Protecting patients’ rights during the clinical study process is paramount to ensuring the safety and well-being of the participants as well as the integrity of the trial. Integral to human subject protection is making sure IRB staff members, investigators, and institutional officials are well-trained, at the very least, in the basic ethical principles governing the conduct of human subjects research. These ethical principles are set forth by the Office for Human Research Protections (OHRP) in what is commonly referred to as the Belmont Report. While many IRBs (institutional review boards) already provide training to their board members and staff, some do not. Furthermore, there are no standard training modules, metrics, or requirements for these voluntary courses, nor is there a clear-cut answer as to who is responsible for funding the training.
In an effort to determine whether initial and continuing training should be overseen by additional guidance or regulation, an advisory committee to OHRP issued a Federal Register notice in July 2008 to solicit comments from the industry. Thus far, OHRP is considering comments from more than 90 individuals and organizations. As of now, OHRP has made no decisions regarding its next steps and has no projected…
The Belmont Report
Enhancing Quality, Protection
Experts on this topic
John Clark. Compliance Officer, Coast IRB LLC, an independent institutional review board. For more information, visit coastirb.com.
Bob Gordon. Senior Director, Clinical Quality Assurance, Americas, Omnicare Clinical Research, a Phase I to IV contract research organization serving the biopharmaceutical and medical-device industries. For more information, visit omnicarecr.com.
Felix Gyi, Pharm.D., MBA, CIP, RAC. Founder and CEO, Chesapeake Research Review Inc., an independent IRB and ethics review business as well as a risk management partner operating in the global research arena to support human research subjects protections. For more information, visit chesapeakeirb.com.
Lynn A. Meyer. President and Founder, IntegReview Ethical Review Board, an independent IRB accredited by the Association for the Accreditation of Human Research Protection Programs. For more information, visit integreview.com.
Gaetano Morelli, M.D. Senior Director of Global Medical Affairs for Early Clinical Research, MDS Pharma Services, which offers a full spectrum of resources to meet the drug discovery and development needs of the pharmaceutical and biotechnology industries. For more information, visit mdsps.com.
Peter Reichertz. Partner and Leader of the Food and Drug Law Group, Sheppard Mullin Richter & Hampton LLP, a law firm with more than 500 attorneys practicing in 11 offices. For more information, visit sheppardmullin.com.