# Presentation: 721828

##                    Office of Research Oversight

**                   **Office of Research Oversight

- D e p a r t m e n t  o f  V e t e r a n s  A f f a i r s

- Richard D’Augusta, RPh, MPA
- Director, Northeast Regional Office

## Introduction and Overview

- ORO Mission
- ORO Areas of Responsibility
- ORO Regional Offices
- ORO Reviews
- Questions and Answers

## ORO Mission

- The Office of Research Oversight (ORO) serves as the primary VHA office in advising the Under Secretary for Health on all matters of research compliance and assurance for human subjects protections, animal welfare, research safety, and research misconduct.  ORO promotes and enhances the responsible conduct of research in these areas in conformance with regulations and policies.

## ORO Areas of Responsibility

- Human Subjects Protections
- Oversee compliance with protections established by the Common Rule (38 CFR Part 16), other applicable federal regulations, and VHA policies.

- Animal Welfare
- Provide regulatory oversight of VHA Animal Care & Use Programs.
- Investigate allegations of animal research non-compliance.
- Help ensure animal welfare in scientific research.

## ORO Areas of Responsibility

- Help ensure safety of VHA research personnel and laboratory security.
- Oversee compliance with federal regulations, VHA policies and procedures, and all applicable NIH/CDC guidelines.

- Research Misconduct
- Oversee facilities' investigations into allegations of research misconduct (fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results).

## ORO Regional Offices

- Western
- March ARB, CA

- Northeastern
- Bedford, MA

- Mid-Atlantic
- Washington, DC

- Southern
- Atlanta, GA

- Midwestern
- Chicago, IL

## ORO Regional Office Directors

| REGIONAL OFFICE | DIRECTOR | PHONE/FAX |
| --- | --- | --- |
| Northeastern
Bedford, MA
VISNs 1, 2, 3 | Richard D’Augusta, RPh, MPA | (781) 687-3850
FAX (781) 687-3858 |
| Mid-Atlantic
Washington, DC 
VISNs 4, 5, 6, 9, 10  | Min-Fu Tsan, MD, PhD | (202) 745-8110
FAX (202) 745-8538 |
| Southern
Decatur, GA 
VISNs 7, 8, 16, 17  | David Miller, PhD, FAClinP | (404) 417-2929
FAX (404) 417-2935 |
| Midwestern
Hines, IL
VISNs 11, 12, 15, 19, 23 | Karen Smith, PhD | (708) 202-7254
FAX (708) 202-7250 |
| Western
March AFB, CA 
VISNs 18, 20, 21, 22 | Paul Hammond, MD, DPhil | (909) 801-5164
FAX (909) 801-5176 |

## ORO Reviews

- Types of Reviews
- Routine and For-Cause

- End Product/Outcome
- Site visit report with recommendations
- Facility develops action plan
- Research activities Restricted/Not Restricted
- Continuous follow-up until remedial action complete

- Reviews Focus on Compliance
- Identify deficiencies

## NCQA and ORO: Take Home Message

- NCQA accreditation + ORO compliance oversight can not completely prevent serious non-compliance

- NCQA and ORO share the same goal

- NCQA accreditation  systems are in place

- ORO compliance oversight  systems properly implemented

- Approaches are complementary

- Exemplary human subjects protections in the VA

**Notes:**
NCQA accreditation and ORO compliance oversight of the VA HRPP are 2 different approaches that share the same goal: exemplary human subjects protections in the VA.

These 2 approaches may seem duplicative, but as I will explain, they are complementary to each other and strengthen the system of ethical protections for veterans participating in research.   
         NCQA accreditation ensures that the VA systems of protecting human research subjects are in place.  The accreditation process is designed to determine to what extent the VAMC HRPP has been put in place using well-defined “standards”.  When VAMCs achieve sufficient standards, e.g., 55% or more of the available “points”, the facilities are “accredited”.  Thus, NCQA accreditation is based on what the facilities have accomplished.  Accreditation is an important goal, but accreditation status still may mean that there are important compliance issues with which a facility must report to ORO and correct with ORO oversight processes (a facility could be accredited while failing to meet several standards, e.g. failing to receive up to 45% of the available “points”).  
         On the other hand, ORO compliance oversight ensures that the systems to protect human research subjects are properly implemented.  ORO compliance oversight, while acknowledging the accomplishments of the facilities, puts more emphasis on identifying and correcting non-compliance and deficiencies. 

Thus, it is clear that a facility, despite being accredited, may at times require ORO attention due to serious non-compliance. It is equally important to remember that non-compliance cannot be completely prevented even with NCQA accreditation and ORO compliance oversight. No system can ensure complete compliance if there is insufficient education, negligence, or willful intent to circumvent the rules and policies.  Consequently, these issues will continue to challenge our systems of protecting human subjects in research.  

In closing, although NCQA and ORO have different approaches, we share the same goal: exemplary protection of veterans participating in research.  

## Questions and Answers