Clinician gate-keeping in clinical research is not ethically defensible: an analysis

Sharkey, Kerith; Savulescu, Julian; Aranda, Sanchia; Schofield, Penelope

doi:10.1136/jme.2009.031716

Cited by 52 publications

(58 citation statements)

References 32 publications

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“…In-line with Sharkey et al, 33 we surmise that only those individuals deemed 'suitable' to participate were invited to do so by staff. As a result, we have no way of knowing whether other participants invited to take part in the study might have done so if they had been approached directly by members of the research team.…”

Section: Discussionmentioning

confidence: 97%

‘It's my pleasure?’: the views of palliative care patients about being asked to participate in research

Bellamy

Gott

Frey

2011

Progress in Palliative Care

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Background: There is a paucity of studies which explore palliative care patients' involvement in research. The involvement of patients with a life-limiting illness in research raises numerous ethical concerns for researchers keen to take account of their views and experiences of service provision. Assumptions are readily made about whether participation is appropriate for this patient group due to their perceived vulnerability. Aim: To explore the views of hospice users regarding their motivations for taking part in a study, designed to inform the delivery of care, and ensure ongoing service improvement. Methods: Based on a larger pilot study to examine patients' satisfaction with hospice care, and using a qualitative interview approach, twenty-one patients under the care of three hospices in the Auckland region of New Zealand took part. Interviews were recorded and transcribed verbatim. Data were analysed using a thematic analysis technique. Results: The involvement of hospice users in research is important and has the capacity to produce a diverse, but significant impact on those involved. Not only does their involvement demonstrate the potential to shape service provision, it also reveals the therapeutic benefits to individuals with a life-limiting illness of simply taking part. Of particular importance is the view that participation enables a sense of personhood to be maintained circumventing the potential of a 'social death'. Unless they are unable to consent, palliative care patients should be regarded as autonomous individuals and given the opportunity to participate in research.

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Section: Discussionmentioning

confidence: 97%

‘It's my pleasure?’: the views of palliative care patients about being asked to participate in research

Bellamy

Gott

Frey

2011

Progress in Palliative Care

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“…At first, there appeared to be a difference between regulators, pregnant women and REC members on the one hand, and healthcare professionals on the other, where the latter seem more willing to include pregnant women for potential group benefits for their population. However, while healthcare professionals in their role as researcher report a willingness to advance inclusion of pregnant women in clinical research, in practice they are also reluctant to include their patients and sometimes even resort to gatekeeping, the fashion where eligible participants are prevented from entering research [4, 33, 34]. It appears that healthcare professionals make their individual judgements about risks and that they sometimes perceive minimal risk as high risk.…”

Section: Discussionmentioning

confidence: 99%

A qualitative study on acceptable levels of risk for pregnant women in clinical research

et al. 2017

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BackgroundThere is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks. The aim of our paper was to explore what stakeholders who are actively involved in the conduct of clinical research in pregnant women deem an acceptable level of risk for pregnant women in clinical research. Accordingly, we used the APOSTEL VI study, a low-risk obstetrical randomised controlled trial, as a case-study.MethodsWe conducted a prospective qualitative study using 35 in-depth semi-structured interviews and one focus group. We interviewed healthcare professionals, Research Ethics Committee members (RECs) and regulators who are actively involved in the conduct of clinical research in pregnant women, in addition to pregnant women recruited for the APOSTEL VI case-study in the Netherlands.ResultsThree themes characterise the way stakeholders view risks in clinical research in pregnant women in general. Additionally, one theme characterises the way healthcare professionals and pregnant women view risks with respect to the case-study specifically. First, ideas on what constitutes an acceptable level of risk in general ranged from a preference for zero risk for the foetus up to minimal risk. Second, the desirability of clinical research in pregnant women in general was questioned altogether. Third, stakeholders proposed to establish an upper limit of risk in potentially beneficial clinical research in pregnant women in order to protect the foetus and the pregnant woman from harm. Fourth and finally, the case-study illustrates that healthcare professionals’ individual perception of risk may influence recruitment.ConclusionsHealthcare professionals, RECs, regulators and pregnant women are all risk adverse in practice, possibly explaining the continuing underrepresentation of pregnant women in clinical research. Determining the acceptable levels of risk on a universal level alone is insufficient, because the individual perception of risk also influences behaviour towards pregnant women in clinical research. Therefore, bioethicists and researchers might be interested in changing the perception of risk, which could be achieved by education and awareness about the actual benefits and harms of inclusion and exclusion of pregnant women.

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“…One third of RCTs in the PICU are terminated before the needed sample size is achieved, often due to recruitment problems [31]. One of the reasons for recruitment problems could be reluctance to approach potential research subjects, also known as 'gate-keeping', an attitude that may be due to the clinicians' fear of excessive patient burden [32]. This usually means that the sickest patients are less likely to be included in research.…”

Section: Recruitmentmentioning

confidence: 97%

Ethics of Drug Research in the Pediatric Intensive Care Unit

et al. 2014

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Critical illness and treatment modalities change pharmacokinetics and pharmacodynamics of medications used in critically ill children, in addition to age-related changes in drug disposition and effect. Hence, to ensure effective and safe drug therapy, research in this population is urgently needed. However, conducting research in the vulnerable population of the pediatric intensive care unit (PICU) presents with ethical challenges. This article addresses the main ethical issues specific to drug research in these critically ill children and proposes several solutions. The extraordinary environment of the PICU raises specific challenges to the design and conduct of research. The need for proxy consent of parents (or legal guardians) and the stress-inducing physical environment may threaten informed consent. The informed consent process is challenging because emergency research reduces or even eliminates the time to seek consent. Moreover, parental anxiety may impede adequate understanding and generate misconceptions. Alternative forms of consent have been developed taking into account the unpredictable reality of the acute critical care environment. As with any research in children, the burden and risk should be minimized. Recent developments in sample collection and analysis as well as pharmacokinetic analysis should be considered in the design of studies. Despite the difficulties inherent to drug research in critically ill children, methods are available to conduct ethically sound research resulting in relevant and generalizable data. This should motivate the PICU community to commit to drug research to ultimately provide the right drug at the right dose for every individual child.

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Clinician gate-keeping in clinical research is not ethically defensible: an analysis

Cited by 52 publications

References 32 publications

‘It's my pleasure?’: the views of palliative care patients about being asked to participate in research

‘It's my pleasure?’: the views of palliative care patients about being asked to participate in research

A qualitative study on acceptable levels of risk for pregnant women in clinical research

Ethics of Drug Research in the Pediatric Intensive Care Unit

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