OHSU Research Ethics Program OREP

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OHSU Research Ethics Program - OREP
Susan Burner Bankowski, MS, JD February 26, 2007
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What is the goal of our program?

• Through multiple initiatives, OREP will combine
  the perspectives of researchers, ethicists,
  healthcare providers, IRB professionals and
  research subjects to improve teaching and
  research about ethical issues in human research
  and translate those innovations into improved
  research methodologies which maximize subject
  protections and ensure that scientific
  investigations involving people are conducted in
  an ethical manner.

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Mission Areas

• Education
• Applied Research Ethics
• Research
• Outreach

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Organization

• OREP will be a program of
• the OHSU Center for Ethics in Health Care (the
  Ethics Center)
• and
• the Oregon Clinical and Translational Research
  institute (OCTRI)

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Organizational Structure

OCTRI
Ethics Center
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Education - Incorporates the teaching ethical
theory and clinical, research and biomedical
ethics into OCTRI initiatives.

• Cindy Morris, OCTRI Director of Research
  Education Training.
• Expanded Ethical Conduct of Human research
  cognate area
• 4 week protection of Human Subjects Course
• K30 Human Investigation program (HIP)
• Academic home for development and coordination of
  research ethics educational offerings.
• Ethics in research for Pediatric and Maternal
  Populations
• Ethics of Research in Special Communities
• Certificate Program in Human Subject Research
  Ethics
• Summer Institute
• Visiting Scholars
• K12 program (confers K23s for clinical and
  translational research)
• T32 (post-graduate clinical and translational
  training for basic scientists)

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Applied Research Ethics - The practical
application of theoretical ethics in attempts to
solve actual research dilemmas.

• Research Ethics Consultation Service - goal of
  consulting service is to help raise awareness of
  and to assist investigators in resolving issues
  of ethics in human subjects research. It will
  help OHSU investigators when considering ethics
  challenges that arise in the design, conduct or
  analysis or the human subjects research projects.
• This service is directed OREP Director assisted
  by issue specialists and oversight council.
• It will be a parallel to the current ethics
  consultation service.
• OCTRI will provide support for this service.
• Consultations are advisory in nature
• Specialty-specific Targeted Ethics programs

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Research - Facilitate empirical analysis,
scientific method and evidence-based problem
solving in human research ethics.

• Identify promote opportunities for
  investigation in research ethics provide an
  academic home for those faculty interested and
  involved in research on research ethics
• Foster collaboration across institution
• OCHTRI to provide support for grant applications
  and internal initiatives.

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Outreach - Support activities that educate and
engage the community, research subjects, and
legislators.

• Community - Human Research Community Advisory
  Board
• Advocacy - Research Subject Advocate
• Policy - Regulatory Updates and Legislative
  Action
• Harriet Barshofsky Research Ethics Library

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CTSA Steering Committees Role

• What can this CTSA Steering Committee do for our
  site?
• Share information, best practices, gather data,
  advisory role, consider models for CTRC review.
• What can we do as participants to make the CTSA
  Steering Committee more effective?
• Work on issues that are not local, create
  guidelines,
• work with OHRP and FDA on relevant issues.