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Office of Research Oversight (ORO)
ORO serves as the primaryVHA office in advising the Under Secretary for Health
and exercising oversight concerning all matters of research compliance and assurance, including human
subject protections, laboratory animal welfare, research safety, research laboratory security, research
information security, research misconduct, debarment for research impropriety, and other matters that the
Under Secretary for Health may assign. ORO is also responsible for developing and conducting research compliance officer education programs as directed by the Under Secretary for Health.
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WHAT'S NEW
Technical Correction to VHA Handbook 1200.01 (06/19/09)
The Chief Research and Development Officer, Dr. Joel Kupersmith, issued a memorandum concerning a technical reference to Handbook 1200.01. Please read the attached memorandum for more information.
Guidance - Pregnancy and VA Research (06/10/09)
The Office of Research and Development (ORD)(12) has published updated guidance on Pregnancy and VA Research.
2009 Annual Facility Directors Certification (05/28/09) (Revised (06.23.09)
The Annual Facility Directors Certification (2009) has now been released. ORO Regional Offices
will be available to answer questions and provide assistance related to this year's Certification Checklist.
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Revised R&D Committee Checklist (05/26/09)
Please see the revised Research and Development Checklist . Please contact ORO if you have any questions. |
July 4, 2009
In the truest sense, freedom cannot be bestowed; it must be achieved.
~ Franklin D. Roosevelt
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Remedial Actions Related to Research Compliance Officer Audit (05/18/09)
ORO has released this memo clarifying that, as always, authority to require remedial actions and to approve proposed remedial actions in response to identified noncompliance rests with the Institutional Review Board (IRB).
However the RCO has an obligation to share their expertise with the IRBs on which they serve (as non-voting members) and should make recommendations to the IRB regarding appropriate remediation if noncompliance — ( See Full Memo Attached Here ).
Further Guidance on ORO Implementation of VA Handbook 6500 (05/14/09)
ORO has issued this Memorandum dated May 14, 2009, as an Update to ORO Memoranda dated May 29, 2008 and February 2, 2009 and reads as follows:
1. This ORO memorandum on Compliance Oversight Procedures For Use And Storage of VA Sensitive Research Information (May 29, 2008) cites the VA Handbook 6500 requirement §6c(4)(j) that “VA sensitive information may not reside on non-VA owned Other Equipment (OE) without . . . a waiver from the VA CIO” Absent a waiver, the memorandum states that ORO will require a written statement from the ISO and the facility Director justifying the storage of VA sensitive information on non-VA OE. Click here to read full memo . . .
OIG Report Issued on VA Informed Consent Review (05/15/09)
The Department of Veterans Affairs, Office of Inspector General (OIG), issued the Healthcare Inspection - Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research (Report No. 08-02725-127). You may view and download this report by clicking on the report title above or by accessing at the following website link: http://www.va.gov/oig/54/reports/VAOIG-08-02725-127.pdf.
Report Summary: The study population consisted of all enrollees of human subjects research projects conducted under VA auspices that were active and required informed consent, and had at least one enrollee as of August 20, 2008. The study used a complex, three-stage sample design that included stratification, clustering, and unequal probabilities of selection. From the 102 facilities that had at least one applicable protocol, we statistically randomly selected 30 (29.4 percent) facilities where we conducted onsite inspections. There were 5,993 sampled participants. We found the following:
- Insufficient IRB documentation for the waiver for 2 of the 33 sampled research protocols that were waived from the required informed consent process.
- An estimated 1.7 percent of the 367,103 VA research subject consent forms could not be located; we are 95 percent confident that the true percent value is somewhere between 0.6 percent to 4.5 percent.
- Thirty-one percent of the VA research subjects consent forms on file were estimated to be noncompliant with VHA standards; 97 percent of the noncompliant forms lacked witness signature.
- One percent of the 110,231 VA noncompliant forms lacked the subject or subject’s authorized representative signature.
