Are we doing things right Quality Assurance in Research Ethics at MUHC

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Are we doing things right?Quality Assurance
in Research Ethics at MUHC

• Andrei SP Brennan, MA
• Quality Assurance Officer
• MUHC Office of Research Ethics

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Overview

• Quality Assurance (QA) in Research Ethics (QARE
  pronounced care)
• QARE is a collaborative and collegial endeavor
  that will combine continuing education of
  research staff with routine (not-for-cause) and
  directed (for-cause) Quality Assurance site
  visits of ongoing clinical research studies
  involving human subjects

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Why do we need QARE?

• Guidelines and law require monitoring for
  compliance with established standards
• Funding agencies require REB oversight of
  approved research according to federal MOU and
  FRSQ agreements
• Ethics monitoring is becoming standard practice
  at large academic health care facilities
• QA Officer is available to investigators and
  their staff as a resource to keep up with
  evolving guidelines and to help prevent simple
  errors

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Situation prior to QARE

• MUHC has 9 REBs with over 1300 ongoing studies
  and over 400 new studies approved per year with
  Faculty IRB approved research contributing an
  additional 20
• REBs are busy volunteers with little time to
  follow-up with Investigators and research staff
• Research Ethics Coordinators are too busy and not
  trained to monitor research for their REBs
• REBs depended entirely on voluntary reporting for
  information about ongoing studies

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Immediate Plan of Action

• Pilot project to test QARE instruments, these
  Reviews will be for educational and program
  development purposes only
• Pilot project will provide a snapshot of
  research at MUHC sites
• Studies from each REB will be reviewed
• Report on findings will be given to REB of Record
  and Investigator

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Education Program

• REO and QA Officer are collaborating with
  Biomedical Ethics Unit and GEREQ to develop
  curricula
• Goal is to have some training options in place by
  Autumn 2004 one presentation at each site in
  Fall and Winter, seminars in local clinical
  research units
• Special programs for REB members, REB
  coordinators, Investigators and Research Staff
• Ultimately may become compulsory

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Education and Monitoring

• Difficult to review studies without having
  education program in place
• Not fair to penalize or criticize researchers
  when we have not offered training to avoid common
  mistakes
• QARE Reviews will seek to be collegial and
  primarily educational and self-correcting

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QARE and the REBs

• The QARE program supports the REBs in their work
  of oversight
• The QA Officer will not conduct a routine review
  without informing the REB in advance
• The REB may direct the QA Officer to review a
  study at their discretion
• All findings of Reviews will be reported to the
  REB and the Investigator

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QARE and MUHC Policy

• Draft Policy is under development that will
  define the authority and reporting
  responsibilities of the QA Officer
• Policy for QARE will be approved by the MUHC
  Board of Directors
• Policy will seek to be clear and concise

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QARE and GEREQ

• The REO is seeking to collaborate with GEREQ for
  Education and SOPs
• QA Officer has been appointed with others to
  working group on GEREQ SOPs for MUHC
• REO will seek to advise GEREQ to ensure
  compliance with current guidelines and regulations

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Feedback needed!

• The QARE program needs feedback from
  Investigators, study coordinators, nurses, etc.
• Opportunity for feedback will be given during the
  pilot project and when the regular QARE program
  is in place
• Quality Assurance is everyones responsibility
  we are a team!

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QAREs Priority - Protection

• Protecting human research subjects is the highest
  priority for QARE
• Protection of the health, dignity, privacy, and
  other rights of subjects is our paramount
  concern.
• By protecting the subject, we protect the
  Investigators, their staff, and the MUHC

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Contact info

• 514-934-1934, Ext 32112
• Fax [phone]
• E-mail andrei.brennan_at_muhc.mcgill.ca
• Montreal Chest Institute, Rm D4.01 or D2.04