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OHSU Research Ethics Program OREP

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Applied Research Ethics - The practical application ... OCHTRI to provide support for grant applications and internal initiatives. ... – PowerPoint PPT presentation

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Title: OHSU Research Ethics Program OREP


1
OHSU Research Ethics Program - OREP
Susan Burner Bankowski, MS, JD February 26, 2007
2
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.

3
Mission Areas
  • Education
  • Applied Research Ethics
  • Research
  • Outreach

4
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)

5
Organizational Structure

OCTRI
Ethics Center
6
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)

7
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

8
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.

9
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

10
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.
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