Clinical Research Ethics

1
Clinical Research Ethics

• The Rockefeller University
• Center for Clinical and Translational Science
• CTSA Ethics Steering Subcommittee Meeting
• February 26, 2007
• Rhonda G. Kost MD

2
Ethics Programs

• Institutional Review Board
• Clinical Research Support Office - Research
  Subject Advocate
• The Hospital Ethics Committee
• Tri-institutional Embryonic Stem Cell Research
  Oversight (ESCRO) committee
• Research Participant Perception of Care Survey
  Project to develop outcome measures for human
  subjects protection and the research subject
  experience

3
Ethics Training Programs

• The Tri-Institutional Course in Responsible
  Conduct of Research
• Required of all PhD and MD-PhD students and
  Clinical Scholars.
• Tutorial on the ethical decision-making process
• Howard Hughes Medical Institute film on
  Scientific Integrity

4
Ethics and Ethics Training Programs

• Tri-Institutional Course in the Responsible
  Conduct of Research
• Research Misconduct (including Whistle blowing)
• Data Management,
• Animal Subjects,
• Human Subjects,
• Conflicts of Interest Commitment
• Authorship,
• Peer Review Publication
• Collaboration Mentoring

5
Ethics and Ethics Training Programs

• The Human Subjects Protection Training course
• The Clinical Research Seminar Series
• The Clinical Scholars Tutorials
• The Humanities in Medicine series

6

• What can the CTSA Steering Committee do for our
  center?
• Collaborate on issues of applied ethics issues
  common across centers
• Normal volunteers
• Compensation
• Underpowered studies
• Extended inpatient studies
• Non-financial conflicts of interest
• Identify best practices
• What can we do as participants to make the CTSA
  Steering Committee more effective?
• Identify common outcome measures and metrics
  independent of local issues