Institutional Review Board Myths and Misconceptions
Information Session
Thursday, January 3
9:00 am - 10:00 am
Rose Library 3311
*Notes: This workshop will be followed by a lockdown from 10:00 am - 12:00 pm. You can register for additional lockdowns by going to the IRB Lockdown page.
What requires IRB approval? Puzzled by myths and misconceptions encountered in the IRB process? Explore definitions of how research and human subjects are defined by the federal regulations. Learn about what requires IRB review and approval. Scenarios seeking audience members’ input will be used to answer common myths and misconceptions. Participants will learn how to generate a protocol once it is determined an IRB review/approval is required.
Participants will:
- Understand what truly is “research” as defined by the federal regulations.
- Determine what qualifies as a research project requiring IRB review/approval.
Gain knowledge about the IRB submission process.
Facilitators:
John D. Hulvey, Director, Office of Sponsored Programs
Carolyn Strong, Research Coordinator, Office of Sponsored Programs
Facilitator Bios:
John Hulvey has been employed by James Madison University since 1986 in a variety of positions. In January 2002 he was offered and accepted the
position of Director of Grants and Contracts Financial Services (now Sponsored Programs Accounting). After learning this post-award side of Sponsored Programs administration and successfully passing the exam to become a Certified Research Administrator (CRA), and upon the retirement of the Office of Sponsored Programs Director in July 2006, John became the Director of a combined department of Sponsored Programs Administration and Accounting. These two offices provide guidance and oversight for a all pre-award and post-award functions related to external funding as well as the compliance areas of the Institutional Review Board (IRB) overseeing research using Human Subjects, and the Institutional Animal Care and Use Committee (IACUC) for the Use of animals in research.
Carolyn Strong received a BS in Business Administration from The University of Tennessee. She came to James Madison University in 2003 and works in the Office of Sponsored Programs Administration. Carolyn currently serves as the Research Compliance Coordinator for both the Institutional Review Board (IRB) and the Institutional Animal Care and Use Committee (IACUC). Carolyn ensures that the integrity of the human subjects and animal subjects research protocol reviews conform to all federal, state, local and institutional policies and procedures. She is the primary liaison between the IRB and IACUC committees. Carolyn receives and provides the initial evaluation of all human subject and animal subject protocols at the university. She performs the first review of each protocol identifying incomplete documents. She notes potential areas of concern, applying knowledge of federal regulations governing human/animal subject research. Carolyn communicates with investigators to recommend remediation steps to complete preliminary review, subsequently preparing and posting documents for review by members of the IRB/IACUC.
For more information contact the Center for Faculty Innovation | 540-568-4846