COTTAGE HEALTH SYSTEM POLICY

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SUBJECT:

IRB Records and Reporting Guidelines

Records and Reporting Guidelines

 

DEPT: IRB POLICY #: 8012.10

 

 

GOAL:

To have written guidelines on IRB procedures as mandated by the Office of Human Research Protection (OHRP) (45 CFR 46.108(a)) and the U.S. Food and Drug Administration (FDA) (21 CFR 56.108 (a)(b)).

 

POLICY:

The CHS IRB shall follow its written guidelines for review and notification procedures, records and reports.

 

PROCEDURE:

I.  IRB Review and Notification Procedures

 

A.  Review by IRB

  1. Review of materials requiring full board review is conducted on a monthly basis.  IRB meetings are held on the third Wednesday of the month, with a quorum being defined as a majority of the membership, including at least one member or alternate member whose primary concerns are in nonscientific areas.
  2. At least one week prior to each meeting all primary members receive a packet containing:
    • the meeting agenda
    • minutes from the prior meeting
    • a summary report of the expedited activities that have taken place since the prior meeting (Expedited Activity Report)
    • member education topic
    • any relevant articles
    • the IRB applications to be reviewed
    • Alternate members receive:
      • a copy of the agenda
      • member education
      • articles sent to primary members.
  3. Full copies of the research protocols are distributed to the IRB Chair and one member (member is designated by the Chair) as part of the application packets.  If available and submitted, a copy of the Investigator’s Brochure is provided to the Chair for review.
  4. Copies of the complete research protocols are available to all IRB members on request during or between meetings.
  5. For studies undergoing continuing review, the IRB members also receive (whenever available) a copy of the sponsor’s Annual/Interim Progress Report to determine/verify that no material changes have occurred in the study since the previous IRB review.
  6. Materials eligible for expedited review are submitted to the IRB Administrator, reviewed by the Administrator and Chair, and are reported to the Full Board in the Expedited Activity Report.

B.  Review by Institution

  1. Research performed within or by representatives of the institution is subject to appropriate review and approval, or disapproval, by officials of the institution. However, institutional approval does not substitute for IRB approval, and the study may not commence until it has been approved by the IRB:
    IRB review
    Operational / Financial review (to determine what services and personnel will be required by the hospital)
    Contractual / Budget (to determine if the study contract and budget meet the requirements of the hospital)
    Scientific review (at the request of the IRB)
  2. The Research Administrator will review the study contract and budget, and will contact other CHS offices/departments as necessary in order to secure institutional approval of the research.
  3. Whenever possible, the Operational / Financial, Contractual / Budget, and Scientific reviews shall be conducted prior to IRB review.  If a study does not secure institutional approval, the IRB will not review the application unless modifications can be made to make the study acceptable to the institution.
  4. In accordance with HHS regulations at 45 CFR 46.112, no other institutional office or official may approve the initiation of a research study that has not been approved by the IRB.

Reporting Procedures

 

The CHS Institutional Official is the individual authorized to assume responsibility for compliance with the research obligations outlined in the Federal Regulations and the Federalwide Assurance on behalf of the institution (see Attachment A).

  • On a monthly basis, the Institutional Official receives the agenda, minutes from the prior meeting, the Expedited Activity Report, educational materials, and the articles sent to IRB members.
  • On an annual basis, the Institutional Official receives the Annual Report to the Medical Staff.
  • The Institutional Official also receives individual audit reports and reports of misconduct or findings associated with IRB-approved research that have a significant impact on the continuation of the study.
  • Any unanticipated problems involving risks to human subjects or others will promptly be reported to the Institutional Official.

The Chief Medical Officer/Vice President of Medical Affairs (CMO / VPMA) has oversight of the Office of Research and its activities (see Attachment A).

  • On a monthly basis, the CMO / VPMA receives the agenda, minutes from the prior meeting, the Expedited Activity Report, educational materials, and the articles sent to IRB members.
  • On an annual basis, the CMO / VPMA receives the Annual Report to the Medical Staff.
  • The CMO/VPMA also receives individual audit reports and reports of misconduct or findings associated with IRB-approved research that have a significant impact on the continuation of the study.
  • Any unanticipated problems involving risks to human subjects or others will promptly be reported to the CMO / VPMA.

The Chief of Staff (COS) appoints the IRB Chair and designates new members. As stated in the By-Laws of the Medical Staff, the IRB reports to the COS in fulfillment of its designation as a Medical Staff Committee.

  • On a monthly basis, the COS receives the minutes from the prior meeting.
  • On an annual basis, the COS receives the Annual Report to the Medical Staff.

The U.S. Food and Drug Administration (FDA) regulates studies conducted by researchers using investigational agents, such as drugs and devices.  The CHS IRB reviews studies under the purview of this agency and will report to it any findings required under the regulations.

  • Any unanticipated problems involving risks to human subjects or others will promptly be reported to the FDA.
  • Any instance of serious or continuing noncompliance with FDA regulations or the requirements or determinations of the IRB will be reported to the agency.
  • Any suspension or termination of IRB approval will promptly be reported.

The Office of Human Research Protection (OHRP) oversees federally funded research.  The CHS IRB reviews studies under the purview of this agency and will report to it any findings required under the regulations.

