Access to Data and Biomaterials
The National Institute of Mental Health (NIMH) Repository and Genomics Resource (RGR) is devoted to the collection and distribution of family data for the genetic analysis of schizophrenia, bipolar I disorder, depression, Alzheimer's disease, autism, obsessive-compulsive disorder, and other mental disorders as part of the NIMH Human Genetics Initiative. Anonymous data on family structure, age, sex, clinical status, and diagnosis ("clinical data"), DNA samples and cell line cultures ("biomaterials"), and data derived from genotyping and other genetic analyses of these clinical data and biomaterials ("genetic analysis data"), are distributed to qualified researchers studying the genetics of mental disorders and other complex diseases at recognized biomedical research facilities.
Researchers may gain access to clinical data, genetic analysis data and biomaterials under one of two conditions: (1) a peer-reviewed NIMH research grant to analyze these data is awarded. In this circumstance, there is no charge to obtain DNA samples or lymphoblastoid cell lines; or (2) certification as a qualified investigator to access the data and biomaterials is obtained. In this circumstance, DNA samples or lymphoblastoid cell lines may be obtained from the NIMH RGR after payment of all access fees as described in paragraph 10 of the Distribution Agreement.
NIMH Support for Research using RGR Resources
The Genetic Basis of Schizophrenia, Mood, and Other Brain Disorders Program in the NIMH's Genetics Research Branch (GRB) supports interdisciplinary research on the localization and identification of genes that influence susceptibility to serious brain disorders. Technical assistance in developing a grant application to analyze data from the Human Genetics Initiative may be obtained by contacting Dr. Thomas Lehner, the chief of this Program. The Developmental Neurobiology Program in the Molecular, Cellular, and Genomic Neuroscience Research Branch (MCGNRB) supports research utilizing induced pluripotent stem cells (iPSCs) and related patient-derived reprogrammed cells. Technical assistance in developing a grant application to derive or study these cells may be obtained by contacting Dr. David Panchision, the chief of this Program.
Instructions for Access to RGR Data and Biospecimens
Requests for access to data and/or biospecimens from the NIMH RGR should be made through the online portal.
- Requests must be submitted through the online portal under the Principal Investigator's log in who is requesting access to the distribution (the PI signing the Distribution Agreement). *Please note that the Principal Investigator status does not apply to students or post-docs. Post-docs and students may access the data; however such requests must be submitted through their Principal Investigator(s).*
- The PI will need to have an Nimhgenetics account to log in to the online portal. If the PI does not have an account, please create one from Create Account. Accounts must be created using an email account associated with the requesting institution. Open accounts, such as Yahoo or Gmail, cannot be used.
All data and/or biospecimen access requests should consist of the following information compressed in a zip file for upload into the online portal:
- COVER LETTER: A cover letter containing the name, mailing address, e-mail address, fax number, and telephone number of the applicant principal investigator (PI). This letter should be written on the letterhead of the sponsoring institution at which the research will be conducted and signed by PI. Within the text of the letter, specify which data set is requested. Data sets are separated by disease, with the exception of those focused on iPSCs and their source cells, which are grouped separately and not by disease. Indicate if the proposed analysis is funded and list the funding organization and grant number, or indicate whether the project is not funded (e.g., institutionally supported), but will form the basis for a new grant application – if the latter, indicate to which NIH institute the application may be submitted.
- BIOSKETCH(ES): The biographical sketches of the applicant PI and all co-investigators (PHS 398 format). *Note: All co-investigators must be affiliated with the requesting PI's institution. If a co-investigator is not affiliated with the requesting PI's institution, an additional Distribution Agreement must be executed by the co-investigator and his/her institution.*
- RESOURCES AND ENVIRONMENT: Resources and Environment (PHS 398 format or short paragraph providing required information).
- 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.
- STUDY DESCRIPTION: A description of the study design that includes an abstract, background, and significance of approximately one page.
- DISTRIBUTION AGREEMENT: A Distribution Agreement signed by PI and Institutional Signing Official. (After Data Access Committee approves request, remaining signatures will be obtained by NIMH and a fully executed copy will be returned to signing institution upon request.) Note that iPSCs or similar reprogrammed biomaterials may be the subject of a patent application or covered by patent rights in one or more countries. Except as provided in this Agreement, no express or implied licenses to such patent rights are provided. For-profit entities in particular should ensure that they obtain appropriate licenses for use of such biomaterials prior to signing the Distribution Agreement.
DATA/RESOURCE SHARING PLAN (applicable mainly for biospecimen requests):
-(General Sample Request): Using the sharing plan template, state what data you will deposit in an NIMH/NIH designated database such as dbGaP and on what timeline will data deposition occur (e.g., data deposited at 9 month intervals after data validation). If you will be submitting data to dbGaP, please also complete and include the dbGaP study registration documents (Instruction Guide, Submission Certificate Template).
-(Fibroblast and/or iPSC Requests): If generating renewable derivatives of NIMH RGR biospecimens (e.g., iPSCs from banked fibroblasts, genetically modified versions of iPSCs), provide a timeline for submission of these derived biomaterials back to the NIMH RGR. All submissions should be complete by the project end date, to be released to the research community under the governance of NIH after the project end date.
- *For CommonMind Requests ONLY*: Synapse data access token. Please see instructions here.
- *For PsychENCODE Requests ONLY*: Synapse data access token. Please see instructions here.
For questions regarding the application process, please contact Nicole North at firstname.lastname@example.org.
Review Process for Access Requests
All requests for access to data and biospecimens from the NIMH RGR will be reviewed by a trans-NIH Data Access Committee consisting of NIH Program Staff from NIDA, NIAAA, and NIMH. Each access request will be considered based on the following by the Data Access Committee:
- The experience and qualifications of the applicant PI and co-investigators;
- Ethical considerations;
- The applicant PI’s familiarity with the characteristics, limitations, and strengths of the dataset/biospecimens;
- The adequacy of the proposed research design;
- The adequacy of the research environment;
- The adequacy of the applicant PI’s funding resources to support the proposed study and;
- The adequacy of the applicant PI’s agreement on data sharing as stipulated in the data/resource sharing plan.
Requesters will be informed of the Data Access Committee decision by email. Approved requests will include further instructions to access the authorized data and biospecimens.