2013 Webinar: Doing More with Less

Webinar Archives - Members  Webinar Archives - Non-Members

Overview

Developing, implementing, and maintaining an effective and robust human research protections program (HRPP) at institutions with limited resources or those with small research programs brings with it a unique set of challenges. The responsibility for managing these challenges often falls within the purview of the institutional review board (IRB) office, which is frequently understaffed and/or operating with limited resources.

Using a case-based approach, presenters Scott Lipkin, DPM, CIP, and Lori Roesch, CIM, CIP, both associated with self-designated small research programs,explained how they successfully leveraged existing resources to develop and implement best practices throughout various components of their  HRPPs. Topics for discussion included:

  • Providing education to the HRPP
  • Engaging the entire HRPP
  • Training and recruiting IRB members
  • Quality improvement and quality assurance
  • Outsourcing IRB review
  • Conflict of interest
  • Leveraging the Federalwide Assurance (FWA)
  • Efficient utilization of staff
  • Running efficient  IRB meetings
  • Grants/contracts

Audience

This webinar was interest to institutional officials, IRB administrators, staff, and members, and others involved in the human research protection program working in an institution with a small research program or with limited resources.

Faculty

Scott Lipkin, DPM, CIP, is the chief of the Network Office of Research and Innovation at the Lehigh Valley Health Network (LVHN) in Allentown, Pennsylvania. In this capacity, Dr. Lipkin is responsible for the oversight of all research operations, including human subject protections, research compliance, research finance, clinical operations, and education. Dr. Lipkin is an experienced investigator, IRB member, IRB chair, and HRPP director. He led LVHN through the AAHRPP accreditation process in 2009. A current member of the AAHRPP Council of Accreditation, Dr. Lipkin conducts site visits as a team leader. Dr. Lipkin received his bachelor’s degree in biology from the Fairleigh Dickinson University in Madison, NJ, and a doctorate in podiatric medicine from the Temple University School of Podiatric Medicine in Philadelphia. After completing a residency in foot and ankle surgery at St. Mary Hospital in Philadelphia, Dr. Lipkin joined the medical staff of LVHN in 1989. He earned diplomat status from the American Board of Podiatric Surgery in 1992. Prior to accepting an appointment as a full-time research administrator, Dr. Lipkin served as chief of the Division of Podiatric Surgery for ten years at LVHN.

Lori Roesch, CIM, CIP, is the manager or the research subject protection program (RSPP) at Aurora Health Care, Inc, which includes both a biomedical and social and behavioral IRBs. Aurora is an integrated not-for-profit health care provider serving communities throughout eastern Wisconsin and northern Illinois. With the expertise of 10 human protection professionals, the RSPP oversees more than 500 active research protocols which includes FDA regulated clinical trials involving drugs, devices, or biologics, cooperative group cancer clinical trials, investigator-initiated single and multisite research, as well as behavioral research. In June of 2004, Aurora’s HRPP was among the first sixteen programs in the country to achieve accreditation (through the Partnership for Human Research Protection, Inc.), and continues to maintain full accreditation with the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). Lori has been serving as an accreditation site visitor for AAHRPP since 2006 and serves as a consultant and mentor to other IRB programs and IRB professionals. Lori has been a PRIM&R member since 1999, and serves as a PRIM&R mentor.

Certificates of Attendance

Certificates of attendance for the Doing More with Less: Best IRB Practices for Institutions with Small Research Programs webinar were made available at the conclusion of the webinar. To access the certificate, you must first complete the online evaluation. Such certificates are useful for obtaining continuing education (CE) credits (not Continuing Medical Education credits) from professional associations. Note that guidelines concerning CE credits may differ, and you should consult the appropriate professional association representative for further guidance.

If you would like to receive a certificate of attendance for a previous PRIM&R educational program, please email info@primr.org or call 617.423.4112, ext. 0.

For recertification by CE, CIPs must complete 30 documented hours of continuing education. At least 15 of the 30 hours must either carry credits issued by a recognized accrediting body or have received advanced recognition from the Council for Certification of IRB Professionals (CCIP). Credits from PRIM&R webinars have received such advance recognition, and may be counted towards these 15 hours.

Additional information about CIP recertification can be found here.