SYSTEM NAME:

Research Regulatory Oversight Records  (July 15, 2014,  79 FR 41265)

SYSTEM LOCATION:

Health Readiness Policy and Oversight, Defense Health Agency, 7700 Arlington Boulevard, Suite 5101, Falls Church, VA 22042-5101.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:

Military, civilian and contractor investigators who engage in or conduct DoD-supported research involving human or animal subjects; and military, civilian or contractor personnel from other Federal agencies, responsible for the review, approval, and regulatory oversight of DoD-supported research involving human or animal subjects.

CATEGORIES OF RECORDS IN THE SYSTEM:

Name, work and home address; work and personal e-mail; work and personal telephone number, resume, employment information.  Documentation of training and certifications required to conduct research involving human or animal subjects or necessary to conduct review, approval, and regulatory oversight of such DoD-supported 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); DoDI 3216.01, Use of Animals in DoD Programs; and DoDI 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD Supported Research.

PURPOSE(S):

To collect information on the training and qualifications of those individuals conducting research involving human and/or animal subjects.

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, as amended, 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 may apply to this system of records.

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

STORAGE:

Paper records and/or 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, Health Readiness Policy and Oversight, Defense Health Agency, 7700 Arlington Boulevard, Suite 5101, Falls Church, VA 22042-5101.

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, Health Readiness Policy and Oversight, Defense Health Agency, 7700 Arlington Boulevard, Suite 5101, Falls Church, VA 22042-5101.

Requests should contain the name and number of this system of records notice individual’s full name, work address, work telephone number and signature.

RECORD ACCESS PROCEDURES:

Individuals seeking access to information about themselves contained in this system of records should address written inquiries to the Chief, Freedom of Information Act Service Center, Defense Health Agency Privacy and Civil Liberties Office, 7700 Arlington Boulevard, Suite 5101, Falls Church, VA 22042-5101.

Requests must include the name and the number of this system of record notice, the individual’s full name, work address, work telephone number, and signature.

CONTESTING RECORD PROCEDURES:

The Office of the Secretary of Defense (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; July 15, 2014, 79 FR 41265.