Ottawa Hospital Research Ethics Board

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Ottawa HospitalResearch Ethics Board

• Raphael Saginur, M.D.
• Chairman
• OHREB

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Objectives

• Introduction
• Jurisdiction of the REB
• To describe the regulatory systems related to
  research ethics, and why they exist
• Privacy
• Education

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It was the best of times . . .

• Innovations in science
• Translation into testable products
• Innovations in information technology

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It was the worst of times

• Scandals deaths of human subjects, conflict of
  interest, fraud
• Increasing control by government of clinical
  research

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There is no right to perform research

• Doing research is a privilege, and the
  opportunity to perform it must be continually
  merited
• Investigators must manage the patients enrolled
  in protocols to minimize risk and conform with
  the protocol

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Research as a privilege

• Investigators who manage inadequately, who breach
  protocol without cause, subject themselves and
  the institution to extra-ordinary legal risk
• Performing research well is a great benefit to
  society necessary for progress.

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Clinical research is fraught with risk

• To participants
• To investigator
• To institutions
• To sponsors and their stockholders
• The nature of the risk to each party differs

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Jurisdiction of Ottawa Hospital REBs

• All research involving Ottawa Hospital, Heart
  Institute, and basic science Faculty of Medicine
  staff, wherever done
• All research involving Ottawa Hospital and Heart
  Institute patients and their information
• Research involves some use of unapproved drugs
• Fuzzy border with other activities when in
  doubt, call REB

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Clinical research is based in principle,articulate
d in regulation and public policy statements

• Principles
• Self-determination informed consent
• Beneficence/ non-maleficence minimize risk,
  look at risk vs benefit of experiment
• Right to privacy
• Justice

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Regulation

• Tri-Council Policy Statement (TCPS)
• Food and Drug Regulations, Health Canada
• Good Clinical Practice (GCP)
• Food and Drug Regulations, U.S. FDA
• Common Rule, U.S.
• all available at OHREB website www.ohri.ca/ohreb

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TCPS

• Applies to research funded by any of 3 Canadian
  federal funding councils (SSHRC, NSERC, CIHR)
• Applies to institutions which receive funds from
  any of councils
• Applies to all studies at Ottawa Hospital,
  Faculty of Medicine and Heart Institute

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Food and Drug Regulations, GCP

• Apply to all pre-marketing studies of
  drugs(Phases I, II, III)
• GCP is an international standard adopted by
  Health Canada
• Canadian Food Drug Regulations were updated in
  September, 2001, to attempt to make the system
  more efficient

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FDA regs

• Apply to all drugs under U.S. IND
• Extra-territoriality
• Reflects that the fact that clinical research is
  an export industry

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Common rule

• Regulations of all U.S. government except for FDA
• Include NIH
• NIH can be involved in various ways grant for
  study by local PI funding MCT in which we
  participate funding study group (e.g., cancer
  groups such as SWOG, ECOG, NSABP AIDS research
  Parkinson's)

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How did we get into this jurisdictional mess?

• The Holocaust the Nuremburg Code Helsinki
• Various and sundry scandals
• Sober second thought
• Bureaucracies creating empires

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Question 1

• You are about to apply to the REB as local PI of
  a multi-centre, multi-group (NCIC, ECOG,SWOG)
  study of an investigational new drug, cytonuke,
  in the treatment of NSCLC. The manufacturer of
  cytonuke is developing it for market in North
  America. What rules apply?

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Answer 1

• 1. Good Clinical Practice (GCP) and Food Drug
  Regulations (Canada)
• 2. GCP Food Drug, FDA, Common Rule (U.S.),
  Tri-Council Policy Statement (TCPS)
• 3. TCPS only
• 4. I dont do rules

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Why does jurisdiction matter? Why must I know
it?

• Picture the scene. It's 3rd and long yardage in
  the Super Bowl game. The quarterback throws a
  perfect sideline pass to his wide end, who leaps
  to catch it to try to make the first down. Must
  both feet land in-bounds for the catch to be
  good?
• What percentage of NFL wide ends and quarterbacks
  know the details of the offside rule?

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Jurisdiction

• If you want to play the game, you gotta know the
  rules

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Jurisdiction

• The institution must know the rules it signs
  MOUs with some of these agencies (Tri-Council,
  OHRP)
• The REB must know the rules it must abide by the
  rules for the research to proceed, and for the
  institution to sign the MOU.

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Jurisdiction

• The investigator must know the rules to ensure
  that the research conforms with them, to inform
  the REB about how to proceed, and to address
  his/her interest
• The sponsor has to know the rules to ensure
  absolute compliance with at least those that
  apply to drug regulation

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Knowledge of regulation the investigator
perspective

• Enhances dialogue with REB e.g., does expedited
  review apply is consent necessary?
• Facilitates management of controversial areas,
  e.g., genetics, privacy
• Compliance may require that certain standards be
  followed for example, NIH demands 1 hour of
  research ethics training!

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Privacy

• A growth industry
• We must comply with relevant law, usually PHIPA
  (Personal Health Information Privacy Act), the
  Ontario statute
• Comes up a lot in consent forms and in planning
  databases
• We avoid getting caught into U.S. law, HIPAA,
  usually successfully

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Education

• The Ottawa Hospital and the Faculty of Medicine
  are urging investigators and research personnel
  to take the TCPS Tutorial, available at
• http//www.pre.ethics.gc.ca/english/tutorial/