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27 Ethics in anesthesiology research using human subjects
The Case
A group of anesthesia researchers undertook a research project to determine if injection of a sedative drug into the subarachnoid space would improve effectiveness of pain control post-operatively for labor and delivery. The literature at the time had scant information about toxicity of the drug in question when administered in this way, although some anesthesiologists had been doing so anyway. While a handful of studies had demonstrated no obvious adverse outcomes in animal models, several studies suggested dramatically otherwise, including one study in which rabbits demonstrated serious spinal cord histological changes. No study had examined the use of the drug in the dosage and mode of administration proposed by the investigators. The investigators obtained institutional ethics review board approval and the study was carried out. No human subjects appeared to suffer an adverse effect. A modest improvement in analgesia was seen in some, but not all, patients. The project was written up and submitted to a journal for publication.
All anesthesiologists will encounter ethical issues related to research. It may be through engaging in their own primary or clinical research projects, in their practice treating a patient who is a research participant in a project from another treating speciality, applying for research funding and ethics approval, publishing research results, or even through determining departmental/divisional funding priorities. The focus of this chapter will be solely on the ethics of conducting research involving human subjects – in particular, some of the main ethical issues that arise with the kind of research conducted by anesthesiologists in clinical settings.
The history of anesthesiology research on human subjects, while at times undertaken in varying degrees of ethically permissible ways, has produced many techniques that are the mainstay of modern surgical, peri-operative and intensive care. It should be recognized by anesthesiologists that both clinical research and research ethics share a common reason for undertaking such activities: to improve clinical practice and care. Research constructed, conducted, and disseminated in an ethical fashion will likely lead to quality improvement, improved outcomes, shared knowledge and best practices, amongst other considerations.
Research ethics in general, and the ethical conduct of clinical research in particular, are concerned with ensuring research participants and their interests are protected, and that the clinical research they are involved in serves the interests of science and the community in which it is conducted.
Most anesthesiologists will split their time working in the operating room, intensive care unit, or pain clinic and divide the rest of their time in administrative, teaching, and research roles. Each of these positions and environments will have their own obligations associated with them; and it is often the case that many of the obligations and issues that arise in the clinical setting will have some overlap with research activities.
Anesthesiologists conducting research have obligations to patients, colleagues, and society that should be adhered to. Some of the main research-based obligations include the following.
• Study design and performance should be based on a thorough knowledge of the scientific literature and other relevant sources of information.
• Studies should address a research question of sufficient value to participants to justify risk exposure.
• There should be clear research question(s) that can be answered reliably and efficiently.
• Sufficient number of participants should be enrolled in a reasonable period.
• All research projects should be reviewed by relevant research ethics committee(s) for consideration, comment, guidance, and approval before the study begins (even studies that are noninvasive or involve accepted therapies need approval both for regulatory reasons and to consider issues of confidentiality, cost and voluntariness).
• Informed consent should be obtained for all parts of the project, including any resulting adverse effects that may require modification of protocols or care.
• Undue inducements, duress, or coercion should not be used in recruiting or retaining participants.
• Research should be conducted only by individuals with the appropriate medical qualifications and scientific training.
• Findings should be valid and reproducible.
• Research design should be preceded by careful assessment of predictable risks and burdens to the individuals and communities, and participation should be dependent upon confidence that the risks involved can be satisfactorily managed.
• Research protocols, and information given to participants, should have clear provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study.
• Participant privacy and confidentiality in the collection, analysis, storage and/or reuse of identifiable and anonymized data should be ensured.
• Positive and negative research findings should be disseminated.
To some, these may seem like scientific or legal considerations, and not ethical considerations. However, these considerations are ethical in that designing and executing a study that is not scientifically rigorous or exhibits scientific misconduct puts participants at risk of burden, loss, or harm.
Why anesthesiology research is special
The kind of research conducted by anesthesiologists deserves special attention by virtue of the fact that a good deal of the human subject research conducted will be with participants who are potentially themselves vulnerable – children, women in labor, critically ill patients – or in temporary vulnerable states – individuals who are sedated, unconscious, about to undergo surgery, in pain, or being resuscitated. This is not to say that vulnerability is not found in other areas of research, merely that it is an acute and central concern in anesthesiology and peri-operative clinical research. Moreover, the unique environment in which clinical anesthesiology research is conducted and consent is obtained, also presents specific challenges. As a result of this, this chapter will focus on three areas where these issues are especially important for the ethical conduct of clinical anesthesiology research: enrollment and consent, potential conflicts of interest, and the balance of risk and benefit.
Enrollment and consent in clinical research
Free and informed consent to participate in a research project must be obtained from the participant or from an appropriate legally designated representative for participants who do not possess the capacity to consent. Participants incapable of providing consent for research participation require special protection.
The consent process should involve providing the participant with sufficient information – in lay language – that includes the aims of the research and potential outcomes, inclusion and exclusion criteria, what happens if the participant agrees to take part, what methods, techniques, or devices will be used, any risks or benefits to participating, what will happen to specimens or data obtained from research, arrangements for ensuring anonymity or confidentiality, and how results will be disseminated, amongst other relevant considerations.
It should be made clear that the primary purpose for medical research is to understand the nature of disease and/or improve preventive, diagnostic, and therapeutic interventions. As such, the decision to participate in research need not result in any direct personal benefit – even if there are associated indirect benefits. It should also be made clear that a decision not to participate will have absolutely no effect on their clinical care.
Research participants need to be given sufficient time to reflect on the information contained within the project description and consent form, and to consult with friends or family members (should they wish). The unique environment in which most clinical anesthesiology research takes place will make this a challenge that must still be accommodated.
It must be made unambiguous that research participants and their data (assuming it is not anonymised) can be withdrawn from a study at any time without explanation and that this withdrawal will also have absolutely no effect on the quality or level of their clinical care. Research involving general anesthetics or other potent central nervous system depressant medications will constrain a participant’s ability to exercise their right to withdraw from a study and this factor must also be taken into account and accommodated within the design and conduct of a study. Due attention must also be paid to the fact that approaching patients in a clinical setting for research purposes will raise questions about a patient’s privacy and the confidentiality of medical information and research data.
Related posts:
Informed consent and the pediatric patient
The use of ethics consultation regarding consent and refusal
Revising the Uniform Anatomical Gift Act – the role of physicians in shaping legislation
Conflicts of interest in research funding
Physician conscientious objection in anesthesiology practice
Opioid therapy in addicted patients: background and perspective from the US
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