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.
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.
CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
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.
CATEGORIES OF RECORDS IN THE SYSTEM:
Demographic data, treatment outcome data, treatment process data, client locator information, and personal identifiers (name and assigned numerical identifier).
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Public Health Service Act, Sections 301, 464p, and 405 (42 U.S.C. 241, and 284).
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES:
NIH contractor(s) and/or interagency collaborators (i.e. Department of Veteranís 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.
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM:
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.
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.
RETENTION AND DISPOSAL:
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.
SYSTEM MANAGER(S) AND ADDRESS(ES):
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.
RECORD ACCESS PROCEDURE:
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.
CONTESTING RECORD PROCEDURE:
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.
RECORD SOURCE CATEGORIES:
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.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT: