Ethical Review and Oversight Issues in Research Involving Standard of Care Interventions Workshop in Brief (2015) / Chapter Skim
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Ethical Review and Oversight Issues in Research Involving Standard of Care Interventions-Workshop in Brief
Ethical Review and Oversight Issues in Research Involving Standard of Care Interventions-Workshop in Brief
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In addition, the IRB also oversees the process of obtaining informed consent so that participants understand the risks and potential benefits of the trial before deciding whether to enroll. Recently, questions have arisen about certain key aspects of regulation and oversight of standard of care trials, including in particular the determination and communication of "reasonably foreseeable risks" associated with participating in a trial comparing standard of care interventions.
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assess and exercise oversight of research studying standard of care interventions. o How concepts relating to participation in studies involving standard of care interventions, including potential risks associated with receiving standard of care interventions and with research participation itself, are communicated with research participants.
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Standard of Care Interventions -- The Usual Practice Experience Sox provided remarks about receiving "standard of care" treatment, including whether and to what extent there is a "cryptic randomness" embedded in this experience. He noted that from a patient's perspective, what care is received generally appears to be "random." He further observed that evidence of disparities in treatment patterns suggest that care can be biased toward an individual physician's preferences or routines and not necessarily based on the individual patient's characteristics or specific needs.
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He identified a variety of ways in which a trial comparing standard of care interventions could differ from receiving the same interventions in usual clinical practice, such as: (1) when continuous variables are being measured, the risks associated with each arm could possibly not be the same as the actual average intervention delivered in standard clinical practice; (2)
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. The OHRP Draft Guidance states that "if evaluating a particular risk of research associated with a standard of care is a purpose of the research, then in general OHRP considers that particular risk to be "reasonably foreseeable."2 In a video presentation shown to workshop participants, Jerry Menikoff, Director of OHRP, stated that this provision of the guidance derives from the concept that, "if a study involves possibly exposing a person to different non-minimal risks from those to which they would otherwise be exposed -- risks that have already been identified .
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Keith Fargo, Alzheimer's Association, reinforced this suggestion when he noted that it is not reasonable to take the position that because we are not good at communicating about risk in standard clinical practice, we do not need to be good at communicating that same risk with patients in the context of a research study, adding that "you do have to be better at explaining risk of research than you have to be at explaining risk of clinical practice." Engaging and Communicating with Research Participants The workshop objectives included exploration of how concepts relating to research participation are communicated with research participants. Workshop discussions included individual speakers' perspectives on how consent forms and the current informed consent process could be improved and suggested approaches to the informed consent process for a trial studying standard of care interventions.
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Gamble and Ruth Macklin, Albert Einstein College of Medicine, added that some underserved populations might not receive clinical care outside of the research setting, and thus the research informed consent process might be their only opportunity to receive information about the standard of care interventions. Models and Approaches to Discussing Risks and Obtaining Informed Consent Lantos offered a model for a "five-point" conversation with prospective research participants: 1.
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For example, a commenter speaking from the perspective of a patient argued that the patient voice ought to be included in the design of each individual clinical trial to ensure that "the patients at risk decide what is a risk and what they are willing to do" rather than to have that determination made for them through generalized definitions about risk. Empirical Studies of Participant Perspectives on Informed Consent in Standard of Care Trials Four research centers have received supplemental awards from the NIH to conduct empirical ethics research to learn about the perspectives of researchers, research participants and patients, and others participating in or overseeing research.
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Sugarman added that an HHS Secretarial waiver could be employed to conduct demonstration projects to learn more about what research participants understand and prefer for informed consent or notification, particularly for research projects that are currently difficult to conduct because a minimal risk determination cannot be obtained and thus individual informed consent cannot be waived. There was also some discussion at the workshop about whether a standard-of-care-specific guidance document is needed.
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