Clinical

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Clinical Translational Research Ethics

• Laura M. Beskow, MPH, PhD
• February 26, 2007

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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

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Ethics Team
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Basic ApproachHow 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

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Basic ApproachHow 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

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Basic ApproachWhat 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)

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Activities To DateCTSA Ethics Listserv

• 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

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Activities To DateInteraction 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?

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Activities To DatePotential 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)

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Activities To DateNear-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)

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Activities To DateNear-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)

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Activities To DateNear-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)

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Activities To DateNear-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)

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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

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