire residency programmes were randomised to a duty-hour intervention. Consequently, refusal to participate would require a resident to transfer to a different training programme—an obvious impracticability. Otherwise, surgical residents would be forced to leave their programme part-way through their residency, interrupting the continuity of their education as well as their established relationships with their programme directors and peers. It would also involve moving to a different hospital and thus likely a different neighbourhood—an uprooting that would very likely involve a considerable financial, or at least logistical, burden. Accordingly, informed consent was not feasible in this case.
Minimal risk refers to ‘the risks of daily life and includes the risks associated with routine physical examinations and review of medical records’.5 Surgical residents are exposed to the burdens of long work hours in their daily lives. Given that other protections were preserved in both study interventions, including limits on total work hours per week, the flexible and standard duty-hour interventions posed only minimal risk to residents. Indeed, we believe that critics of the FIRST trial erred in failing to apply the minimal risk standard to the incremental risks posed to residents because of study participation (and acknowledge the continuing application of core ACGME policy protections). A waiver of resident informed consent for the FIRST trial was therefore likely appropriate.
Finally, the Ottawa Statement notes that consent may be feasible for some but not all aspects of a study (eg, study interventions, data collection procedures) and researchers should obtain informed consent for each aspect where possible. In the FIRST trial, surgical residents received a non-routine survey at the end of their annual national examination. Obtaining consent for the survey is likely feasible and, accordingly, resident consent to data collection procedures is required.
Gatekeepers ‘are individuals or bodies who may be called on to protect the group-based interests that are affected by enrolment in a CRT’.5 In CRTs, cluster-level interests are often at stake and thus researchers are required to obtain gatekeeper permission for trial recruitment. Gatekeepers play an important role in the protection of cluster interests and thus may agree to provide or withhold permission to enrol a cluster when they have legitimate authority to do so. Gatekeeper permission, however, should not be understood as providing proxy consent on behalf of individual cluster members; legitimate proxy consent requires the proxy decision-maker to be ‘well acquainted with the potential research participant’s values and beliefs’, which gatekeepers are not.5 Importantly, gatekeeper permission does not supplant the requirement for the informed consent of research participants.
In the FIRST trial, gatekeepers at least included the ACGME, hospital administrators at the 154 affiliated hospitals and the administrators of the 118 participating surgical residency programmes. The ACGME has the legitimate authority both to pass duty-hour reforms and to waive them. Hospital administrators are charged with the local implementation of these policies. Finally, programme administrators are authorised to ensure that policies are observed in practice. The FIRST trial investigators ought to have obtained permission for the duty-hour interventions from these gatekeepers before residency programmes and surgical residents were enrolled in the trial.
Investigators, in consultation with gatekeepers, should also identify and safeguard cluster-level interests. Cluster interests in the FIRST trial may have included the reputation of hospitals and residency programmes, concerns over the erosion of trust from patients and communities in healthcare professionals and negligence or other legal suits. These and any other issues identified through consultation between researchers and gatekeepers should have been accounted for in the design, implementation and ethical review of the FIRST trial.
Assessing benefits and harms
Component analysis provides researchers and RECs with a systematic approach to the ethical analysis of study benefits and harms.27 However, the interventions in CRTs are often varied and complex, rendering the application of component analysis difficult. To address these difficulties, the Ottawa Statement provides three recommendations to guide researchers and RECs in the assessment of study benefits and harms in CRTs: (1) the benefits and harms of the study intervention must be consistent with competent practice in the relevant professional domain; (2) individuals assigned to the control arm must not be deprived of known effective treatments or programmes and (3) the risks associated with data collection procedures must be (i) minimised consistent with sound scientific design and (ii) stand in reasonable relation to the knowledge to be gained.5
Assessment of the first two recommendations amounts to a determination as to whether a state of clinical equipoise obtained between the flexible and standard duty-hour interventions in the FIRST trial. We contend that equipoise obtained for three reasons. First, the initial evidence-base for the standard duty-hour policy was lacking. The ACGME duty-hour restrictions were based on weak evidence and intuitive concerns over fatigue-related errors and patient safety. Second, subsequent retrospective studies and a systematic review cast doubt on these initial assumptions, further rendering the state of scientific evidence uncertain; for instance, some studies showed a worsening in patient outcomes and resident education after duty-hour reforms.1 Third, because of this uncertainty, there was substantial disagreement among surgeons, many believing that patients are less safe and resident training quality is reduced. The state of evidential uncertainty and professional disagreement was sufficient to satisfy the condition of clinical equipoise at the outset of the FIRST trial.
With respect to the third recommendation: resident data were collected from a multiple-choice survey appended to the annual ABSITE examination, mandatory for all surgical residents in USA. While it was not part of routine collection, insofar as the FIRST trial investigators took steps to ensure that the survey data were anonymised prior to study analysis, the risks of data collection procedures to residents are low and reasonable in relation to the knowledge to be gained. According to the Ottawa Statement, then, the benefits and harms of the FIRST trial were adequately justified.
