The proposed research - EDICT (Effective Delivery of Informed Consent Trial) - directly responds to the funding opportunity announcement (FOA) PA-11-180, Research on Ethical Issues in Biomedical, Social and Behavioral Research. Consistent with the FOA, EDICT addresses an important ethical challenge related to the conduct of clinical and behavioral research funded by National Institutes of Health (NIH): the persistent use of long informed consent forms and their adverse impact on potential participants'comprehension of the research. There is substantial evidence that potential research participants do not fully understand information disclosed in consent forms. The long length of consent forms is a contributing factor. EDICT will identify pertinent and extraneous information included in consent forms as perceived by key stakeholders;incorporate this information in the development of short consent form templates for both behavioral and clinical research;and then evaluate the short consent forms derived from the templates, compared to standard consent forms within two actual HIV Prevention Trials Network (HPTN) studies, using a randomized controlled design. Specifically, EDICT will proceed in three stages. In Stage 1, interviews will be conducted with key research stakeholders -- 1) participants, 2) members of host-country research ethics committees, 3) members of oversight bodies, 4) investigators and study coordinators, and 5) members of the HPTN Community Working Group and local Community Advisory Boards -- to identify components of informed consent forms that are perceived to be either pertinent or extraneous to potential research participant decision making. In Stage 2, interview data will be used to create short informed consent templates. The final language to be incorporated in the templates will be determined during a meeting of HPTN representatives, representatives from oversight bodies, and experts in research ethics, and then cognitively pre-tested with potential participants. In Stage 3, using a two-arm randomized controlled design, we will evaluate participant comprehension, participant satisfaction, and quality of informed consent among participants assigned to the short consent form developed using the template compared to participants assigned the standard consent form in actual behavioral and clinical HPTN studies. While short consent forms have been previously shown to be as effective or better at achieving participant understanding compared to longer forms, they have not been tested in the context of Phase III randomized trials or in research that involves greater than minimal risk as proposed in EDICT, and longer consent forms are still commonly used. EDICT will therefore provide data needed to inform long-term policy debates regarding the length of consent documents and their effect on the quality of informed consent.
Ensuring comprehension of informed consent among potential research participants continues to be a challenge. A contributing factor to limited understanding is the length of consent forms. Long consent forms are also burdensome for both potential research participants and study staff and affect the efficiency of research. EDICT, which will be conducted within the global HIV Prevention Trials Network (HPTN), will develop short consent templates based on data collected from important stakeholders - research participants, research ethics committee members, investigators and study coordinators, community representatives, and members of oversight bodies of HPTN studies. The data-driven consent templates will be used to create short consent forms for two active HPTN studies. These short consent forms will be compared to the standard consent forms for the two HPTN studies using a two-arm randomized controlled design, and participant comprehension, participant and counselor satisfaction, and quality of informed consent will be evaluated. EDICT will provide data needed to inform long-term policy debates regarding the length of consent documents and their effect on the quality of informed consent.
| Corneli, Amy; Namey, Emily; Mueller, Monique P et al. (2017) Evidence-Based Strategies for Shortening Informed Consent Forms in Clinical Research. J Empir Res Hum Res Ethics 12:14-25 |
| Corneli, Amy; Sugarman, Jeremy (2017) Reducing Consent Form Length: Stakeholder Support, Evidence-Based Strategies, and Regulatory Requirements. IRB 39:18-20 |
