# Presentation: 675831

## FEDERAL UPDATEOFFICE OF RESEARCH OVERSIGHT (ORO) DEPT. OF VETERANS AFFAIRS David A. Weber, Ph.D., FACNPChief OfficerFriday, November 12, 2004

## FACILITIES AND PERSONNEL

- 118 VAMCs & VAHCSs
- >3000 Investigators
- Four Research Services
- Clinical Science R&D (CSR&D)
- Biomedical Research R&D (BLR&D)
- Health Services R&D (HSR&D)
- Rehabilitation R&D (RR&D)
- Overall Research Budget:~$1.6 B (est. 2004)

## ORO OVERSIGHT RESPONSIBILITIES

**HUMAN SUBJECTS PROTECTIONS**
**RESEARCH MISCONDUCT**
**ANIMAL WELFARE**
**RESEARCH SAFETY**

## ORO OVERSIGHT RESPONSIBILITY

_**Human Subjects Protections**_
**Oversee compliance with protections established by Common Rule following 38 CFR Part 16, VHA HB 1200.5, other VHA policies, and federal regulations.**
**Manage VAMCs Assurances and MOUs**

## ORO OVERSIGHT RESPONSIBILITY

_**Human Subjects Protections**_
**Review accreditation survey reports for regulatory compliance**
**Oversee and guide investigations of allegations of research misconduct (FFP in proposing, performing, or reviewing research, or in reporting research results).**
**	****M-3, P-1, C-15/ HB 1200.14**

## ORO REGIONAL OFFICES

## ORO REGIONAL OFFICES

**Northeastern**
**	****Bedford, MA**
**	****VISNs 1, 2, 3**
**Mid-Atlantic**
**	****Washington, DC**
**	****VISNs 4, 5, 6, 9, 10**
**Southern**
**	****Decatur, GA**
**	****VISNs 7, 8, 16, 17**

**Mid-Western**
**	****Hines, IL**
**	****VISNs 11, 12, 15, 19, 23**
**Western**
**	****March AFB, CA**
**	****VISNs 18, 20, 21, 22**

## ORO REGIONAL OFFICES

**Conduct routine* and for cause reviews**
**Participate in QA* reviews**
**Oversee reporting* to ORO**
**Monitor site action plans**
**Review compliance issues by phone, fax, etc.**
**Answer questions about regulations, policies, directives, & best practices**
**Helps locate information/resources on compliance**

## ROUTINE ON-SITE REVIEWS

**Consultative assessment of C&A with the laws, regulations, policies, and procedures governing research**
**Rotate thru VHA facilities with research programs**
**Site visit may require action plan**
**Follow-up if action plan required**

## SYSTEM WIDE QA PROJECT

- ORO review of IRB minutes
- IRB minutes for 5 month period
- Nearing completion of all VA IRB minutes
- Will provide individual/system findings
- Next step to review minutes of affiliates

## WHAT TO REPORT TO OROMEMORANDOM*

**Identifies issues VHA facilities must report to ORO as required by various Federal regulations and VHA policies. **
**	****	**
**	****	**_[http://www.va.gov/oro/](http://www.va.gov/oro/)_
***November 12, 2003**

## WHAT TO REPORT TO ORO

- Findings of serious or continuing noncompliance with regulations for protection of human subjects or IRB requirements
- For cause suspension or termination of IRB approval
- Change in status of FWA or IRB, IO, IRB members
- Changes in shared responsibilities in HRPP MOU with academic affiliate or VA facility
- AEs- new AE policy in VHA concurrence process

## WHAT TO REPORT TO ORO

- Research Misconduct (RM)
- All initiations of inquiries and investigations of RM (FFP in proposing, performing, or reviewing research, or in reporting research)
- Copies of inquiry and investigation reports
- All adjudications (w/wo findings of RM)

## THE END