Grant Budget Guidance

NIMH issued a Guidance Document for studies that plan to collect biospecimens. This Guidance changes the way that studies must plan to fund biospecimen services, increasing the transparency of costs to NIMH and investigators. All grant applicants must now include a detailed budget for submission to an appropriate biorepository during the life of the grant.

Supporting Documents

• Example Consent Form — for GRU sharing of biospecimens from adult subjects through a NIH-controlled biorepository. NIMH strongly recommends your study obtain General Research Use (GRU) consent from research subjects.
• Example Data Sharing Plan
• NRGR Data Submission Budget Guidance
• NIH GDS Policy/Certificate

Budget Requirements

Although specific sharing requirements will differ depending on study design and proposed sample deliverables, NIMH requires that all studies plan and budget for sample collection materials (kits), shipping, quality control, sample processing, long-term storage, and management of sample distributions for approved requests. If your study needs international shipping, you must investigate whether the shipping carrier will include all relevant foreign taxes and fees in their invoices. If you have questions about the specific biospecimen sharing requirements for your application, email NIMH.genomics.resources@mail.nih.gov. There are different models for sample processing that studies may pursue, depending upon study characteristics:

1. Full Service at NRGR — most studies will find the best solution for sample processing and long-term sample management is to utilize the NIMH Repository for all services. NRGR can offer study consultation and bundled services to maximize budget efficiency.
2. Distribution of final samples via NRGR — a subset of studies may qualify to send bulk shipments of externally produced DNA to NRGR for storage and distribution. For this sharing method, the study must:

   • Share high-density whole genome sequencing data
   • at an NIH-approved database for all subjects.

To assist you in planning and budgeting for data submission to NRGR, we provide below a list of activities that occur at different phases of your award. The estimated number of hours may be higher or lower depending on the complexity of the data you will submit. The estimates assume proficiency with the clinical instruments being submitted and with handling tabular datasets (e.g. Excel).

Phase 1

Preplanning and Post-Award

10 Hours Y1 of award

• Review and sign necessary documents verifying appropriate consents for data and sample sharing as directed by NIMH
• Prepare and submit Material Transfer Agreement with Rutgers University
• Modify consent form to include biorepository sharing language
• Define data sharing schedule
• Attend NRGR training on data submission procedures and confirm expected data to be submitted to NRGR
• Attend Coriell training on biomaterial submission procedures

Phase 2

Develop Data Submission Workflow for NRGR Standard Submission Files

15–20 Hours

• Review Data Dictionaries to be used for submission Submission Requirements
  • For all submissions, we require the Submission (_sub) file and the Diagnosis (_dx) file at a minimum. For submissions with data at additional repositories (e.g. NDA, dbGaP), the Alternate ID (_id) file is also required.
• Develop procedure to extract data from local database into format specified by data dictionaries — We suggest using the AutoQC submission tool to test and validate a subset of extracted data before the final year of your grant.
• Prepare auxiliary material for data submission (e.g. public-facing study description)

Phase 3

Develop Data Submission Workflow for Item Level Assessments

5–10 Hours simple 15–30 Hours complex

• Prepare Data Dictionaries to be used for submission Submission Requirements
  • For studies submitting item-level instrument data, we require the user to define a Phenotypic Data Dictionary (_phen_dd) for each assessment being submitted. In some cases, there may be an existing data dictionary available.
  • Simple Instrument (e.g. YBOCS): <100 fields, few different value types (e.g. all "integer, encoded"), no/few conditional requirements
  • Complex Instrument (e.g. SCID): >100 fields, many different value types, more conditional requirements
• Develop procedure to extract data from local database into format specified by data dictionaries — We suggest using the AutoQC submission tool to test and validate a subset of extracted data before the final year of your grant.
• Prepare auxiliary material for data submission (e.g. copy of assessment(s))

Phase 4

Submit Data

5–20 Hours Final Year

• Use AutoQC tool to Validate/Correct Errors and Submit — Resolve any data quality issues identified by NRGR AutoQC Tool. Frequently users need to verify and correct biospecimen IDs and their corresponding Subject codes at the time of sample submission.
• Review and Resolve Post Submission QA/QC Issues — After successful AutoQC submission, NRGR curators review the details of your submission and may request additional data fields, clarifications about diagnoses to assist in cross-study harmonization, or data on additional samples received and stored at the biorepository but absent from the initial submission.