Section VII:

General Operations

WPP #: VII-3

Title 3:

Records, Minutes and Communications (Combines previous WPPs VII-7 and 8)

Effective Date:

07-01-16

Revision History:

06-20-00; 09-20-01; 06-07-04; 04-30-06; 06-21-06; 02-05-07; 4-22-14; 09-24-14

Policy Statement

ORSP maintains all records in accordance with regulatory requirements and institutional policy. IRB files contain a complete history of all IRB actions related to the review and approval of a protocol, as well as any continuing reviews, modifications, reports of unanticipated problems, subject complaints and reports of serious and continuing noncompliance. All IRB decisions are appropriately documented and communicated to principal investigators and the institution.

Description and Procedures

  1. Minutes:

    Minutes are recorded, undergo quality assurance review and are retained. The content of the minutes are in accordance with federal regulations and institutional policy, as well as these WPPs.

    IRB minutes document:

    1. Voters for each protocol as numbers for, against or abstaining
    2. The basis for requiring changes in research
    3. A written summary of the discussion of controverted issues and their resolution
    4. For initial and continuing review, the approval period.
  2. Records:

    IRB records document determinations required by laws, codes and guidance.

  3. Record Retention:

    The Office for Research Subjects Protections will maintain all records, reports, and other required documents, as specified by regulation and these WPPs. Records relating to a specific research activity shall be maintained for at least 3 years after completion of the research (HHS 45 CFR 46.115(b); FDA 21 CFR 56.115(b); ICH 3.4). If a protocol is cancelled /closed without subject enrollment, IRB records are maintained for at least three years after cancellation/closure.

    In order to allow a reconstruction of a complete history of IRB actions related to the review and approval of the protocol, the IRB records include copies of:

    1. Investigator brochure, if any.
    2. Scientific evaluations, when provided by an entity other than the IRB.
    3. Recruitment materials.
    4. Consent documents.
    5. Progress reports submitted by researchers.
    6. Reports of injuries to participants.
    7. Data and safety monitoring reports, if any.
    8. Significant new findings.
    9. All correspondence between the IRB and researchers.
  4. Inspection of Records:

    The VCU IRB records shall be accessible for inspection and copying by authorized representatives of FDA, the Office for Human Research Protections (OHRP) or other agencies, when appropriate jurisdiction exists, at reasonable times and in a reasonable manner (HHS 45 CFR § 46.115(b); FDA 21 CFR § 56.115(c); ICH § 3.4).

  5. IRB Communications:

    The IRB shall notify investigators and the institution of its decision to approve or disapprove the proposed research activity or of modifications required to secure IRB approval of the research activity. IRB communications will include the decision of the IRB, and will be reviewed by the IRB Chairperson/Vice Chairperson, IRB Directors, or IRB staff. The VCU IRB relies upon the following general methods of communication:

    1. Letters of Approval:

      The IRB shall inform principal investigators in writing of the decision of the VCU IRB to approve any human subject research activity. The Letter of Approval (LOA) will include reference to the VCU IRB number, principal investigator, and title of the project. The LOA will specify Conditions of Approval (COA).

    2. Request for Revisions/Modifications (in order to review for approval):

      The Panel itemizes any changes that must be made to the research as a condition for IRB approval of the proposed research. These changes are communicated to the Principal Investigator. (See VCU IRB WPP# VIII-6 for more information regarding the process for review of revisions and modifications.)

    3. Approval Stamp:

      The VCU IRB Approval Stamp indicates that the document has been reviewed and approved by the VCU IRB and shows the date the approval was granted. The stamp is only used on finalized documents and appears on each page of the consent form. The approval stamp is used for the following types of documents:

      1. Consent documents
      2. Consent form addenda
      3. Assent documents
      4. Information Sheets associated with the consent process (as directed by the VCU IRB Panel)
    4. Letters of Disapproval:

      The IRB shall inform all approved investigators in writing of the decision of the VCU IRB to disapprove any human subject research activity. The Letter of Disapproval (LOD) will include reference to the VCU IRB number, principal investigator, and title of the project. The LOD will specify any necessary actions to securing approval, if applicable.

    5. Reporting to the Institution:

      The IRB shall make copies of agendas, attachments to the agendas, and minutes available to the Vice President for Research and Innovation, who also serves as the Signatory Official for the institution's Federalwide Assurance.

    6. Records for initial and continuing review of research by the expedited procedure include:
      1. The justification for using the expedited procedure
      2. Actions taken by the reviewer
      3. Any findings required by laws, regulations, codes and guidance
    7. Records for initial review of exempt research include:
      1. The justification for exempt determinations

References

45 CFR § 46.115
21 CFR § 56.115
ICH §§ 3.1.2, 3.4
Research Data Ownership, Retention, Access and Security