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Categories of individuals covered by the system:
The following categories of individuals will be covered by this system: (1) Veterans; (2) patients; (3) employees; or, (4) volunteers who have indicated their willingness to be a participant in medical research projects being performed by VA, by a VA contractor or by another Federal agency in conjunction with VA; and (5) research and development investigators.

Categories of records in the system:
Records, or information contained in records, vary according to the specific medical research involved and may include: (1) Research on biomedical, prosthetic and health care services; (2) research stressing spinal cord injuries and diseases and other disabilities that tend to result in paralysis of the lower extremities; and (3) morbidity and mortality studies on former prisoners of war. VACO records contain (4) a merit review of the project; and (5) a review and evaluation of the research and development investigators and of the participants in the program. The review and evaluation information concerning the research and development investigators may include personal and educational background information as well as specific information concerning the type of research conducted. Invention records contain: a certification page, describing the place, time, research support related to the invention and co- inventors; Technology Transfer Program Invention Evaluation Sheet Internal or External Invention Assessment reports; Research and Development Information System (RDIS) reports on research support related to the invention; Correspondence; and the Office of General Counsel Letter of Determination.

Authority for maintenance of the system:
Title 38, United States Code, Section 7301.

Purpose(s):
The records and information may be used to determine eligibility for research funding, to determine handling of intellectual properties, and to manage proposed and/or approved research endeavors.

Routine uses of records maintained in the system, including categories of users and the purposes of such uses:

1. Transfer of statistical and other data to Federal, State, and local government agencies and national health organizations to assist in the development of programs.
2. In the event that a system of records maintained by this agency to carry out its functions indicates a violation or potential violation of law, whether civil, criminal or regulatory in nature, and whether arising by general statute or particular program statute, or by regulation, rule or order issued pursuant thereto, the relevant records in the system of records may be referred, as a routine use, to the appropriate agency, whether Federal, State, local or foreign, charged with the responsibility of investigating or prosecuting such violation or charged with enforcing or implementing the statute or rule, regulation or order issued pursuant thereto.
3. Disclosure may be made to a congressional office from the record of an individual in response to an inquiry from the congressional office made at the request of that individual.
4. Disclosure may be made to National Archives and Records Administration (NARA), General Services Administration (GSA) in records management inspections conducted under authority of 44 United States Code.
5. Disclosure of medical record data, excluding name and address (unless name and address is furnished by the requester) for research purposes determined to be necessary and proper, to epidemiological and other research facilities approved by the Under Secretary for Health.
6. In order to conduct Federal research necessary to accomplish a statutory purpose of an agency, at the written request of the head of the agency, or designee of the head of that agency, the name(s) and address(es) of present or former personnel of the Armed Services and/ or their dependents may be disclosed (a) to a Federal department or agency or (b) directly to a contractor of a Federal department or agency. When a disclosure of this information is to be made directly to the contractor, VA may impose applicable conditions on the department, agency and/or contractor to ensure the appropriateness of the disclosure to the contractor.
7. Upon request for research project data, the following information will be released to the general public, including governmental and non-governmental agencies and commercial organizations: Project title and number; name and educational degree of principal investigator; Veterans Health Administration (VHA) medical center location; type (initial, progress, or final) and date of last report; name and educational degree of associate investigators; and project summary. In addition, upon specific request, keywords and indexing codes will be included for each project.
8. Upon request for information regarding VA employees conducting research, the following information will be released to the general public, including governmental agencies and commercial organizations: Name and educational degree of investigator; VHA title; academic affiliation and title; hospital service; primary and secondary specialty areas and subspecialty.
9. Records from this system of records may be disclosed to a Federal agency or to a State or local government licensing board and/ or to the Federation of State Medical Boards or a similar nongovernment entity which maintains records concerning individuals' employment histories or concerning the issuance, retention or revocation of licenses, certifications, or registration necessary to practice an occupation, profession or specialty, in order for the agency to obtain information relevant to an agency decision concerning the hiring, retention or termination of an employee or to inform a Federal agency or licensing boards or the appropriate nongovernment entities about the health care practices of a terminated, resigned or retired health care employee whose professional health care activity so significantly failed to conform to generally accepted standards of professional medical practice as to raise reasonable concern for the health and safety of patients in the private sector or from another Federal agency. These records may also be disclosed as part of an ongoing computer matching program to accomplish these purposes.
10. Identifying information in this system, including name, address, social security number and other information as is reasonably necessary to identify such individual, may be disclosed to the National Practitioner Data Bank at the time of hiring and/or clinical privileging/reprivileging of health care practitioners, and other times as deemed necessary by VA, in order for VA to obtain information relevant to a Department decision concerning the hiring, privileging/reprivileging, retention or termination of the applicant or employee.
11. Relevant information from this system of records may be disclosed to the National Practitioner Data Bank and/or State Licensing Board in the State(s) in which a practitioner is licensed, in which the VA facility is located, and/or in which an act or omission occurred upon which a medical malpractice claim was based when VA reports information concerning: (a) Any payment for the benefit of a physician, dentist, or other licensed health care practitioner which was made as the result of a settlement or judgment of a claim of medical malpractice of an appropriate determination is made in accordance with agency policy that payment was related to substandard care, professional incompetence or professional misconduct on the part of the individual; (b) a final decision which relates to possible incompetence or improper professional conduct that adversely affects the clinical privileges of a physician or dentist for a period longer than 30 days; or, (c) the acceptance of the surrender of clinical privileges or any restriction of such privileges by a physician or dentist either while under investigation by the health care entity relating to possible incompetence or improper professional conduct, or in return for not conducting such an investigation or proceeding. These records may also be disclosed as part of a computer matching program to accomplish these purposes.
12. Information concerning individuals who have submitted research program proposals for funding, including the investigator's name, social security number, research qualifications and the investigator's research proposal, may be disclosed to qualified reviewers for their opinion and evaluation of the applicants and their proposals as part of the application review process.
13. Any information in this system may be disclosed to the Department of Justice (DOJ), including U.S. Attorneys, upon its official request in order for VA to respond to pleadings, interrogatories, orders or inquiries from DOJ and to supply DOJ with information to enable DOJ to represent the U.S. Government in any phase of litigation or in any case or controversy involving VA.
14. Any invention information in this system may be disclosed to affiliated intellectual property partners to aid in the possible use, interest in, or ownership rights in VA intellectual property.

Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system:

Storage:
(1) Paper documents. (2) Microscope slides. (3) Magnetic tape or disk. (4) Photographs. (5) Microfilm.

Retrievability:
Records are retrieved by individual identifiers and indexed by a specific project site or location, project number, or under the name of the research or development investigator.

Safeguards:

Physical Security:
Access to VA working space and medical record storage areas is restricted to VA employees on a ``need to know'' basis. Generally, VA file areas are locked after normal duty hours and protected from outside access by the Federal Protective Service. Employee file records and file records of public figures or otherwise sensitive medical record files are stored in separate locked files. Strict control measures are enforced to ensure that disclosure is limited to a ``need to know'' basis. Access to a contractor's records and their system of computers used with the particular project are available to authorized personnel only. Records on investigators stored on automated storage media are accessible by authorized VACO personnel via terminals which are dedicated to this research and development information system.

Retention and disposal:
The project records are held five (5) years after completion of the research project and/or publication of a final report unless they become part of the patient's individual medical history file in which case the record would remain 75 years after the last activity of care. At the end of a study, records maintained by a contractor are returned to VA for appropriate disposition.

System manager(s) and address:
Director of Operations, Research and Development (12C), Department of Veterans Affairs, 810 Vermont Ave, NW., Washington, DC 20420.

Notification procedure:
Interested persons should write to: Director of Operations, Research and Development (12C), Department of Veterans Affairs, 810 Vermont Ave, NW., Washington, DC 20420. All inquiries must reasonably identify the project and site location; date of project and team leader.

Record access procedures:
Interested persons desiring access to and contesting of research records should write to the address in Notification Procedure above.

Contesting record procedures:
(See Notification Procedure above.)

Record source categories:
(1) Patients and patient records; (2) employees and volunteers; (3) other Federal agencies; (4) National Institutes of Health; (5) Centers for Disease Control (Atlanta, Georgia); (6) individual veterans; (7) other VA systems of records; and, (8) research and development investigators.

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