September 28 th 2006 Research Administration

September 28 th, 2006

Research Administration & Development Overview FH Policies FH Research Approved: June 21, 2005 The Ethical Conduct of Research and Other Studies Involving Human Subjects Approved: June 21, 2005 The Collection, Use and Disclosure of Personal Information for Research. Related Purposes Approved: June 21, 2005 The Provision Of Research. Related Services to Non-FH Researchers Research Integrity Intellectual Property Approved: TBA Approved: June 21, 2005 Grants 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 Investigational Committee Legal Services 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. 3 a.

KEY REQUIREMENTS 2. What Initial Approvals are Required? § Mandatory: § 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 Research. Related 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 þ Implementing responsibilities defined in FH research policies þ Disclosing conflict of interest þ Retaining records of verifiable data (25/5 yrs. ) þ Training and supervising research team þ Managing research budget and expenditures þ Complying with funding agency requirements þ Registering Clinical Trials þ Obtaining annual renewal BEFORE date of expiry

KEY REQUIREMENTS 5. What Ongoing Approvals are Required? LACK OF COMPLIANCE q Withdraw of ethics approval Stop Study q Authorizes new subject recruitment and/or secondary data collection q Sanctions by funding agency CIHR) q Authorizes annual release of funds from granting agency Investigation q Certificate of Approval for Renewal of a Previously approved Study (e. g. q Sanctions by Commercial Sponsor q Sanctions by FH

Et hi ca l Research Integrity Scientific Fi du ci ar y

RESEARCH ETHICS BOARD STATUS REPORT 01 September 2006 Total Studies 263 (From 2005 September 01 to Date) ACTIVE STUDIES =168 PENDING APPROVAL = 13 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. Dr. Bob Gillies [Pharmacy] Michael Vince [RCH lab, Retired] 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

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 2 nd 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 No Application completed & submitted to admin. supervisor for signature Appl’n & consent form pre-reviewed 10 business days FHREB co-Chair conducts review Yes Study approved? FHREB ‘approves’ Expedited Review Full Board Review No 5 business days Request for Deferral Notice sent Modifications sent to PI 5 business days PI responds within 6 months FHREB co-Chair conducts review of response No FH Research issues Certificate of Ethical Approval to PI No Yes 5 business days Has all of the required documentation been submitted? Mail Appl’n screened for completeness 1 business day PI/designate submits Appl’n to FH Research for 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 Appl’n screened for completeness No 1 business day Yes **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 Expedited Renewal Applications: - Notice of Renewal sent to PI 4 weeks prior to due date - PI to send Renewal Appl’n 2 weeks prior to due date 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 Title of Project Preliminary OVERALL GRADE Date Research Evaluator(s) Protocol Completion OVERALL GRADE Date Research Evaluator(s) PERFORMANCE SCALE Y=YES N=NO NI=NEEDS IMPROVEMENT NA=NOT APPLICABLE OVERALL GRADING SCALE 1=EXCELLENT 2=VERY GOOD 3=AVERAGE 4=NEEDS IMPROVEMENT

ACTUALIZATION: Building FH Research Capacity To Improve Health of FH Residents § § § 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? ? ?