Mark Barnes Examines Subject-Sponsor Interactions in Report on Research Compliance
The Report on Research Compliance features extensive analysis from health care partner Mark Barnes (Boston). He discusses the Secretary’s Advisory Committee on Human Research Protections’ new recommendations to the U.S. Department of Health and Human Services.
The recommendations address the increasingly problematic interactions between research study sponsors and subjects and the rise of third-party vendors, outlining a role for institutional review boards in establishing a framework for such interactions and for vendor activities.
“The line between advising or giving information to a disease advocacy group versus becoming an advocate for people affiliated with the advocacy group to get first priority for Phase 1 or Phase 2 trials can itself be problematic,” said Mark.