Understanding the Research Ethics Board and the Informed Consent Process

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Understanding the Research Ethics Board and the
Informed Consent Process

• Ronald Heslegrave
• Chair, UHN REB
• DOCH II Presentation
• November 7, 2006

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T R I -C O U N C I L P O L I C Y S T A T E M E
N T
Ethical Conduct for Research Involving Humans

• Medical Research Council of Canada
• Natural Sciences and Engineering Research Council
  of Canada
• Social Sciences and Humanities Research Council
  of Canada

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Research Ethics Board Function

• Protect the safety of patients
• Ensure the autonomy of patients
• Protect the investigator
• Protect the institution
• To inspire public confidence in
• biomedical research so that findings are
• accepted and the public will actively
• participate in the research enterprise

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The Legacy of the Past A System of Confrontation
R E B
Investigators and Sponsors
Patients And Volunteers
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Elements of an Effective Human Subjects
Protection Program
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What is the UHN REBs Process to Review Research
Protocols?
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Research Ethics Process
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Research Ethics Process
STUDY DESIGN
UHN REB APPROVAL
UHN REB ADVISORY
STUDY DESIGN AND SUBMISSION STAGE WITH
DEPARTMENTAL APPROVAL
Clinical Trials, Experimental Protocols, Survey,
Observational Studies, Chart Reviews, Use of
Tissue, Cancer Registry Requests
Principal Investigator, Co-investigators, and
Sponsors
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Research Ethics Process
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Research Ethics Board Office

• Dr. Ronald Heslegrave, Chair
• Mr. Paul Macpherson, Manager
• Ms. Lorraine Baladjay, Ethics Coordinator
• Ms. Lori DiMonte, Ethics Coordinator
• Ms. Katrine Milner, Ethics Coordinator
• Ms. Paola Cubillos-Rizo, Ethics Coordinator
• Mr. Alex Kerr, Ethics Coordinator
• Ms. Alison Miculan, Ethics Coordinator
• Ms. Larissa Potanina, Ethics Coordinator
• Ms. Janet Papadakos, Analyst
• Ms. Rebecca Morgan Quin, Administrative Assistant
• Ms. Danielle Sheppard, Administrative Assistant
• Ms. Tracy-Ann Townsend, Administrative Assistant

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Research Ethics Process
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Research Ethics Process
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Research Ethics Process
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Research Ethics Process
STUDY DESIGN
UHN REB APPROVAL
UHN REB ADVISORY
UHN REB Approval Stage
EXPEDITED
Oncology
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Research Ethics Process
STUDY DESIGN
UHN REB APPROVAL
UHN REB ADVISORY
UHN REB Advisory Stage
UHN Medical Advisory Committee
PMH Cancer Committee
UHN Board of Trustees
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UHN REB Application Process
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Research Ethics Process

• Application to the REB for review
• Form of review (full or expedited) decided by REB
• Chart Review Application
• Annual Review Form
• Available Terms of Reference, Operating
  Procedures, Guidelines for reviewers and for
  applicants
• Extensive website on UHN intranet forms and
  guidelines

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New UHN REB Application

• Identification, Departmental Approval and
  acceptance by institution from VP Research if
  funded externally
• Ethics
• Funding and Impact on other department
• Executive Summary

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New Application Ethics

• Previously reviewed for science or ethics?
• Subjects and location
• Recruitment
• How potential subjects will be identified?
• Who will initially approach subjects?
• How much time can subjects review consent?
• Relationship between the investigator and
  subjects?
• Condition of subjects (incompetent, unconscious,
  psychotic, emergency)?

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New Application - Ethics

• Remuneration for injury and expenses
• Are new drugs or devices involved and approved?
• How is confidentiality protected?
• Are there conflicts of interest?
• Are there publication restrictions?

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New Application - Funding

• Is there a source of funding?
• When do you expect funding?
• Attach a copy of itemized study budget
• Charge overhead of 30 for industry sponsored
  studies
• Contract reviewed by VP Research Office
• Does the sponsor have liability insurance
• cover reasonable out-of-pocket expenses
• immediate medical care is provided?

