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Instructions for Access to Repository Data and/or Biospecimens

Only principal investors (PIs) can request access. PI 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). Additionally, PIs from both academia and industry can request data and/or biospecimens. One access request covers one institution. If you are collaborating with investigators from another institution, each institution must have an access request.

To request access please follow the steps below:

  1. Prepare the following documents:
    1. Cover letter must:
      1. Be written on letterhead of the sponsoring institution at which the research will be conducted.
      2. Contain the name, contact information, and signature of the applicant PI.
      3. If there are any co-investigators, you must list their names and roles on the project.
      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. State which NRGR collection(s) you are requesting. In regard to the NRGR collections, please note that:
        1. All induced pluripotent stem cell lines (iPSCs) and the related data and metadata are in the iPSC collection, not the disorder specific collections.
    2. Biosketch(s) for the applicant PI and all co-investigators listed in the cover letter must follow the format described in section 4.6 of the PHS 398 instructions. If you or your co-investors have never prepared a biosketch, the Biographical Sketch Format Page has blank biosketches that you can update to create a biosketch. Note: All co-investigators should be affiliated with the requesting PI's institution and this affiliation should be listed in the Positions and Honors section of their biosketch.
    3. Resources and environment should be no longer than a page or two and must:
      1. Identify the facilities to be used (laboratory, clinical, animal, computer, office, other). If appropriate, indicate their capacities, pertinent capabilities, relative proximity, and extent of availability to the project. Describe only those resources that are directly applicable to the proposed work. Provide any information describing the Other Resources available to the project (e.g., machine shop, electronic shop) and the extent to which they would be available to the project.
      2. Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport). In describing the scientific environment in which the work will be done, discuss ways in which the proposed studies will benefit from unique features of the scientific environment or subject populations or will employ useful collaborative arrangements.
      3. Demonstrate how you will maintain the requested data securely. For example, you could describe how the computer or server authenticates and authorizes a user or firewalls for a server.
      4. If you are an Early Stage Investigator, describe the institutional investment in your success as an investigator, e.g., resources for classes, travel, training; collegial support such as career enrichment programs, assistance and guidance in the supervision of trainees involved with the ESIs project, and availability of organized peer groups; logistical support such as administrative management and oversight and best practices training; and financial support such as protected time for research with salary support.
    4. Funding information: If the proposed analysis is:
      1. Funded, list the funding organization, grant number, period of support, and active/pending status.
      2. Not funded (e.g., institutionally supported), list the period of time for which the project will have institutional support. If the project will form the basis for a new grant application, indicate to which NIH institute you are planning to submit the application.
    5. Study description must describe the study design, including an abstract, background, and significance, in roughly one page.
    6. You must download and complete our latest Distribution Agreement. It must be signed by the PI and the institutional Authorized Organizational Representative (AOR). The AOR is a senior official at your institution is authorized to enter your institution into a legally binding contract. The PI and the AOR must be two separate individuals.
    7. If you are requesting biospecimens, you will need to submit a Data/Resource sharing plan. Please see the example sharing plan. Your sharing 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 NRGR biospecimens (e.g., iPSCs from banked fibroblasts, genetically modified versions of iPSCs), provide a timeline for submission of these derived biomaterials back to NRGR. 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.
  2. Once the documents are completed, sign in to your NRGR account. (If you don't already have one, request an NRGR account first.)
  3. Complete and upload the documents that you prepared in step #1.
  4. Click the Request Access button.

It tends to take at least four weeks for NIMH to review your application. If any required information is missing from your application, it will increase the amount of time that it takes for your request to be reviewed and you will be contacted by the NIMH Genomics Resources Support Team to update your request. Prompt responses to their questions helps to get your application reviewed more quickly. If you fail to respond to requests from the NIMH Genomics Resources Support Team for more complete information your application will be denied. For questions regarding the application process, please contact the NIMH Genomics Resources Support Team at NIMH.genomics.resources@mail.nih.gov.

Instructions for Renewing Access to Repository Data and/or Biospecimens

Once an access request has been approved, the distribution agreement grants access for a 3-year period. At the time the access request expires, the Principal Investigator (PI) may not maintain any raw data files. Additionally, data and analyses generated from NIMH biospecimens and/or data are required to be made publicly available. To maintain access to distributions once a request has expired, the PI must submit a renewal request to renew their access.

As with all requests, data access is automatically included for all biospecimens requests. If the PI submitted a biospecimens request and does not anticipate requesting more biospecimens but wishes to continue to use the materials that were previously requested, the PI should submit a new biospecimens request with the number of samples listed as zero. If the PI only anticipates needing the data related to the previously requested samples and is prepared to destroy the remaining samples, as required per the distribution agreement, or the original request was for data only, then the PI should submit a data only request.

If you have an already approved access request that will expire soon or that already has expired, please follow the steps below to submit a request for renewed access:

  1. Prepare the required documents. The same documentation that was submitted in the initial request is required for renewal requests. However, the following additional information must be provided for assessment by the NIMH Repository Data Access Committee (DAC):
    1. The Cover Letter must include/specify:
      1. A progress report on what was accomplished since the initial access request.
      2. A list of the publications AND the locations of the data or analyses that have been made publicly available if these were not previously reported through the automatic reporting portal. The PI is required to report yearly on publications and the locations of the data or analyses that have been made available at public repositories (e.g. dbGaP, NDA, GEO).
      3. Any requested biomaterials the PI will be maintaining possession of.
    2. The Study Description must include/specify:
      1. Whether any changes have occurred to alter the study design from what was originally proposed and approved. *NOTE: The study description should be substantially the same as your original request for an expedited renewal review.
      2. An explanation of what the continued need is for the previously requested biospecimens entails where applicable.
  2. Once the documents are completed, sign in to your NRGR account.
  3. Click on the button.
  4. Find the previous request that you want to renew. Click on its ID.
  5. Click on the Renew Request button.
  6. Complete the Request Access Form.
  7. Submit your renewal request.