Can Consent to Participate in Clinical Research Involve Shared Decision Making?

Abstract

Shared decision making honors patient autonomy and improves patient comprehension and therefore should be a part of every clinical decision a patient makes. Use of shared decision making in research informed consent conversations is more complicated due to diverse and potentially divergent investigator and patient interests, along with the presence of clinical equipoise. This article clarifies these different interests and discusses ways in which shared decision making can be applied in research. Provided there is transparency about competing interests, patient-centered and values-focused communication approaches embodied in shared decision making can support the ethical recruitment of patients for clinical research. CaseDr T is a rheumatologist and principal investigator in several clinical trials on biologic agents. One of her patients, Mr X, has rheumatoid arthritis that has not responded well to standard treatment. Dr T approaches Mr X about enrolling in a phase II trial, the purpose of which is to evaluate the efficacy, safety, and dose specifications of a new monoclonal antibody. Dr T explains the trial's design to Mr X, emphasizing the possibility that he would not receive the antibody if he is randomized to the placebo arm of the study. Dr T also explains that, if he does receive the antibody, Mr X could experience negative side effects and complications. Mr X agrees to participate in the trial.About 2 weeks into the trial, during a follow-up visit, Dr T asks Mr X about his responses to the experimental agent. Mr X says, "Thank you, Dr T, for letting me try this treatment." Dr T explains that the antibody is neither a treatment nor (even anywhere near being) an approved clinical intervention. Dr T reminds Mr X of the trial's goals. Mr X responds, "I'm so lucky I have a doctor like you who can use research to help patients in ways other doctors can't. This new medicine is great." Dr T wonders how to respond.

Fragmented understanding: exploring the practice and meaning of informed consent in clinical trials in Ho Chi Minh City, Vietnam

“…An adapted informed consent form developed with systematic self-reported information needs [ 55 ] and with contribution from different expert groups and tested by target audiences [ 53 ] was proved to improve the understanding of study participation. Moulton et al [ 56 ] proposed a shared decision making strategy focused on being transparent about competing interests of stakeholders involved in the study and the alignment of patients’ goals and values with their decision of research participation. Moreover, being open about clinical research with the general public is also a method for improving quality of informed consent [ 57 ].…”

“My Blood, You Know, My Biology Being out There…”: Consent and Participant Control of Biological Samples

“…We asked our participants to assess the acceptability of hypothetical genomic studies that varied on four factors: race of the investigative team, research goal, sponsoring institution and form of consent. Each of these factors is strongly connected to research participation in the literature (Davis et al, 2013; Echeverri et al, 2018; Frierson et al, 2019; Fryer et al, 2015; Guillemin et al, 2018; Levkoff & Sanchez, 2003; Moulton et al, 2020). Our choice of “form of consent” was additionally motivated by previous studies that have indicated that the use of, specifically, broad consent is a barrier to research participation as well as its common use in genomics research (Passmore et al, 2020b).…”

Engagement of Older Adults Receiving Home Care Services and Their Caregivers in Health Decisions in Partnership With Clinical Teams: Protocol for a Multimethod Study to Prioritize and Culturally Adapt Decision Aids for Home Care

“…Shared decision-making (SDM) is a collaborative process whereby clinical teams support individuals and their families to make informed health and social care decisions based on the best evidence and what matters most to them [ 6 , 7 ]. It fosters informed consent [ 8 ] and improves care experiences [ 9 , 10 ], health outcomes [ 10 - 12 ], clinical team well-being, and efficiency [ 13 , 14 ]. SDM also reduces the uptake of unproven treatments and, consequently, reduces health care waste [ 15 ].…”