Community-based participatory research ensures that community protections, risks, and benefits are considered during ethical reviews of research protocols.
AMA J Ethics. 2017;19(10):989-998. doi:
10.1001/journalofethics.2017.19.10.ecas3-1710.
Some commentators say comparative trials of FDA-approved drugs are overburdened by current Common Rule regulations and that researchers should not be required to obtain explicit consent for participation in the most innocuous of these trials.
Thomas W. LeBlanc, MD, MA, MHS and Arif H. Kamal, MD, MBA, MHS
Clinical trials should assess patients’ distress and test interventions to address it, just as they assess adverse events and test novel therapeutic agents.
AMA J Ethics. 2017;19(5):460-466. doi:
10.1001/journalofethics.2017.19.5.stas1-1705.