How to Prepare for Ethical Review by the Fraser Health Research Ethics Board - PowerPoint PPT Presentation

Loading...

PPT – How to Prepare for Ethical Review by the Fraser Health Research Ethics Board PowerPoint presentation | free to view - id: 7298ea-ZjJkY



Loading


The Adobe Flash plugin is needed to view this content

Get the plugin now

View by Category
About This Presentation
Title:

How to Prepare for Ethical Review by the Fraser Health Research Ethics Board

Description:

How to Prepare for Ethical Review by the Fraser Health Research Ethics Board Presented by: Susan Chunick Director, Research Administration and Development – PowerPoint PPT presentation

Number of Views:208
Avg rating:3.0/5.0
Slides: 73
Provided by: Silk152
Category:

less

Write a Comment
User Comments (0)
Transcript and Presenter's Notes

Title: How to Prepare for Ethical Review by the Fraser Health Research Ethics Board


1
How to Prepare for Ethical Review by the Fraser
Health Research Ethics Board
  • Presented by Susan Chunick
  • Director, Research Administration and Development
  • October 12, 2007

2
Objectives
  • By the end of the workshop, you will be able to
  • Submit an application for initial ethical review
    that meets the requirements of the FH ethics
    review process
  • Prepare an application that takes into account
    the ethical principles considered in the ethical
    review by the FH Research Ethics Board REB
  • Understand the decision-making process used by
    the FHREB in conducting an ethical review
  • Understand the differences between a Full Board
    versus an Expedited Review of initial
    applications, amendments, renewals and serious
    adverse events
  • In general, describe the standard wording
    requirements for consent forms
  • Design a consent form using the FH standard
    template, and
  • Describe the fundamental differences in consent
    forms used for genetic studies and incompetent
    subjects.

3
(No Transcript)
4
But first, some background
5
WHO IS THE FH REB?Meets TCPS Health Canada
quorum requirements
  • Research Ethics Co-ordinator
  • Rosa Haywood
  • Ex-officio
  • Susan Chunick

6
WHO IS THE FH REB?Meets TCPS Health Canada
quorum requirements
  • Co-Chairs
  • Dr. Allan Belzberg SMH nuclear medicine
  • Dr. Marc Foulkes RCH anaesthesia
  • Clinical Experts
  • Bob Gillies, Ph.D SMH Pharmacy
  • Michael Vince, Ph.D retired FH biochemist
  • Dr. Arthur Friesen RCH Cardiologist
  • Arun Chockinglam, Ph.D SFU health services
    researcher

7
WHO IS THE FH REB?
  • Ethicist
  • Lindsay Meredith, Ph.D SFU
  • Statistician
  • Michael Wasdell, M.A. FH Research Administration
    and Development
  • Legal Representation non-FH
  • Ms. Camille Ciarniello LLB
  • Ms. Mara Stickland LLB
  • Lay member
  • Mrs. Nancy Magnee

8
WHAT IS THE SCOPE OF THE FHREB?
  • Research versus Evaluation

9
WHAT IS THE SCOPE OF THE FHREB?
  • 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.
  • Generalizable means knowledge that can be
    applied beyond the specific situation in which
    the work was conducted. Government of Canada.
    Refinements to the Proportionate Approach to
    Research Ethics Review in the TCPS, December
    2005

10
WHAT IS THE SCOPE OF THE FHREB?
  • Clinical Research
  • Includes research on animal models of human
    disease, clinical trials and other therapeutic
    interventions.
  • E.g. Testing the effectiveness of a new
    medication, a new rehabilitation treatment, a new
    pharmacy intervention, a new assessment tool

11
WHAT IS THE SCOPE OF THE FHREB?
  • Health Services/Systems Research
  • Multidisciplinary field
  • Aims to improve the efficiency and effectiveness
    of health professionals and the health care
    system.
  • Interventions at the level of practice and
    policy.
  • i.e. Evaluating a new intervention for improving
    patient flow.

