09-25-0209 SYSTEMS LISTING

Subject-Participants in Drug Abuse Research Studies on Drug Dependence and in Research Supporting Investigational New Drug and New Drug Applications, HHS/NIH/NIDA.

None.

Veterans Administration Hospital, Cooperative Studies Program, Department of Veterans Medical Center, Perry Point, MD 21902.

Division of Treatment Research and Development, National Institute on Drug Abuse (NIDA), Neuroscience Center, Room 4123, 6001 Executive Boulevard, Bethesda, MD 20892.

Division of Intramural Research Programs, National Institute on Drug Abuse (NIDA), 4940 Eastern Avenue, Baltimore, MD 21224.

Write to the System Manager at the address below for the address of any new locations where records from this system may be stored.

Voluntary clients of Federally funded and other drug abuse treatment programs who have requested to receive investigational new or marketed drugs, such as but not limited to, naltrexone, levo-alpha acetylmethadol (LAAM), buprenorphine, disulfiram, selegiline, bupropion, and GBR-12909 as part of their treatment. Data collection will continue through calendar year 2010.

Demographic data, treatment outcome data, treatment process data, client locator information, and personal identifiers (name and assigned numerical identifier).

Public Health Service Act, Sections 301, 464p, and 405 (42 U.S.C. 241, and 284).

1. To maintain information on the safety and effectiveness of drugs for treatment of drug dependence with or without abuse potential in various treatment environments and modalities and changes in the behavior and characteristics of drug abusers who received these substances as part of their treatment regimen.
2. To provide data required by the Food and Drug Administration (FDA) to support research on drug dependence, Investigational New Drug Applications (INDs) and potential New Drug Applications (NDAs) for various drugs, and to treat drug dependence with or without abuse potential. A new drug application is a notice to FDA that a pharmaceutical company believes they have enough data to demonstrate the safety and efficacy of a substance to satisfy FDA for marketing the substance. FDA may also use the records in routine inspections that FDA conducts in accordance with its responsibilities to develop standards on the composition, quality, safety and efficacy of drugs administered to humans, and to monitor experimental usage of drugs.
3. To conduct research on the pharmacology, toxicology, and behavioral characteristics of drugs of abuse alone or in combination with proposed treatment drugs.

NIH contractor(s) and/or interagency collaborators (i.e. Department of Veteran’s Affairs) use the records in the system to accomplish the research and development purposes for which the records were collected. In the event of a followup study or continuation study, the responsible project officer may disclose records in this system to a subsequent NIH contractor(s). Any new contractor(s) is and would be required to maintain Privacy Act safeguards with respect to such records and to comply with the confidentiality restrictions of 42 CFR Part 2.

Interview and assessment forms, video tapes, magnetic tapes, disks and microfiche in boxes in closed cabinets in a locked room with limited accessibility.

The records are indexed and retrieved by subject-participant's name code (i,e., initials--not name) and unique numerical identifier. In order to relate the data collected to specific individuals, however, one must use the link file discussed under safeguards.

1. Authorized Users: For all of the studies, the System Manager or Federal Project Officer and only authorized contract staff have access to the records (computerized and hard copy files) in the system. The contractor provides only aggregate data in reports to NIDA, FDA, or the public. Only the NIDA personnel mentioned previously and selected authorized contract staff, have access to the stored records. A certificate of confidentiality is issued to researchers conducting these studies under 42 CFR, Part 2, Protection of Identity--Research Subjects. 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 the 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 proceedings to identify such individuals. These regulations do not prohibit voluntary disclosure by the researcher. However, the records of these studies also are subject to 42 CFR Part 2, the Confidentiality of Alcohol and Drug Abuse Patient Records Regulations (42 CFR Part 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 of in response to any legal process whether Federal or State." The contractor's institutional review board reviewed and approved the safeguards described above in accordance with 45 CFR Part 46 on the Protection of Human Subjects.
2. Physical Safeguards: For the study records, the contractor(s) stored individually identified forms in a locked room with controlled entry, i.e., only on written authority of the professional staff member in charge of data handling and processing). The contractor staff enters the collected information onto computer systems or disks as soon after contact with the subject-participant as possible, and stores the computerized records in a secured area with access limited as above.

For the study records, NIDA stores any individually identified forms in a lockable cabinet in a secure room. Only authorized NIDA personnel (i.e., select members of the Division of Treatment Research and Development professional staff and their support staff have access to the room with controlled entry. The room is in a building which has a 24-hour guard/television surveillance system and has controlled entry (picture identification sign in and out procedures) before and after normal working hours.

Another safeguard for these studies is that the forms containing subject identification information do not include any reference to the purpose of the study. The identification information is separate from any information that would suggest that the respondent is or has been in a drug abuse treatment program. In addition, the computer centers being utilized for data analyses have developed an extensive security system to protect computer account codes and data.

3. Procedural Safeguards: Access to the computerized records of the studies is protected by a computerized password routine which is changed periodically. In addition, the project staff complies with the contractor's standard procedures for safeguarding data. The link file system that identifies individuals with personal data has three components: (1) identification information, (2) data base information, and (3) the link file, which contains identifying number pairs which match data with individuals. The advantage of this system is that one may use the baseline data directly for report generation, etc., without using the subroutines or accessing the personal information or link files.
4. 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.

NIDA will destroy identifiable information by shredding or burning when it is no longer needed for analysis or research purposes; then the tapes, and/or other electronic media, will be erased. NIDA will destroy individual identification and match-up information from other studies by shredding or burning five years after FDA completes the review and approves the new drug applications or when they are no longer needed for research purposes.

NIDA will retain the aggregate data tapes, and/or other electronic media, and/or paper records from studies for research purposes. These tapes will not have any individually identifiable information. In accordance with the FDA regulations governing new drug applications, the aggregate tapes will be retained for at least two years after FDA approves the new drug applications or the IND is withdrawn. At that time, the tapes will be retired to the Federal Records Center and destroyed when they are five years old or when they are no longer needed for research purposes.

Chief, Regulatory Affairs Branch, Division of Treatment Research and Development, National Institute on Drug Abuse (NIDA), Neuroscience Center, Room 4123, 6001 Executive Boulevard, Bethesda, MD 20892.

An individual may determine if a record exists about himself/herself upon written request, with notarized signature if request is made by mail, or with suitable identification if request is made in person, to the appropriate system manager at the address above. The following information should be included, if known: subject-participant's full name and a letter of request with notarized signature of the subject-participant of the record, any alias used, subject-participant's identification number, name of the researcher, name of clinic or research center, name of substance, and approximate date of study participation.

An individual who requests notification of a medical record must, 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.

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

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

Research subject-participants, staff in the participating drug abuse treatment programs, written clinical evaluations, private physicians, counselors, psychiatrists, psychotherapists, family members, research assistants, and hospital records.

None.