The definition of clinician gate-keeping

Clinician gate-keeping has been defined as ‘the process whereby healthcare providers prevent access to patients for research recruitment’.4 For the purposes of this paper, we have refined the definition to: the process whereby healthcare providers prevent access to eligible patients for research recruitment. Eligible patients are those who fit defined eligibility criteria based on factors such as age, gender, the type and stage of disease and previous treatment history or scheduled treatment.8 Furthermore, eligibility criteria (along with other aspects of study protocols) must be approved by a human research ethics committee/review board. Typical gate-keeping scenarios involve the ad hoc denial of access to individual patients or systematic denial for particular groups of patients for reasons outside the framework of the trial eligibility criteria. For example, a clinician may believe a particular patient is too busy for trial participation, or that research participation is too burdensome for particular types of patients such as rural patients or those with advanced disease.

Gate-keeping and research ethics

We contend that clinician gate-keeping violates three principles that underpin international ethical guidelines9 10 governing research involving human participants. First, the principle of respect for persons or autonomy; second, the principle of beneficence or a favourable balance of risks and potential benefits; and third, the principle of justice or a fair distribution of the benefits and burdens of research. Although we advocate against the practice of gate-keeping, we do not wish to devalue clinicians' (or other stakeholders') concerns. We acknowledge such concerns are important, but assert that gate-keeping is not an ethically sound method of resolution.

Principle 1: respect for persons

According to international guidelines, research involving human participants must abide by the principle of respect for persons, defined as treating individuals as autonomous agents by respecting their capacity for self-determination.9 10 By denying patients decision-making authority regarding trial participation, gate-keeping does not respect patients' capacity for self-determination and therefore violates the principle of respect for persons.4 5 7

Our critics would agree that gate-keeping violates the principle of respect for persons, but would argue that this violation is justified by adherence to the alternative principle of beneficence (ie, acting in a way to benefit the patient3 7). The existence of belief in the primacy of beneficence is demonstrated in published opinion/commentary (eg, Woodward11 claims respect for patient autonomy should not always take precedence over beneficence because patients often lack the knowledge required to make a decision, ie, in their best interests). As well findings from a survey of medical oncologists (eg, a survey on unsubsidised high-cost chemotherapy drugs showed that 28–41% of medical oncologists would violate respect for persons by not informing patients about high-cost chemotherapy drugs with beneficent intent; ie, to avoid distress to the patient and their family from the knowledge that they could not afford the drug.)12 Although these examples relate to the context of treatment decision-making, they still provide adequate evidence that some clinicians believe beneficently intentioned actions can trump the principle of respect for persons.

So far we have been careful to use the term ‘beneficent intent/beneficently intentioned actions’ rather than beneficence; this is because we do not believe that gate-keeping truly upholds the principle of beneficence. We assert beneficently intentioned actions are not equivalent to beneficence as it is difficult for clinical staff to discern the best interests of a patient in a holistic sense. First, because the concept of ‘best interests’ is largely subjective and individual, and second, because clinicians are likely to be biased towards valuing physical wellbeing.

The concept of ‘best interests’ is largely subjective and individual

The concept of ‘best interests’ or ‘wellbeing’ is a largely subjective and individual concept because of its complex nature. For instance, the World Health Organization defines health as: ‘a state of complete physical, mental and social wellbeing and not merely the absence of disease or infirmity’.1 13 In addition to the number of factors that contribute to wellbeing, individuals also vary in the value they attribute to the different factors. Some individuals may place a high value on physical wellbeing, whereas others are more concerned with psychological wellbeing or the maintenance of family relationships.14 Furthermore, each individual factor has many aspects. For instance, physical wellbeing includes diverse aspects such as pain relief or minimisation of physical limitation.14 This description of the potential complexities in defining ‘wellbeing’ or ‘best interests’ is provided to demonstrate how difficult it is for a third party to predict another's best interests. At a minimum it requires discussion with the patient to elicit and thoroughly understand the individual's account of their personal desires and values15 16 (particularly those relating to clinical trial participation). However, such discussions would be complex and time-consuming; they may require specialised training to conduct and would carry a high risk of misinterpretation/misunderstanding. Therefore, we propose that a ‘firsthand’ decision regarding trial participation directly from eligible patients is preferable in terms of ethics as well as the efficient use of healthcare resources.

