Access to Data and Biomaterials

Background

The National Institute of Mental Health (NIMH) Repository and Genomics Resource (RGR) is devoted to the collection and distribution of data for the genetic analysis of mental health disorders (e.g. schizophrenia, bipolar disorder, depression, Alzheimer's disease, autism, obsessive-compulsive disorder, etc.) 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 apply to gain access to clinical data, genetic analysis data and/or biomaterials by following the instructions provided below.

For approved requests, biomaterials may be obtained from the NIMH RGR after payment of all access fees as described in paragraph 10 of the Distribution Agreement.

Please note that access fees may be waived for NIMH investigators requesting biomaterials in reference to an active grant. Please contact the NIMH Genomics Resources Program Office for further details.

For questions regarding available biosamples, please contact the RGR at Rutgers: nimh@dls.rutgers.edu

NIMH Support for Research using RGR Resources

Technical assistance in developing a grant application to analyze data from the Human Genetics Initiative may be obtained by contacting the Genomics Resources Program Office. 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 the Program Chief, Dr. David Panchision.

Instructions for Access to RGR Data and Biospecimens

  1. Regardless of funding, all requests for access to data and/or biospecimens from the NIMH RGR should be made through the online portal.
    1. Access requests must be submitted under the NIMHgenetics.org account of the Principal Investigator (PI) who is requesting access to the distribution (the PI signing the Distribution Agreement). *Please note that the Principal Investigator status applies only to those conducting independent research and does not apply to students, post-docs, or research associates/lab managers. Members of a PI(s) group may access the data, however, such requests must be submitted through their PI(s).*
    2. If the PI does not have an NIMHgenetics.org account, they should create one from the Create Account page. Accounts must be created using an email account provided by the requesting PIs institution. *Open accounts, such as Yahoo or Gmail, cannot be used. If you have previously registered with such an account, we ask you to either re-register with your institutional email address or contact us at NIMH.genomics.resources@mail.nih.gov to request the email for your account be changed prior to submitting your request.*
    3. Co-investigators named in a request should 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 executed by the co-investigator and his/her institution must be provided and a separate request may need to be executed.*
  2. All data and/or biospecimen access requests should consist of the following documents compressed in a zip file for upload into the online portal. *Please verify that your zip file opens correctly on both Windows and Mac platforms and contains all documents prior to upload.*
    1. COVER LETTER: This letter should:
      1. Contain the name, mailing address, email address, fax number, and telephone number of the applicant principal investigator (PI).
      2. Be written on the letterhead of the sponsoring institution at which the research will be conducted and signed by PI.
      3. Specify which data set is requested - please refer to the list provided when specifying your choice and only select those distributions necessary for your proposed research.
      4. *If you are requesting sample access for a research project not supported through NIMH, please indicate your intention to pay all access fees.*
      5. Explain the role of any persons for whom additional biosketches are uploaded.
    2. BIOSKETCH(ES): The biographical sketches of the applicant PI and all co-investigators must be uploaded. Please follow the format described in section 4.6 of the PHS 398 instructions. *Note: All co-investigators should 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 and they may need to execute a separate access request.*
    3. RESOURCES AND ENVIRONMENT: A paragraph or two (no more than a page) describing the applicable information requested in section 4.7 of the PHS 398 instructions.
    4. FUNDING INFORMATION: 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 it is the latter, please indicate to which NIH institute the application may be submitted. This section should include all sources of funding for the request, with period of support and active/pending status.
    5. STUDY DESCRIPTION: An approximately one page description of the study design that includes an abstract, background, and significance.
    6. DISTRIBUTION AGREEMENT: A Distribution Agreement signed by PI and Institutional Signing Official. After the Data Access Committee approves the request, the remaining signatures will be obtained by NIMH and a fully executed copy will be returned to signing institution upon request. An agreement must be provided for each separate institution included in the 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.
    7. DATA/RESOURCE SHARING PLAN: This is required ONLY for biosample requests. A sharing plan may be requested for data access depending on the proposed analysis. Please see the sharing plan example provided. The plan must include:
      1. What data/analyses you will deposit in an NIMH/NIH designated database such as (e.g., dbGaP, NDA, etc.)
      2. On what timeline will data/analysis 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).
      3. 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.
    8. SYNAPSE Data Access Token: *Please note that a Synapse token must be obtained and submitted in your request for all investigators who plan to analyze the data. This is required ONLY for data requests utilizing data from the following consortia:*
      1. CommonMind - Please see instructions here.
      2. PsychENCODE - Please see instructions here.
      3. Brain Somatic Mosaicism Network - Please see instructions (coming soon).

Please be thorough when compiling your request packet. Much of this information will be necessary for you to properly complete the online access request form for our database. Your packet must match what you indicate in the access request form. For questions regarding the application process, please contact the NIMH Genomics Resources Support Team at NIMH.genomics.resources@mail.nih.gov.

*YOU WILL BE CONTACTED BY THIS TEAM IF ANY REQUIRED INFORMATION IS MISSING FROM YOUR APPLICATION. FAILURE TO RESPOND TO REQUESTS FOR MORE COMPLETE INFORMATION WILL RESULT IN A DENIAL OF YOUR APPLICATION.*

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:

    1. The experience and qualifications of the applicant PI and co-investigators;
    2. Ethical considerations;
    3. The applicant PI’s familiarity with the characteristics, limitations, and strengths of the dataset/biospecimens;
    4. The adequacy of the proposed research design;
    5. The adequacy of the research environment;
    6. The adequacy of the applicant PI’s funding resources to support the proposed study and;
    7. 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.

Rutgers University Rutgers University USC Information Sciences Institute Washington University in St.Louis National Institute of Mental Health