09-25-0203 SYSTEMS LISTING

National Institute on Drug Abuse, Intramural Research Program, Federal Prisoner and Non-Prisoner Research Files, HHS/NIH/NIDA.

None.

Intramural Research Program, National Institute on Drug Abuse (NIDA), P.O. Box 5180, Baltimore, MD 21224.

NIDA Warehouse, 5550 Eastern Avenue, Baltimore, MD 21224.

Quest, Pathology Building, 1901 Silver Spring Road, Baltimore, MD 21227.

Federal Records Center, 1557 St. Joseph Avenue, East Point, GA 30344.

Washington National Records Center, 4205 Suitland Road, Washington, D.C. 20409.

NOVA, Johns Hopkins Bayview Medical Center, Building C, 5500 Nathan Shock Drive, Baltimore, MD 21224.

Iron Mountain, 8200 Preston Court, Suite One, Jessup, MD 20794.

Volunteers, adult males (from 1968 to present), adult females (beginning in l985) and adolescents (ages 13-18, beginning in 1983) and children (neonate to 12 beginning in 1989). Clinical research projects conducted at the Addiction Research Center (ARC). This system also includes records on adult Federal prisoners involved in research projects at ARC when located at Lexington, Kentucky, from 1968-1976, and some records from system 09-30-0020 to be used for statistical research only.

The categories of records involved are administrative, medical and research records.

Public Health Service Act, Section 301(a) (42 U.S.C. 241(a)); Sections 341(a) and 344(d) (42 U.S.C. 257(a) and 260(d)); Sections 503 and 515 (42 U.S.C. 290aa-2 and 290cc). These sections authorize the conduct of research in all areas of drug abuse.

1. To collect and maintain a data base for research activities at NIDA/IRP.
2. To enable Federal drug abuse researchers to evaluate and monitor the subjects' health during participation in a research project. The areas of research include, but are not limited to, biomedical, clinical, behavioral, pharmacological, psychiatric, psychosocial, epidemiological, etiological, statistical, treatment and prevention of narcotic addiction and drug abuse.

1. The National Institute on Drug Abuse (NIDA) uses a contractor to recruit volunteers and to screen these individuals for their acceptability to participate in specific research projects, and limits the contractor's access to the records to these procedures. NIDA also uses a contractor to perform routine medical laboratory tests on blood and urine samples. These routine tests verify that the subject is in good health. Both contractors disclose records from this system only to NIDA and are required to maintain Privacy Act safeguards with respect to such records.
2. (a) PHS may inform the sexual and/or needle-sharing partner(s) of a subject individual who is infected with the human immunodeficiency virus (HIV) of their exposure to HIV, under the following circumstances: (1) The information has been obtained in the course of clinical activities at PHS facilities carried out by PHS personnel or contractors; (2) The PHS employee or contractor has made reasonable efforts to counsel and encourage the subject individual to provide the information to the individual's sexual or needle-sharing partner(s); (3) The PHS employee or contractor determines that the subject individual is unlikely to provide the information to the sexual or needle-sharing partner(s) or that the provision of such information cannot reasonably be verified; and (4) The notification of the partner(s) is made, whenever possible, by the subject individual's physician or by a professional counselor and shall follow standard counseling practices.

   (b) PHS may disclose information to State or local public health departments, to assist in the notification of the subject individual's sexual and/or needle-sharing partner(s), or in the verification that the subject individual has, notified such sexual or needle-sharing partner(s).

    

Data may be stored in file folders or on an internal EISnet, CDS, computer disk, magnetic tape, or microfilm.

Administrative and medical records are indexed and retrieved by the subject's name and identification code number. Research records are indexed and retrieved by the subject's name and identification code number.r.

