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GUIDANCE NOTES FOR NEW APPLICATIONS FOR CLINICAL ETHICAL REVIEW

By Dorothy Martin,2014-05-19 13:15
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GUIDANCE NOTES FOR NEW APPLICATIONS FOR CLINICAL ETHICAL REVIEW

    UBC Research Ethics Boards Guidance Notes for Application for Renewal of a Previously Approved Project __________________________________________________________________________________________________________________

    GUIDANCE NOTES FOR APPLICATION FOR

    RENEWAL OF A PREVIOUSLY APPROVED PROJECT

TABLE OF CONTENTS

    ; INTRODUCTION

    ; GUIDANCE NOTE #1: WHAT RESEARCHERS NEED TO KNOW TO SUBMIT A REQUEST

    FOR RENEWAL

    ; GUIDANCE NOTE #2: SUBMISSION CRITERIA FOR FULL BOARD or EXPEDITED

    APPROVAL

    ; GUIDANCE NOTE #3: REQUIRED DOCUMENTATION

    ; GUIDANCE NOTE #4: CONTACT PERSON

    ; GUIDANCE NOTE #5: SUMMARY OF STUDY PROGRESS

    ; GUIDANCE NOTE #6: SUMMARY OF SERIOUS AND UNEXPECTED ADVERSE EVENTS

INTRODUCTION

The following notes, which comprise some of the UBC Research Ethics Boards standard operating procedures

    and policies, are intended to ensure that the applicant has the necessary information to be able to complete the

    Annual Renewal of a previously approved project correctly.

The UBC Research Ethics Board (REB) policies/procedures correspond to, and therefore comply with, the Tri-

    Council Policy Statement (TCPS) on „Ethical Conduct for Research Involving Humans‟, specifically Article 1.13,

    which states: “Normally, continuing review should consist of at least the submission of a succinct annual status report to the REB”.

In addition, the ICH Good Clinical Practice Guidelines state in Article 3.1.4: “The IRB/IEC should conduct

    continuing review of each ongoing trial at intervals appropriate to the degree of risk to human participants,

    but at least once per year”.

    Both the TCPS and the ICH GCP guidelines have their origin in the ethical principles that were developed in the Declaration of Helsinki. The UBC REBs operate under the authority of the UBC Policy #89: Research and Other

    Studies Involving Human Subjects.

These Guidance Notes (GNs) are not meant to be a substitute. Please refer to the original documents for

    complete information.

    GUIDANCE NOTE #1: WHAT RESEARCHERS NEED TO KNOW TO SUBMIT A REQUEST FOR RENEWAL

1.1 Obligations of the Principal Investigator

    The Principal Investigator is responsible for understanding and adhering to the TCPS and other relevant guidelines.

1.2 Current REB Policies on Consent Form Requirements

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UBC Research Ethics Boards Guidance Notes for Application for Renewal of a Previously Approved Project __________________________________________________________________________________________________________________

    The annual review conducted by the REB includes ensuring that any consent forms used in the study under review reflect the current policies of the REB with respect to consent form requirements.

The REB Guidance Notes for the initial application for review include these policies and are available on the CREB

    website.

1.3 Expiry Dates of Studies

The initial REB approval for a research study is for a one-year term only, such that the approval expires on the

    one-year anniversary date of the original approval date. The REB approval for a study must be renewed on an annual basis. Subsequent renewals also expire on the one-year anniversary date of the approval for renewal.

Amendments approved after the initial approval/renewal date also expire at the same time as the initial

    approval/renewal of the study.

See below for clarification regarding particular types of studies.

1.3.1 Studies That Involve Human Subjects

    All clinical research studies that have received initial approval from the REB must be resubmitted to the REB prior to the approval expiry date if:

    1) the research study is open to accrual/enrolment, or;

    2) the research study is closed to accrual/enrolment but the subjects are still participating in research procedures

    that have been specified in the protocol, such as ongoing follow-up.