12
WHAT IS THE SCOPE OF THE FHREB?
  • Population Health Research
  • Studies the impact of social and environmental
    factors on the health of populations/subpopulation
    s.
  • May examine social, cultural, environmental,
    occupational, and economic factors that determine
    health status.
  • Research data is used to identify areas where the
    health of a population can be improved.
  • i.e. Statistics Canada Community Health Survey.

13
WHAT IS THE SCOPE OF THE FHREB?
  • 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)

14
WHAT IS THE SCOPE OF THE FHREB?
  • Clarification of Ethical Review Requirements for
    Studies Involving Quality Assurance/Improvement,
    Program Evaluation, Operational Review and
    Product Evaluation
  • Approved by FH Executive Committee 2005/09/27

15
(No Transcript)
16
WHAT IS THE SCOPE OF THE FHREB?
  • Degree of FHREB Oversight in Proportion to
    Probability Magnitude of the Risk of Harms
  • Continuum of risk of harms can encompass the
    following determinants, e.g.
  • Invasiveness of intervention
  • Intrusiveness of data collection
  • Toxicity of intervention
  • Vulnerability of subjects
  • Sensitivity of information
  • Availability of risk mitigation strategies
  • Potential for conflict of interest i.e.
    industry sponsored

17
WHAT IS THE SCOPE OF THE FHREB?
  • Degree of FHREB Oversight in Proportion to
    Probability Magnitude of the Risk of Harms
  • Harms can include potential for
  • Physical injury/adverse event
  • Emotional or psychological injury
  • Social harm e.g. loss of insurance,
    employability
  • Financial harm
  • Breach of confidentiality
  • Loss of trust

18
WHAT IS THE SCOPE OF THE FHREB?
  • Degree of FHREB Oversight in Proportion to
    Probability Magnitude of the Risk of Harms
  • Expedited/Delegated Review for minimal risk
    studies.
  • Review delegated to FHREB co-Chair
  • FHREB co-Chair may refer to FHREB
  • Expedited versus Speedy

19
WHAT IS THE SCOPE OF THE FHREB?
  • Expedited Review for Minimal Risk Studies
    involving Vulnerable Subjects
  • Secondary Sources of Data Retrospective Chart
    review no consent required
  • Prospective Observational research Primary
    sources of data consent required

20
WHAT IS THE SCOPE OF THE FHREB?
  • Ethics Review and Approval BEFORE any contact
    with prospective subjects and/or data collection
    begins.

21
WHAT IS THE SCOPE OF THE FHREB?
  • Ethics Review and Approval UNTIL ALL data
    collection is completed.

22
Obligations of the FHREB
  • The Ethical Review Process is transparent and
    meets obligations according to international and
    national guidelines and legislation, provincial
    legislation and FH policies.
  • Researchers meet their obligations
  • according to international and national
    guidelines and legislation, provincial
    legislation and FH policies.

23
Obligations of the FHREB
  • What are the main FHREB obligations?
  • To protect human subjects
  • To preserve rights of human subjects

24
TCPS and Health Canada
  • ALL CANADIAN RESEARCH
  • TCPS The Tri-council Policy Statement on
    Ethical Conduct for Research Involving Human
    Subjects 1998 updates
  • http//www.pre.ethics.gc.ca/english/policystateme
    nt/policystatement.cfm
  • ALL CANADIAN CLINICAL DRUG/DEVICE TRIALS Health
    Canada Food and Drug Act Regulations
  • http//www.hc-sc.gc.ca/dhp-mps/prodpharma/legisla
    tion/acts-lois/index_e.html

25
Why Should We Worry About Protecting Human
Subjects?
  • The Recent Past
  • 2002 Ryan Lucio Childrens Hospital-Ottawa
  • 2001 Ellen Roche Johns Hopkins
  • 1999 Jessie Gelsinger U Penn
  • 1998 Hoiyan Wan U Roch
  • 1997-2001 Nancy Olivieri U of Toronto