Protecting vulnerable participants
The Ottawa Statement defines ‘vulnerable participants’ as individuals who fall into any of the following categories: ‘(1) children, (2) incapable adults, (3) people at undue risk of harm as a result of study participation and (4) people in subordinate positions within social or organisational structures’.5 Research may legitimately include vulnerable participants provided that adequate protections are in place. But, identifying vulnerable participants in CRTs can present unique challenges. The Ottawa Statement identifies two reasons for this: first, vulnerable individuals may constitute a small proportion of a cluster composed primarily of individuals who are not vulnerable; second, there may be individuals in a cluster who are made vulnerable by virtue of their cluster membership but are otherwise not normally viewed as vulnerable, such as healthcare professionals.5 The Ottawa Statement therefore recommends that RECs, ‘pay special attention to recruitment, privacy and consent procedures for those participants’.5
Surgical residents are clearly ‘people in subordinate positions within social or organisational structures’, and therefore vulnerable.5 While residents may not commonly be understood as vulnerable, it is by virtue of their cluster membership—namely, residency programmes—that they are made vulnerable: residents may feel obligated, or unduly pressured, to participate in research involving their programmes. But this fact does not make research involving surgical residents impermissible. Rather, it requires that appropriate protections for residents are put in place. For instance, whether residents agree to participate in the trial should be kept confidential from superiors; residents should not be recruited for study enrolment by a supervisor or other superior in the organisational hierarchy and resident responses to questionnaires should, if possible, be anonymised.28 However, in the FIRST trial conditions for a waiver of consent obtain and thus concerns about duress and coercion to consent to the study interventions do not apply, or rather, simply dissolve.
Ethical issues requiring further analysis
As demonstrated, the Ottawa Statement systematically identifies and provides recommendations to address the ethical issues common to a broad class of CRTs. Moreover, the Ottawa Statement grounds its recommendations in internationally accepted ethical principles, as opposed to national research regulation, thereby ensuring its guidance is of global relevance. As such, the Ottawa Statement provides much-needed clarity to the debate about the FIRST trial. The confusion inherent to the debate about the FIRST trial is perhaps predictable, as US federal regulations were not written with CRTs in mind and neither critics nor defenders cite the recommendations outlined in the Ottawa Statement.
Nonetheless, the application the Ottawa Statement to the FIRST trial makes it clear that there remain important issues to be addressed, specifically pertaining to policy trials involving healthcare providers and trainees. Here, we briefly enumerate three ethical issues requiring further work.
First, a clearer understanding of the conditions that satisfy equipoise for trials involving policies is needed. Application of equipoise to policy CRTs seems to lead to solutions that are at once too restrictive and too permissive. Critics of the FIRST trial effectively argue that clinical equipoise did not obtain with respect to a policy once it has been implemented in practice. On this view, once a policy has been enacted, it becomes the standard of care and depriving individuals of the protection of the policy violates equipoise. However, this position would undermine our ability to study existing policies that lack sound support and would hinder the development of evidence-based policy. Conversely, if a paucity of evidence—characteristic of many policies—is sufficient to establish equipoise, then it appears that the conduct of almost any CRT involving policy interventions is ethically permissible, even in cases in which policies clearly protect people from substantial risks. Neither view seems entirely palatable. What, then, is the appropriate application of equipoise to CRTs involving policy interventions?
Second, a clearer account of the duties of health providers in the research setting is needed. The main REC determined that the FIRST trial was not research involving human participants and failed to recognise the fact that the surgical residents were research participants. Indeed, it is not uncommon for RECs to miss that healthcare providers, including trainees, are research participants. This phenomenon may stem, in part, from the belief that healthcare providers have an obligation to participate in research.25 This raises the following important questions, which are also applicable to a broader class of CRTs: What additional guidance might help researchers and RECs recognise when healthcare providers are research participants? Do healthcare providers have an obligation to participate in research? If so, are healthcare providers obligated to participate in research categorically or is their participation subject to their own discretion? What are the implications for informed consent procedures?
Third, and finally, when ought health providers be considered vulnerable participants? As we have seen, some argue that CRTs are simply ethically impossible to conduct when they involve vulnerable healthcare providers or trainees. However, it plainly does not follow from the contention that trainees are vulnerable, that research involving them is ethically impermissible. Rather, research involving vulnerable participants may be conducted with the appropriate protections in place.24 Nevertheless, these concerns do raise the following important questions: Are trainees and other individuals in subordinate positions ‘vulnerable participants’, as the Ottawa Statement contends? If so, what protections should be implemented to alleviate concerns about vulnerability, such as duress and coercion?
With the increased prevalence of CRTs involving policy interventions that target healthcare providers, a definitive answer to these important questions is urgently required. The answers to these questions are central to the debate about the FIRST trial and to CRTs of policy interventions involving healthcare providers generally. Future guidance on the design and conduct of CRTs must therefore adequately address these questions if important research—critical to informing evidence-based policy for healthcare providers and trainees—is to proceed both ethically and expeditiously.
Contributors ARH was responsible for the writing, research, design, analysis and revisions of the many drafts of this article and therefore accepts responsibility as the guarantor for the work. CW contributed to the planning and design of the article, important intellectual content and substantive written edits and oral feedback on drafts. The remaining coauthors made significant contributions to the analysis and intellectual content of the article through both written and oral comments on the numerous drafts. All authors approved the final draft of the article and thus accept responsibility for the accuracy and integrity of the work.
Funding This work is supported by the Canadian Institutes of Health Research through the Project Grant competition (competitive, peer reviewed), award number PJT-153045. JG holds a Canada Research Chair in Health Knowledge Transfer and Uptake. CW holds a Canada Research Chair in Bioethics.
Competing interests None declared.
Patient consent Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Correction notice This article has been corrected since it was published Online First. The funding statement has been updated.
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