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How to Conduct Research in FH Workshop
September 24, 2013
Susan Chunick, Director
Julie Hadden, Research Ethics Coordinator
Camille Viray, Education and Communications Coordinator
Linda Howard, Librarian, Surrey Memorial Hospital
© Fraser Health Authority, 2013
The Fraser Health Authority (“FH”) authorizes the use, reproduction and/or modification of this publication for purposes other than commercial
redistribution. In consideration for this authorization, the user agrees that any unmodified reproduction of this publication shall retain all copyright and
proprietary notices. If the user modifies the content of this publication, all FH copyright notices shall be removed, however FH shall be acknowledged
as the author of the source publication.
Reproduction or storage of this publication in any form by any means for the purpose of commercial redistribution is strictly prohibited.
This publication is intended to provide general information only, and should not be relied on as providing specific healthcare, legal or other
professional advice. The Fraser Health Authority, and every person involved in the creation of this publication, disclaims any warranty, express or
implied, as to its accuracy, completeness or currency, and disclaims all liability in respect of any actions, including the results of any actions, taken or
not taken in reliance on the information contained herein.
1
Therapeutics Education Collaborative
 http://www.youtube.com/watch?v=QUW
0Q8tXVUc&feature=youtu.be
2
Skill Testing Question
How many studies are active at any one
time in FH?
a. Under 100
b. 101 to 150
c. 151 to 200
d. 201 to 250
e. 251 to 300
3
RESEARCH ETHICS BOARD
STATUS REPORT – Septem ber 2nd, 2013
Total Studies – 1096
Type of Ethics Review for
ACTIVE Studies
100
165
(Septem ber 1, 2005
to P resent)
ACTIVE STUDIES =265
PENDING APPROVAL = 38
Funding for ACTIVE Studies
140
121
120
101
100
80
60
40
24
20
5
9
0
Full Board
Delegated
Sponsor
Grants
Grant-in-Aid Unfunded
Other
Active Studies by Program
Aboriginal Health
1
Older Adult
15
Cardiac Services
22
Paediatrics
1
Critical Care
5
Pharmacy Services
21
Emergency
10
Porter Services
1
End of Life
6
Primary Care
12
Food & Nutrition Services
1
Professional Practice
7
Home Health & Specialized Populations
4
Public Health
14
Infection Control
1
Rehabilitation & Centralized Allied
Health Service
7
Information Management
3
Renal Services
5
Laboratory Medicine & Pathology
5
Residential Care & Assisted Living
9
Maternal, Infant, Child & Youth
19
Surgical Services
41
Medicine
32
Workplace Health
3
Mental Health & Substance Use Services
7
Other
10
4
Scope of Research-related Activities in FH
Contributions to Thinking, Decision Making, Practice and Policy
n.b. excludes health technology assessments, biomedical/basic science and insurance-related research
POLICY
Analysis/Research
Research Synthesis:
•Structured Literature
review
•Systematic Reviews
•Quantitative
Synthesis, i.e. metaanalysis
Environmental
Scans:
•Expert Consultations
•Web/document scans
EVALUATION
RESEARCH
Formative/Implementation
& Summative:
Experimental
Quasi-experimental
Non-experimental
•Descriptive/Observational
•Analytical/Secondary Use
of Data Designs
•Qualitative Methods
•Quantitative
Experimental:
•Phase II, III, IV Clinical
trials –
drug/device/therapeutic
intervention
Quasi-experimental,
Non-experimental
5
Research in FH
Cardiac Sciences
 Drs. Kornder (SMH),
Kuritzky, Simkus, Rupka
(RCH)
 41 clinical trials
 Liz da Silva (Dietician), Dr. Gerald Simkus
Dr. Bonet (co-I)
 1st FH investigator-initiated Health
Canada Clinical Trial Application
 A Randomized Double-blind
Placebo-controlled Trial of Vitamin D
In Heart Failure: A Pilot Study
Dr. Jan Kornder
Liz da Silva
6
Research in FH
Rehabilitation
 Chiara Singh
(Physical Therapist)
 UBC Physical Therapy
School collaboration
 The effect of prospective
monitoring and early
physiotherapy intervention
on the incidence of arm
morbidity (at 6 months)
post breast Cancer
surgery- a pilot study.
Chiara Singh
7
Research in FH (add other non-MD
researchers)
Professional Practice
 Angela Wolff, PhD
 The Prevalence of and Outcomes Associated
with Ostracism in Healthcare Workplaces
(Coworker Treatment and Social Support)
Angela Wolff, PhD
Surgery
 Dr. Ramin Mehin (Provincial collaborative)
 CIHR PHSI/MSHR - $439,000
 Why are so Many Patients Dissatisfied with Knee
Replacement Surgery? Exploring Variations of the Patient
Experience
8
Differences between Research,
Evaluation, & Quality Improvement
9
What is Research?
 "Research involving human subjects is defined
as any systematic investigation (including pilot
studies, exploratory studies, and academic
course work assignments) designed to
contribute to generalizable knowledge.
 Generalizable knowledge consists of facts,
theories, principles or relationships, or the
accumulation of information on which they are
based, that can be corroborated by accepted
scientific methods of observation and inference."
Source: FH Research Ethics Policy
10
What is Evaluation?
 "the systematic application of social
research procedures for assessing the
conceptualization, design,
implementation, and utility of ...
programs."
Source: J. Krajnak: Rossi and Freeman (1993)
11
What is Quality Improvement?
 To improve internal processes, practices,
costs or productivity for a specific
intervention (i.e. determine how this
intervention affected this participant
group in this setting).
Link to document:
http://research.fraserhealth.ca/about_us/research%2C_program_evaluation_%26_quality_improvement/
12
FH Researcher Responsibilities
Above: Dr. Galina Vorobeychik in her Burnaby
Hospital Multiple Sclerosis Clinic
13
Principal Investigators (PI)
 Only ONE PI on a FH application for ethical review
 Must be capable of carrying out the study, i.e. have the
correct credentials for the type of study
 Has overall responsibility for study conduct and for
research team
 PI obligations detailed in FH Research Policy (page 16)
# of active PI’s as of Mar 31, 2013:
146
14
Co- Investigators (Co-I)
 Any # of Co-I’s for a research study
 Not restricted to FH; may be from
academic institutions, other HA’s, nonlocal, e.g. international
 Co-I must have defined responsibilities
 Co-I under ‘supervision’ of PI
# of active co-Is as of Sept 2012:
15
Skill Testing Question
Which is Riskier?
Research
Evaluation
16
17
Steps Along Your Path to Success
1.
2.
3.
4.
5.
Know your DERS team
Lay out a clear & detailed action plan
Pick excellent team players
Know the factors involved
Keep your sense of humour!!!
18
Know your DERS Team
“One Stop Shopping”
Step 1
19
X-MEN
FIRST
CLASS
ONE
STOP
SHOP
20
FH X-MEN FIRST CLASS
MAGNETO
JEAN GRAY
Dr. Andrew Webb
Susan Chunick
DAZZLER
POLARIS
M
Julie Hadden
Magdalena Swanson
Samar Hejazi
ROGUE
SAGE
MYSTIQUE
WHITE QUEEN
SWAY
Camille Viray
Dr. Sonia Singh
Michelle Purdon
Lisa Kristiansen
Anat Feldman
21
http://research.fraserhealth.ca/
22
“One Stop Shopping”
Coordination of All Required APPROVALS
“The Letter of Authorization to
Conduct Research”
23
Letter of Authorization

