Transcript Slide 1

September 28th, 2006
Research Administration
&
Development Overview
FH Policies
FH Research
Approved:
June 21, 2005
The Ethical
Conduct
of Research
and Other
Studies
Involving
Human
Subjects
The Collection,
Use and
Disclosure
of Personal
Information
for ResearchRelated
Purposes
Approved:
June 21, 2005
Approved:
June 21, 2005
The Provision
Of ResearchRelated
Services
to Non-FH
Researchers
Research
Integrity
Intellectual
Property
Approved:
TBA
Approved:
TBA
Approved:
June 21, 2005
Grants
Administration
Administration
Structures
[Mike Wasdell &
Rosa Haywood]
Contracts
[Rosa Haywood &
Kathy Dunstan]
DAR
- Pharmacy
- Lab
- Health Records
- Procurement
-Patient Care
FHREB
Ethics
Administration
[Rosa Haywood]
Information
FH
[Privacy Manager]
Research
Integrity
&
FH Departments
Legal Services
Investigational
Committee
Finance
[Ian Perry]
Services
Ethical Review
Peer Review Compliance
Education
Research
Capacity
Building
Affiliation
Agreements
Key Requirements for
Conducting Research
1. Who is a FH Researcher

FH Research Policy
3. POLICY
3.1 Scope
This policy applies to all research activities carried out by any individual who is carrying out
research in their FH capacity as defined below:
I.
the research is under the direction of, conducted by or involves any FH employee or
agent [e.g. any physician with privileges at FH] using any FH property or facility, or
II.
the research is under the direction of, conducted by, or involves any FH employee or
agent [e.g. any physician with privileges] in connection with his or her FH
responsibilities, such that the research may also be conducted outside of the FH
jurisdiction, or;
III.
the research is directed or conducted by non-FH employees/agents at any FH facility
who have Affiliated status with FH [e.g. faculty with an academic appointment at a FH
‘affiliated’ post-secondary education institution], or;
IV.
a portion of the research [i.e. a particular research procedure] is being carried out by a
FH principal investigator as a service to another non-FH researcher.
3.2 Criteria For Permitted Research
a.
The Principal Investigator PI for any study conducted at a FH site shall be directly
affiliated with FH, by being either directly employed, having privileges, or by having met
the requirements [Application] to obtain affiliated status. Refer to Procedures:
General Procedures 4.3a.
KEY REQUIREMENTS
2. What Initial
Approvals are Required?
 Mandatory:
 As Applicable:
 As Applicable:
 As Applicable:
 Mandatory:
Certificate of Initial Ethical Approval
Health Canada Letter of No
Objection [Clinical Trials]
Department Agreement for Providing
Research-Related Services
Authorization
Executed Clinical Trial Agreement
Letter of Authorization to Conduct
Research [LOA]
“This letter authorizes the Principal Investigator to begin
research-related procedures” Signed by S. Chunick
KEY REQUIREMENTS
3. How do you use the LOA?
a. LOA
Principal Investigator/Designate
e.g. signed LOA
b. LOA
Departments Providing ResearchRelated Services
Principal Investigator/Designate
Research: Rosa Haywood
Health Records for
release of charts
FH Finance
[Authorization to set-up FH
Research Account]
KEY REQUIREMENTS
4. What are the Principal Investigator/
Researcher Ongoing Obligations
Implementing responsibilities defined in FH
research policies
Disclosing conflict of interest
Retaining records of verifiable data (25/5yrs.)
Training and supervising research team
Managing research budget and expenditures
Complying with funding agency requirements
Registering Clinical Trials
Obtaining annual renewal BEFORE date of
expiry
KEY REQUIREMENTS
5. What Ongoing Approvals
Required?
are
LACK OF COMPLIANCE
COMPLIANCE
 Withdraw of ethics approval Stop Study
 Authorizes new subject
recruitment and/or secondary
data collection
 Sanctions by funding agency
(e.g. CIHR)
 Authorizes annual release of
funds from granting agency
Investigation
 Certificate of Approval for Renewal
of a Previously approved Study
 Sanctions by Commercial Sponsor
 Sanctions by FH
Research Integrity
Scientific
RESEARCH ETHICS BOARD
STATUS REPORT 01 September 2006
Total Studies 263
(From 2005 September 01 to Date)
ACTIVE STUDIES =168
Type of Ethics Review for
ACTIVE Studies
70
PENDING APPROVAL = 13
Funding for ACTIVE Studies
70
60
66
50
40
F ull B o a rd
E xpe dit e d
99
30
20
10
0
44
35
Sponsor
Grant
Grant-Aid
8
2
14
Unfunded
FH Internal
Other
Anaesthesia
3
Family Medicine
1
Nursing Obstetrics
1
Psychiatry
19
Audiology
1
Family Practice
1
Nutrition
1
Public Health Prevention
2
Cardiology
29
Health Planning
1
Obstetrics
7
Quality of Life
1
Communicable Diseases
1
Health Services
2
Occupational Therapy
1
Residential Care
1
Community Site
1
ICU
4
Oncology
2
Respiratory
3
Critical Care
5
Internal Medicine
2
Orthopaedics
13
Social Work
3
Decision Support Service
1
Medicine
2
Palliative Care
2
Surgery
1
Education Med Students
1
Mental Health
4
Paediatrics
1
Systems
Analysis/Performance
1
Elder Research
2
Multiple Sclerosis
6
Pharmacy
4
Non FH Research
13
Emergency
10
Nephrology
5
Physiotherapy
1
Endocrinology
1
Neurology
3
Prevention/Promotion
1
Epidemiology
2
Nursing
2
Professional Practice
1
ETHICAL REVIEW
THE FHA REB ROLE:
TO ENSURE THE PROTECTION and WELL-BEING OF
RESEARCH SUBJECTS
WHO IS THE FH REB?
Meets TCPS & Health Canada quorum requirements
Co-Chairs/Primary Reviewers:
Dr. Allan Belzberg [SMH]
Dr. Marc Foulkes [RCH]
Primary Reviewers:
Dr. Bob Gillies
[Pharmacy]
Dr. Michael Vince [RCH lab, Retired]
Dr. Arthur Friesen [RCH Cardiologist]
WHO IS THE FH REB?
Ethicist: Prof. Lindsay Meredith [SFU]
Statistician: Michael Wasdell [FH]
Legal Representation:
Ms. Camille Ciarniello [LLB]
Ms. Mara Stickland
[LLB]
Lay member:
Mrs. Nancy Magnees
 Rosa Haywood:
Ethics administration
The REB Role: Protecting the rights, dignity,
welfare, safety and integrity of the research
subject
The REB ensures that:
1.


