Abstract
INTRODUCTION: Pragmatic clinical trials conducted in the context of routine care frequently satisfy the regulatory criteria for a waiver of research consent. When they do, investigators and Institutional Review Boards might assume that there is no reason to communicate any information regarding the study to participants. Yet, this approach ignores the possibility that there may be value in providing information to participants, even when the study does not pose significant risks and researchers are not obtaining their consent. METHODS: Members of the NIH Collaboratory Ethics and Regulatory Core working group used ethical analysis to determine whether there are reasons to provide information to research participants, other than notifying them of significant risks or obtaining their consent. Study team members then provided examples of trials which illustrate the feasibility and different options for providing information to participants in the context of trials conducted with a waiver of research consent. RESULTS: Communicating information to participants can promote one or more of six goals: respect for persons, participant understanding of the research, participant understanding of their contributions, participant ability to voice any concerns, participant engagement, and trust and trustworthiness. Providing information can also raise potential concerns about feasibility and cost, which need to be balanced against these reasons to inform participants. Depending on the study, a variety of methods can be used to communicate information; for example, letters, email, flyers, posters, as well as brief conversations with clinicians. CONCLUSION: Even when researchers are not obtaining participants' consent, communicating information can promote one or more of six important goals. Providing information to participants should thus be the default for trials conducted under a waiver of research consent.