26
The Distant Past
  • Nuremberg NAZI Doctors Trial
  • PHS Syphilis Study Tuskegee, Tennessee

27
Governing Legislation, Guidelines
  • 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. Agencies
  • 2001 Association of American Universities
    Conflict of

    Interest Guidelines

28
Cont Governing Legislation, Guidelines
  • 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
  • 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)

29
FH POLICIES AND GUIDANCES
  • 2005 April 12 Revised 2007 Jan
  • Ethical Conduct of Research Other Subjects
    Involving Human Subjects
  • 2005 June 21 Revised 2007 Jan
  • FH Research
  • The Collection, Use and Disclosure of Personal
    Information for Research-related Purposes
  • The Provision of Research-related Services to
    Non-Researchers
  • 2007 January Research Integrity Policy
  • FHREB GUIDANCE NOTES and POLICIES

30
Some Definitions
  • APPLICATION FORMS http//www.fraserhealth.ca/Initi
    atives/Research/FormsandTemplates.htm
  • Initial Application one application regardless
    of study type
  • Amendment Application for Previously Approved
    Research Changes to a protocol
  • genetic testing, new genetic tests or tissue
    banking where genetic testing may or will be
    performed
  • open label extension phase following a randomized
    trial
  • emergency amendments
  • change in drug dosing/duration of
    exposure/intervention
  • decrease in monitoring esp. clinical trials,
  • change in recruitment technique
  • change in experimental procedure or study
    population.

31
Some Definitions
  • APPLICATION FORMS http//www.fraserhealth.ca/Initi
    atives/Research/FormsandTemplates.htm
  • Request for Annual Renewal Form
  • Close-out Forms Non-clinical Clinical
  • Clinical Trial specific
  • Serious Adverse Events Forms Local
    International
  • Protocol Deviation

32
Some Definitions
  • RESEARCHER RESPONSE FORM http//www.fraserhealth.c
    a/Initiatives/Research/FormsandTemplates.htm
  • Revision of Research Studies for Removal of
    Modifications Required or Deferred Status
  • IF Modifications Required
  • Does not require Full Board review
  • Reviewed approved under Expedited Review
  • IF Study Deferred
  • Requires resubmission to Full Board for review

33
FEES
  • 2500 fee required for studies that are
    industry-sponsored ONLY
  • Grant funded and unfunded studies are exempt

34
The Ethical Review Process
Full Board Review Greater Risk Expedited Review Minimal Risk
Schedule All board members meet 2nd Tuesday of every monthhttp//www.fraserhealth.ca/Initiatives/Research/Ethics/EthicsCustomerService.htmMeeting Schedule Reviews conducted weekly by one of the FHREB co-chairs
Meeting Agenda New applications, Amendments renewals that require FB review regulated clinical trials only or co-Chair refers from Expedited Review Researchers responses to Deferral memo Policy, procedures, education Review Agenda New applications, Amendments renewals, Serious adverse events, Protocol deviations Researchers responses to modifications memo
Application Process Mail in 12 copies of all documents 2 weeks before meeting date to Rosa Haywood Pre-review conducted Documents sent to members 1 week before meeting Application Process Email the documents i.e. one copy only in at any time to Rosa Haywood Signature page may be faxed Pre-review conducted prior to review Documents received 1 business day before the review date will be reviewed

35
The Ethical Review Process
Full Board Review Greater Risk Expedited Review Minimal Risk
Meeting Process Discuss approve protocol, Investigators Brochure, consent forms, questionnaires, recruitment notices, other documentation Input from clinical experts, lawyer, ethicist, lay person. Review Process Co-chair reviews protocol, consent forms, questionnaires, recruitment notices, other documentation Summary document sent to FHREB with decision for approval.
Decisions Modifications Required 92 Deferral 8 Deferral with External Peer Review Decisions Approval 52 Modifications Required 48 Referral to Full Board
Decision Criteria Study Deferred if research design/statistical design/sample size incapable of answering research question, if information re risks/risk mitigation is insufficient. Modifications Required if clarifications required are not substantive in nature, i.e. application/consent form inconsistencies /or inaccuracies. External Peer Review if additional scientific expertise required. Decision Criteria Modifications Required if research design/statistical design/sample size incapable of answering research question. Modifications Required if clarifications required that are not substantive in nature, i.e. application/consent form inconsistencies /or inaccuracies. Referral to Full Board if additional expertise required.