FHREB Certificate of Initial Approval – Dated:
 Consent Required and Approved
Or
Consent Not Required [i.e. retrospective data analysis]
Or
Consent Waiver

Department Agreement for Providing Research-related Services (DAR)

Regulated Clinical Drug/Device Trials ONLY
Health Canada Letter of No Objection

Industry or Academic-sponsored Studies ONLY
Executed Clinical Trial Agreement

Grant /Grant-in-Aid Agreements
This letter authorizes the Principal Investigator to begin research-related
procedures.
24
Methodology Unit
25
Methodology Unit
 Magdalena Swanson, Research & Grant
Development Facilitator
 Samar Hejazi, Epidemiologist
 Library Services, Michelle Purdon
__________________________________
Individual consultation services
Team development
Peer review
Education/training
26
Magdalena Swanson
Research & Grant Development Facilitator
27
Consultation for Research
Proposal Development
 Searches for funding opportunities
 Individual and FH News notification of new funding sources and
deadlines
 Develops proposal management plan & timeline
 Consults on






Research team
Preparing letters of intent
Resources required for conducting the research
Formulating the research budget
Proposal development
FH and funding agency document and signature requirements
 Briefs V.P. if required
 Administers the GRANT
28
EPIDEMIOLOGIST
29
Consultation for Research/Evaluation
Proposal Development
Design & Analysis:
 Specifies the goal, objectives and
hypothesis
 Identifies measurable outcomes
 Specifies the variables for analysis
 Identifies sources of data
 Develops data collection tools for
quantitative or qualitative studies
30
Cont. of Services
 Develops the statistical analysis plan
 Provision of guidelines/examples for code
book design and feedback on codebooks
 Analyzes and interprets the data
 Trains users in statistical software, e.g.
SPSS
31
FH Library Services
“...enabling access to the best evidence to advance care, research
and decision m aking across the FH com m unity”
Your largest libraries
(with the most resources & full staffing)
ARHCC
BUH
CGH
RCH
SMH
Other Library Spaces








