Research Ethics Review Committee

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• Research Ethics Review Committee
• Henry Silverman, MD, MA

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Outline

• Function of Research Ethics Committees
• Few Points About Structure
• Emphasis on composition of members
• Need for openness Standard Operating Principles
  (SOPs)
• Examples of Ethics Review at the National Level

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Rationale

• Recognized need for independent review
• History of abuses
• Self-regulation is insufficient
• Because scientists have an interest in promoting
  research, they might
• Overestimate benefits of research
• Underestimate risks of research
• Ensure that research adheres to research ethics
  regulations

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Standard Operating Procedures (SOPs)

• Transparency
• Structure, composition, mandate
• Operating procedures regarding ethics review
  should be known
• internal
• governmental and research funding bodies
• Compensation for activities
• Members honorarium, part of their job in the
  institution
• Outside Sources review of research
• Operating budget for RECs

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Composition of RECs

• Number 5-12
• Different professional backgrounds
• Non-medical and non-science representation
• Gender balance
• Representation from outside institution
• Key Independence

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Membership

• Membership Requirements
• Terms of Appointment
• Conditions of Appointment
• Education Requirements

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Review Tasks of RECs

• Evaluate relevance of clinical trial value
• Evaluate trial design
• Evaluate risks and benefits
• Review informed consent form
• Review adequacy of data and safety monitoring
• Review procedures to ensure confidentiality
• Review special safeguards for vulnerable
  populations
• Review qualifications of research staff

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Decision Procedures

• Quorum Requirements
• Communication of Decision
• Types of Decision
• Approval
• Rejection
• Revision
• Authority for Actions Taken

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Review Tasks

• Continuing Review
• Expedited Review
• Exempt Review

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Different Types of RECs

• National
• Regional
• Institutional Academic and Research
• Belonging to International agencies or
  organizations
• UNAIDS
• WHO

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Supporting Mandate

• National legislation
• covering all research
• or only outside funding
• Indirect by regulations covering physician
  behavior by medical society Thailand
• Indirect by funding agencies China
• Indirect by requirements of journal editors or
  funding agencies.

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Examples for Ethics Review

• United States
• National Legislation
• National Body for Oversight Activities (Office
  for Human Research Protections)
• Institutional Review Boards
• Academic
• Private
• Private Accreditation Organizations

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Examples for Ethics Review

• Tanzania
• Parliamentary Act (1979) forming the National
  Institute for Medical Research (NIMR)
• Key areas stipulated in the act
• Monitoring, control and coordinate health
  research
• Registration of clinical research
• National Health Research Ethics Subcommittee
• Review foreign proposals
• National Health Research Guidelines
• Without the force of law

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Tanzania

• Academic and Research Institutions
• Independent and its own mandate
• Institutional Review Boards
• Encouraged to follow National Ethics Guidelines
• Challenges
• Law is silent on oversight
• Penalty for breaching ethics procedures is
  negligible
• National IRB does not have accreditation functions

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Ethiopia

• National Health Science Technology Council
  (NHSTC) was established in 1993
• National Ethics Review Committee was established
  as one of the standing committees of NHSTC in
  1993
• The Ethics Committee formulated National health
  research ethics review guidelines.
• They serve as a guide for the various ethics
  review committees (ERCs) of different levels in
  the country.

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Ethiopia

• There are three levels of ERCs
• National
• Regional
• Institutional

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National Ethics Review Committee (NERC)

• NERC is responsible for the final approval of
• All clinical trials
• Research on very sensitive issues, e.g. HIV/AIDS
• Multi-centered collaborative research
• Research to be financed and/or carried out by
  external donors
• Research to be conducted in more than one region

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Regional Ethics Review Committees (RERCs)

• Responsible for the ethical review of projects
  involving more than one institution in the
  region
• Review projects other than those mentioned under
  the mandate in NERC, in absence of institutional
  ethics review committees

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Institutional Ethics Review Committees (IERCs)

• Reviews all health research proposals of the
  institute
• Responsible to review and decide all proposals of
  the institute which are not stated under the
  mandates of both NERC and RERC

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Application and Review Process

• All applications need to be submitted to the
  respective IERC/RERC
• IERC/RERC give the final decision for projects
  stated under their mandates
• IERC/RERC review, give recommendation and send to
  NERC for projects stated under NERCs mandate
• Secretariat of NERC receives application, does
  preliminary screening, and forwards those with
  all the necessary document to NERC members

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Application and Review Process

• Special attention is paid when reviewing proposal
  involving vulnerable groups
• Decisions of NERC could be approved, approved
  on condition or not approved
• NERC assures and safeguards, the dignity, safety,
  and well being of research participants
• NERC organizes, conducts and facilitates training
  on health research ethics
• Each Ethics Review Committee develops its own SOPs

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Egypt

• What system of review should be adopted?
• National Ethics Committee
• Review Functions
• Development of Guidelines
• Oversight Functions
• Education Functions
• Institutional Review Committees
• How can we improve the functioning of RECs
  within the system?

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