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Informed consent process enhancement approaches for research participants who may be considered vulnerable populations



Wright, Matthew; Lynne, Julia; Hardter, Eric; Kondapaka, Radhika; Williams, Kayla; Salazar, Dagmar; Shmueli-Blumberg, Dikla; Jelstrom, Eve; Lindblad, Robert

SCT Annual Meeting

Liverpool, UK


Trial Management & Research Coordination Recruitment & Retention Involving Research Partners

The informed consent process is paramount to the legal and ethical conduct of clinical trials. Adequately explaining study details to potential participants in a manner that permits comprehension and promotes study retention is challenging; this is compounded when recruiting populations that Institutional Review Boards (IRBs) may view as potentially vulnerable populations, such as persons facing concurrent mental or physical illness resulting in diminished capacity for comprehension, or with socioeconomic issues such as unstable housing, limited educational status, or low functional literacy. Notwithstanding any applicable legal thresholds for a legally authorized representative’s involvement, these factors may not negate the participant’s autonomy and capacity to make an informed decision on trial participation. In planning studies that involve such potentially vulnerable populations, investigators should consider and implement additional safeguards to ensure that informed consent materials are readily understandable, and that the consent process balances adequate coverage of required elements while avoiding overwhelm for the participant and burden on the research team. The National Institute on Drug Abuse National Drug Abuse Treatment Clinical Trials Network Clinical Coordinating Center (CCC) and the National Cancer Institute’s AIDS Malignancy Consortium (AMC) develop clinical trials for populations that IRBs may consider vulnerable: people living with HIV/AIDS (PLWHA) and/or persons who inject drugs (PWID). Common challenges that CCC and AMC investigators face during the consenting process include designing informed consent materials that communicate required regulatory elements simply yet effectively, engaging the individual in the consent discussion, and assessing comprehension. Methods to be discussed include: • Consent design factors for readability • Ancillary visual and written aids • Consent process standard operating procedures • Patient advocate feedback and involvement • Participant comprehension assessment This presentation will highlight these challenges and offer tools and best practices for research teams to develop informed consent materials and augment consenting processes.

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