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What's New?
 
ORO Comments During VHA Director's Call (05/01/09)
In response to the many questions concerning the new requirments for RCOs and mandatory compliance audits, Dr. Tom Puglisi, ORO Chief Officer, read this attached statement, "Compliance Officer and Research Audit Requirements".
Technical Correction to VHA Handbook 1200.01 (05/01/09)
The Chief Research and Development Officer,
Dr. Joel Kupersmith, issued a memorandum concerning a technical reference to Handbook 1200.01, Paragraph 4.d. Please read the attached memorandum for more information.
VHA Handbook 1058.01 vs. FY 2009 ECF Performance Plan
Please note that VHA Handbook 1058.01 supersedes all previous ORO memoranda on reporting requirements as well as those identified in the FY 2009 ECF Performance Plan.
RCO Conference Call Notes and Updates
Thanks to all of you who participated in the February 26, 2009, conference call. Revisions to documents discussed during the call were sent out via the RCO ListServ and are listed below:
~ Instructions for Research Compliance Officer (RCO) Informed Consent
and Regulatory Audits and Facility Director Certification of Audits
(02.26.09 revision)
~ Annual Certification of FAcility Audits of VHA Research First
Reporting Period (02.26.09 revision)
Other documents that are referenced in the Instructions for RCO Informed Consent and Regulatory Audits and Facility Director Certification of Audits are:
~ Sample Audit Tool for Research Compliance Officers (RCO) Annual
~ Informed Consent Document (ICD) Audits of VHA Research
(01/09/09)
~ VHA Triennial Regulatory Compliance Audit/Good Clinical Practice and
~ Human Research Protection Audit Work Sheet (01/12/09)
The next RCO call is tentatively scheduled for March 26, 2009. More information will be sent out via the ListServ.
Audits of Human Subjects Protocols
VHA Directive 2008-064 requires annual informed consent audits and triennial regulatory audits of all human subjects protocols. Any protocol that is completed in less than 3 years must be audited at closeout if it was not audited previously.
ORO has developed worksheets for conducting the required Informed Consent Audits and Regulatory Audits of Human Subjects Protocols. Although use of this worksheet is optional, regulatory audits of human research must include all the information in the worksheet. Audit Worksheet Directions are attached. These worksheets should be retained in the facility for 5 years after completion of the study, or longer if required by VA-approved records retention schedules. Tools to assist in the audit are being developed and will be distributed soon.
Corrections to Reporting Times and Places
for Noncompliance Issues (02/09/09)
1. The Research Compliance Officer must report serious or continuing noncompliance found in audits of protocols and in informed consent audits to the Facility Director, the Associate Chief of Staff for Research (ACOS/R), the Research and Development Committee (R&DC), and the Institutional Review Board (IRB) Chairperson within 5 business days of identifying it. The Facility Director has an additional 5 business days to report the noncompliance to the ORO Regional Office, the Office of Research and Development (ORD), and the Veterans Integrated Service Network (VISN) leadership. This information will be provided in VHA Handbook 1058.01 that should be issued in February 2009.
2. The 2009 Executive Career Field (ECF) Performance Plan indicated that a Research Compliance Officer will perform several functions. One needs a slight revision. The current statement reads that, "the Research Compliance Officer will serve as a non-voting member on the Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), Biosafety Committee, and Research and Development (R&D) Committee". This is not entirety correct . The "Biosafety Committee" should not be cited — the revised stated should read as:
"The Research Compliance Officer will serve as a non-voting member on the Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), Subcommittee on Research Safety (SRS), and Research and Development (R&D) Committee".
Annual Certification of Facility Audits
The Annual Certification of Facility Audits of VHA Research, First Reporting Period, has been recently updated (12/16/2008/pm) and covers annual reporting of informed consent audits and regulatory audits for protocols of all types. This certification must be submitted to ORO as required by the FY 2009 Executive Career Field (ECF) Performance Plan.
Initial Annual Report: This report is due July 1, 2009, and will cover all regulatory audits accomplished for a portion of studies active (open to enrollment or closed in enrollment but still with data collection or data analysis) during January 1, 2009, through May 31, 2009.
Subsequent Annual Reports: In subsequent years, annual reports will cover all regulatory audits for a portion of studies active from June 1 of the previous year to May 31 of the current year.
RCOs are encouraged to plan thoughtfully in determining which protocols to audit during the reporting period. For example, RCOs might plan that protocols are to be audited sooner if: (i) they will expire and have not been previously audited; (ii) they involve greater than minimal risk; (iii) their investigators have a previous history of serious noncompliance; etc.
Stay Connected
 Bi-monthly Nationwide Call - This call is open to anyone interested in VA research and focuses on a wide range of research-related topics. If you are a facility or VISN Research Compliance Officer (RCO), and if you haven't done so already, be sure to join the RACO/RCO ListServ discussion group by clicking here. NOTE: This is a VA Intranet Site.
New Monthly Call for RCOs - The next RCO Call will be held February 26th at 3:00pm (Eastern). This call provides an opportunity for RCOs to exchange questions, answers, and guidance with one another. The call-in information and agenda will be distributed via the RACO/RCO ListServ. This call will be hosted by ORO and is limited to VA RCOs ONLY.
RCO Training and Presentations
This hyperlink (on the blue horizontal bar across the top of the page) is now available! Follow the link above or click here to view few additional information. There you will upcoming training opporunities and presentations from past conferences.
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