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Ethics Activities within the Mayo CTSA

Ethics Activities within the Mayo CTSA. Barbara A. Koenig, Ph.D. Co-director, Department of Medicine Program in Professionalism and Bioethics Mayo Clinic College of Medicine Rochester, Minn. Clinical Research Ethics Resource.

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Ethics Activities within the Mayo CTSA

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  1. Ethics Activities within the Mayo CTSA Barbara A. Koenig, Ph.D. Co-director, Department of Medicine Program in Professionalism and Bioethics Mayo Clinic College of Medicine Rochester, Minn.

  2. Clinical Research Ethics Resource • Part of the Mayo Center for Translational Science Activities (CTSA) • Mission: • Provide new consultative services to investigators • Generate evidence-based innovation in clinical research ethics practices and procedures • “Move ethics beyond compliance”

  3. Primary structures • Clinical Research Ethics Incubator • CTSA Service Center • Ethics Education Activities

  4. CTSA Clinical Research Ethics Incubator *Please note, the CCTR is now called the CTSA

  5. Incubator Activities • Membership includes RSA, investigators, representatives from IRB & compliance, study coordinators, and CTSA ethics personnel • Identify priority areas for innovation in research ethics. • Assist investigators in developing pilot projects related to clinical research ethics. • Ensure that the methods that are developed are widely disseminated.

  6. CTSA Service Center • Integration of ethical considerations into existing support services for investigators developing research protocols • A doctoral-level Research Ethics Coordinator will oversee this component

  7. Current Pilot Studies • Assessing Patient Comprehension of Informed Consent • Ethical, Legal, and Social Issues in DNA Biobanking • Incidental Findings in Radiology Research

  8. Assessing Patient Comprehension of Informed Consent • Semi-structured interviews to assess volunteers’ understanding of the Informed Consent Form, including study goals, risks and benefits. • 24 participants equally distributed among three on-going research studies: • a large epidemiological study • Phase II trial for metastatic melanoma • a greater-than-minimal-risk study recruiting healthy volunteers

  9. Ethical, Legal, and Social Issues in DNA Biobanking • Semi-structured interviews of 75 current and potential biobank donors from 5 different groups: • Native Americans (non-donors) • “Normal control” biobank participants • Genomics of Addiction biobank participants • Diabetes biobank donors • Colon cancer participants • Study informed consent process (observation of 5 participant/consenter dyads) • Deliberative Democracy exercise

  10. Incidental Findings in Radiology Research • Retrospective assessment of medical benefit or harm arising from Mayo Clinic’s practice of reviewing all research imaging studies for incidental findings and communicating these to primary care physicians • Imaging findings from 2002-2004 will be assessed by “expert panel” of bioethicists, radiologists, oncologist, and internist.

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