36
The Ethical Review Process
Full Board Review Greater Risk Expedited Review Minimal Risk
Timelines business days Email of Decisions 5 days 92 Meeting to Approval median 39.5 days Timelines business days Email of Decisions 3 days Review to Approval median 4.5 days



37
Full Board Review
DR. FRANK ERVIN IMPROVE IT - Improved Reduction of Outcomes Vytorin Efficacy International Trial A multicentre, double-blind, randomized study to establish the clinical benefits and safety of Vytorin (Ezetimibe/Simvastin tablet) vs. Simvastin monotherapy in high-risk ACUITY - A Randomized Comparison of Angiomax (bivalirudin) vs. Heparin (unfractionated heparin or enoxaparin) in Patients Undergoing Early Invasive Management for Acute Coronary Syndrome Without ST-Segment Elevation DR. GERALD SIMKUS RCH PLATO - A Randomized, Double-Blind, Parallel Group, Phase 3, Efficacy and Safety Study of AZD6140 Compared with Clopidogrel for Prevention of Vascular Events in Patients with Non-ST or ST Elevation Acute Coronary syndrome (ACS) DR. SEAN KEENAN RCH DECRA - Multi-Centre Prospective Randomised Trial of Early Decompressive Craniectomy in Patients with Severe Brain Injury DR. GALINA VOROBEYCHIK BH A 12-month, Double-blind, Randomized, Multicenter, Active-Controlled, Parellel-Group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY20) Administered Orally Once Daily Versus Interferon b-1a (Avonex) Administered i.m. Once Weekly
38
Expedited Review Minimal Risk
  • DR. DANTE MANYARI
  • Canadian Congestive Heart Failure Network
    National Registry Database
  • DR. SONIA SINGH
  • Mechanism of Falls in the Elderly
  • HOLLY KENNEDY-SYMONDS
  • Evaluation of Novel Balistocardiograph Analysis
    Methods
  • JOAN ARNOLD
  • Consumption of a Liquid Meal Replacement in
    Hospitalized Patients An Anonymous
    Observational Study

39
SUBMISSION PROCESS
  • Refer to Guidance Notes for specific guidance
    related to the application form at
  • http//www.fraserhealth.ca/Initiatives/Research/Fo
    rmsandTemplates.htm

40
Initial Application Requirements Problem Areas
  • APPLICATION FORM FOR INITIAL ETHICAL REVIEW
  • Application form information must be consistent
    with protocol, subject consent form(s) other
    documentation
  • Pages 1 2
  • Primarily administrative
  • Signatures must be obtained BEFORE review.
  • Document version and dates must be included.
  • New requirement Clinical Trial Registration
  • Contact information

41
Application Requirements Problem Areas
  • Box 20 Recruitment methods
  • see Guidance Note 17 and 18
  • Box 22 Description of Procedures
  • - related to Box 7 use of the DAR form
    Department Agreement for Providing Research
    Related Services
  • Box 25 Risks
  • - See Guidance Note 22
  • - use template provided
  • -quantify all measurable risks
  • -can include psychological and social risks of
    harm

42
Application Requirements Problem Areas
  • Box 31 Confidentiality Guidance Note 28
  • 28a. Will the data be completely anonymized
    (i.e. the data becomes anonymous because it is
    completely stripped of all identifiers such that
    there is no possibility of re-linking data to the
    subjects identity)? Yes No
  • 28b. If NO, will the data be de-identified by
    using a unique code ONLY before leaving the FH
    site? Yes No
  • 28c. If YES, describe how the data will be
    de-identified.
  • 28d. If NO, describe what identifier(s) will be
    used. E.g. DOB
  • 28e. Clarify where the data will reside. Will it
    be kept at FH or sent elsewhere. Specify
    location if sent offsite.

