09-25- 0012 SYSTEMS LISTING

Clinical Research: Candidate Healthy Volunteer Records, HHS/NIH/CC.

None.

Clinical Research Volunteer Program, Building 61, 10 Cloister Court, Bethesda, MD 20892-4754.

Normally healthy individuals who volunteer to participate in NIH studies.

Program application, health questionnaire and record of participation.

42 U.S.C. 241, 263.

1. To determine suitability for participation in the normal volunteer program.
2. To document remuneration of normal volunteers.
3. To provide a record of participation to be used (a) in writing letters of recommendation/reference for the volunteer, and (b) preparing reports on the normal volunteer program.

1. Clinical research data are made available to approved or collaborating researchers, including HHS contractors and grantees.
2. Certain diseases and conditions, including infectious diseases, may be reported to appropriate representatives of State or Federal Government as required by State or Federal law.
3. Information may be used to respond to congressional inquiries for constituents concerning admission to the NIH Clinical Center.
4. 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.

Program applications and health questionnaires are stored in file folders. Records of participation are stored in databases and date files.

Records are retrieved by name.

Measures to prevent unauthorized disclosures are implemented as appropriate for each location and for the particular records maintained in each project. Each site implements personnel, physical, procedural safeguards such as the following:

1. Authorized Users: Access is granted only to the Healthy Volunteer Program staff and to NIH physicians who have requested the recruitment of volunteers for their clinical research projects.
2. Physical Safeguards: Access to the files is strictly controlled by the files staff. Records may be removed from the file only at the request of the system manager or other authorized employees. Record facilities are locked when system personnel are not present.
3. Procedural Safeguards: Access to the files is strictly controlled by the files staff. Records may be removed from the file only at the request of the system manager or other authorized employees.

Records are retained and disposed of under the authority of the NIH Records Control Schedule contained in NIH Manual Chapter 1743, Appendix 1 - "Keeping and Destroying Records" (HHS Records Management Manual, Appendix B-361), item 3000-E-61, which allows records to be kept for a maximum period of three years after the volunteer period ends. Refer to the NIH Manual Chapter for specific conditions on disposal.

Director, Clinical Research Volunteer Program, Building 61,10 Cloister Court, Bethesda, MD 20892-4745.

Write to the System manager to determine if a record exists. The requester must also verify his or her identity by providing either a notarization of the request or a written certification that the requester is who he or she claims to be and understands that the knowing and willful request for acquisition of a record pertaining to an individual under false pretenses is a criminal offense under the Act, subject to a five thousand dollar fine.

An individual who requests notification of or access to a medical record shall, at the time the request is made, designate in writing, a responsible representative, who may be a physician, who will be willing to review the record and inform the subject individual of its contents at the representative's discretion.

A parent or guardian who requests notification of, or access to, a child's or incompetent person's medical record shall designate a family physician or other health professional (other than a family member) to whom the record, if any, will be sent. The parent or guardian must verify relationship to the child or incompetent person as well as his or her own identity.

To obtain access to a record, contact: Clinical Research Volunteer Program, National Institutes of Health, 10 Cloister Court, Building 61, Bethesda, MD 20892-4754 and provide the information described under notification procedures above. Requesters should also reasonably specify the record contents being sought. Individuals may also request listings of accountable disclosures that have been made of their records, if any.

Write to the official at the address specified under notification procedures above, and reasonably identify the record and specify the information to be contested, the corrective action sought, and the reasons for the correction, with supporting justification. The right to contest records is limited to information which is incomplete, irrelevant, incorrect, or untimely (obsolete).

Volunteer.

None.