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University of Rochester Clinical and Translational Science Institute CTSI Ethics Resource

University of Rochester Clinical and Translational Science Institute CTSI Ethics Resource. Robert G. Holloway, MD, MPH Associate Professor Co-Director, Clinical Research Ethics. UR CTSI Research Ethics Resource Goals.

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University of Rochester Clinical and Translational Science Institute CTSI Ethics Resource

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  1. University of RochesterClinical and Translational Science Institute CTSI Ethics Resource Robert G. Holloway, MD, MPH Associate Professor Co-Director, Clinical Research Ethics

  2. UR CTSI Research Ethics ResourceGoals • To provide investigators, key personnel, and trainees with research collaboration, education, and consultation that address ethical issues in the design and conduct of translational and clinical research. • To heighten awareness and promote a dialogue and culture of research integrity while furthering the mission of the UR CTSI

  3. UR CTSI Research Ethics Resource UR Faculty and Trainees Translational Methods and Pilot Studies Research Education, Training, Career Development Design, Biostatistics and Clinical Research Ethics Clinical Research Ethics Resource Center for Ethics, Humanities and Palliative Care Community Engagement/Upstate Consortium Office of Regulatory Compliance and Support

  4. UR CTSI Research Ethics ResourceStimulate discussion/research • Stimulate discussion/research of difficult research ethics dilemmas • Faculty/institutional conflicts of interest • Decision-making/High risk interventions (eg, gene transfer) • Trial design (eg, sham surgery, outcome measures) • Informed consent (COI language, decision-making) • Vulnerable populations (ie, end-of-life) • Impact/cost-effectiveness • Genetic information/biorepositories

  5. UR CTSI Research Ethics ResourceEducation/Mentoring Courses/Seminars • Ethics and Professional Integrity in Research Biomedical Sciences • Recruitment and Retention of Human Subjects into Clinical Research • Cost-Effectiveness Research • Integrated in various other courses Mentoring/Culture • Faculty Development/Mentoring Program

  6. UR CTSI Research Ethics ResourceConsultation Service • Involvement up stream in the process of research design, conceptualization, legal/policy issues • Involvement as consultants and researchers, ultimately as collaborators • Up stream prior to RSRB or funder submission or implementation • Integration • Promotion of resource through UR CTSI website and meeting with leadership • Include research ethics sensitive variables in various log-ins and registries??

  7. UR CTSI Research Ethics ResourceCurrent Work • Work with leadership/constituencies to operationalize • Feasibility of consultation service • Constituency-specific programs for focal areas of interest • Education/seminars • National CTSA Research Ethics Steering Committee • UR CTSI taking the lead on COI agenda

  8. UR CTSI Research Ethics ResourceOutcome metrics • Set up infrastructure • Initiation of new collaborations • Manage, track, and assess impact of consultations • Publications • Dissemination of results of consultation and research to the wider CTSA community

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