Section I:

VCU Human Research Protection Program Overview

WPP #: I-1

Title 1:

VCU IRB WPP Document Control

Effective Date:

5-28-14

Revision History:

06-07-04; 12-06-04; 04-28-06; 06-21-06; 11-1-06; 6-30-07; 9-1-09; 1-19-14; 1-28-14

Policy Statement

The VCU IRB Written Policies and Procedures (WPPs) describe the Human Research Protection Program (HRP) at VCU and outline policy requirements, procedures, and guidance for Institutional Review Board (IRB) approval of research and for study conduct. The WPPs make every effort to incorporate critical regulatory requirements, as well as to offer guidance. Deviations from the WPPs are permitted if necessary to comply with regulations, meet ethical standards of reasonableness, and/or serve in the best interest of a research subject.

Procedures

  1. WPP Approval:

    The official version of the WPPs is a dynamic, searchable electronic tool located on the VCU IRB webpage. Official institutional approval occurs internally prior to posting on the VCU IRB website. Approvals are documented by official posting to the VCU IRB website. Approvals necessary include:

    1. Director of the Office of Research Subjects Protection
    2. Chair of the VCU IRB Leadership and Enhancement Committee (ILEC) - approval required for outlined procedural points impacting either investigator responsibilities or IRB member responsibilities and procedures (subject to review by the full ILEC).
  2. Standard Format:

    This WPP (I-1) serves as a sample format for all other WPPs, which typically include the following features:

    1. Header:
      1. "Section": The name of the section heading within the WPP document and section Roman numeral.
      2. "WPP #": The number is a combination of the Section Roman numeral, a hyphen, and the Title placement within that section (e.g. Title 1 in Section I is written as WPP#: I-1).
      3. "Title": A concise description of the subject of the WPP and number of title.
      4. "Effective Date": This date indicates the date on which the content of this WPP became official/effective. This date corresponds (as closely as possible) to posting to the website.
      5. "Revision History": These dates record the history of revisions to this WPP. The last date to appear is the date of the last revision and must match or be prior to the effective date.
      6. "Approvals": WPPs with an effective date prior to 6-30-07 include signatory approvals. After 6-30-07, approvals are granted by the Director of the ORSP in an internal process, prior to posting to the web.
    2. Content Format may include:
      1. "Policy Statement": This section states describes the specific policy requirements addressed by the WPP.
      2. "Description": This section provides an overview of the WPP and describes related requirements and/or guidance information.
      3. “Procedures”: This section describes specific procedures that should be carried out.
      4. "Reference": This section lists any reference materials that may be consulted for additional information. This section may be completed as 'none listed', if appropriate.
  3. Maintenance of WPPs:

    IRB members, investigators, institutional officials, and others may contact the Office for Research Subject Protections (ORSP to make comments or suggest changes to the procedures followed by the VCU IRB. Involvement in the maintenance of these WPPs is strongly encouraged.

    When a change to the WPPs relates directly to IRB Panel procedures, the Chair of the VCU IRB Leadership and Enhancement Committee (ILEC) will be consulted (regarding the impending change). The ILEC will review the draft change prior to approval, as appropriate. All changes to the WPPs are evaluated to determine if a new effective date and educational outreach is needed.

    The ORSP performs a review of WPP material on an ongoing basis.

  4. Distribution and Education for New and Revised WPPs:

    The IRB is educated regarding new or revised WPPs by way of IRB meeting discussions, programmatic and electronic communication, and ILEC Meetings. IRB members and chairs/vice chairs are notified once new or revised policies are approved and posted to the website as part of the WPPs. The larger research community is notified of updates via listserv and blog postings when relevant.

References

None listed