The Ethical Review Process:
is transparent &
meets obligations under TCPS & under Health
Canada regulations when applicable.
2.
Researchers meet their obligations under
TCPS & under Health Canada regulations when
applicable
Why Should We Worry About Protecting
Human Subjects?
The Recent Past: Late ’90’s
Ryan Lucio – Children’s Hospital-Eastern Ont.
Nancy Olivieri – U of Toronto
Ellen Roche – Johns Hopkins
Jessie Gelsinger – U of Pennsylvania
Hoiyan Wan – U of Rochester
The Distant Past
Nuremberg NAZI Doctors Trial
PHS Syphilis Study – Tuskegee, Tennessee
What are the Regulations?
WORLD MEDICAL ASSOCIATION /INTERNATIONAL
1964
Declaration of Helsinki
1997
ICH Good Clinical Practice Guidelines
UNITED STATES for U.S. Government Funded Studies
1979
Belmont Report: 45 CFR 46; 21 CFR 50,56
1983
45 CFR 46: Subpart D (children)
1991
Common Rule: 17 U.S. federal departments
2001
Association of American Universities Conflict of
Interest Guidelines
What are the Regulations?
CANADA
1998
Health Canada: Food & Drug Act Medical Device Regulations
1998 Tri-Council Policy Statement on Ethical Conduct for Research
Involving Humans
2001
Health Canada: Regulations Amending the Food & Drug Act – Clinical
Trials
2002 FOIPP – Freedom of Information and Protection of Privacy (B.C.)
Section 35 Amendment re “Disclosure for research or statistical
purposes”
Con’d
What are the Regulations?
2002 Health Canada: CIHR Requirements for Ethical Review of Pluripotent
Stem Cell Research [Updated 2006]
2004 Health Canada: Natural Health Products Regulations Part 4 – Clinical
Trials
2004 Personal Information Protection Act of BC (PIPA)
2004 Canada: Personal Information Protection and Electronic Documents
Act (PIPEDA)
OBLIGATIONS OF THE REB
Does the science have value?? Is there clinical
equipoise?
 Testable hypothesis/research
question/endpoints/outcomes specified
 Placebo justification
 Adequacy of peer review (FB only)
 Sufficient sample size (power)
 Risk-benefit
OBLIGATIONS OF THE REB
Is the Sample Selection Fair?
 Inclusion Criteria
 Incompetent subjects
 Exclusion Criteria
 Women; ESL
OBLIGATIONS OF THE REB
Does the Consent Process Preserve Autonomy?
 Subject Consent
 Protect privacy [FOIPPA]
OBLIGATIONS OF THE REB
“ The consent form is not meant to
reassure the subject, quite the
contrary, it is meant to raise every
possible concern that might be
relevant to the subject’s
participation.”
Time 2002 April 22
OBLIGATIONS OF THE REB
Is the Recruitment/Consent Process Non-coercive?
 Initial Contact
 If PI is primary care-giver
 Time to consent > 24 hours
 CF: Voluntary decision
 CF: Opportunity to ask questions
 CF: Full disclosure* of all information in lay
terms including alternatives if therapy
OBLIGATIONS OF THE REB
Are Potential Harms Mitigated?
Provide stopping rules; rescue medication
CF: Emergency contact information
CF: New information re risks
CF: Compensation for research-related
harms
 CF: Legal rights
 CF: How to withdraw
 CF: Research Subject Information Line


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OBLIGATIONS OF THE REB
Is Subject Confidentiality Preserved?
- Remove subject identifiers [DOB
exception]
- Secure storage of data [preventing
breach of confidentiality]
- Out of Canada data transfer
Process Tips
 Full Board Review – meetings held
2nd Tuesday of each month;
 hard copy submissions [12 copies]
required 2 weeks in advance
 Expedited Review – conducted
weekly by co-Chairs;
 submissions by email to Rosa Haywood
FH RESEARCH REVIEW PROCESS
PI/designate submits appl’n to
FH Research for Expedited
Review
Email
Application completed & submitted
to admin. supervisor for signature
Mail
Appl’n screened for completeness
No
No
1 business day
PI/designate submits
Appl’n to FH Research
for Full Board Review
Appl’n & consent form pre-reviewed
Yes
5 business days
10 business days
FHREB co-Chair conducts review
Yes
Study approved?
FHREB ‘approves’ Expedited
Review
5 business
days
Has all of the required
documentation been submitted?
No
5 business days
Request for
Deferral Notice sent
Modifications sent to PI
to PI
PI responds within 6
months
PI responds within 6
months
FHREB co-Chair conducts review of
response
No
FH Research issues Certificate of Ethical Approval to PI
Full Board Review
Yes
Study Approved?
5 business days
If applicable, PI submits to FH Research:
•Signed DAR Form
Yes
FH Research issues “Letter of
Authorization to Conduct Research”
•Contract for clinical trial research
•Health Canada No Objection Letter
EXPEDITED REVIEW PROCESS - Minimal Risk
Applications, Amendments, & Renewals
PI/designate submits appl’n to
FH Research for Expedited
Review
Email
Application completed & submitted
to admin. supervisor for signature
Expedited Renewal Applications:
Appl’n screened for completeness
No
1 business day
Yes
- Notice of Renewal sent to PI 4 weeks prior to due date
- PI to send Renewal Appl’n 2 weeks prior to due date
**NO NEW SUBJECTS CAN BE ENROLLED UNTIL
RENEWAL CERTIFICATE IS ISSUED**
5 business days
FHREB co-Chair conducts review
Yes
Application approved?
No
5 business days
FHREB ‘approves’ Expedited
Review
Request for
Modifications sent to PI
5 business
days
PI responds within 6
months
FHREB co-Chair conducts review of
response
No
FH Research issues Certificate Approval to PI
Yes
Application Approved?
5 business days
For New Applications ONLY:
Has all of the required
documentation been submitted?
If applicable, PI submits to FH Research:
Yes
FH Research issues “Letter of
Authorization to Conduct Research”
•Signed DAR Form
ACTUALIZATION: Building FH Research
Capacity To Improve Health of FH
Residents
ACTUALIZATION: Building FH Research
Capacity To Improve Health of FH
Residents
Research Proposal
Consultation
Rae Spiwak –
FH Epidemiologist:
ACTUALIZATION: Building FH Research
Capacity To Improve Health of FH
Residents
What Kind Of Services?
Consultation for Research Proposal Development