Clinicians are likely to over-value physical wellbeing

In addition to the general difficulties in understanding the best interests of another, clinicians are likely to be further hampered by bias towards the value of physical wellbeing as a result of their training and work experience.17 For example, psychological distress in cancer patients is often underestimated or overlooked by oncology professionals.18–23 Passik et al21 assessed the ability of 12 oncologists to determine the level of depression in 1109 ambulatory cancer patients. They found oncologists identified depression in only 33% of patients with mild-to-moderate self-reported depressive symptoms and only 13% of patients with severe depressive symptoms.21 Also, although oncologists often discuss heath-related quality of life with patients, they tend to focus on physical aspects such as disease symptoms and treatment side-effects.24 There is thus an increased likelihood that ‘secondhand’ decisions made on behalf of patients by clinicians (as occurs in gate-keeping) will not truly reflect patients' best interests.

The pro-gate-keeping argument in support of the precedence of the principle of beneficence over respect for persons is based on the assumption that ‘secondhand’ decisions made with beneficent intent will always translate into the promotion of beneficence or of patients' best interests. We have brought this assumption into question by highlighting the complex and subjective nature of the concept of ‘best interests’ as well as the additional difficulties clinicians may face in understanding patients' best interests. We thus maintain that clinician gate-keeping violates the ethical principle of respect for persons and (because it is questionable that beneficent intent will consistently translate to the actual promotion of best interests) this violation cannot be ethically justified by appeals to the principle of beneficence.

Principle 2: beneficence and research merit

According to international guidelines, research involving human participants should fulfil the ethical principle of beneficence.9 10 Beneficence in the research context is primarily understood as a favourable balance of possible benefits versus potential harms (including immediate, individual, group and long-term benefits/harms). That is, the risks must be reasonable compared with the anticipated benefits. This principle leads to a requirement for research merit because, without merit, research exposes participants to risks without possible benefit.9 25 Clinician gate-keeping can jeopardise the merit of the research and violate the principle of beneficence by creating sample selection bias and by causing a decreased rate of accrual.

Selection bias

Clinical trials test clinical interventions. Ultimately, interventions that are effective in improving outcomes should be integrated into standard practice. Therefore, it is critical to recruit a representative sample of the clinical population under investigation to ensure that the trial results can be confidently generalised.26 Clinician gate-keeping may result in a biased sample (and thus diminish the merit of the research) if certain types of patients within the eligible population are excluded due to gate-keeping; for example, rural patients or patients with advanced disease.4 7

Decreased rate of accrual

Clinician gate-keeping may also decrease the accrual rate of eligible patients to clinical trials. This can result in a smaller than anticipated sample size because accrual can usually only occur over a fixed time period due to funding limitations. A small sample size may decrease research merit by increasing the probability of type II error (ie, a false-negative result)27 by means of a reduction in statistical power. In addition to lowering statistical power, a decreased rate of accrual as a result of clinician gate-keeping may decrease research merit by causing the failure of a trial, because difficulty in recruiting study participants is the most common reason for the termination of clinical trials.28

Principle 3: justice

International ethical guidelines demand that research upholds the principle of justice. Justice requires there is equitable distribution of the benefits and burdens of research participation across individuals and groups.9 10 The benefits of research may include direct benefits from trial interventions as well as indirect benefits such as finding meaning through social contribution or the provision of more intensive medical care.6 The exclusion of individual or groups of eligible patients from research participation as a result of clinician gate-keeping could result in the unfair distribution of the burdens and/or benefits (direct and indirect) of research and therefore violate the principle of justice. If an individual patient is excluded from participation as a result of gate-keeping they are denied access to the benefits of research and the burdens of research participation will not be equitably distributed. Furthermore, if gate-keeping excludes certain types of patients within the eligible population, there will be an inequitable distribution of the long-term or wider benefits of research because interventions brought into practice as a result of evidence from the clinical trial may not be useful for these excluded populations.26