Delta Hospital (not regularly staffed)
Eagle Ridge Hospital (staffed Tuesdays)
Fraser Canyon (not regularly staffed)
Langley Memorial Hospital (not regularly staffed)
Mission Memorial Hospital (not regularly staffed)
Peace Arch Hospital (not regularly staffed)
Queen’s Park Care Centre (staffed Tuesdays)
Ridge Meadows Hospital (staffed Thursdays)
32
FH Library Services
“...enabling access to the best evidence to advance care, research
and decision m aking across the FH com m unity”

Workshops
Library Tips & Tricks for Using Google
(Fall/Winter 2013)

Loans – books and journals

Photocopying & computer access
Other workshops (on request):

LibraryRX – bi-monthly newsletter
highlighting events and resources

Subject Guides & Journal Watch –
editions on medical topics and specialties

Research Databases – Medline, CINAHL,
EMBASE, PsycINFO, UpToDate...
Finding Drug Information
Library Orientation
Finding Articles in CINAHL
Finding Articles in Medline
Finding UpToDate Evidence Summaries

Reference – convenient access to
expert searching

Drug Databases – LexiComp, King
Guide, eCPS

Training in evidence-based
searching

A-to-Z Journals List – over 2,000 full
text electronic journals

Find a paper – in the collection or by
interlibrary loan

eBooks
COMING SOON…
online video tutorials!
33
Camille Viray
Education & Communications
34
Education and Communications
Coordinates:
 Education
http://research.fraserhealth.ca/education/
:
 Workshops (September 2013 to June 2014)
 Researchers’ Cafes
 Research Week (June 2013)
 Communications:




DERS website http://research.fraserhealth.ca/
Research Rx
Monthly Research News (on FH Pulse)
Promotion and Marketing
35
Program Assistant
36
Program Assistant
Coordinates:
 FHREB data entry, archiving, and 10%
overhead (invoicing/collection)
 Clinical Trial Agreements
 Affiliated Researcher Agreements
 Statistical Reporting
 Finances
 Everything else…
37
Susan Chunick
Director
 Infrastructure:
 Service Agreements – RCH Pharmacy, SMH Lab, UBC
 IT – software [SPSS, RefWorks], systems
 FH Finance





Research Collaboration Agreements – academic
Policies and procedures – CIHR MOU
Best Practices
Research Development & Promotion – Research Week
Education – in collaboration with FH Library Services,
Medical Education, Pharmacy Services, Professional
Practice and Integration, and Workplace Health
38
Julie Hadden
Research Ethics
39
Research Ethics Coordinator
 Coordinates all ethical review processes
for initial applications, amendments,
renewals, adverse events, close-outs
 Coordinates all applicable approvals for
“Letter of Authorization”
 Monitors studies to ensure annual
renewal of ethics
 Consults with researchers
40
Lay Out A Clear
Detailed Action Plan
Step 2
41
Requirement for Research Protocol
for ALL Studies
literature review (incl. references)
need/justification for the study
study purpose
hypotheses
objectives
specification of endpoints/outcomes (if applicable)
research design including statistical analysis plan
(if applicable)
 detailed research procedures







Link to ‘Protocol Template’:
http://research.fraserhealth.ca/research_support/research-toolkit/ (under
research proposal development)
Reference: FH Research Ethics Board Policy # 13
http://research.fraserhealth.ca/about_us/research_policies/
42
Schedule of Work
Aims of the Project
Personnel

Investigators

Staff

Students

Volunteers
Research Project Management

Overall Lead (usually PI or delegate)

Team Responsibilities (detail responsibilities / tasks)

Project Meetings (frequency, location, required personnel,
meeting chair, meeting minute taking)

Reporting plans

Knowledge dissemination plan
43
15
44
Pick Excellent
Team Members
Step 3
45
Pick Excellent Team Members
Team members can include FH staff, non-FH
researchers & contracted research assistants
ROLES & RESPONSIBILITIES
 Key Personnel: FH Research Policy
 Memorandum of Understanding (MOU)
between PI & individual team members
46
Team Member Roles
Co-Investigator
Co-Principal Investigator
Principal Investigator
Collaborator
Coordinator
Assistant
47
Team Members Responsibilities
48
Principal Investigator
 Accountable for the entire scope of
research related activities
*evidence of oversight MUST be documented
 Managing, monitoring and ensuring integrity of:







Study design
Study conduct
Study reporting
Collaborative relationships
Ethics compliance
Finances
Personnel
49
Co-Investigator
 Shared accountability for the entire scope of research
related activities
 Individual(s) involved in the development or execution
of a project
 May be employed by, or be affiliated with, FH or
another organization participating in the project
 Typically devotes a specified percentage of time to the
project and is considered "key personnel"
 Do not have spending authority unless delegated in
writing by the PI
50
Collaborator
 Involved with a key component of project
development or execution, provides expertise
at specific points in time
 Not ‘key’ team members
 Involvement less than that of a Co-Investigator
51
Consultant
 Individual/firm retained to provide professional
advice or services on a project and is not an
employee of FH
 FH policies governing the use of consultants
must be observed
52
Other Research Staff
 Individuals working on a research project under
the supervision and direction of a PI or a Co-I
Study Coordinator
Research Assistant
 Generally performs clerical, data collection and
data entry tasks
53
Who to Include?
Academic partners
Clinical partners
Decision Makers
Individuals/Organizations with
access to the subject
population
 Individuals/Organizations
possessing the expertise
required to conduct the
research
 Stakeholders




54
Documenting
Roles and Responsibilities
55
Documentation
Charter/MOU/ Collaboration Agreement:
Source Document!
 Recipient of funding – sponsor agency, e.g.
FH
 Ownership of IP if co-PI’s for grant purposes
[usually co-PI with academic]
 Authorship (LINK: under ‘relate findings’
http://research.fraserhealth.ca/research_support/research-toolkit/)
 Who does what, when & how: Tasks – be
precise!
 Schedule of meetings
 Document management
56
Group Activity - 15 minutes
Team Example:
The Total Knee Arthroplasty Research Team plans to
submit a grant application to address the research
question:
“Why are so many patients dissatisfied with
knee replacement surgery?” Exploring
variations of the patient experience.
57
Group Activity - 15 minutes
Total Knee Arthoplasty Team
They propose a research study that will ask patients to
fill out surveys before and after their knee replacement
surgery, and take part in interviews to access their full
experience
To answer the research question, the team includes
clinicians, academic researchers, health authority and
ministry decision makers, knowledge users, and
patient representatives / advocates
58
Group Activity - 15 minutes
Your task is to assign roles to the
team members, based on the
handout describing each team member
Start… now!
59
Report Back
60
Understand the factors
involved
Step 4
61
5 X-FACTORS
62
X-Factor 1: Meet the FHREB Requirements for Approval
X-Factor 2: Have Your Contract Reviewed
(for some studies)
X-Factor 3: Know Your Budget
X-Factor 4: Comply with Grant Agreements
X-Factor 5: Knowledge Dissemination
63
1: Meet the FHREB Requirements
A Brief History of Governing Legislation
WORLD MEDICAL ASSOCIATION /INTERNATIONAL
1947
Nuremberg Code
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. Agencies
2001
Association of American Universities Conflict of
Interest Guidelines
64
A Brief History Cont.
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
FOIPPA – Freedom of Information and Protection of Privacy (B.C.) Section 35 Amendment
re “Disclosure for research or statistical purposes”
2002
Health Canada: CIHR Requirements for Ethical Review of Pluripotent Stem Cell Research
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)
65
TCPS and Health Canada
ALL CANADIAN RESEARCH:
TCPS = The Tri-council Policy Statement on Ethical Conduct for
Research Involving Human Subjects [1998 + updates] (TCPS or the
Policy) is a joint policy of Canada’s three federal research agencies
– the Canadian Institutes of Health Research (CIHR), the Natural
Sciences and Engineering Research Council of Canada (NSERC),
and the Social Sciences and Humanities Research Council of Canada
(SSHRC), or “the Agencies.”
ALL CANADIAN CLINICAL DRUG/DEVICE TRIALS:
Health Canada = Food and Drug Act Regulations
66
FHREB
67
The Role of the FHREB
What are the primary goals of the FHREB?
 To protect human subjects
 To preserve rights of human subjects
68
The Scope of the FHREB
 Initial Ethical Approval of New Research
69
The Scope of the FHREB cont.
 Annual Review & Approval of
Ongoing Studies BEFORE
Expiry Date
 Review and approval of
amendments to previously
approved studies
 Review of serious adverse
events & protocol violations
 Acknowledgement of study
close-outs
70
What Does the FHREB Look For?
Study Value
1. Testable hypothesis/outcomes specified?
2. Sufficient sample size (statistically
powered)?
3. Do benefits outweigh the risks?
4. Is there clinical equipoise?
* FH protocol template
71
What Does the FHREB Look For?
 Consent
http://research.fraserhealth.ca/approvals_%26_ethics/forms_and_guidan
ce_notes/
 Recruitment Plan (FHREB GN#12)
http://research.fraserhealth.ca/media/FHREB_FHGN_Initial_Application_Ethical_Re
view.pdf
 Confidentiality (FHREB GN#23)
http://research.fraserhealth.ca/media/FHREB_FHGN_Initial_Application_Ethical_Re
view.pdf
72
Review Processes – Full Board
FULL BOARD REVIEW REQUIRED IF:
Above minimal risk [e.g. more than
standard clinical practices]
Vulnerable subjects
 Exception: Observational research or
retrospective chart review
Industry sponsored
At the discretion of the FHREB
73