43
Application Requirements Problem Areas
  • Box 35 Competency, Consent and Assent
  • See Guidance Note 35 and Policy 17
  • No legal age of consent for research in B.C.
  • Competency TCPS states that competence
    (capacity to consent) consists in "the ability of
    prospective subjects to give informed consent in
    accord with their own fundamental values. It
    involves the ability to understand and to
    appreciate the potential consequences of a
    decision..."
  • Appreciation assumes adequately developed adult
    capacities for forming and revising personal
    values.
  • Understanding ability to discern in significant
    measure the nature of the research and the
    consequences of choosing/forgoing participation
    in it.

44
Application Requirements Problem Areas
  • Children under 7
  • parental/legally authorized rep consent
  • Children between 7 and 13
  • assent form
  • parental/legally authorized rep consent form
  • Children 14 and older
  • parental/legally authorized rep consent
  • statement of signed assent in the consent

45
ETHICAL PRINCIPLES REB Obligations
  • Pre-study implementation Study Value
  • Subject recruitment
  • Consenting Process
  • Study Implementation
  • Data Analysis

46
ETHICAL PRINCIPLES REB Obligations
  • Study Value
  • Ethical Principle Beneficence
  • Maximize possible benefits and minimize possible
    harms

47
ETHICAL PRINCIPLES REB Decisions
  • Does the science have value??
  • For experimental research Is there clinical
    equipoise?
  • Literature review
  • Testable hypothesis/endpoints/outcomes specified
  • Placebo justification
  • Adequacy of peer review (FB only)
  • Sufficient sample size (power)
  • Do benefits outweigh possible risks?

48
ETHICAL PRINCIPLES REB Decisions
  • Recruitment
  • Ethical Principle
  • Distributive Justice
  • fairness in distribution of the risk of harms
    and benefits among the population

49
ETHICAL PRINCIPLES REB Decisions
  • Inclusion Criteria
  • Do inclusion criteria unfairly put one group at
    risk of harm versus other potential subjects?
  • Exclusion Criteria
  • Do exclusion criteria provide valid reasons for
    excluding subjects based on for e.g. culture,
    religion, language, race, sex, age, mental or
    physical capacity?

50
ETHICAL PRINCIPLES REB Decisions
  • Recruitment
  • Ethical Principle Respect
  • treat individuals as autonomous agents

51
ETHICAL PRINCIPLES REB Decisions
  • Subject Identification
  • Protect privacy FOIPPA
  • Section 35 prohibits using personal information
    for contact if collected for a non-research
    purpose, i.e. medical records
  • Initial Contact
  • If Principal Investigator is primary care-giver,
    ensure non-coercive contact
  • No inducements subjects must not be encouraged
    to trade incentives for risks

52
ETHICAL PRINCIPLES REB Decisions
  • Obtaining Consent
  • 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 subjects participation.
  • Time 2002 April 22

53
The Consent Form
  • Three basic elements
  • Complete and Accurate Information
  • Readable
  • -well organized
  • -lay terms
  • -grade 7 level
  • 3. Voluntary
  • avoid coercion and undue influence
  • FH REB Consent Form Templates at
    http//www.fraserhealth.ca/Initiatives/Research/Et
    hics/EthicsInitialApplication.htmConsent
  • Main Consent Form
  • Optional Research, e.g. genetic testing
  • Assent Form
  • Consent to Screen
  • Consent to Contact

54
ETHICAL PRINCIPLES REB Decisions
  • Consenting to Participate
  • Ethical Principle Respect for free and informed
    consent throughout the study
  • treat individuals as autonomous agents

55
ETHICAL PRINCIPLES REB Decisions
  • Ensure Non-coercive Consent Process
  • Time to consent gt 24 hours
  • CF Voluntary decision
  • CF Informed decision
  • Opportunity to ask questions
  • Full disclosure of all information in lay terms
    including alternatives if therapy
  • Opportunity to withdraw at any time

