EQA Austrian FH sector Kurt Sohm managing director, FH Council.
How to Conduct Research in FH Workshop - Fraser Health · How to Conduct Research in FH Workshop...
Transcript of How to Conduct Research in FH Workshop - Fraser Health · How to Conduct Research in FH Workshop...
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How to Conduct Research in FH Workshop 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.
September 24, 2013
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Therapeutics Education Collaborative
http://www.youtube.com/watch?v=QUW
0Q8tXVUc&feature=youtu.be
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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
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RESEARCH ETHICS BOARDSTATUS REPORT – September 2nd, 2013
Total Studies – 1096(September 1, 2005
to Present)
ACTIVE STUDIES =265PENDING APPROVAL = 38
Type of Ethics Review for ACTIVE Studies
100
165
Full Board Delegated
10Other 7Mental Health & Substance Use Services
3Workplace Health 32Medicine
9Residential Care & Assisted Living5Laboratory Medicine & Pathology
5Renal Services3Information Management
41Surgical Services19Maternal, Infant, Child & Youth
7Rehabilitation & Centralized Allied Health Service
1Infection Control
14Public Health4Home Health & Specialized Populations
7Professional Practice1Food & Nutrition Services
12Primary Care6End of Life
1Porter Services10Emergency
15Older Adult1Aboriginal Health
21Pharmacy Services5Critical Care
1Paediatrics22Cardiac Services
Active Studies by Program
Funding for ACTIVE Studies
24
121
5
101
90
20
40
60
80
100
120
140
Sponsor Grants Grant-in-Aid Unfunded Other
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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. meta-analysis Environmental Scans: •Expert Consultations •Web/document scans
EVALUATION
Formative/Implementation & Summative: Experimental Quasi-experimental Non-experimental •Descriptive/Observational •Analytical/Secondary Use of Data Designs •Qualitative Methods •Quantitative
RESEARCH
Experimental: •Phase II, III, IV Clinical trials – drug/device/therapeutic intervention Quasi-experimental, Non-experimental
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Research in FH
Cardiac Sciences Drs. Kornder (SMH), Kuritzky, Simkus, Rupka (RCH)
41 clinical trials
Liz da Silva (Dietician), 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
Liz da Silva
Dr. Gerald Simkus
Dr. Jan Kornder
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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
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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)
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
Angela Wolff, PhD
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Differences between Research, Evaluation, & Quality Improvement
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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
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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)
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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/
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FH Researcher Responsibilities
Above: Dr. Galina Vorobeychik in her Burnaby Hospital Multiple Sclerosis Clinic
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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
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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, non-local, e.g. international Co-I must have defined responsibilities Co-I under ‘supervision’ of PI
# of active co-Is as of Sept 2012:
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Skill Testing Question
Which is Riskier?
Research Evaluation
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Steps Along Your Path to Success
1. Know your DERS team 2. Lay out a clear & detailed action plan 3. Pick excellent team players 4. Know the factors involved 5. Keep your sense of humour!!!
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Know your DERS Team
“One Stop Shopping”
Step 1
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X-MEN FIRST CLASS ONE STOP SHOP
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FH X-MEN FIRST CLASS
JEAN GRAY Susan Chunick
MAGNETO
Dr. Andrew Webb DAZZLER
Julie Hadden
ROGUE Camille Viray
POLARIS Magdalena Swanson
SAGE Dr. Sonia Singh
MYSTIQUE Michelle Purdon
SWAY Anat Feldman
M Samar Hejazi
WHITE QUEEN Lisa Kristiansen
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“One Stop Shopping”
Coordination of All Required APPROVALS
“The Letter of Authorization to
Conduct Research”
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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.
Letter of Authorization
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Methodology Unit
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Methodology Unit
Magdalena Swanson, Research & Grant Development Facilitator Samar Hejazi, Epidemiologist Library Services, Michelle Purdon __________________________________ Individual consultation services Team development Peer review Education/training
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Magdalena Swanson Research & Grant Development Facilitator
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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
Consultation for Research Proposal Development
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EPIDEMIOLOGIST
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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
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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
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FH Library Services
“...enabling access to the best evidence to advance care, research and decision making across the FH community”
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)
Your largest libraries (with the most resources & full staffing)
ARHCC BUH CGH RCH SMH
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FH Library Services
“...enabling access to the best evidence to advance care, research and decision making across the FH community”
Workshops Library Tips & Tricks for Using Google
(Fall/Winter 2013)
Other workshops (on request): Finding Drug Information Library Orientation Finding Articles in CINAHL Finding Articles in Medline Finding UpToDate Evidence Summaries Reference – convenient access to
expert searching
Training in evidence-based searching
Find a paper – in the collection or by interlibrary loan
Loans – books and journals Photocopying & computer access
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...
Drug Databases – LexiComp, King Guide, eCPS
A-to-Z Journals List – over 2,000 full text electronic journals
eBooks
COMING SOON… online video tutorials!
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Camille Viray Education & Communications
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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
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Program Assistant
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Program Assistant
Coordinates: FHREB data entry, archiving, and 10%
overhead (invoicing/collection) Clinical Trial Agreements Affiliated Researcher Agreements Statistical Reporting Finances Everything else…
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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
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Julie Hadden Research Ethics
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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
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Lay Out A Clear
Detailed Action Plan
Step 2
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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/
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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
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Pick Excellent
Team Members
Step 3
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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
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Team Member Roles
Principal Investigator
Co-Principal Investigator
Co-Investigator
Collaborator
Coordinator
Assistant
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Team Members Responsibilities
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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
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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
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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
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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
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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
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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
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Documenting Roles and Responsibilities
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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
Documentation
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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.
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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
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Group Activity - 15 minutes
Your task is to assign roles to the team members, based on the handout describing each team member Start… now!
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Report Back
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Understand the factors
involved
Step 4
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5 X-FACTORS
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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
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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
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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)
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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
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FHREB
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The Role of the FHREB
What are the primary goals of the FHREB? To protect human subjects To preserve rights of human subjects
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The Scope of the FHREB
Initial Ethical Approval of New Research
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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
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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
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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
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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
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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
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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)
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Review Processes – Full Board
Emailed to PI/contact person within
5 business days
FHREB Decisions
Modifications Memo – resubmit to Delegated Review Deferral Memo – resubmit to Full Board
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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
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Timelines for New Studies
Full Board Meeting to Approval: Median # of business days: 32 days
??
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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)
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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/
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Contract review for industry or academic sponsored research
Some sponsors…
2: Have Your Contract Reviewed
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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
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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
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5: Knowledge Dissemination
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Research Products
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Keep Your
Sense of Humour!
Step 5
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Department of Evaluation and Research Services Contact Info – Updated September 2013
Susan Chunick
Director
604.587.4681
Julie Hadden
Research Ethics Coordinator
604.587.4436
Dr. Sonia Singh
Program Medical Director
604.541.5830
Magdalena Swanson
Research & Grant Development Facilitator
604.587.4637
Anat Feldman
Research Leader, SMH JPOCSC
Lisa Kristiansen
Evaluation Specialist
604.587.4445
Camille Viray
Education & Communications Coordinator
604.587.4413
Michelle Purdon
Library Services Manager
604.851.4700 x 646832
Samar Hejazi, PhD
Epidemiologist
604.587.4438
http://research.fraserhealth.ca/
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Thank You!
Department of Evaluation and Research Services