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New Application - Impact

• Does the study impact on other hospital
  departments such as
• Pharmacy
• Pathology
• Nursing Services
• Diagnostic Imaging
• TML laboratory services
• Radioactive Materials
• Biosafety Committee Services

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New Application - Summary

• Abstract (50-100 words)
• Rationale and Hypothesis
• Study Design
• design
• subjects/controls
• intervention
• primary outcome measure
• study endpoints for withdrawal
• sample size rationale
• Risk/Benefit Estimates

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New Application Clinical Trials

• What Phase is the clinical trial (I, II, III, IV,
  Open)?
• If a placebo control is used, how is this
  justified?
• Is there a data and safety monitoring board and
  is it independent of the sponsor?
• What is the usual standard of care at UHN for
  these patients?
• How is the usual standard of care UHN altered in
  this study?
• What are the incremental risks over the usual
  standard of care associated with the study?

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Consent

• UHN Letterhead (TGH/TWH/PMH)
• Font 12 (larger if all elderly or visually
  impaired)
• Page Numbers (x of y)
• Version Code/Date 
• Language
• Subject Headers
• Full Title 
• Identify Principal Investigator
• Introduction and Statement of Research 

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Consent

• Risks
• Benefits
• Alternatives to Participation
• Confidentiality
• Participation / Freedom to Withdraw
• Compensation/Reimbursement
• Questions
• Consent
• Signatures

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Administrative Requirements
Rebecca Morgan Quin Administrative Assistant, UHN
REB
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Application Form Checklist

• The Principal Investigator must be on staff at
  UHN and must be willing to take responsibility
  for the conduct of the study. This should be your
  supervisor at UHN
• DOCH student should be listed as Co-Investigator
• Signature of PI and DOCH Student
• Provide a secure e-mail addresses. External
  non-secure e-mail addresses will not be accepted
  (e.g. hotmail, yahoo, etc.)
• Division/Department Approval Signature (check
  with your supervisor for the appropriate
  signature)

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Application Form Checklist

• Include Supplementary Material (e.g.
  questionnaires, scales, interview scripts, focus
  group discussion themes, etc.)
• Advertisements (e.g. posters, e-mail scripts)
• Consent form
• ILP (Protocol)
• Two collated copies of the complete TAHSN
  application form and all supporting documents

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Simple tips to ensure speedy processing

• Dont embed budgets, surveys, questionnaires or
  other documents in your ILP. If they are an
  appendix to the ILP, either detach them, or
  submit separate copies.
• Staple each section (i.e. consent form, budget)
  separately
• Use N/A where necessary it shows that you
  didnt neglect to answer a question
• Answer 14B even if 14A doesnt apply

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Submitting an Application to the REBPreparing
the Package

• Documents should be collated in the
• following order
• TAHSN form
• Study budget
• Consent form(s)
• Recruiting materials (posters, e-mail scripts),
  Surveys and/or questionnaires
• ILP

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Wightman-Berris AcademyTop 10 List of Reasons
for Ethics Delays

• 1. Submitted to wrong REB because not submitted
  to Medical Education office first
• 2. Survey questionnaires were not included or
  were incomplete
• 3. Student signed as Principle Investigator
• 4. Negative impact on study group not detailed
• 5. How student will deal with negative impact not
  included

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Wightman-Berris AcademyTop 10 List of Reasons
for Ethics Delays

• 6. Security of research files not described
• 7. Consent form not included
• 8. Full title on the protocol was different from
  title on the ILP
• 9. Copies of all documents not submitted
• 10. ILP (Protocol) not included

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For more information

• UHN REB internet site http//www.uhnresearch.ca/r
  eb/index.htm
• UHN REB intranet site
• http//intranet.uhnres.utoronto.ca/support_servic
  es/reb/index_reb.php