Giving voice to research participants: should IRBs hear from research participant representatives?

The current decision-making model for the review of human research contains inadequate mechanisms to ensure that the interests and perspectives of research participants are considered by Institutional Review Boards, whose decisions may profoundly affect the safety and well-being of participants. As a result, this model is far from being optimized to realize Institutional Review Boards' principal mandate and undermines the credibility of the research review process. This article proposes a procedural mechanism that would ameliorate these systemic deficiencies by allowing "research participant representatives" to give voice to participants during the research review process.