Please use either Adobe Acrobat Reader version 8 or equivalent PDF reader software to open and view our reports. Adobe Acrobat Reader may be obtained free of charge from Adobe's website. Vision-impaired customers and those with text-only browsers may want to try Access Adobe for converting PDF documents into text. (Our disclaimer for these software products.)
Consent for Use of Picture and/or Voice (05/07/09)
ORO has obtained the following clarification from the Office of Research and Development regarding use with research subjects of VA Form 10-3203, Consent for Use of Picture and/or Voice:
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VHA Handbook 1907.01, Paragraph 8(s)(3) requires use of VA Form 10-3203 when a video or audio recording of a research subject is made and documentation of the research subject’s participation is included in the research subject’s VHA health record. There is no reference to required use of this form when a VHA health record is not required to be created or updated. Therefore, VA Form 10-3203 would only apply for research subjects whose documentation is required in the VHA health record. |
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 (06/19/09)
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.
Technical Correction to VHA Handbook 1200.05 (04/24/09)
A technical correct to Handbook 1200.05 “Protection of Human Subjects in Research” has been made. The change is in Paragraph 7j and this paragraph now reads:
j. Record Retention. The required records, including the investigator’s research records, must be retained until disposition instructions are approved by the National Archives and Records Administration and are published in VHA's Records Control Schedule (RCS 10-1).
(1) All records must be accessible for inspection and copying by authorized representatives of VA, OHRP, FDA and other authorized entities at reasonable times and in a reasonable manner.
(2) Records are the property and the responsibility of the local research office. The medical center must designate where the records will be maintained and/or stored.
(3) Complete (non-redacted) minutes, whether from the VA or affiliate IRB reviewing VA research, must be submitted to the R&D Committee and maintained in the facility research office. The R&D Committee must review and act upon all IRB minutes regardless whether the IRB is established at the medical center or at the affiliate university.
Until a schedule for local research records is published, ALL records including identifiers must be retained. Consent forms and HIPAA authorization forms should not include a timeframe for destruction. If there is language in the consent or authorization about destruction, it must only say “in accordance with the record control schedule.” ORO is working with the Privacy Office and ORD to get this situation resolved as soon as possible.
VHA Handbook 1200.01 Issued (04/24/09)
This handbook, "Research and Development Committee" is a major revision to the current VHA procedures governing Research and Development (R&D) Committees' responsibilities and operations. The major change is that the R&D Committee may focus on oversight of the local research program rather than individual protocols. Changes enable the R&D Committee to prioritize their deliberations around broad areas of program development, risk management, and quality and performance activities.
New Handbook Released (04/20/09)
VHA Handbook 1605.03, Privacy Compliance Assurance Program and Privacy Compliance Monitoring, has been released. Be sure to review Appendix A which specifically addresses research.
DON'T FORGET
Reporting Serious or Continuing Noncompliance to ORO
Serious or continuing noncompliance identified during a Research Compliance Officer’s audit (or otherwise) must be reported as described in VHA Handbook 1058.01(Requirements for Reporting Research Events to Facility Oversight Committees and the Office of Research Oversight) to be issued soon. The Handbook specifies the nature of serious and continuing research noncompliance that must be reported to ORO as well as time intervals for such reporting.
Remember —
VHA Policy Is More Restrictive than the National Institutes of Health's (NIH) guidance regarding recruitment of study subjects under the HIPAA Privacy Rule. Click here to view the revised clarification. (09/05/2007)
Office of Research Oversight (10R)
Mailing Address: 810 Vermont Avene, NW, Washington, DC 20420
Physical Location: 1717 H Street NW, Fourth Floor, Washington, DC 20006
Phone: (202) 266-4577
ORO Regional Office Locations
ORO Staff Directory
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Click here for Regional Office locations and contact information.
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Development of this site was sponsored in part by a grant from the "Bataan-Corregidor Memorial Fund."
American Defenders of Bataan and Corregidor
Bringing together WWII Veterans who were POWs of the Japanese and assisting the families of those men killed in action or who died in captivity.
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