Rethinking Informed Consent Requirements for Pragmatic Comparative Effectiveness Trials
Whicher, Danielle Marie
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Recently, there has been an increasing demand for more and higher quality evidence of the comparative effectiveness of different health technologies. Much of the comparative effectiveness research (CER) designed to address this demand will compare widely-used technologies and will be closely integrated with clinical care. These design features raise the question of whether current standards of informed consent should always be required for CER studies. Considering the acceptability of alternatives to informed consent is important as alternatives may improve the efficiency and quality of this research. This dissertation considers whether alternatives to informed consent are morally and socially acceptable by addressing three aims, each of which is explored in a separate paper. Aim one explores which alternatives to informed consent are acceptable to key stakeholders for low-risk CER trials of widely-used therapies. To address this aim, interviews were conducted with institutional review board members and researchers and focus groups were conducted with patients at two health systems. The results demonstrate that many participants felt that although it was important for eligible individuals to be informed about CER trials, it was acceptable to streamline the amount of information disclosed and to ask individuals to opt-out if they would prefer not to participate. Aim two considers which alternatives to prospective informed consent are morally permissible for CER studies. Addressing this aim, paper two is a moral analysis that argues that when enrolling individuals in these activities, it is sometimes acceptable to limit individual choice in situations where the decision to participate is unlikely to engage important self-determination interests that individuals have. Based on this argument, several recommendations regarding the moral permissibility of altering consent requirements for CER are provided. Aim three develops preliminary policy recommendations for reforming the informed consent regulations. Building on aims one and two, paper three suggests that it may be appropriate to streamline disclosure statements for low-risk CER trials and that it may also be appropriate to ask participants to opt-out instead of opt-in. However, in order for policy change to occur, it is necessary to continue to build the case for the importance of conducting CER studies.