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

 

 

                                                                                                                       

 

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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

 

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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.

 

 

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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.

 

 

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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.

 

d. Title 45 CFR Part 46.

 

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.

 

 

 

 

 

 

 

 

 

 

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