56
ETHICAL PRINCIPLES REB Decisions
  • During the Study Ongoing Consent
  • Ethical Principle
  • Non-maleficence
  • duty to avoid, prevent, or minimize harms to
    others

57
ETHICAL PRINCIPLES REB Decisions
  • Risk of Harms
  • Full Board Review of Clinical Trials
  • The risk of harms to the subject of
    participating in the study has been evaluated by
    the FHREB. The FHREB agrees that the foreseeable
    harms to this subject population do not outweigh
    the anticipated benefits to society and that the
    foreseeable harms are documented in the written
    consent form compared to the review of the
    Investigators Brochure for this study. In
    addition, the FHREB agrees that the risk
    management strategies described in the consent
    form to prevent, mitigate and/or manage the
    occurrence of harms are reasonable and reflect
    current medical practice.

58
ETHICAL PRINCIPLES REB Decisions
  • Minimize Harms
  • Provide stopping rules rescue medication
  • CF Emergency contact information
  • CF New information re harms
  • CF Compensation for research-related harms
  • CF Legal rights
  • CF How to withdraw
  • CF Subject rights

59
ETHICAL PRINCIPLES REB Decisions
  • Data Analysis
  • Ethical Principle Respect
  • do not harm

60
ETHICAL PRINCIPLES REB Decisions
  • Is collection of personal data limited to
    essential information for study purposes?
  • Is consent obtained for collection/use of data?
  • Are subjects informed about possible uses of
    research data?
  • How is confidentiality of subject data
    maintained?
  • - Removal of personal identifiers, i.e. initials,
    name, PHN, etc.
  • - Secure storage of data preventing breach of
    confidentiality

61
Consent Form Review
  • MODIFICATIONS REQUIRED MEMORANDUM
  • TO Dr. Wendy Gordon
  • Pharmacy Department, Royal Columbian Hospital
  • FROM Dr. Marc Foulkes
  • Co-Chair, Fraser Health Research Ethics Board
  • DATE 2007 September 11
  • RE FHREB 2007-070
  • National, Prospective, Observational Cohort
    Study of Venous Thromboembolism Management with
    the Low Molecular Weight Heparin, Enoxaparin, in
    the Outpatient Setting in Canada
  • Research Protocol Dated 2007 March 22.
    Application Form Dated 2007 August 27. Consent
    Form Version 1 2007 August 27.

62
Consent Form Review
  • If health records are to be accessed this should
    be noted in the consent form.
  • Page 1
  • Under Investigator Add Principal before
    Investigator and identify the hospital site,
    i.e. Royal Columbian Hospital.
  • Under Background Clarify that the subject is
    also being invited to participate because they
    are being prescribed Enoxaparin for the initial
    treatment of VTE and that treatment will be at
    home.
  • 1st paragraph Use lay terms for prospective,
    observational. Briefly explain why this study
    is important.
  • Include the following wording required for
    industry-sponsored studies under a separate
    heading as follows Who is Conducting the Study?
    This consent document is to enable participation
    in a clinical research protocol. The protocol
    has been sponsored by sanofi-aventis Canada Inc.
    The physicians and other health care personnel,
    who are conducting this research, will receive
    funds or other payment in return for the work
    required in doing clinical research. These
    funds, from the sponsoring organization, are
    associated with obligations, defined in a signed
    contractual agreement. Researchers must endeavor
    to serve both the interests of the
    patient/subject and abide by contractual
    obligations with the sponsor.
  • Move the 2nd, 3rd and 4th paragraphs beginning
    This study is non-interventional . to the
    section What will Happen During the Study? .
  • 2nd paragraph Use lay term for
    non-interventional.
  • 3rd paragraph. Use lay terms for concomitant,
    anti-platelet agents or NSAIDS.

