# Presentation: 323586

## Update from the Office of Research Oversight (ORO)Meeting of ACOS/R & Center DirectorsThursday, January 22, 2004

## Office of Research OversightORO [Formerly ORCA]

**David A. Weber, Ph.D., FACNP**
**Acting Chief Officer, ORO**

## ORCA →??→OHRO→ORO(1999 →→→2003)

**Few changes in mission & responsibilities**
**Educational responsibilities transferred to ORD**

## ORO OUTLINE

- Congressional Legislation
- Mission
- Areas of Responsibility
- Compliance Reviews
- Regional Offices
- Required Reporting to ORO
- New AE Reporting Policy
- Misconduct, Assurance Program

## Legislation in Support of ORO

- 11/19/2003  -  S.1156 Passed Senate
- 11/21/2003  -  Cleared for White House
- 11/25/2003  -  Presented to President
- 12/6/2003 – President Signs Pub. L. 108(170)

## S.1156- Veterans Health Care, Capital Asset, and Business Improvement Act of 2003 Pub. L. 108(170)

- Title IV-OTHER MATTERS
- 	Sec. 401. Office of Research Oversight in Veterans Health Administration
- 	(a) Statutory Charter.-(1) Chapter 73 is amended by inserting after section 7306 the following new section:

## ¶ 7307. Office of Research Oversight“(a) Requirement for Office.-(1) There is in the Veterans Health Administration an Office of Research Oversight (hereinafter in this section referred to as the ‘Office’).  The Office shall advise the Under Secretary for Health on matters of compliance and assurance in human subjects protection,...........”

## ORO

## ORO Mission

**Advise USH ****on matters of C&A related to human subjects and animal welfare, research safety, and research misconduct.**

## ORO Actions

**Office monitors, reviews, and investigates regulatory C&A with respect to HSP, AW, RS, and RM in medical research**

## ORO RESPONSIBILITIES

**Human Subjects Protections**
- Oversee compliance with protections established by the Common Rule (38 CFR Part 16), other applicable federal regulations, and VHA policies.
- Manage VAMCs Assurances and MOUs Nationwide
- Review accreditation survey reports for regulatory compliance issues

## ORO RESPONSIBILITIES

**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 RESPONSIBILITIES 

**Research Safety**
- Help ensure safety of VHA research personnel and laboratory physical 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 (FFP in proposing, performing, or reviewing research, or in reporting research results).

## For Cause On-Site Reviews

**To investigate reported or alleged instances of noncompliance with the laws, regulations, policies, and/or procedures governing research**
**May require either a focused or systematic on-site review**
**Teams of 2-5 members for 2-4 days depending on the seriousness and scope of potential noncompliance **

## Routine On-Site Reviews

**To assess C&A with the laws, regulations, policies, and procedures governing research**
**At all VHA facilities with research programs on a rotating basis**
**To include HSP, AW, RS, and RM**
**Remediation includes corrective actions recommended by ORO**

## ORO REVIEWS

- Routine and For-Cause

**End Product/Outcome**
- Site visit report with recommendations
- Facility develops action plan
- Assurance Restricted/Suspended
- Continuous follow-up until remedial action complete

**Reviews Focus on Compliance**
- Identify deficiencies

**ORO REVIEWS**

## What is ORO’s Organizational Structure ?

- Central Office Component
**Manage ORO **
**Strategic guidance, coordination, and oversight**
- Regional Offices:
**Field operational units**
**Geographically distributed**
**5 locations across the country**
**Oversee RC&A for 21 VISNs**
**Oversee RC&A for ~115 VAMC Res. Prog. with Assurances & VAMC affiliates**

## 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

## Regional Office Directors

**Northeastern RO **
**	****Richard J. D’Augusta, RPh, MPA **
**	****(781) 687-3850**
**Mid-Atlantic RO**
**	****Min-Fu Tsan, MD, PhD**
**	****(202) 745-8110**
**Southern Regional Office**
**	****David J. Miller, PhD, FAClinP**
**	****(404) 417-2929**

**Mid-Western RO**
**	****Karen M. Smith, PhD**
**	****(708) 202-7254**
**Western RO**
**	****Paul St. J. Hammond, MD, DPhil**
**	****(909) 801-5164**

## ORO Regional Office

**Conducts routine and for cause reviews**
**Answers questions about regulations, policies, directives, & best practices.**
**Assists with concerns about incidents that may pose compliance problems**
**Helps locate information & resources**

## WHAT TO REPORT TO ORO

- Date: November 12, 2003
- From: Acting Chief Officer, Office of Research Oversight (ORO) (10R)
- Thru: Deputy Under Secretary for Health (10A)
- 	Deputy Under Secretary for Health for Operations and Management (10N)
- To:	Institutional Officials of VHA Facilities Conducting or Supporting Research

## 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/**

## REPORTING AEs in RESEARCH TO ORO

- Replaces previous procedures for reporting all S&U AEs in research to ORO.  New HB requires reporting to ORO RO all AEs that result in: (1) an IRB taking substantive action(s) with respect to a protocol, ICF, or research personnel; or (2) unexpected death of a research subject, regardless of IRB action.

## DEFINITIONS

_**Substantive Action**_**.  **Action taken by an IRB that materially alters the substance and meaning of a protocol, ICF or process, or research personnel, including, but not limited to, restriction, suspension or termination of a study or research personnel participation, and actions.

## DEFINITIONS

_**Unexpected Death**_**.  **The death of a research subject when high risk of death is not projected in the written protocol, ICF, and/or sponsor brochure.  Does not include deaths associated with a terminal condition unless the research hastened the subject’s death.  A subject death that is not associated with research is not an “unexpected death.”

## IN PROGRESS

**Misconduct Handbook**
**Assurance Handbook**

## ORO TAKE HOME MESSAGE

**ORO** promotes & enhances  responsible conduct of research; advises USH on compliance & assurance
**ORO** reviews  focus on regulatory compliance
**ORO** is receptive to questions (hypothetical or real) on research compliance
**ORO** requires reporting: What to Report to ORO?
**ORO** facilitates/maintains assurances with facilities
**ORO** supports accreditation
**New ORO** Handbooks

_**ORO TAKE HOME MESSAGE**_

**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.  

## THE END