Department of Veterans Affairs VHA
DIRECTIVE 1058 Veterans Health Administration Washington, DC 20420 May 23, 2001 |
RESPONSIBILITIES OF THE
OFFICE OF RESEARCH COMPLIANCE AND
ASSURANCE |
1. REASON FOR
ISSUE: This Veterans Health
Administration (VHA) Directive defines the policy and responsibilities of the
Office of Research Compliance and Assurance (ORCA) (10R) within VHA. 2.
SUMMARY OF CONTENTS AND/OR MAJOR
CHANGES: ORCA serves as the
primary VHA office in advising the Under Secretary for Health on all matters
related to the protection of human research subjects, research misconduct,
laboratory animal welfare, and bio-safety. ORCA functions to promote and
enhance the ethical conduct of research and the investigation of allegations
of research misconduct in conformance with regulations and policies. 3.
RELATED ISSUES: None. 4.
RESPONSIBLE OFFICIALS: Director, ORCA (10R), is responsible for this directive.
Questions may be referred to (202) 565-7191 or (202) 565-8379. 5.
RESCISSIONS: None. 6.
RECERTIFICATION: This document is scheduled for
recertification on/before the last working day of May 2006. Thomas L. Garthwaite,
M.D. Under Secretary for Health DISTRIBUTION: CO: E-mailed 5/24/2001 FLD: VISN, MA, DO, OC, OCRO, and 200
-E-mailed 5/24/2001
T-l May 23, 2001 VHA
DIRECTIVE 1058 RESPONSIBILITIES OF
THE OFFICE OF RESEARCH COMPLIANCE AND ASSURANCE
1.
PURPOSE: This Veterans Health Administration (VHA) Directive defines the
policy and responsibilities of the Office of Research Compliance and
Assurance (ORCA) (10R) within the VHA. 2.
BACKGROUND a. The Under Secretary for Health
announced the establishment of ORCA in April 1999. ORCA is the primary Department
of Veterans Affairs (VA) component for promoting and enhancing the ethical
conduct of research, as well as investigating allegations of research
misconduct. ORCA is a key office in the implementation of the Common Rule
(Federal Policy for Protection of Human Subjects of Research) in Title 38
Code of Federal Regulations (CFR) Part 16. NOTE: ORCA
functions to enhance the ethical conduct of research in conformance with
regulations and policies. . b. ORCA has an emphasis on quality
improvement, with a specific interest in promoting the education and training
of VA employees involved in the conduct of research. These include, for
example, investigators and members of local VA medical centers and academic
affiliate Institutional Review Boards charged with approving research
protocols, and ensuring that the consent process for enrolling human subjects
is administered ethically. c. The VHA Headquarters component of the
ORCA office provides oversight to several Regional Offices, the main
operational components in ORCA to develop the necessary working-level
arrangements with the VA medical centers and the Veterans Integrated Service
Networks (VISNs). The Regional Offices execute ORCA's program for the
protection of human subjects in research, research misconduct, laboratory
animal welfare, and bio-safety via routine surveillance and for-cause site
visits. The Regional Offices also promote opportunities for training and
education. ORCA Headquarters and the Regional Offices coordinate with the
VISNs (through the Research Assurance and Compliance Officers, as
appropriate, and VA medical center Research Compliance Officers where they
exist) to carry out assurance and compliance responsibilities. d. ORCA has the responsibility of
managing the human subject assurance program required of VA medical centers
that commits them to abide by regulations that govern research involving
human subjects. e. ORCA serves as the chief VHA office
for liaison with the Office for Human Research Protections (OHRP) and the
Food and Drug Administration (FDA) in the Department of Health and Human
Services, as well as with other Federal departments and agencies with like
responsibilities (including signatories to the "Common Rule" (see
subpar.6b) and various other external groups (e.g., medical and dental school
affiliates and professional organizations). THIS VHA DIRECTIVE EXPIRES MAY 31, 2006
1
VHA DIRECTIVE 1058 May
23, 2001 3. POLICY: It is VHA policy that
ORCA serves as the primary VHA office for advising the Under Secretary for
Health on all matters affecting the integrity of research in the protection
of human subjects, laboratory animal welfare, and bio-safety; and it oversees
investigations of allegations of research misconduct. 4. ACTION: ORCA is responsible
for: a. Periodic comprehensive inspections of
research integrity (human subjects, animal welfare, and bio-safety) at each
VA medical center using a standardized Multi-Assessment Program (MAP) review
process to promote and enhance compliance with regulatory and policy
requirements. b. Observation at the external
accreditation site visits for human subjects and animal welfare conducted
tri-annually at each VA medical center. c. Investigations of allegations of
research improprieties and non-compliance with policies and regulations
through a variety of mechanisms such as Special Inquiry Force Team (SIFT)
reviews and research misconduct investigations, as appropriate. d. Development of training, education,
and development (TED) activities in conjunction with the VISNs and
implementation of these activities and programs. e. Development of specific areas of
emphasis and expertise in conjunction with established academic affiliation
arrangements and advancement of "the state of the art" research
assurance and compliance activities. f. Negotiation and/or maintenance of
Federal-wide assurances or other assurance documents with each VA medical
center conducting research involving human subjects and comparable agreements
with VA sites conducting research with laboratory animals. g. Collaboration with other Federal and
VA offices on the development of policies and procedures regarding the
office's mission. h. Management of VHA 's research adverse
and serious adverse events program. 5. DEFINITIONS a. Accreditation
Responsibilities. The National Council for Quality Assurance, under contract
to the Office of Research and Development (12), carries out reviews of VA
medical centers conducting research involving human subjects to ensure that
they are complying with the appropriate regulations, policies and procedures.