63
Consent Form Review
  • Page 2
  • Include a section on Who Can Participate in this
    Study? and delete If you correspond to the
    population.in this study, as the inclusion
    criteria should be specific.
  • Enoxaparin should be named as the LMWH used.
  • Under What Will Happen in the Study State
    explicitly how the data collection will occur
  • Is this data collection over and above the
    collection of routine information? The
    application form box 24 b states that the time
    for subject involvement over and above routine
    care will be 1 hour. Clarify this in the
    consent.
  • Does the subject have to return for a separate
    visit for the data collection? Clarify.
  • Does the subject have to respond to questions
    that are different from what would be routinely
    asked? Clarify.
  • Explain how the follow up data will be collected,
    i.e. by telephone?, by whom?
  • The protocol, p. 17 states that a contact person
    will be identified in the baseline CRF. The
    consent form must explain that a contact name for
    future follow up will be required.
  • Put the paragraph beginning No direct benefit.
    under a separate heading titled What are the
    Benefits of Participating?
  • Include a separate paragraph that explains
    possible risks if any titled What Are The
    Possible Harms And Side Effects Of
    Participating?

64
Consent Form Review
  • Page 2 continued
  • Under Is My Participation Voluntary? 1st
    paragraph
  • Clarify that the subject can contact the
    investigator by any means convenient to them to
    explain that they are withdrawing. 2nd paragraph
  • Explain under what circumstances the subject may
    be withdrawn from the study.
  • Remove although for your own safety.to do
    this.
  • Under Confidentiality, last sentence Delete
    and DOB as this has not been identified as an
    identifier in the application form.

65
Consent Form Review
  • Page 3
  • Under Funding Re-title this section as What
    will this Study Cost Me? Explain if the subject
    is required to present receipts for payment.
  • 2nd paragraph Delete this paragraph as the
    required information is included in the new
    section Who is Conducting the Study.
  • Add the following standard wording regarding
    legal rights You do not waive any of your legal
    rights to compensation by signing this consent
    form.
  • Under Further Information your physician Dr.
    Wendy Gordon should be a more defined role.
    Clarify her actual role in this study.
  • Please use consistent wording with respect to
    study doctor, your doctor, your physician,
    investigator (p. 4).
  • Clarify who is actually collecting the data is
    it Dr. Wendy Gordon or the subjects actual
    physician at the clinic?
  • Also, please note that on page 4, Dr. Gordon is
    identified as a physician. According to her C.V.
    she has a doctor of pharmacy degree. Please
    delete physician.

66
Consent Form Review
  • Page 4
  • Under 1 research team members should be
    defined.
  • Under 6 Delete independent ethics .board
    and use the Fraser Health Research Ethics
    Board.
  • A word is missing in other than that information
    protected by law.
  • Clarify if medical records means the
    research-related records, as the review of
    medical records has not been mentioned previously
    in the consent form.
  • Please clarify if this is part of the data
    collection and if so, specify review of the
    subjects medical records for collection of data
    in the section on What Will Happen in the Study?
    or foreign regulatory authorities should be
    removed.
  • Under 7 1st sentence Delete and for
    treatment in this study as there is no study
    treatment taking place.
  • 3rd sentence Delete complete sentence, again as
    there is no treatment for research occurring in
    this study.
  • Add the following items to the list on page 5
  • I understand that all of the information
    collected will be kept confidential and that the
    result will only be used for scientific
    objectives.
  • I understand that I am not waiving any of my
    legal rights as a result of signing this consent
    form.
  • Add a line for the signature and printed name of
    a witness. The witness signature is an
    attestation that the subject actually signed the
    consent form.
  • Add a signature and printed name line for the
    principal investigator.

