Ethics Activities within the Mayo CTSA

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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.

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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

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Primary structures

• Clinical Research Ethics Incubator
• CTSA Service Center
• Ethics Education Activities

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

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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

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Current Pilot Studies

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

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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

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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

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Incidental Findings in Radiology Research

• Retrospective assessment of medical benefit or
  harm arising from Mayo Clinics 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.