Specify the research goal, objectives and hypothesis
Identify measurable outcomes
Specify the variables for analysis
Identify sources of data
Develop data collection tools for quantitative or qualitative studies
Develop the statistical analysis plan
Develop ‘coding’ books for database design
Analyze and interpret the data
Train how to use statistical software, such as SPSS
ACTUALIZATION: Building FH Research
Capacity To Improve Health of FH
Residents
Research Project
Management
Michael Wasdell
FH Grant Facilitator-Writer
ACTUALIZATION: Building FH Research
Capacity To Improve Health of FH
Residents
What Kind Of Services?
Project Management of the Grant Application Process



Search for funding opportunities
 Automatic notification of new funding sources and deadlines
Manage timeline
 Identify research team
 Prepare letters of intent
 Identify resources required for conducting the research
 Formulate the research budget
 Write the grant application in collaboration
 Meet FH and funding agency document and signature requirements
Grant administration
ACTUALIZATION: Building FH Research
Capacity To Improve Health of FH
Residents
TOGETHER, TOGETHER!
Is it a good research question?
Can the research be done?
Health Research
Intelligence Unit
Report
Name of Principal Investigator/Client
Department
Preliminary OVERALL GRADE
Protocol Completion OVERALL GRADE
PERFORMANCE SCALE
Y=YES
N=NO
NI=NEEDS IMPROVEMENT
NA=NOT APPLICABLE
Title of Project
Date
Research Evaluator(s)
Date
Research Evaluator(s)
OVERALL GRADING SCALE
1=EXCELLENT
2=VERY GOOD
3=AVERAGE
4=NEEDS IMPROVEMENT
ACTUALIZATION: Building FH Research
Capacity To Improve Health of FH
Residents
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TYPES OF CONCLUSION-ORIENTED
RESEARCH
Epidemiological
Experimental
Effectiveness/Evaluation
Theory Generation
Health Services
ACTUALIZATION: Building FH Research
Capacity To Improve Health of FH
Residents
TYPES OF DECISION-ORIENTED
RESEARCH
 Technical Analyses – systematic reviews
 Policy Analysis & Research
 Evaluation Research
ACTUALIZATION: Building FH Research
Capacity To Improve Health of FH Residents
What Kind Of Services? Knowledge Transfer
Awareness


FH Expert Database, Research Website http://www.fraserhealth.ca/Initiatives/Research/Default.htm
‘After Action Review’ database
Learning - Collaboration
FH Library, Pharmacy, Professional Practice, Workplace Health


Research Education Series: Skill Development workshops, Researchers’ Cafes, Research Week, Research
Rounds
Training Tools
Research Collaborations

Affiliation Agreements – UBC, SFU, TWU
Relationship Building


Network linkage [MSFHR Population Networks]
PHSA
Writing to Publication
Decision Framework
 THANKS!!
 QUESTIONS???