67
Consent Form Review
  • The FHREB mandated changes as outlined above must
    be completed within six months otherwise a
    complete resubmission will be required. The form
    for reply to this request is attached. Revisions
    of the consent should be clearly marked by using
    highlighted text.
  • Please email the response directly to Rosa
    Haywood at rosa.haywood_at_fraserhealth.ca
  • Ensure that the response to this letter and all
    subsequent documentation clearly utilizes the
    FHREB identification number e.g. 2007-010 and
    is signed by the researcher.
  • Recruitment of research subjects MUST not
    commence until the response has been reviewed and
    approved by the co-Chair under the Expedited
    Review process, and the certificate issued.
  • The FH REB Board membership consists of Dr. A.
    Belzberg Co-Chair (Physician, Nuclear Medicine),
    Dr. M.R. Foulkes Co-Chair (Physician,
    Anesthesia), Dr. Bob Gillies (Doctor of
    Pharmacy), Dr. Arthur Friesen (Cardiologist),
    Prof. Lindsay Meredith (Ethicist), Ms. N. Magnee
    (Lay Member), Dr. M. Vince (Biochemist, Clinical
    Laboratory Scientist), M. Wasdell (Statistician),
    and alternating Ms. C. Ciarniello and Ms. M.
    Strickland (Lawyers with Expertise in Health
    Care).
  • Dr. Marc Foulkes, Co-Chair
  • Fraser Health Research Ethics Board
  • MF/rh
  • While every effort has been taken to ensure the
    accuracy of this document, the signee has not
    reviewed this copy and an electronic signature
    has been used if you note any errors please
    contact the Research Office as soon as possible.

68
FH RESEARCH REVIEW PROCESS
Application completed submitted to admin.
supervisor for signature
PI/designate submits Appln to FH Research for
Full Board Review
PI/designate submits Appln to FH Research for
Expedited Review
Email
Mail
Appln screened for completeness
No
No
1 business day
Yes
Appln consent form pre-reviewed
5 business days
10 business days
Full Board Review
FHREB co-Chair conducts review
Study approved?
Yes
No
5 business days
FHREB approves Expedited Review
Request for Modifications sent to PI
Deferral Notice sent to PI
PI responds within 6 months
PI responds within 6 months
5 business days
FHREB co-Chair conducts review of response
Study Approved?
No
5 business days
Yes
FH Research issues Certificate of Ethical
Approval to PI
Has all of the required documentation been
submitted?
  • If applicable, PI submits to FH Research
  • Signed DAR Form
  • Contract for clinical trial research
  • Health Canada No Objection Letter

Yes
FH Research issues Letter of Authorization to
Conduct Research
69
EXPEDITED REVIEW PROCESS Minimal Risk
Applications, Amendments, Renewals U.S. regs
apply to clinical trials
Application completed submitted to admin.
supervisor for signature
PI/designate submits appln to FH Research for
Expedited Review
Email
  • Expedited Renewal Applications
  • - Notice of Renewal sent to PI 4 weeks prior to
    due date
  • - PI to send Renewal Appln 2 weeks prior to due
    date
  • NO NEW SUBJECTS CAN BE ENROLLED UNTIL
  • RENEWAL CERTIFICATE IS ISSUED

Appln screened for completeness
No
1 business day
Yes
5 business days
FHREB co-Chair conducts review
Application approved?
No
Yes
5 business days
FHREB approves Expedited Review
Request for Modifications sent to PI
PI responds within 6 months
5 business days
FHREB co-Chair conducts review of response
No
Application Approved?
5 business days
Yes
FH Research issues Certificate Approval to PI
For New Applications ONLY Has all of the
required documentation been submitted?
  • If applicable, PI submits to FH Research
  • Signed DAR Form

Yes
FH Research issues Letter of Authorization to
Conduct Research
70
Last But Not Least
  • The Letter of Authorization to Conduct Research
  • FHREB initial approval
  • - consent
  • Health Canada Letter of No Objection
  • Clinical Trial Agreement
  • Department Agreement for Providing
    Research-related Services
  • Clinical Trial Registration
  • Grant Agreement start date

71
Last but not least
  • HAVE FUN!

72
  • THANK YOU !!!
  • Susan Chunick
  • 604-587-4681
  • Rosa Haywood
  • 604-587-4436
About PowerShow.com