Review Processes – Full Board
FULL BOARD REVIEW:
2nd Wednesday of every month,
except August
PI must submit 1 hard copy and 1
electronic copy of all documentation by
deadline
Pre-review of application & consent
forms prior to meeting
Documents distributed to FHREB one
week before meeting for their review
74
Review Processes – Full Board
AT THE MEETING, REVIEW OF:
Protocol must be approved; if not, then
Deferred & resubmit to future Full Board
meeting
Investigator’s Brochure [drug trials only]
Application Form
Subject Consent Form
Other Documents (recruitment material)
75
Review Processes – Full Board
FHREB Decisions
Emailed to PI/contact person within
5 business days
Modifications Memo – resubmit to Delegated Review
Deferral Memo – resubmit to Full Board
76
Review Processes - Delegated
Conducted by one of the FHREB
co-Chairs
Weekly
Preview
All documentation reviewed
Decision usually Modifications Memo
Decision emailed within 5 business days
78
79
Timelines for New Studies
Full Board Meeting to Approval:
Median # of business days: ??
32 days
80
Researcher Support
 Individual consultation – Research Ethics
Coordinator
 Education – Workshops
 Research Ethics website
 Guidance Notes
 Consent Form Templates – Main Consent, Optional
Substudy Consent, Review of Health Records
Consent
 FAQs
 Educational Tutorials (e.g. TCPS 2)
81
Tutorials
 Tricouncil Policy Statement 2: Ethical Conduct of Research
Involving Humans – Tutorial
http://www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel/
 National Institutes of Health Office of Extramural Research
(OER) http://grants.nih.gov/grants/oer.htm
References

Nuremberg Code http://ohsr.od.nih.gov/guidelines/nuremberg.html



Declaration of Helsinki http://ohsr.od.nih.gov/guidelines/helsinki.html
The Belmont Report http://ohsr.od.nih.gov/guidelines/belmont.html
ICH Good Clinical Practice Guidelines http://www.ich.org/
82
2: Have Your Contract Reviewed
 Contract review for industry or academic
sponsored research
Some sponsors…
83
3: Know Your Budget
Overruns not permitted
Expenses for budgeted items only
Keep expense records
Materials must be purchased through FH
Procurement
 Capital purchases owned by FH
 FH Finance sets up research account for
funds to be disbursed upon release of LOA
ONLY–Request Budget Template from M.
Swanson




84
4: Comply with Grant Agreements
 Final report to granting agency including
record of expenses
 Report proposal changes
 Audit by granting agency
 Annual renewal of study
 Detail how payments to service providers
will be made
85
5: Knowledge Dissemination
86
Research Products
87
Keep Your
Sense of Humour!
Step 5
88
Department of Evaluation and Research Services
Contact Info – Updated September 2013
Susan Chunick
Magdalena Swanson
Camille Viray
Director
Research & Grant Development
Facilitator
604.587.4681
604.587.4637
[email protected]
[email protected]
Julie Hadden
Samar Hejazi, PhD
Research Ethics Coordinator
Epidemiologist
Michelle Purdon
604.587.4436
604.587.4438
Library Services Manager
[email protected]
[email protected]
604.851.4700 x 646832
Education & Communications
Coordinator
604.587.4413
[email protected]
[email protected]
Dr. Sonia Singh
Lisa Kristiansen
Program Medical Director
Evaluation Specialist
Anat Feldman
604.541.5830
604.587.4445
Research Leader, SMH JPOCSC
[email protected]
[email protected]
[email protected]
http://research.fraserhealth.ca/
89
Department of
Evaluation
and Research
Services
Thank You!
90