  • Any unanticipated problems involving risks to human subjects or others will promptly be reported to OHRP.
  • Any instance of serious or continuing noncompliance with OHRP regulations or the requirements or determinations of the IRB will be reported to the agency.
  • Any suspension or termination of IRB approval will promptly be reported.
  • Updated membership rosters will be sent to OHRP, as needed, indicating the composition of the IRB.
  • At 3-year intervals, the IRB will renew its Federalwide Assurance (FWA), IRB registration, and Institutional (organizational) registration, as required by OHRP.

 

II.  IRB Records and Reports

 

A.  IRB Records

1.  Investigator-Specific.  The IRB documents and retains the following Investigator-specific information:

  • The investigator’s curriculum vitae
  • A signed and dated Investigator Agreement
  • A copy of any certificates of completion for research/bioethics training courses
  • A list of investigator education provided by the IRB
  • Copies of all correspondence between the IRB and investigators.

2.  Member-Specific.  The IRB documents and retains the following information for primary members and alternate members:

  • The member’s curriculum vitae
  • Signed and dated IRB Membership Agreement
  • Signed and dated Confidentiality Agreement
  • Official letter of appointment to the IRB from the Chief of Staff
  • A membership roster listing each member and alternate by name, earned degrees, representative capacity, and relationship between the member and the institution.

3.  Study-Specific.  The following information is filed for each active research study and is retained for 6 years after the study is closed:

  • The original IRB application packet, including:
    —  The written responses to the 10 items, consent form, Patient Authorization to Access Protected Health Information form (if not included as a section in the consent form), Experimental Subject’s Bill of Rights form, and the study protocol
    If available and / or applicable these additional items are also received and retained by the IRB:  The investigator’s brochure, recruitment materials, Investigator’s Financial Disclosure Statement, study budget, Supplemental Report on the Inclusion of Women and Minorities in Clinical Research
  • Continuing review applications, including study Progress Reports
  • Reports of all on-site and off-site serious adverse events
  • Changes to the study affecting the consent form, protocol, or otherwise modifying the research in some way
  • Additional advertisements and recruitment materials not reviewed with the original application
  • Any correspondence to be provided to the participants, including statements of significant new findings
  • All correspondence from the sponsor that discusses changes to or updates in the study’s progress, including interim analysis reports
  • Audit reports, including reports from study monitors or outside examiners

4. Retention of IRB Records.  HHS regulations at 45 CFR 46.115(b) require that IRB records be retained for at least 3 years, and records relating to research which is conducted be retained for at least 3 years after completion of the research.  However, in compliance with HIPAA regulations, all study-related materials will be maintained for 6 years after the close of the study.

All IRB records are accessible for inspection and copying by authorized representatives of the Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), or other regulatory organizations at reasonable times and in a reasonable manner.

 

B.  IRB Reports

1. Minutes.  Minutes of IRB meetings are in sufficient detail to show attendence at the meetings; actions taken by the IRB; the vote on these actions; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution.

  • As required by regulations, separate deliberations, actions, and votes for each protocol undergoing initial or continuing review by the convened IRB are documented.
  • The votes documented in the IRB minutes include the number of members voting for, against, and abstaining.  In order to substantiate the continued existence of a quorum, the votes are recorded in the minutes using the following format, as recommended by OHRP:  Vote:  For-10, Opposed – 0, Abstained – 1; Total = 11.
  • The minutes clearly reflect the determinations made by the IRB regarding risks and the approval period (review interval).

2.  Expedited Activity Report.  The Expedited Activity Report is provided to each member at least one week prior to the IRB meeting.  Members are asked to review the activities and pose their questions at the convened meeting or by calling the IRB Administrator prior to the meeting.

 

3.  Audit Reports.  Individual reports of the findings of on-site audits are sent to the investigator, Chief Medical Officer/VPMA, Institutional Official, Compliance Director, and the members of the IRB.  If the IRB finds any aspect of the study, or the actions of the investigator/study staff, to be non-compliant with regulations or institutional policies; and, if it appears that these infractions may compromise the safety of individuals enrolled in the study, the IRB will notify each of the individuals previously listed, in addition to the study sponsor and the appropriate regulating agency.

 

4.  Annual Report to the Medical Staff.  The Annual Report to the Medical Staff is submitted to the IRB Committee, Chief of Staff, Institutional Official, Chief Medical Officer/VPMA, and Medical Staff Executive Committee.  This report summarizes IRB activities over a 12-month period from 10/1 to 9/30 of the following year.  The report provides information on:  the number of total active studies; the number and types of full board reviews and expedited reviews; IRB fees collected; member education topics for the year; new policies developed; a list of audit activities; and any important/noteworthy IRB business which occurred.

 

5.  IRB Activities.  All of the activities conducted by the IRB are documented and retained.  There are written IRB policies and procedures for the IRB.  These policies are reviewed and updated as necessary

 

02/13

 

 

COTTAGE HEALTH SYSTEM POLICY

RECOMMENDED BY: Leilani Price DATE: 3/2003

ORIGINAL POLICY EFFECTIVE DATE: 6/03

APPROVED BY: .. DATE: -

DATE REVISED: 1/05, 8/07, 1/08, 3/11
DATE REVIEWED: 4/06, 1/08