ORCA staff accompany the visits of the contractor as observers, help prepare
sites through educational activities and visits, and aggregate data from
visits to evaluate the areas in which additional training, education,
consultation, and policies and/or procedures development need to be provided
either regionally or throughout VHA. NOTE: The Association for Assessment and
Accreditation of Laboratory Animal Care (AAALAC) International carries out
accreditation of animal research programs maintained by VA. ORCA staff
monitor the sites to ensure that accreditation is accomplished. 2 May 23, 2001 VHA DIRECTIVE 1058 b. Adverse Event (AE). An
AE is defined as any untoward medical (physical or psychological) occurrence
in a human subject administered a pharmacological product or participating in
research. An AE does not necessarily have to have a causal relationship with
the research, or any risk associated with the research, the research
intervention, or the assessment. An AE can, therefore, be any unfavorable or
unintended event including abnormal laboratory finding, symptom or disease
associated with the research, or the use of medical investigational product. (1) Serious Adverse Event (SAE). A SAE is defined as death; a life-threatening experience; hospitalization (for a person not already hospitalized); prolongation of hospitalization (for a patient already hospitalized); persistent or significant disability or incapacity; congenital anomaly or birth defects; or an event which jeopardizes the subject and requires medical or surgical treatment to prevent one of the preceding outcomes. (2) Unexpected Adverse Event (UAE).
Any adverse event or reaction, the specificity of which is not consistent
with the informed consent, current investigator brochure, or product
labeling. Further it is not consistent with the risk information described in
the general investigational plan or proposal. c. Bio-safety Program. Laboratory
practices, techniques, safety equipment and facilities appropriate for the
operations performed and the hazards posed by particular bio-hazard materials
used in VA research. d. ORCA Oversight Activities.
ORCA uses a number of mechanisms to oversee VA facilities carrying out
research. These include SIFT inspections; accompanying accreditation site
visits; and MAP reviews. e. ORCA Regional Offices.
ORCA field offices are headed by an ORCA Regional Office Director and a
staff who can fulfill the full scope of responsibilities. Each ORCA Regional
Office interacts with several VISNs and carries out assurance and compliance
activities in coordination with VISN offices and VHA ORCA Headquarters. Each
site acts as a repository of information and center of expertise on a
particular aspect of ORCA's mission, e.g., Institutional Review Boards,
laboratory animal welfare, and so on. f. Research Assurance and
Compliance Officers (RACOs). Officials at the VISN who advise
and assist the Chief Network Officer in carrying out human subject
protections, research misconduct responsibilities, laboratory animal welfare,
and bio-safety. RACOs are employed by the VISN offices to coordinate with
ORCA VHA Headquarters, ORCA Regional Offices, and VA medical centers in
fulfilling training, education, and development activities; assurance
negotiation facilitation; compliance and oversight activities, and
aggregation of information necessary to ensure quality assurance. NOTE:
Some VA medical centers have established Research Compliance Officer (RCO)
positions that provide a similar role as a VISN RACO. g. Research Misconduct. Fabrication,
falsification, or plagiarism in proposing, performing, or reviewing research,
or in reporting research results. 3
VHA DIRECTIVE 1058 May 23, 2001
h. TED Activities. Development
of manuals, modules, workshops, and other techniques to ensure that VA
employees understand, adopt, and implement their responsibilities for the
protection of human research subjects, research integrity, laboratory animal
welfare, and bio-safety. i. Assurances of Compliance.
Written agreements between the Chief Officer, ORCA, and institutional
officials at VA medical centers, with the concurrence of the VISN Directors,
that institutions will carry out their regulatory and policy responsibilities
with regard to protection of human subjects in research. Currently, each site
has a VA Multiple Project Assurance of Contracts and ORCA will approve and
assist the move to a Federal-Wide Assurance (FWA ) procedure. 6. REFERENCES a. Title 38 CFR
Parts 16 (codification of "Common Rule," Federal Policy for
Protection of Human Research Subjects, June 18, 1991, 56 Federal Register
28001). b. Title 21 Code of Federal Regulations (CFR) Parts 50 and 56. c. Title 42 CFR Part 50, subpart A. e. Title 9 CFR Parts
1 and 2. f. Title 7 United States Code, Sections
2131-2156, the Federal Animal Welfare Act. g. The Public Health Service Guide for the
Care and Use of Laboratory Animals. The Institute of Laboratory Animals
Resources Commission on Life Sciences National research Council, National
Academy Press, Washington, DC 1996. h. The Public Health Service Policy for Humane
Care and Use of Laboratory Animals. Office for Protection from Research Risks, National Institutes
of Health, September 1986. 4 |