1 / 15

Clinical & Translational Research Ethics

Clinical & Translational Research Ethics. Laura M. Beskow, MPH, PhD February 26, 2007. Purpose. Serve as an essential advisory group to the leadership of the DTMI General aims: To identify ethical, legal, and policy issues encountered in carrying out clinical translational science

chico
Download Presentation

Clinical & Translational Research Ethics

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Clinical & Translational Research Ethics Laura M. Beskow, MPH, PhD February 26, 2007

  2. Purpose • Serve as an essential advisory group to the leadership of the DTMI • General aims: • To identify ethical, legal, and policy issues encountered in • carrying out clinical translational science • applying that science in practice • To identify options to address those issues

  3. Ethics Team

  4. Basic Approach:How Will We Identify Issues? • Participate in DTMI leadership meetings • Participate in an advisory capacity on translational research teams to help anticipate, identify & address ethical issues • Communicate and collaborate with individuals involved in the ethics component at other CTSA-funded sites

  5. Basic Approach:How Will We Address Issues? • Serve as a consultative resource on specific issues • Design / conduct / collaborate on: • Research to examine ethical, legal, and policy issues • Projects to inform and/or develop policies, guidelines, and tools

  6. Basic Approach:What Products Will We Produce? • Referrals to existing resources • “Issue briefs” on specific issues • White papers • Seminars, workshops, conferences • Published manuscripts • Educational modules, other tools (and build web-based “repository” of these products)

  7. Columbia Ruth Fischbach Duke (shown on previous slide) Mayo Barbara Koenig, Marguerite Strobel Oregon Darlene Kitterman, Susan Bankowski, Kathryn Schuff Rockefeller Rhonda Kost UC Davis Alexander Kon UC San Francisco Bernie Lo U Penn Jason Karlawish, Jon Merz, Pamela Sanakr U Pitt Alan Meisel, David Barnard, Howard Degenholtz, Lisa Parker U Rochester Robert Holloway U Texas - Houston Eugene Boisaubin, Paula Knudson, Chris Pappas Yale Robert Levine Activities To Date:CTSA Ethics Listserv

  8. Activities To Date:Interaction with DTMI Leadership • Regularly attend DTMI leadership meetings • Individual meetings with DTMI team leads -- we asked: • How can the ethics core best be of assistance? • Ethics team member as active participant in scheduled meetings • What do you anticipate will be the most important ethics / policy issues for your team?

  9. Activities To Date:Potential Project Inventory • Informed consent • Conflict of interest • Community-based research & outreach • Pediatric research • Intellectual property / patents • Race / ethnicity • IRB-related issues • Other (identified ~40 potential projects / topics)

  10. Activities To Date:Near-Final Project List for 2006-07 • Informed consent • Improving informed consent for biorepositories: An empirical study of participants’ comprehension & decision processes (Beskow) • Conflict of interest • Conflict of interest disclosures in published cardiac stent trials (Weinfurt) • Relationship between sponsorship & reported result in cost-effectiveness studies (Weinfurt)

  11. Activities To Date:Near-Final Project List, continued • Community-based research & outreach • Community engagement in research: An online educational module for researchers (Michener/Holder) • Possible project: Geomapping - Informed consent & HIPAA issues in data access and segmentation (Cook-Deegan) • Pediatric research • Ethical implications of (a) pediatric trials in developing countries for US patient extension; and (b) predictors of publication of IRB-approved pediatric protocols (TBD)

  12. Activities To Date:Near-Final Project List, continued • Intellectual property / patents • Assistance & consultation available through Duke Center for Public Genomics, a Center of Excellence in ELSI Research, co-funded by DoE and NIH (Cook-Deegan) • Race / ethnicity • Predictors of participation in acute care clinical trials at Duke (Cairns/Haga) • Policies concerning the collection & use of information about “race” for the Duke IGSP Biorepository (Dame)

  13. Activities To Date:Near-Final Project List, continued • IRB-related issues • Linking the Society of Thoracic Surgeons National Database to administrative data (Beskow) • Innovative surgical procedures: The boundary between research & therapy (Holder) • Other • Referring patients for inclusion in clinical trials: Developing a survey of physician attitudes & behaviors (Rosoff) • Off-shoring Phase I and Phase II clinical trials (Haga)

  14. Some High-Priority Issues for Discussion Across CTSAs • Conflict of interest • What and how should conflicts be disclosed to subjects, peers? • Promoting high-quality research implementation • Importance of empirical ethics • Role of former NCRR/GCRC regulations concerning patient advocates, adverse event reporting • IRB issues • Are there ways we can streamline the process while maintaining appropriate oversight? • Biorepositories • Policies, procedures, oversight

More Related