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September 28 th, 2006. Research Administration & Development Overview FH Policies FH Research Approved: June 21, 2005 The Ethical Conduct of Research.

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Presentation on theme: "September 28 th, 2006. Research Administration & Development Overview FH Policies FH Research Approved: June 21, 2005 The Ethical Conduct of Research."— Presentation transcript:

1 September 28 th, 2006

2 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 Approved: June 21, 2005 Research Integrity Approved: TBA Intellectual Property Approved: TBA Administration Structures Grants Administration [Mike Wasdell & Rosa Haywood] Contracts [Rosa Haywood & Kathy Dunstan] DAR - Pharmacy - Lab - Health Records - Procurement -Patient Care Finance [Ian Perry] FHREB Ethics Administration [Rosa Haywood] Information FH [Privacy Manager] Research Integrity & Investigational Committee Legal Services Ethical ReviewComplianceEducation Research Capacity Building Affiliation Agreements Services FH Departments Peer Review

3 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; Affiliated 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. PIApplication General ProceduresPIApplication General Procedures

4 KEY REQUIREMENTS 2. What Initial Approvals are Required?  Mandatory:Certificate of Initial Ethical Approval  As Applicable:Health Canada Letter of No Objection [Clinical Trials]  As Applicable:Department Agreement for Providing Research-Related Services Authorization  As Applicable:Executed Clinical Trial Agreement  Mandatory:Letter of Authorization to Conduct Research [LOA] “This letter authorizes the Principal Investigator to begin research-related procedures” Signed by S. Chunick

5 KEY REQUIREMENTS 3. How do you use the LOA? a. LOADepartments Providing Research- Related Services Principal Investigator/Designate e.g. signed LOA Principal Investigator/Designate Health Records for release of charts b. LOA FH Finance Research: Rosa Haywood [Authorization to set-up FH Research Account]

6 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

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

8 Research Integrity Scientific Ethical Fiduciary

9 RESEARCH ETHICS BOARD STATUS REPORT 01 September 2006 Total Studies 263 (From 2005 September 01 to Date) ACTIVE STUDIES =168 PENDING APPROVAL = 13Anaesthesia3 Family Medicine 1 Nursing Obstetrics 1Psychiatry19Audiology1 Family Practice 1Nutrition1 Public Health Prevention 2 Cardiology29 Health Planning 1Obstetrics7 Quality of Life 1 Communicable Diseases 1 Health Services 2 Occupational Therapy 1 Residential Care 1 Community Site 1ICU4Oncology2Respiratory3 Critical Care 5 Internal Medicine 2Orthopaedics13 Social Work 3 Decision Support Service 1Medicine2 Palliative Care 2Surgery1 Education Med Students 1 Mental Health 4Paediatrics1SystemsAnalysis/Performance1 Elder Research 2 Multiple Sclerosis 6Pharmacy4 Non FH Research 13 Emergency10Nephrology5Physiotherapy1 Endocrinology1Neurology3Prevention/Promotion1 Epidemiology2Nursing2 Professional Practice 1

10 ETHICAL REVIEW THE FHA REB ROLE: TO ENSURE THE PROTECTION and WELL-BEING OF RESEARCH SUBJECTS

11 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]

12 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

13  Rosa Haywood: Ethics administration

14 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

15 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

16 The Distant Past Nuremberg NAZI Doctors Trial PHS Syphilis Study – Tuskegee, Tennessee

17 What are the Regulations? WORLD MEDICAL ASSOCIATION /INTERNATIONAL 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, CFR 46: Subpart D (children) 1991 Common Rule: 17 U.S. federal departments 2001 Association of American Universities Conflict of Interest Guidelines

18 What are the Regulations? CANADA 1998 Health Canada: Food & Drug Act Medical Device Regulations 1998Tri-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” Disclosure for research or statistical purposesDisclosure for research or statistical purposesCon’d

19 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)

20 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

21 OBLIGATIONS OF THE REB Is the Sample Selection Fair?  Inclusion Criteria  Incompetent subjects  Exclusion Criteria  Women; ESL

22 OBLIGATIONS OF THE REB Does the Consent Process Preserve Autonomy?  Subject Consent  Protect privacy [FOIPPA]

23 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

24 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

25 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 harms  CF: Legal rights  CF: How to withdraw  CF: Research Subject Information Line

26 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

27 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 to Rosa Haywood

28 FH RESEARCH REVIEW PROCESS Application completed & submitted to admin. supervisor for signature PI/designate submits appl’n to FH Research for Expedited Review PI/designate submits Appl’n to FH Research for Full Board Review Mail Appl’n screened for completeness Yes No FHREB co-Chair conducts review Appl’n & consent form pre-reviewed 5 business days Full Board Review 10 business days 1 business day Study approved? Yes FH Research issues Certificate of Ethical Approval to PI No FHREB ‘approves’ Expedited Review Request for Modifications sent to PI Deferral Notice sent to PI 5 business days PI responds within 6 months FHREB co-Chair conducts review of response Study Approved? Yes No 5 business days If applicable, PI submits to FH Research: Signed DAR Form Contract for clinical trial research Health Canada No Objection Letter Has all of the required documentation been submitted? Yes FH Research issues “Letter of Authorization to Conduct Research”

29 EXPEDITED REVIEW PROCESS - Minimal Risk Applications, Amendments, & Renewals EXPEDITED REVIEW PROCESS - Minimal Risk Applications, Amendments, & Renewals Application completed & submitted to admin. supervisor for signature PI/designate submits appl’n to FH Research for Expedited Review Appl’n screened for completeness Yes No FHREB co-Chair conducts review 5 business days 1 business day Application approved? Yes FH Research issues Certificate Approval to PI No 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 Application Approved? Yes No 5 business days If applicable, PI submits to FH Research: Signed DAR Form For New Applications ONLY: Has all of the required documentation been submitted? Yes FH Research issues “Letter of Authorization to Conduct Research” 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 **NO NEW SUBJECTS CAN BE ENROLLED UNTIL RENEWAL CERTIFICATE IS ISSUED**

30 ACTUALIZATION: Building FH Research Capacity To Improve Health of FH Residents

31 Research Proposal Consultation Rae Spiwak – FH Epidemiologist:

32 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

33 ACTUALIZATION: Building FH Research Capacity To Improve Health of FH Residents Research Project Management Michael Wasdell FH Grant Facilitator-Writer

34 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

35 ACTUALIZATION: Building FH Research Capacity To Improve Health of FH Residents TOGETHER, TOGETHER! Is it a good research question? Can the research be done?

36 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

37 ACTUALIZATION: Building FH Research Capacity To Improve Health of FH Residents TYPES OF CONCLUSION-ORIENTED RESEARCH  Epidemiological  Experimental  Effectiveness/Evaluation  Theory Generation  Health Services

38 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

39 ACTUALIZATION: Building FH Research Capacity To Improve Health of FH Residents What Kind Of Services? Knowledge Transfer Awareness  FH Expert Database, Research Website  ‘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

40  THANKS!!  QUESTIONS???


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