2009 Webinar: Refocusing on Crucial Issues for IRBs

Webinar Archives - Members  Webinar Archives - Non-Members

Overview

Refocusing on Crucial Issues for IRBs: New Year, New Lens was an intermediate-level program that addressed some of the most challenging issues facing institutional review board/human research protection program (IRB/HRPP) professionals, and provided in-depth information and concrete strategies for enhancing your IRB’s or HRPP's operations. Examples of best practices were given, and participants gained insight into areas in which enhancement of their policies and procedures may be needed.

Agenda

In this engaging and highly practical offering from our highly respected faculty, participants learned more about...

  • Approaches to informed consent - Assess the process of consent, and identify new approaches to simplifying the forms.
  • Flexibility in the review process - Understand how to effectively use exemptions and expedited review mechanisms, how to ensure the role of the IRB in the review process is clearly understood by all involved, how to avoid mission creep, and more.
  • Assent (and permission) in research with children and adolescents - Learn about the developmental aspects (when are children old enough to give permission?) and the regulatory aspects (when can you and should you waive permission?).

Faculty

Bruce Gordon, MD
Bruce Gordon, MD is Professor of Pediatrics in the section of Pediatric Hematology/Oncology and Stem Cell Transplantation at the University of Nebraska Medical Center (UNMC), and in the Division of Health Promotion, Social and Behavioral Health Sciences, University of Nebraska College of Public Health. He received his BA and MD from Johns Hopkins University, and completed residency and fellowship at Case Western University and UNMC. He has been a faculty member at UNMC since 1989.

Dr. Gordon has been a member of the UNMC Institutional Review Board since 1992 and served as Chair since 1996. He served on the Applied Research Ethics National Association (ARENA), PRIM&R’s former membership division, Public Policy Committee, and on the conference planning committees for PRIM&R/ARENA. He is a founding member of the Collaborative Institutional Training Initiative (CITI), serves on its Executive Advisory Committee, and is the author of two modules for the course. He has been a site visitor for OHRP and for AAHRPP. He served on the American Society of Clinical Oncology Task Force on Oversight of Clinical Research, the NIH Regulatory Burden Advisory Group Human Research Subcommittee, and the AAMC Informed Consent Working Group. In 2004 he was appointed chairman of the National Cancer Institute Pediatric Central IRB, and in 2005 he was appointed to the Secretary’s Advisory Committee on Human Research Protections (SACHRP) subpart A subcommittee.

Moira Keane, MA, CIP
Moira Keane is the Director of the University of Minnesota, Research Subjects' Protection Programs (RSPP) which includes the Institutional Review Board (IRB), the Institutional Animal Care and Use Committee (IACUC), and the Institutional Biosafety Committee (IBC). The RSPP oversees the research of all University of Minnesota campuses which encompasses review of basic science, clinical research, and social and behavioral sciences projects conducted by faculty, staff, and students. She is actively involved in subjects protections and serves as Co-Chair of the AAHRPP Council on Accreditation, as Vice Chair of the Council on Certified IRB Professionals (CCIP (CIP) ), as a member of the Secretary’s Advisory Committee on Human Subjects Protection (SACHRP) Sub Part A Sub Committee, and as a member of PRIM&R's Board of Directors.

Audience

The audience for this webinar included all those working with an IRB/HRPP work and/or those engaged in conducting research more broadly.  IRB chairs, administrators, staff, and members, as well as institutional officials/signatory officials, researchers, and industry representatives found this webinar beneficial.