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December 12, 2011

Human Research Subject Protection: A Time of Reflection, Renewal and Reform? No--It's Time to Redesign!

Keynote Speaker for this Event:

                                  GREG KOSKI, PhD, MD          
                                  Senior Scientist, James Mongan Institute for Health Policy 
                                  Associate Professor of Anesthesia, Harvard Medical School 
                                  Associate Editor, Journal for Empirical Research on Human Research Ethics

This webinar will include a live audience Q&A session with Dr. Koski and Jack Corman, President and Founder, Institutional Review Board Services

Learn more about our speakers   Learn More

The National Research Act of 1974 ushered in an unprecedented era of legislative and regulatory actions to protect research subjects from harms they suffered as participants in studies like the Tuskegee Syphilis Study. The Common Rule (45CFR46) and FDA regulations Title 21 Parts 50 and 56 have been in effect since 1981, with various additions and modifications since then. Over the ensuing three decades, the conditions leading to the current regulatory framework have changed and "the rules" have had unintended consequences, driving a culture of compliance in which the ethos behind those regulations is often lost, squandering time and resources without evidence demonstrating whether or not these regulatory requirements are effective in achieving the overall objective. Further, the research landscape itself has changed with the advent of multicenter, multinational research as the norm rather than the exception.

This webinar will consider recent proposed changes to the regulatory and legislative environment and efforts to better define the roles of the IRB and the investigator in effectively carrying out their responsibilities. Many claim that the current system must be reformed to make it more effective as well as more efficient, and to focus on the critical determinants of subject protection, to move from a compliance-focused environment to one that balances compliance with conscience. Dr. Koski, the first director of the Office for Human Research Protections, argues that nothing short of a complete redesign will be effective and offers and alternative approach for achieving these goals.

THIS PROGRAM IS INTENDED FOR:

Senior Researchers, Investigators, IRB Administrators, and individuals responsible for research performance and oversight at research sponsors, organizers, CROs and SMOs.

ABOUT OUR SPEAKERS:

GREG KOSKI, PhD, MD
    - Senior Scientist, James Mongan Institute for Health
    - Associate Professor of Anesthesia, Harvard Medical School
    - Associate Editor, Journal for Empirical Research on Human Research Ethics

Dr. Koski was the first director of the Office for Human Research Protections in the Department of Health and Human Services. He is currently Anesthetist, Cardiac Anesthesia Group, Massachusetts General Hospital; Senior Scientist, MGH/Partners Institute for Health Policy; Associate Professor of Anesthesia, Harvard Medical School. He is co-founder of the Alliance for Clinical Research Excellence and Safety (ACRES), a non-profit organization striving to build a global network for clinical research modeled after the international air transportation system.

Professional activities include:

  • Past President and former Chairman of the Board of Trustees, Academy of
        Pharmaceutical Physicians and Investigators
  • Former member of the Board of Trustees, Association of Clinical Research Professionals
  • Associate Editor, Journal of Empirical Research on Human Research Ethics
  • Former Chair, Ethics Advisory Board, Framingham Heart Study, National Heart, Lung and
        Blood Institute
  • Chair, Advisory Committee, Strategic Initiative for Developing Capacity for Ethical Review
        (SIDCER), World Health Organization
  • JACK CORMAN, B.Sc, B.Ed
        - President and Founder, Institutional Review Board Services

    Jack Corman worked in the pharmaceutical industry for 17 years, rising to General Manager, before founding Institutional Review Board Services (IRBS) in 1993, an independent research ethics review service that has reviewed thousands of studies, mainly in Canada but also the US.

    Mr. Corman is Executive Committee Member, National Council on Ethics in Human Research, a voting member, Experts Committee on Human Participant Protection in Canada, and voting member, Committee to Establish a National Standard for Biomedical Research Ethics Boards. Currently, he is participating with the Canadian Institutes for Health Research on harmonization of multicenter ethics review in Canada. He is an Executive Member, US Consortium of Independent Review Boards (CIRB), which has representation on the Clinical Trials Transformation Initiative (CTTI) and also a member of the Project to Harmonize Health Research Guidelines, Health Improvement Institute, Bethesda, MD.

    In addition, Mr. Corman is a Member of the Canadian Association of Research Ethics Boards Canadian Society of Clinical Pharmacology and Therapeutics, the Association of Clinical Research Professionals, the Drug Information Association (DIA), and the Canadian Business Ethics Research Network.

    RELATED WEBINARS

    This webinar is part of a series on FDA Guidance. Click on the links below for more information:

    December 12, 2011
    Human Research Subject Protection: A Time of Reflection, Renewal and Reform? No--It's Time to Redesign!
    This archive is available. For access contact Xtalks at +1 (416) 977-6555 ext 371, or email register@xtalks.com

    May 1, 2012
    New FDA Guidance for Industry: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring - Implications for Sponsors, CROs, Investigators and IRBs

    September 6, 2012
    A Risk-Based Approach to Monitoring - Implications for Sponsors, CROs, Investigators and IRBs — AN UPDATE

    January 18, 2013
    Protection of Phase 1 Research Volunteers in an Age of Pandemics and Re-emergence of Contagious Diseases Long Thought Conquered, e.g., TB

    October 7, 2013
    Gender Issues in Clinical Trials: Ethical, Regulatory and Practical Considerations

    OUR XTALKS PARTNER FOR THIS EVENT:

    Institutional Review Board Services™ (IRB Services), established in 1993, is a wholly independent company with ethics boards and knowledgeable staff in both Canada and the USA. We are the only independent IRB designated by the Minister of Health to review research in the province of Saskatchewan.

    IRB Services is a service-driven organization striving for excellence in human research participant protection. We are committed to providing efficient and effective customer-oriented services by:

    • Maintaining an effective HRPP to protect the rights and welfare of human participants in research reviewed under the auspices of our IRBs
    • Partnering with sponsors, CROs, institutions and researchers to promote scientifically and ethically sound research
    • Continuously evolving our processes to exceed customer expectations as well as applicable regulatory, legal, and ethical requirements
    • Being advocates, in the research community and with peers, regulators and the public, for the ongoing evolution of these standards

    IRB Services has a real sensitivity to researcher and sponsor needs to provide a level of uniquely individualized service. IRB Services’ clients appreciate being able to reach a support person familiar with their research and able to intelligently discuss research developments with them.

    Our senior staff is internationally recognized through their active collaboration with the research community and both governmental and non-governmental organizations and is available to provide expert advice on any aspect related to the ethical conduct of research involving humans.

    IRB Services has been awarded Full Accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

    For information about the recorded archive for this webinar contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com

     
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