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Irving Institute for Clinical and Translational Research

Irving Institute for Clinical and Translational Research. John F. Ennever Regulatory Knowledge and Support Resource and Ethics. Components. Combined RKSR with CRE Develop an educational program that integrates the ethical considerations that drive regulations Clinical Research Advocate

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Irving Institute for Clinical and Translational Research

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  1. Irving Institute for Clinical and Translational Research John F. Ennever Regulatory Knowledge and Support Resource and Ethics

  2. Components • Combined RKSR with CRE • Develop an educational program that integrates the ethical considerations that drive regulations • Clinical Research Advocate • Shared role with PCIR • Clinical Trials Office • Joint office of both University and Hospital

  3. Functions • Education/Training • Tiered curriculum (Basic course, Intermediate workshops, Constituent-specific programs, Emerging areas) • Specific training on CUMC administrative system (basic and advanced) • Research Ethics fellowship • Consultation • Ethics (self-referral, IRB chairs) • Regulatory (IRB and/or Privacy Board staff, self-referral, outliers)

  4. Functions (cont.) • Support Functions • Review of IRB submissions prior to or after submission • Development of DSMPs • Investigator-initiated IND/IDE fillings • Assist investigators in CMS fillings for coverage of device studies • Assist investigators in obtaining industry support

  5. Challenges • Inattention by PIs to Regulatory Issues • “Just send it in, the IRB will send it back anyway” • Unlike animal researchers, clinical researchers are almost all part- time • Unawareness on the part of Board members of difficulties faced by investigators • Changes that have no impact on human subject protection • Rejecting a study because of the bias of the primary reviewer • Difficulty in communication

  6. Successes • Inattention by PIs to Regulatory Issues • Training limited to coordinators or regulatory staff of PIs who commit to playing a role in submissions • Unawareness on the part of Board members of difficulties faced by investigators • A detailed ethical consult provided at the request of a chair changed the board’s decision. • Difficulty in communication • Working with Informatics developed WorkWeb – a wiki-based tool

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