Topics cover institutional review board (IRB) administration, research oversight, and research ethics
Princeton, NJ – Nov. 14, 2019 – WIRB-Copernicus Group® (WCG™), the world’s leading provider of solutions that measurably improve the quality and efficiency of clinical research, has experts from its Ethical Review Division leading nine educational sessions at the Public Responsibility in Medicine and Research (PRIM&R) 2019 Advancing Ethical Research Conference (AER19). This year’s meeting will be held from Nov. 17-20 at the Hynes Convention Center in Boston, MA.
“As clinical research studies become increasingly complex, it is imperative that the industry continues to prioritize continuing education for clinical research practitioners and IRB members to ensure that we maintain the highest levels of ethical reviews, research oversight and human subject protections. WCG considers sharing our knowledge and experience to be an integral and vital part of our role as an industry leader. We are proud to continue our long-standing relationship with PRIM&R,” said WCG Chief Medical Officer Lindsay McNair, MD, MPH, MSB.
WCG’s contributions to AER19 include:
Monday, Nov. 18
1:00 – 2:15 p.m.
- A01: Seven Habits of Highly Effective and Flexible IRBs – WCG Vice President, Process & Strategic Improvement Jeffrey Cooper, MD, MMM, will describe ways in which an IRB can become more efficient, while also protecting subjects more effectively. In partnership with Jonathan M. Green, MD, MBA, Director in the Office of Human Subjects Research Protections at the National Institutes of Health, Dr. Cooper will identify activities that may be better addressed by non-IRB components of a human research protection program, discuss ways to streamline IRB submission and review procedures, and create mechanisms for recognizing and resolving issues prior to IRB review.
- A04: FDA Clinical Holds and 21 CFR 50 Subpart D – WCG Chief Compliance Officer David Forster, JD, MA, CIP will discuss the circumstances under which the US Food and Drug Administration (FDA) may issue a clinical hold to the sponsor of an investigational new drug, delaying a proposed clinical investigation or suspending an ongoing one. Together with Kevin A. Prohaska, DO, MPH, Senior Medical Policy Advisor/Bioethics Consultant, FDA, and Donna L. Snyder, MD, Senior Pediatric Ethicist and Team Leader, FDA, Mr. Forster will describe deficiencies in 21 CFR 50 Subpart D (these are additional safeguards for children in clinical investigations) that can trigger a clinical hold and ways in which IRBs can track the FDA status of impacted clinical studies.
- A23: Making Limited Review Work Without Reinventing the Wheel – WCG Vice President, IRB Compliance David Borasky, MPH, CIP, will discuss limited review, the new regulatory concept included in the revised Common Rule for exempt research. He will partner with Teresa Doksum, PhD, MPH, Senior Director of Quality and Research Ethics, IRB Chair, and Research Integrity Officer at Abt Associates Inc., to outline this requirement and propose a process for managing it without putting significant additional burden on IRB programs.
2:45 – 4:00 p.m.
- B23: Flexible Strategies to Manage Unregulated Research in the Era of the Revised Common Rule – Dr. Cooper will discuss the ethical requirements for oversight of unregulated research and how to manage them in a manner that is consistent with local institutional requirements.
- B11: Navigating State Law Differences in the Era of Single IRB (sIRB) Review – Forster will discuss variations in state laws and the impact they can have on the sIRB review process. He will partner with Michael J. Linke, PhD, CIP, IRB Chair, Professor of Internal Medicine at the University of Cincinnati College of Medicine, and Adjunct Professor at the University of Cincinnati, to propose practical solutions for both reviewing IRBs and relying organizations that are trying to manage these variances.
Tuesday, Nov. 19
10:15 a.m. – 12:45 p.m.
- C22: Scientific Aspects of Study Design: A Primer for Non-scientists – Dr. McNair will describe the scientific process, clinical study designs, and the structure of research programs for non-scientist IRB members. She will partner with Susan S. Fish, PharmD, MPH, who is Professor of Biostatistics at Boston University School of Public Health, to explain the differences between observational and interventional clinical study designs and the best applications for each. They will also discuss factors that can affect the validity of a study and the analysis of its data.
11:45 a.m. – 12:45 p.m.
- A Dialog with the Secretary’s Advisory Committee on Human Research Protections (SACHRP) – Forster, co-chair of SACHRP’s Subcommittee on Harmonization, will join others to discuss the initiatives, issues, and guidance on which they are currently working and participate in a Q&A session. The other SACHRP participants will be Stephen J. Rosenfeld, MD, MBA, President of Freeport Research Systems; Nancy M.P King, JD, Professor of Social Sciences and Health Policy at Wake Forest School of Medicine; and Julia G. Gorey, JD, Public Health Analyst at the U.S. Department of Health & Human Services’ Office for Human Research Protection.
Wednesday, Nov. 20
11:15 a.m. – 12:30 p.m.
- E17: Building Models for Hospital and Practice-based Research Programs – Agony and Ecstasy – WCG Director, Operations Patricia Seymour, CCRP, CIP, MA will describe how to build a community hospital research program from the ground up. Together with Paul Papagni, JD, CIP, Executive Director of Research Programs at Holy Cross Hospital/Trinity Health, Ms. Seymour will discuss the challenges and rewards of working closely with physicians, coordinators, IRBs, patients, and compliance officers on this complex endeavor.
11:30 a.m. – 12:45 p.m.
- E23: Implementing Key Information in Multi-site Research – Forster will discuss how best to present the key information that the revised Common Rule requires be included at the beginning of the patient consent form. He will partner with Jeanne Velders, JD, CIP, Interim Director of the Human Research Protection Office at the Washington University in St. Louis, and Joan Affleck, MA, MBA, Executive Director and Head of Medical Writing at Merck & Co., Inc., to review the available agency guidance and compare key information templates proposed by IRBs, institutions and sponsors.
Experts from WCG’s Ethical Review division will also be available to answer questions at booths #225, #227, #229 and #231.
Additional information about AER19 is available at https://www.primr.org/aer19.
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