    Subjects already enrolled in the study may continue to receive the study intervention while the renewal application is processed, even if the initial approval/subsequent renewal has expired as their participation is covered by the initial approval.

    Enrolling new subjects after the expiry date of the initial approval/subsequent renewal can only begin once the application has been approved and a Certificate of Approval: Annual Renewal is issued to the researcher.

1.3.2 Studies That Do Not Involve Subjects

    Studies that do not involve direct subject participation, for example, secondary use of data, must be submitted for renewal up until the point that the data acquisition is completed.

1.3.3 Ongoing Renewal

    Annual renewal of studies may always continue at the request of the investigator. This may occur, if for example, the investigator believes that there may be a future need to obtain more data for a research project.

1.4 Timelines for Submitting Renewal Requests

    The Principal Investigator is responsible for submitting the application for annual renewal to the REB office in a timely manner. Ideally, the REB office should receive the submission at least four weeks before the expiry date of the most recent Certificate of Approval. This will ensure that the Principal Investigator has time to

    respond to any concerns raised by the REB before the approval certificate expires.

1.4.1 Simultaneous Submission of Amendments

    For studies submitted to the UBC Clinical Research Ethics Board (CREB) or Behavioural Research Ethics Board (BREB), amendments may be submitted with, and will be reviewed at the same time as, a request for Annual Renewal, using the separate „Annual Renewal with Amendments to Study‟ form. Do not use the „Annual Renewal‟

    form for amendments.

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    UBC Research Ethics Boards Guidance Notes for Application for Renewal of a Previously Approved Project __________________________________________________________________________________________________________________ For CREB and BREB studies, the Certificate of Annual Renewal will include the approval of any amendments if these were submitted at the same time as the request for annual renewal.

1.5 Notification of Study Completion

Refer to the „Guidance Notes for Notification of Study Closure‟, available on the CREB website.

1.6 Whom To Contact For Assistance

    Questions regarding the preparation of an Annual Renewal submission can be directed to:

BC Cancer Agency Research Ethics Board - (604) 877-6284 or email reb@bccancer.bc.ca

Providence Health Care Research Ethics Board - (604) 682-2344 ext. 63496 or email

    VBearder@providencehealth.bc.ca

Clinical Research Ethics Board - (604) 875-4111 ext.68918 or email creb.rise@ors.ubc.ca

GUIDANCE NOTE #2: SUBMISSION CRITERIA FOR FULL BOARD or EXPEDITED

    APPROVAL

Any request for renewal must be submitted on RISe using the „Annual Renewal‟ form.

2.1 Expedited Approval

    TCPS Article 1.6 stipulates that the REB can delegate the authority for the approval of annual renewals to the Chair (or designate) of the REB when “there has been little or no change in the ongoing investigation”. If this criterion is met, the Chair (or designate) will review the request for approval under the category of „Expedited Review‟.

    The Chair (or designate) can at any time put a request for annual renewal forward to the Full Board.

2.1.1 Timelines for Expedited Review

2.1.1.1 Review

    Renewal applications are reviewed usually on a weekly basis. The time from submission of a renewal application to review will vary according to the volume of submitted renewals as well as amendments.

2.1.1.2 Issuing REB Decisions

    All decisions arising from the review are emailed to the Principal Investigator and the contact person identified in Question #1.2 of the Application Form.

    Certificates of Approval for approved renewal applications are usually issued within one business day from the decision of the Associate Chair. A certificate with digital approval signatures is displayed on the application homepage in RISe, as well as on the Renewal submission, and is the REB‟s official notification of the decision.

Provisos are usually issued within one business day from the decision of the REB.

2.2 Full Board Review

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UBC Research Ethics Boards Guidance Notes for Application for Renewal of a Previously Approved Project __________________________________________________________________________________________________________________

    Some institutions and sponsors may require that the Full Board review their submission for annual renewal. These requirements are described below. If this is the case, ensure that „No‟ is selected in Question #1.1 of the

    Application Form.

