They say you can’t teach an old dog new tricks, but in the world of clinical research regulations, many would also say if a guideline isn’t broken, don’t fix it—even if the guideline in question dates back to the Carter administration.
Such is the case with the Belmont Report, finished in 1978 and published in the Federal Register in 1979 (full title: Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research). It was crafted to address ethics in clinical research by a commission whose own creation was prompted in part by the revelations of unethical research practices condoned by U.S. health officials across the decades-long Tuskegee Syphilis Study.
In his August 20 ACRP Webinar on “Ethical Principles in Clinical Research,” presenter James Riddle, MSCE, CIP, CPIA, CRQM, Senior Vice President for Global Review Operations with Advarra, will explain how the Belmont Report has stood the test of time since its earliest days of formation, during the golden age of disco, right up to the present. Along the way, the report has been incorporated into the Federal Policy for Protection of Human Subjects (also known as the “Common Rule”) found in 45 CFR part 46 of the Code of Federal Regulations, in which the Department of Health and Human Services outlines, among other things, the duties of institutional review boards (IRBs)—the relationship of which to the Belmont Report will be addressed by Riddle in his talk.
“I’m inviting webinar attendees to pause and reflect on the ethical foundations that safeguard human participants in research,” Riddle says. “We’ll explore the historical milestones that shaped today’s protections, examining how past research abuses led to the creation of oversight structures like the Belmont Report and IRBs.”
The report is perhaps most famously known among stakeholders in clinical trials for elucidating three ethical principles for human subject research—“Respect for Persons,” “Beneficence,” and “Justice”—the ramifications of which for informed consent, assessment of risks and benefits, and the selection of study participants, will be laid out by Riddle.
Riddle also will show how the Belmont Report has its ties to the recently updated International Council for Harmonization’s (ICH’s) Guideline for Good Clinical Practice E6(R3), followed by clinical researchers around the world and a focus of fundamental training for the profession, highlighting key similarities and differences.
“Together in the webinar, we’ll delve into core ethical principles outlined in the Belmont Report and review how they continue to guide decision-making in response to contemporary challenges in research,” Riddle notes. “Once you know the history behind it, it’s easy to appreciate how the Belmont framework remains relevant in navigating today’s complex clinical research landscape.”
[Note: ACRP commemorated the 30th anniversary of the Belmont Report in the December 2008 issue of The Monitor, the predecessor journal of today’s Clinical Researcher. Anyone who is interested in receiving a complimentary PDF of key articles from that issue should contact the Managing Editor at [email protected].]
Reported by Gary Cramer