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Privacy Act of 1974; Medical and Research Study Records of Human Volunteers System of Records

Note: EPA no longer updates this information, but it may be useful as a reference or resource.






[Federal Register: February 6, 1997 (Volume 62, Number 25)]
[Notices]               
[Page 5625-5627]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-5681-6]

 
Privacy Act of 1974; Medical and Research Study Records of Human 
Volunteers System of Records

Agency: Environmental Protection Agency.

ACTION: Proposed new Privacy Act system of records.

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SUMMARY: The Environmental Protection Agency (EPA) is publishing a 
notice for public comment on a system of records subject to the Privacy 
Act of 1974, 5 U.S.C. 552a. This system is entitled ``Medical and 
Research Study Records of Human Volunteers.'' Additional information on 
this system is described in the Supplementary Information section of 
this notice.

EFFECTIVE DATE: This notice shall become effective, without further 
notice on March 18, 1997, unless comments are received which dictate a 
contrary determination.

ADDRESSES: Comments should be addressed to the Director, Human Studies 
Division, Office of Research and Development, U.S. EPA Human Studies 
Facility, 104 Mason Farm Road, Chapel Hill, N.C. 27599-7315.

FOR FURTHER INFORMATION CONTACT: Dr. Hillel S. Koren, Director, Human 
Studies Division, U.S. EPA Human Studies Facility, 104 Mason Farm Road, 
Chapel Hill, N.C. 27599-7315. Tel. (919) 966-6200.

SUPPLEMENTARY INFORMATION: The EPA human research program examines the 
effects of exposure to environmental pollutants on human subjects. The 
studies will provide information needed to improve assessments of 
exposure, biologically relevant doses, and adverse health effects. 
Thus, the studies are used primarily to support EPA's regulatory 
process by providing scientific information on the health effects of 
environmental pollutants. The records will be used 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.
    All EPA human studies research protocols are subject to an 
extensive review and approval process before any research is begun. 
This includes review and approval by the investigators' peers and 
supervisors, by an independent Institutional Review Board, and by the 
EPA Office of Research and Development. Protocols are also reviewed by 
the Agency Approving

[[Page 5626]]

Official to assure that all Federal rules and regulations regarding 
safety and ethical requirements are met.
    Individuals who volunteer for human subject research are required 
to be fully informed of the nature of the research and the risks 
involved. EPA will also provide each participant with the Privacy Act 
notice required by subsection 552a(e)(3) of that Act, 5 U.S.C. 
552a(e)(3).

    Dated: November 12, 1996.
 Alvin M. Pesachowitz,
Acting Assistant Administrator for Administration and Resources 
Management.
EPA-34

System Name:
    Medical and Research Study Records of Human Volunteers--EPA/ORD.

Security Classification:
    None.

System Location:
    U.S. EPA Human Studies Facility, 104 Mason Farm Road, Chapel Hill, 
N.C. Storage space limitations at this location may result in some 
records being maintained at the Federal Records Facility in Atlanta, 
GA. Some records, particularly back-up data, are stored off site in a 
secure facility maintained by a contractor to the EPA Human Studies 
Division.

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:
    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):
    The primary purpose of this system of records is to support the EPA 
regulatory process by providing scientific information on the health 
effects of environmental pollutants. The records will be used 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 Purpose of Such Uses:
    Routine use disclosures of records in this system may be made as 
follows:
    1. To EPA contractors, grantees, and persons working under 
cooperative agreements who have been engaged to assist EPA in the 
performance of an activity related to this system of records and who 
need to access the records in order to perform the activity. This 
includes, but is not limited to, disclosures to members of the Public 
Health Service Commissioned Corps and to scientists working under 
cooperative agreements with EPA to perform research for the Agency.
    2. To a Member of Congress or a congressional office in response to 
any inquiry from that Member or office made at the request of the 
individual to whom the record pertains.
    3. To the Department of Justice to the extent that each disclosure 
is compatible with the purpose for which the record was collected and 
is relevant and necessary to actual or anticipated litigation in which 
one of the following is a party or has an interest: (a) EPA or any of 
its components, (b) an EPA employee in his or her official capacity, 
(c) an EPA employee in his or her individual capacity where the 
Department of Justice is representing or considering representation of 
the employee, or (d) the United States where EPA determines that the 
litigation is likely to affect the Agency.
    4. In a proceeding before a court, or other adjudicative body or 
grand jury or in an administrative or regulatory proceeding, to the 
extent that each disclosure is compatible with the purpose for which 
the record was collected and is relevant and necessary to the 
proceeding in which one of the following is a party or has an interest: 
(a) EPA or any of its components, (b) an EPA employee in his or her 
official capacity, (c) an EPA employee in his or her individual 
capacity where the Department of Justice is representing or considering 
representation of the employee, or (d) the United States where EPA 
determines that the litigation is likely to affect the Agency.
    5. To scientists at governmental or private institutions, research 
centers, and businesses to further EPA's mission in connection with 
human studies research.
    6. To public health authorities in conformity with Federal, state, 
and local laws when necessary to protect the public health.

Policies and Procedures for Storing, Retrieving, Retaining and 
Disposing of Records in the System:
Storage:
    Records are stored in file folders, index cards, and magnetic 
media.

Retrievability:
    Records are indexed and retrieved by the names of individual 
subjects and by identifying numbers.

Safeguards:
    Access is limited to EPA, Public Health Service, and EPA contractor 
personnel on a strict need to know basis. Contractors will be required 
to maintain the records in accordance with the requirements of the 
Privacy Act. All records are maintained in locked file cabinets, in 
locked rooms at all times in buildings with controlled access. Computer 
files are further protected by passwords.

Retention and Disposal:
    The records are maintained for seventy-five (75) years.

System Manager(s) and Address
    Director, Human Studies Division, U.S. EPA Human Studies Facility, 
104 Mason Farm Road, Chapel Hill, NC. 27599-7315.

Notification Procedures:
    Write to the System Manager at the above address. The requester 
must provide a written statement that he or she is the person he or she 
claims to be and understands that knowingly and willfully requesting or 
obtaining a record under false pretenses is a criminal offense subject 
to a fine of up to $5,000. The System Manager may require additional 
information to verify the identities of requesters.

Record Access Procedures:
    Same as notification procedures. Additionally, requesters should 
specify the particular records sought.

Contesting Record Procedures:
    Same as notification procedures. Additionally, requesters should 
specify the information contested, state the corrective action sought, 
and provide support for the action requested.

[[Page 5627]]

Record Source Categories:
    Individual subjects and research staff.

Systems Exempted from Certain Provisions of the Act:
    None.

[FR Doc. 97-2996 Filed 2-5-97; 8:45 am]
BILLING CODE 6560-50-P

 
 

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