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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

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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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http://research.fraserhealth.ca/

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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

susan.chunick@fraserhealth.ca

Julie Hadden

Research Ethics Coordinator

604.587.4436

julie.hadden@fraserhealth.ca

Dr. Sonia Singh

Program Medical Director

604.541.5830

sonia.singh@fraserhealth.ca

Magdalena Swanson

Research & Grant Development Facilitator

604.587.4637

magdalena.swanson@fraserhealth.ca

Anat Feldman

Research Leader, SMH JPOCSC

anat.feldman@fraserhealth.ca

Lisa Kristiansen

Evaluation Specialist

604.587.4445

lisa.kristiansen@fraserhealth.ca

Camille Viray

Education & Communications Coordinator

604.587.4413

camille.viray@fraserhealth.ca

Michelle Purdon

Library Services Manager

604.851.4700 x 646832

michelle.purdon@fraserhealth.ca

Samar Hejazi, PhD

Epidemiologist

604.587.4438

samar.hejazi@fraserhealth.ca

http://research.fraserhealth.ca/

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Thank You!

Department of Evaluation and Research Services