Translation into practice: strategies to decrease clinician gate-keeping

As our anti-gate-keeping arguments are novel, we have dedicated the bulk of the paper to their description. Although we wish to influence opinion regarding the ethical permissibility of clinician gate-keeping, the most meaningful outcome of our article would be the creation and implementation of strategies to reduce the incidence of gate-keeping in practice. To this end, the remainder of the paper will outline possible strategies for reform. Unfortunately, as a result of space constraints, this section is comparatively brief. We thus present these strategies with the aim of stimulating further research and debate. We begin with a review of possible reasons for clinician gate-keeping.

Reasons for clinician gate-keeping

Literature review reveals a number of possible reasons for clinician gate-keeping: first, clinicians may lack the time to deal with the paperwork or the extra demands of a trial protocol and recruitment procedures.29–34 Second, clinicians may have difficulties explaining trial protocols to patients or with consent procedures.29–32 34 Third, clinicians may have concerns about the quality of the trial design (eg, concerns that the trial would not yield meaningful results).35 Fourth, clinicians may worry about patient burden (eg, patient burden due to extra time or effort, extra financial costs, or transportation difficulties as a result of trial participation).32 33 Fifth, clinicians may feel uneasy about the potential effect of trial participation on the clinician–patient relationship.29 30 34 Finally, clinicians may be uninterested in the trial's research question.29 These six causes work synergistically to promote clinician gate-keeping. We propose three key strategies to address these concerns and reduce gate-keeping: partnership with professional research staff; collaborative research design and clinician education.

Partnership with professional researchers

A solution to the problems of lack of time, difficulties with recruitment processes and clinical relationship concerns is the strategy of partnership with professional researchers who have expert knowledge in clinical trial management and processes.4 29–32 If professional researchers are employed to manage clinical trial work, this eliminates the clinician problem of lack of time. Partnership with professional researchers also solves the problems of difficulties with recruitment processes and concerns about the impact on the clinical relationship as it removes clinicians from trial recruitment and management. While this makes the process of conducting research more expensive (at least in the short term) it has been found to reduce clinician gate-keeping,31 which may reduce the cost and improve the statistical power of trials in the long term.

Collaborative research design

The strategy of collaborative research design is likely to solve the problems of lack of interest in research questions, study quality concerns and lack of time. For example, involving clinicians in the design phase is likely to result in high-quality research projects that investigate clinically relevant research questions with feasible protocols that integrate easily into the existing clinical setting. Furthermore, collaboration with consumer representatives during research design ensures patient burden is kept to a minimum3 36 and addresses the problem of clinician concerns about patient burden.

Hudson et al4 suggest that the strategy of collaborative research design could be implemented by practical methods such as establishing regular contact between researchers and clinicians to promote the discussion of issues or concerns and ensure clinicians are kept up to date. Engaging clinicians as consultants or co-investigators on research projects gives them an opportunity to contribute to the research and to allow for any concerns to be pre-emptively addressed in the study protocol.

Clinician education

Clinician education could address the problem of difficulties in explaining trial protocols to patients or consent procedures. For example, research demonstrates that clinicians trained in discussing randomised clinical trials with patients were significantly more confident discussing clinical trials.37 Moreover, clinicians who feel more comfortable explaining trials to patients tend to refer more patients for trial recruitment.31 Therefore, the strategy of clinician education could be enacted by a programme of education focussed on the discussion of clinical trials with patients.

Other suggestions for the implementation of the strategy of clinician education include: clinician education to increase understanding of research ethics4; as well as training in reflective practice to enhance patient autonomy by raising clinician self-awareness regarding their influence over patients' involvement in decision-making.38