2010 Webinar: Who Moved My Approval?

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Overview

Who "moved" my approval? Managing Suspended Research addressed different reasons for suspending approved research and the management of those suspensions. Research can be suspended for several reasons, including compliance problems or because new information arises that mandates a re-evaluation of the study design or the experiences of subjects. This webinar provided valuable guidance on understanding the implications of a suspension and successfully managing the repercussions of such a development.

  • What is the meaning of IRB approval in the context of continuing review, revisions, and ongoing compliance? What conditions or the experiences of subjects may require a re-evaluation of the study design or the approval of the research? 
  • Why might a protocol be suspended temporarily or permanently? 
    • What does it mean when an IO suspends a study? 
    • What are the IRB’s responsibilities once a study has been suspended? 
  • How do you respond when research transcends the IRB's approval (research that has lapsed, continued beyond the scope of the approval, or changed based on what the IRB approved)? How do you determine whether it’s a compliance issue or something else?
  • What is the IRB’s responsibility with respect to problematic studies? Should the IRB have the authority to put a study on “clinical hold” and stop new accruals without suspending it?

Audience

The audience for this webinar included all those working with an IRB/HRPP work and/or those engaged in conducting human subject research more broadly. IRB chairs, administrators, staff, and members, as well as institutional officials/signatoryofficials, researchers, and industry representatives found this webinar beneficial.  Additionally, while this webinar focused on biomedical research, the topics are relevant to SBER as well, so this webinar will include some SBER examples.

Faculty

Michele K. Russell-Einhorn, JD
Michele K. Russell-Einhorn is the senior director of the Office for Human Research Studies at the Dana-Farber Cancer Institute and is responsible for scientific review and institutional review board review, as well as other regulatory matters, involving all cancer research involving human subjects conducted at the five Harvard clinical institutions under the umbrella of the Dana-Farber/Harvard Cancer Center.  Trained as a lawyer, she has over 26 years of professional experience including service as the conflicts of interest attorney for the National Institutes of Health; director of regulatory affairs for the U.S.D.H.H.S Office for the Protection from Research Risks and its successor office, the Office for Human Research Subjects; Director in the Global Pharmaceuticals Practice at PWC; as well as the associate general counsel for the J. Craig Venter Institute.  She is a speaker at numerous conferences on various topics relating to research involving human subjects.  She also is a faculty member in the Northeastern University Masters in Regulatory Affairs Program where she teaches core courses on Human Experimentation.

Don E. Workman, PhD
Don Workman, PhD is the founder and CEO of Workman & Associates Consulting Group where he has been providing consultative services including program review and training in human subject protections and animal welfare requirements since 2003. Additionally, Dr. Workman has developed a practice of providing executive coaching for IRB Professionals. Dr. Workman recently served as the associate vice president for research operations at Northwestern University, where he was responsible for the operating units within the Office for Research including the Office for the Protection of Research Subjects (IRB and IACUC administration), the Office for Sponsored Research, the Office for Research Safety, the Center for Comparative Medicine, and the Office for Research Information Systems. He was also an assistant professor in the Department of Psychiatry and Behavioral Sciences at Northwestern University. Prior to the Associate Vice President role at Northwestern University, Dr. Workman was the Executive Director of the Office for the Protection of Research Subjects, where we was responsible for the day-to-day operations of the human subject protection program and the IACUC portion of the animal welfare program.

Dr. Workman has co-sponsored training workshops with several federal agencies on issues related to human subject protections, and has been invited to participate in a number of federal working groups/panels. He is an international workshop presenter, programmatic consultant, and has been a frequent contributor to the IRBForum listserv.