Topics to be covered include unregulated research, genetically modified vaccines, electronic research oversight and reporting, staff education, and managing meetings remotely.
(PUYALLUP, WA – Nov. 30, 2020)
Several WCG IRB thought leaders will participate in presentations at the virtual 2020 Public Responsibility in Medicine & Research (PRIM&R) Advancing Ethical Research (AER) Conference. This virtual event will be held on Dec. 1-2, Dec. 8-9, and Dec. 15-16. WCG is also sponsoring the opening night Happy Hour.
“We are proud to be able to continue supporting PRIM&R in meaningful ways during the pandemic,” said WCG Chief Medical Officer Lindsay McNair, MD, MPH, MSBioethics. “Clinical research is progressing at a furious pace as we seek safe and effective therapies and vaccines for COVID-19, and we must all ensure that the highest standards of ethical review are maintained. As many IRB staff members are working remotely, it is more important than ever that we make time to reach out and share encouragement, knowledge and experience with each other.”
- Dr. McNair will participate in the first panel discussion, entitled “Coloring Outside the Lines: Ethical Conduct of Unregulated Research,” which will be held from 11:30 a.m. to 12:45 p.m. on Dec. 1. This session will focus on ethical issues relating to human participant research that is not federally funded and therefore is not regulated by the U.S. Food and Drug Administration (FDA) and Department of Health and Human Services (DHHS). Examples include student projects and surgical research in academia, privately funded biopharma research on biospecimens and real-world data, and technology research involving big data and medical records. This panel will discuss how institutional review boards (IRBs) should address ethics issues with these types of research, highlighting opportunities to learn collaboratively and set standards.
- WCG Senior Scientific Advisor, Gene Therapy Daniel Kavanagh, PhD, RAC, will review “Points to Consider for Human Subjects Protections in Next-Generation Vaccine Trials,” from 12:45 p.m. to 1:15 p.m. ET on Dec. 2. Dr. Kavanagh’s presentation will focus on vaccine development involving genetically modified DNA, RNA, or viral vectors, and the unique issues it raises with respect to ethical review and human participant protection.
- WCG Chief Compliance Officer, David Forster, JD, MA, CIP, will present, along with Irene Stith-Coleman, PhD, of OHRP, “Navigating State Law Differences in the Era of Single IRB (sIRB) Review,” from 1:15 – 2:15 p.m. ET on Dec. 2. Share practical tips for IRBs in considering and applying variances in state laws as part of their sIRB review. Mr. Forster and Dr. Stith-Coleman will review key areas where state laws vary and identify how these variances impact the IRB review process.
- WCG Consultant Stuart Horowitz, PhD, MBA, will lead “Adapting to the New Reality–Enhancing Human Research Protections and Managing Workflow and Compliance While Remaining Financially Responsible” from 12:45 to 1:15 p.m. ET on Dec. 9. Panelists will describe how they reconfigured their organization’s Human Research Protection Program (HRPP) to reduce costs during the pandemic, while still maintaining the highest quality human participant protections. Strategies employed included focusing local IRB attention on high-risk research, relying on IRB partners for multicenter clinical trials, and implementing WCG’s IRBNet electronic submission and review system.
- Mr. Forster will also speak at a breakout session on “How to Investigate, Mitigate, Report, and Learn from Noncompliance: Avoiding Pitfalls and Seizing Opportunities for Improvement” at 1:15 – 2:15 p.m. ET on December 15. This session will address how institutions can use incidents of alleged noncompliance (both investigator and IRB) as learning opportunities, and will identify strategic and substantive pitfalls to avoid.
- WCG Vice President, IRB Compliance David A. Borasky, MPH, CIP, will offer “Strategies for IRB Member & Staff Education” during the panel discussion from 1:15 to 2:15 p.m. ET on Dec. 15. Panelists will describe educational resources that are interactive, adaptable, and readily available, including videos, webinars, and case studies. They will also outline several effective strategies for increasing IRB member buy-in and engagement in educational activities.
- Mr. Borasky will also lead the session on “Effectively Managing Teams and Meetings in a Remote Environment” from 1:15 to 2:15 p.m. ET on Dec. 16. He will suggest tools and offer tips to build rapport, keep staff engaged, and facilitate collaboration when most HRPP/IRB office operations and meetings are taking place online. Mr. Borasky will also discuss future considerations for office operations.
Additional information about PRIM&R AER, including the complete agenda, can be found at https://www.eventscribe.net/2020/aer20/index.asp.