Privacy Act System of Records: Medical and Research Study Records of Human Volunteers, EPA-34

[excerpted from: Federal Register: February 22, 2002 (Volume 67, Number 36)]

System Name: Medical and Research Study Records of Human Volunteers.

System Location: Human Studies Facility, Human Studies Division, National Health and Environmental Effects Research Laboratories, Office of Research and Development, Environmental Protection Agency, 104 Mason Farm Road, Chapel Hill, NC, 27599.

Categories of Individuals Covered by the System: Individuals who volunteer for participation in EPA-sponsored, human studies research, whether or not they are accepted for participation, and individuals who participate in the research.

Categories of Records in the System: Names, addresses, telephone numbers of individual volunteers; individual vital statistics; medical histories; psychological profiles; results of laboratory tests; results of participation in specific research studies; and related records pertinent to the human subject research program.

Authority for Maintenance of the System (includes any revisions or amendments): Resource Conservation and Recovery Act, 42 U.S.C.6981; Comprehensive Environmental Response, Compensation and Liability Act, 42 U.S.C. 9660; Clean Air Act, 42 U.S.C. 7403; Safe Drinking Water Act, 42 U.S.C. 300j-1; Federal Water Pollution Control Act, 33 U.S.C. 1254; Toxic Substances Control Act, 15 U.S.C. 2609; Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136r.

Purpose(s): To support the EPA regulatory process by providing scientific information on the health effects of environmental pollutants; to screen volunteers to protect them from unnecessary health risks, to document their medical condition, and to document the specific research activities in which the subjects participated.

Routine Uses of Records Maintained in the System, Including Categories of Users, and the Purposes of Such Uses: General routine uses D, E, F, H, and K apply to this system. Records may also be disclosed:

1. To scientists at governmental or private institutions, research centers, or businesses who assist with EPA research projects or who conduct related research (normally peer reviewed and institutional review board approved) that can benefit from access to EPA research records.
2. To public health authorities in conformity with federal, state, and local laws when necessary to protect the public health. Individuals whose records might be disclosed under this authority are normally notified of the possibility of disclosure through informed consent agreements.

Policies and procedures for storing, retrieving, retaining and Disposing of Records in the System:

• Storage: In file folders, on index cards, and in an electronic database. Some records may also be stored off site in a secure facility maintained by a contractor to the EPA Human Studies Division.

• Retrievability: By name and by identifying numbers assigned for each project.

• Safeguards: Electronic records are maintained in a secure, password protected electronic system. Paper records are maintained in lockable file cabinets. All records are maintained in secure, access-controlled areas or buildings.

• Retention and Disposal: The records are permanently maintained.

System Manager(s) and Address: Director, Human Studies Facility, Human Studies Division, National Health and Environmental Effects Research Laboratories, Office of Research and Development, Environmental Protection Agency, 104 Mason Farm Road, Chapel Hill, NC 27599.

Notification Procedures: Any individual who wants to know whether this system of records contains a record about him or her, who wants access to his or her record, or who wants to contest the contents of a record, should make a written request to the System Manager.

Access Procedure: Requesters will be required to provide adequate identification, such as a driver's license, employee identification card, or other identifying document. Additional identification procedures may be required in some instances.

Contesting Procedure: Requests for correction or amendment must identify the record to be changed and the corrective action sought. Complete EPA Privacy Act procedures are set out in 40 CFR Part 16.

Record Source Categories: Research subjects. Medical records of a research subject may be obtained occasionally with the consent of the research subject.