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Recruiting participants to clinical trials often involves collaboration between researchers and clinical staff. This is because eligibility criteria frequently include medical characteristics such as disease stage or treatment type, and clinical expertise may be required to confirm patients' eligibility for trial participation according to such medically defined criteria. A common difficulty with this process is clinician gate-keeping (defined below). 1-7 The primary aim of this paper is to assert that clinician gate-keeping is not ethically defensible. In order to stimulate further research and debate, we also briefly present three possible strategies to eliminate gate-keeping: partnership with professional researchers; collaborative research design and clinician education.
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 guidelines 9 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...