Considerations for protecting research participants

Abstract

Abstract As pragmatic randomized clinical trials (pRCTs) are being designed, pertinent regulations, laws, and guidance for protections of human subjects in research should be reviewed, including requirements related to privacy and clinical trial registries. Pragmatic RCTs present unique ethical challenges. For example, the extent that a pRCT reflects usual care will affect how risk is assessed by ethics boards. Since usual care is often not well-understood, there is a critical need for research which quantifies usual care across healthcare settings, in order to better inform the design of pRCTs. Regulations and ethical consensus support informed consent for all research participants in pRCTs, whether they are patients or providers. However, newer models of consent are needed to improve both comprehension and the consent process. A priori discussions with ethics boards regarding alterations of consent may streamline the process of ethical review and approval of pRCTs, and may ultimately result in more robust approaches to consenting research participants. To foster greater agreement and consistency in determinations made by ethics boards, specific guidance from regulatory agencies for the ethical conduct of pRCTs is needed.