1. Authorized Users: Only authorized NIDA Intramural Research Program staff are allowed access to these files.
2. Physical Safeguards: Files and file rooms are locked after business hours. Building has electronic controlled entry at all times with a 24-hour guard/television surveillance system. The computer terminals are in a further secured area.
3. Procedural Safeguards: All users of personal information in connection with the performance of their jobs protect information from unauthorized personnel. Access codes to the research records are available only to the Principal Investigator and his/her research team. Access to the records is strictly limited to those staff members trained in accordance with the Privacy Act. The contractor staff members are required to secure the information in accordance with the Privacy Act. Project Officer and contracting officials will monitor contractor compliance.
4. Access to the Clinical Data Warehouse (EISnet): The NIDA IRP computerized medical and research record is strictly limited. All staff must be authorized to use the system and be granted an access code (user name and password) by the system sponsor (NIDA, IRP Chief of Biomedical Informatics). Passwords are required to be changed every six months. Access is limited by job classification and is on a need to know basis only. Data entered is time and date stamped by the staff member’s name. Data is not altered once entered. While logged into the system, the name of the staff member is displayed on the screen. An activity log of each use is kept. Data is backed up on a daily basis.
5. Implementation Guidelines: These practices are in compliance with the standards of Chapter 45-13 of the HHS General Administration Manual, "Safeguarding Records Contained in Systems of Records," supplementary Chapter PHS hf: 45-13, and the HHS Automated Information Systems Security Program Handbook.

In addition, because much of the data collected in these research projects are sensitive and confidential, special safeguards have been established. Certificates of confidentiality have been issued under Protection of Identity - Research Subjects Regulations (42 CFR Part 2a) to those projects initiated since February 1980. This authorization enables persons engaged in research on mental health, including research on the use and effect of psychoactive drugs, to protect the privacy of research subjects by withholding their names or other identifying characteristics from all persons not connected with the conduct of the research. Persons so authorized may not be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding to identify such individuals. In addition, these records are subject to 42 CFR Part 2, the Confidentiality of Alcohol and Drug Abuse Patient Records Regulations (42 CFR 2.56), which state: "Where the content of patient records has been disclosed pursuant to these regulations for the purpose of conducting scientific research...information contained therein which would directly or indirectly identify any patient may not be disclosed by the recipient thereof either voluntarily or in response to any legal process whether Federal or State."

Records will be disposed of in accordance with the NIH Records Control Schedule, i.e., when the records are ten years old or no longer required for administrative or research purposes.

Medical Records Officer, Intramural Research Program, National Institute on Drug Abuse (NIDA), Johns Hopkins Bayview Medical Center, Building C, P.O. Box 5180, Baltimore, MD 21224.

To determine if a record exists, write to the System Manager at the address above. Provide a notarized signature as proof of identity. This can be waived if the request is made through official Federal, state, or local channels. The request should include the patient's register number and/or the number of years of incarceration (for prisoner subjects), full name at time of participation in the research project, date(s) of research participation, and title of research project or name of drug being studied. An individual who requests notification of a medical record shall, at the time the request is made, designate in writing a responsible representative who will be willing to review the record and inform the subject individual of its contents at the representative's discretion.

A parent or legal guardian who requests notification of an adolescent's record shall designate a family physician or other health professional (other than a family member) of the Addiction Research Center staff to whom the record, if any, will be sent. The parent or legal guardian must verify in writing the relationship to the adolescent as well as his/her own identity.

Same as Notification Procedures. Requesters should also reasonably specify the record contents being sought. An individual may also request an accounting of disclosures that have been made of his/her records, if any.

Contact the official at the address specified under Notification Procedures above and reasonably identify the record, specify the information being contested, and state the corrective action sought and reasons for requesting the correction, along with supporting information to show how the record is inaccurate, incomplete, untimely, or irrelevant.

The individual; observations and medical recordings (such as blood pressure, dosage of compound administered, etc.) made by the Principal Investigator and his/her research team; system of records number 09-30-0020; drug treatment programs; Bureau of Prisons; case workers; psychiatrists; research laboratories; and pharmacies and hospitals. Many of these records are confidential and privileged communication is guaranteed under Section 344(d) of the PHS Act.

None.