Defense Privacy and Civil Liberties Office

U.S. Department of Defense

System of Record Notices (SORNs)

DOD Component Notice

Defense Health Agency

EDHA 18

SYSTEM NAME:

Research Regulatory Oversight Records  (November 18, 2013,  78 FR 69076)

SYSTEM LOCATION:

Deputy Assistant Secretary of Defense (Force Health Protection and Readiness Programs), Research Regulatory Oversight Office, Skyline 4, Suite 901, 5113 Leesburg Pike, Falls Church, VA 22041-3206.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:

Military, civilian, and contractor investigators who engage in or conduct research involving human participants; and military, civilian, or contractor personnel, including civilian or contractor personnel from other Federal agencies, responsible for the review, approval, and regulatory oversight of such research.

CATEGORIES OF RECORDS IN THE SYSTEM:

Name, work address, work email, work telephone number, resume, and documentation of training required to conduct research involving human participants or necessary to conduct review, approval, and regulatory oversight of such research.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

10 U.S.C. 136, Under Secretary of Defense for Personnel and Readiness; 32 CFR 219, Protection of Human Subjects; DoD Directive 5136.01, Assistant Secretary of Defense for Health Affairs (ASD(HA)); and DoD Directive 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD Supported Research.

PURPOSE(S):

To document proper training and qualifications of those individuals conducting and reviewing research involving human participants.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES:

In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974, these records may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:

To Federal, State, local, or foreign government agencies for identification, tracking, and oversight of authorized research procedures and tracking of individual researchers and reviewers involved in the process.

To private business entities for matters relating to eligibility, quality assurance, peer review, and program integrity.

The DoD ‘Blanket Routine Uses’ set forth at the beginning of the Office of the Secretary of Defense (OSD) compilation of systems of records notices apply to this system.

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM:


STORAGE:

Paper file folders and electronic storage media.

RETRIEVABILITY:

Individual’s name.

SAFEGUARDS:

Media, data and/or records are maintained in a controlled area. The computer system is accessible only to authorized personnel. Entry into these areas is restricted to those personnel with a valid requirement and authorization to enter. Physical entry is restricted by the use of locks, passwords which are changed periodically, and administrative procedures. The system provides two-factor authentication including Common Access Card and password. Access to personal information is restricted to those who require the data in the performance of their official duties, and have received proper training relative to the Privacy Act of 1974 and Information Assurance.

RETENTION AND DISPOSAL:

Records are retained for 10 years after completion or termination of the research protocol (coincides with the term of the research) and then destroyed.

SYSTEM MANAGER(S) AND ADDRESS:

Program Manager, Deputy Assistant Secretary of Defense (Force Health Protection and Readiness Programs), Research Regulatory Oversight Office, Skyline 4, Suite 901, 5113 Leesburg Pike, Falls Church, VA 22041-3206.

NOTIFICATION PROCEDURE:

Individuals seeking to determine whether information about themselves is contained in this system of records should address written inquiries to the Program Manager, Deputy Assistant Secretary of Defense (Force Health Protection and Readiness Programs), Research Regulatory Oversight Office, Skyline 4, Suite 901, 5113 Leesburg Pike, Falls Church, VA 22041-3206.

Requests should contain the full name of the individual, work address, work telephone number, and must be signed.

RECORD ACCESS PROCEDURES:

Individuals seeking access to information about themselves contained in this system of records should address written inquiries to TRICARE Management Activity, Attention: Freedom of Information Act Requester Service Center, 16401 East Centretech Parkway, Aurora, CO 80011-9066.

Requests must include the name and number of this system of record notice, individual’s name and address, and must be signed.

CONTESTING RECORD PROCEDURES:

The OSD rules for accessing records, for contesting contents and appealing initial agency determinations are published in OSD Administrative Instruction 81; 32 CFR Part 311; or may be obtained from the system manager.

RECORD SOURCE CATEGORIES:

Individual.

EXEMPTIONS CLAIMED FOR THE SYSTEM:

None.

FEDERAL REGISTER HISTORY:

June 29, 2011, 76 FR 38110; November 18, 2013, 78 FR 69076