Each university member is expected to report actual or suspected violations of laws, regulations, VCU policies and procedures or other misconduct. Management has a special duty to recognize and report violations.
To provide guidelines for creating, maintaining, and distributing the Written Policies and Procedures (WPPs) for the VCU Institutional Review Board, including descriptions of the VCU Human Research Protection Program.
Description
The WPPs described in this manual cover the operations of the VCU Institutional Review Board (IRB) Panels and staff. These procedures are described in detail to help ensure efficient and consistent functioning among the panels of the VCU IRB and to serve as a resource for investigators. Deviations from the WPPs are permitted if necessary to comply with regolations, meet ethical standards of reasonableness, and/or serve in the best interest of a research subject. These deviations shoold be noted in the research file, with the reason given, and may lead to a suggested change or recommended edit in these WPPs. Every effort is made to incorporate critical regolatory requirements.
Creation of, or revision to current, WPPs:
The official version of the WPPs is a dynamic, searchable electronic tool located on the VCU IRB webpage at http://www.research.vcu.edu/irb/wpp_guide.htm. 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:
Director of the Office of Research Subjects Protection
Director of the Office of Research Compliance and Education
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 foll ILEC).
Standard Format:
This WPP (I-1) serves as a sample format for all other WPPs, which typically include the following features:
Header:
"Section": The name of the section heading within the WPP document and section Roman numeral.
"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).
"Title": A concise description of the subject of the WPP and number of title.
"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.
"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.
"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 ORCE and the Director of the ORSP in an internal process, prior to posting to the web.
Content Format:
"Objective": This section states the intent of the WPP.
"Description": This section provides an overview of the WPP and describes related procedures.
"Responsibility": This section specifically designates who is assigned to perform and/or review the work performed as outlined.
"Reference": This section lists any reference materials that may be consolted for additional information. This section may be completed as 'none listed', if appropriate.
Maintenance of WPPs:
IRB members, investigators, IRB members, institutional officials, and others may contact the Office for Research Subject Protections (ORSP) or the Office of Research Compliance and Education (ORCE) 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 Board procedures, the Chair of the VCU IRB Leadership and Enhancement Committee (ILEC) will be consolted (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 and the ORCE performs a review of WPP material on an ongoing basis.
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. In addition, a reference list is maintained by "Effective Date" on the VCU IRB webpage as part of the WPPs, so that all persons may monitor and review new WPP postings as they occur.
Responsibility
It is the responsibility of the ORSP and ORCE to oversee all WPP content, availability, and distribution.
