Testing Modified Approaches to Informed Consent

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DESCRIPTION (provided by applicant): The dominant ethics paradigm for clinical research requires, first, that an Institutional Review Board (IRB) establish the ethical acceptability of a study. Once the IRB determines, generally, that risks are reasonable in relation to anticipated benefits, eligible individuals, through the informed consent process, can decide whether the risk/benefit balance and specific procedures are reasonable to them. In theory, this paradigm has significant moral merit. In practice, however, evidence suggests many research subjects do not understand the primary purpose or key procedures of studies in which they enroll. Further, consent forms the legally required mechanism for delivering and documenting study information often are written at highly complex levels and investigators rarely, if ever, determine what subjects actually understand. Many types of interventions have been tested to modify informed consent and improve subjects' understanding, with mixed results. In general, shortening consent forms and increasing dialogue have improved understanding scores, as has giving a knowledge quiz, correcting incorrect answers, and repeating the quiz. These interventions, however, generally were tested in simulated research settings, asking individuals to "pretend" they were being recruited for research, and/or with very small samples. Investigators acknowledge these methodological limitations but describe feasibility challenges, including finding actual trials and investigators willing to collaborate, given fears that collaborations will decrease parent trial accrual and/or will be overly burdensome to subjects and staff. The goal of this R21 exploratory project is to design simple informed consent interventions with an approach relevant to most types of trials; and then determine the feasibility of testing them in the context of six ongoing clinical trials at Johns Hopkins. Specifically, through this planning grant we will a) develop the intervention (simpler consent forms that emphasize critical study information; and a verbalization-feedback tool to be used with all subjects to identify and discuss misunderstandings); b) develop a Consent Understanding Evaluation tool to assess experimentally subjects' understanding when exposed to standard vs. enhanced consent approaches; c) pilot testing the intervention, assessments, and randomization and recruitment procedures in ongoing COPD, pulmonary hypertension, HIV (2), and cancer (2) trials; and d) Refine procedures, determine sample size estimates, and meet with future collaborators for an R01 application for a randomized trial of standard vs. enhanced consent procedures in multiple, national, ongoing clinical studies. PUBLIC HEALTH RELEVANCE This project will a) develop simplified informed consent forms and an original Verbalization-Feedback intervention tool to promote subjects' understanding of research; and b) will determine the feasibility of comparing these consent process enhancements to standard consent approaches in six ongoing clinical research studies (in COPD, pulmonary hypertension, HIV (2), and cancer (2)). This exploratory work will be used as background material for a future R01 submission, whereby we will plan a large, national clinical trial of standard vs. enhanced consent approaches in ongoing clinical studies. While numerous informed consent improvements have been recommended, none has been tested in field settings in the context of several large ongoing clinical studies.