2.2.1 Sponsors that Require Full Board Review

    Some sponsors require Full Board Review for renewal. These requirements are described below. For studies that require Full Board Review ensure that „No‟ is selected in Question #1.1 of the Application Form and refer to

    Guidance Note #3 for details on the required documentation.

2.2.1.1 Studies sponsored by the United States Department of Health and Human Services

Studies sponsored by the United States Department of Health and Human Services (DHHS) (e.g. NIH and its

    related Institutes, US Center for Disease Control, etc.) may require Full Board Review under 45 CFR 46.109 (e)

    and 45 CFR 46.110 (Code of Federal Regulations). Refer to Guidance on the Use of Expedited Review

    Procedures for an interpretation of these codes as they apply to studies sponsored by the DHHS.

2.2.1.2 Studies sponsored by other United States federal agencies

Studies that are funded by other American federal agencies (e.g. US Department of Defense) may require Full

    Board Review under 21 CFR 56.110.

2.2.1 Timelines for Full Board Review

2.2.2.1 Review

    Refer to the links on your RISe homepage for the REB meeting schedule and submission deadlines.

2.2.2.2 Issuing REB Decisions

    All decisions arising from the review are emailed to the Principal Investigator and the contact person identified in Question #1.2 of the Application Form.

    Certificates of Approval for approved renewal applications are usually issued within one to three business days from the date of the REB meeting. A certificate with digital approval signatures is displayed on the application homepage in RISe, as well as on the Renewal submission, and is the REB‟s official notification of the decision.

Provisos are usually issued within five business days from the date of the REB meeting.

GUIDANCE NOTE #3: REQUIRED DOCUMENTATION

    For studies submitting consent forms, ensure that the consent form attached on Page 9 of the Application Form is the most recently approved version (check to ensure that the correct version number/date is on every page of the consent form).

    It is not necessary to resubmit the protocol, most recent versions of Investigator Brochures, advertisements, letters of initial contact or questionnaires/tests/interview scripts, if updated since the original approval, provided these have been previously reviewed and are listed in a previously issued Certificate of Approval (i.e. for amendment).

3.1 Exceptions for Studies Closed to Accrual/Enrolment with Subject Follow-up

The current version of the consent form(s) does not have to be submitted if the study has been closed to accrual,

    and subjects are on follow up. Please make this information explicit in the Application Form and state when the study closed its enrolment.

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UBC Research Ethics Boards Guidance Notes for Application for Renewal of a Previously Approved Project __________________________________________________________________________________________________________________

    3.2 Certificate of Annual Renewal

    The approval date on the Certificate(s) of Annual Renewal will be the one-year anniversary of the original approval/subsequent renewal date.

    Industry sponsors/institutions that require renewal at a particular time before the expiry date must submit their application for renewal before this required date.

The Certificate of Annual Renewal will not be backdated for any reason.

    If the request for renewal is approved after the expiry date, the Certificate of Approval will be dated with the date on which the request for renewal was actually approved by the REB.

GUIDANCE NOTE #4: CONTACT PERSON

    All notifications regarding the renewal are emailed only to the Principal Investigator and the contact person specified in Question #1.2 of the Application Form.

GUIDANCE NOTE #5: SUMMARY OF STUDY PROGRESS

    The summary of progress to date should include information on whether subjects are still participating in the research study, especially, when in the case of clinical trials, the trial is closed to enrolment. Remarks about the ability to recruit subjects are also appropriate as is any information about the results from any interim analyses.

GUIDANCE NOTE #6: SUMMARY OF SERIOUS AND UNEXPECTED ADVERSE EVENTS

    The Principal Investigator is responsible for summarizing the impact of any Serious AND Unexpected adverse events either observed throughout the study period or submitted to the Principal Investigator by the sponsor for other sites in multi-centre trials.

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