Distribution of Genetic Data and Biomaterials from the NIDA Center for Genetic Studies

Description and Policy for Access

Statement of Purpose

The National Institute on Drug Abuse (NIDA) Center for Genetics Studies is a repository of biosamples and associated data that was created by NIDA to advance the study of the human genetics of drug addiction vulnerability. NIDA is funding numerous human genetics research projects aimed at identifying the genes that confer susceptibility to drug abuse, drug addiction, and drug abuse-related behaviors. Since progress in scientific understanding depends upon free and open exchange of knowledge, NIDA established the NIDA Center for Genetic Studies repository to facilitate timely access by other researchers to the primary data and biomaterials generated by these studies. Analysis of the data and materials in the repository by other scientists may stimulate research, speeding the identification and characterization of the genes that contribute to addiction, and related behaviors as well as other diseases, conditions, or behaviors. Knowledge of the specific genes involved may eventually lead to development of novel therapeutic strategies and agents, and to improvement of preventive interventions.

In September 1998, NIDA issued a Request For Applications (RFA), entitled, "Genetics of Drug Addiction Vulnerability," (RFA DA-99-003) to identify human chromosomal regions containing genes that confer susceptibility to drug abuse and addiction and related behaviors. The investigators funded under this RFA formed the initial membership of the NIDA Genetics Consortium (NGC); other NIDA-funded investigators have joined subsequently. NGC members provide the NIDA Center for Genetic Studies repository with anonymized data on family structure, age, sex, clinical status, and diagnoses, as well as blood samples from which DNA and immortalized cell lines are derived. In addition, data derived from genotyping and other genetic analyses of these clinical data and biomaterials are stored in the NIDA Center for Genetic Studies repository. Data and DNA samples are distributed by the repository to qualified biomedical researchers at recognized biomedical research facilities for secondary analysis. The NGC meets regularly to discuss issues related to the collection and analyses of data from human genetic studies on drug addiction.

NIDA, in consultation with the NGC and with other members of the biomedical research community, has established procedures governing access to the materials stored in the NIDA Center for Genetic Studies repository. Access is gained by approval of an Access Request, as described in the following section.

Access to Data and Biomaterials

Researchers may gain access to clinical data, genetic analysis data, and DNA by obtaining formal approval from the NIDA Genetic Data Access Request Committee. The NIDA Genetic Data Access Request Committee is selected by NIDA staff and is composed of a bioethicist and 4 other individuals with expertise in one or more areas including human genetics, genetics of complex traits, statistical analysis, molecular genetics and drug addiction research. NIH Program and Review staff are excluded from membership on the Committee.

Procedures for access to data and DNA samples:

Applicants wishing to obtain access must submit an Access Request, which will be considered based on:

1. the experience and qualifications of the applicant principal investigator and co-investigators
2. the adequacy of research environment
3. ethical considerations
4. the applicant principal investigator's familiarity with the characteristics, limitations, and strengths of the dataset
5. the adequacy of proposed research design
6. the adequacy of the applicant principal investigator's funding resources to support the proposed study
7. A statement of public health good. Identify the public health benefits and risks of the proposed research, and describe how the findings from the proposed research would be used to promote public health.

Access requests should consist of an original and one (1) copy of the following:

1. A cover letter containing the name, mailing address, e-mail address, fax number, and telephone number of the applicant principal investigator. This letter should be written on the letterhead of the sponsoring institution at which the research will be conducted.

2. The biographical sketches of the applicant principal investigator and all co-investigators (PHS 398 format)

3. Resources and Environment (PHS 398 format)

4. Funding Information - Including source of funding, period of support, active/pending status. In lieu of the above grant information, the "Other Support" pages from a PHS 398 application may be attached.

5. A description of the study design that includes the following sections:

1. Abstract - No longer than one half page.
2. Specific Aims - Clearly state the hypotheses to be tested.
3. Background and Significance - The applicant principal investigator must justify that the hypotheses are of interest to the scientific community and that the resources of the NIDA Center for Genetic Studies are essential to the study.
4. Experimental Approach - The applicant principal investigator must include a clear description and justification of the research to be conducted including the DNA sample and data requirements, the markers to be used and the general methods of analysis. In addition, the applicant principal investigator must present evidence of a clear understanding of the limitations, strengths, and feasibility of using the dataset to address the proposed study question.
5. Statistical Analysis - The applicant principal investigator must indicate what analytical techniques will be applied, including, when relevant, power calculations to justify the numbers of DNA samples requested.

 

6. Human Subject Approval - The applicant principal investigator must document human subject approval by an Institutional Review Board (IRB or human subjects committee) constituted according to the requirements of the Dept. of Health & Human Services Office for Human Research Protections (OHRP). Applicant principal investigators should note that all data and materials in the repository were stripped of all personal identifiers before they were submitted to the repository, such that no identifying information is associated with the samples. However, applicants should provide documentation of IRB review and either approval of the proposed project or exemption of the proposed project from the need for further IRB review. The IRB approval will not be required at the time the Access Request is submitted. However, neither data nor DNA samples can be released until evidence of IRB approval has been received.

7. A completed Distribution Agreement.

8. A completed List of Requested DNA Samples and Associated Data (use attached form).

The Access Request may be faxed, but data and DNA samples will not be provided until an original signed copy of the Distribution Agreement is received. The request should be sent to:

Secretary, NIDA Genetic Data Access Request Committee
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Blvd., Room 4274
Bethesda, MD 20892-9643
Rockville, Maryland 20852 (for courier/overnight mail service)
FAX: 301-443-1887

After access certification, an electronic data file, documentation, and pedigree drawings will be sent to the applicant principal investigator. Please use the attached form to e-mail or fax a list comprised of the NIDA Repository ID number and NIDA subject ID number for each subject for which DNA is requested to the NIDA Center for Genetics Studies Project Officer designated on the form. This list will be forwarded to the NIDA Center for Genetic Studies, which will contact the applicant principal investigator regarding shipping and payment instructions.

LIST OF REQUESTED DNA SAMPLES AND ASSOCIATED DATA

Applicant Name		Date of request
Department
Telephone:
Fax
e-mail
P.O.#
FedEx Account # (Optional):
SHIPPING ADDRESS:
Name
Address
BILLING INFORMATION:
Individual placing the order:
Department
Telephone
BILLING ADDRESS:
Academic _____ NonProfit _____ Industry _____ Govt _____

Email or fax this completed form to the NIDA Center for Genetic Studies Project Officer: