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Table 1 Guideline approaches to protect voluntary informed consent within a dependent relationship

From: Strengths and weaknesses of guideline approaches to safeguard voluntary informed consent of patients within a dependent relationship

Guidelines Professional association Approach
Declaration of Helsinki, 2013 World Medical Association §27: ‘When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship.’
International Ethical Guidelines for Biomedical Research Involving Human Subjects, 2002 Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO) Commentary on Guideline 6: ‘The physician/investigator must assure [patients] that their decision on whether to participate will not affect the therapeutic relationship or other benefits to which they are entitled. In this situation the ethical review committee should consider whether a neutral third party should seek informed consent.’
Tri-Council Policy Statement, Ethical Conduct for Research Involving Humans, 2010 Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada Article 3.1 a (Application): ‘Pre-existing entitlements to care, education and other services should not be prejudiced by the decision of whether or not to participate in, or to withdraw from, a research project. Accordingly… a physician should ensure that continued clinical care is not linked to research participation.’
National Statement on Ethical Conduct in Human Research, 2007 National Health and Medical Research Council, Australia 4.3.2 ‘In the consent process, researchers should wherever possible invite potential participants to discuss their participation with someone who is able to support them in making their decision.’
4.3.10 ‘Where the researcher has a pre-existing relationship with potential participants, it may be appropriate for their consent to be sought by an independent person.’
Institutional Review Boards: Report and Recommendations, 1978 The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, United States ‘In cases in which the investigator is responsible for the care of the subjects, the IRB may require that a neutral person, not otherwise associated with research or the investigator, be present when consent is sought, to explain the research to prospective subjects, or to observe the conduct of the research … Such a person may be designated to play a role in informing subjects of their rights and the details of protocols, assuring that there is continuing assent to participation, determining the advisability of continued participation, receiving complaints from subjects, and bringing grievances to the attention of the IRB as part of its continuing review of research.’
Ethical issues in clinical research in neurology: advancing knowledge and protecting human research subjects, 1998 The Ethics and Humanities Subcommittee of the American Academy of Neurology, United States ‘[R]esearchers and IRBs may want to consider additional safeguards. For example, the IRB may request that an “uninterested” individual … discuss with prospective subjects the research study and other clinical or research alternatives.’
Ethics Manual, Sixth Edition, 2012 Ethics, Professionalism, and Human Rights Committee, American College of Physicians, United States ‘It should … be clear to patients that participation in research is voluntary and not a requirement for continued clinical care. The right to withdraw consent and discontinue participation at any time must be communicated.’
Managing Conflicts of Interest in the Conduct of Clinical Trials, 2002 The council on ethical and judicial affairs, American Medical Association, United States ‘[T]he physician who has treated a patient on an ongoing basis should not be responsible for obtaining that patient’s informed consent to participate in a trial that will be conducted by the physician. .. Instead … someone other than the treating physician should obtain the participant’s consent. The non-treating health care professional also could remain available to answer additional questions during the trial.’