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OHSU Research Ethics Program - OREP

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

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OHSU Research Ethics Program - OREP

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  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. Research Ethics Oversight Council OCTRI Faculty Ethics Center Sr. Scholars Program Director Education Applied Ethics Research Outreach Core Mission areas are supported by OCTRI & Ethics Center resources & faculty work. 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 Committee’s 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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