Please read the instructions below, prepare the required documents, and submit the form here. Please contact us if you have questions.

Checklist

All fields are required unless otherwise noted. Brief descriptions can be found the form itself. Detailed descriptions of the more complex items can be found below.

• Name
• Email
• Name of organization
• Organization website (optional)
• Addresses: main, billing and shipping
• Phone
• Employer Identification Number (EIN) or Business License Number (optional)
• Cover letter
• Non-technical summary
• Funding information
• NIH biosketches: applicant, relevant investigators and co-investigators with full legal names.
• Internal and External Collaborators
• Supervised Associates (optional)
• Facilities and other resources
• At least one of the following:
  • Requested phenotypic datasets
  • Requested samples
• Optional: requested genetic data
• Digitally signed distribution agreements if you are requesting samples.
• Data and resource sharing plan
• Data Use Agreement (see below)
• Research Use Statement (see below)
• Institutional Signing Official (SO): name, email, website, proof of authority, CV (see below)
• Institutional Certification digitally signed by the SO
• Cloud Use Statement if applicable
• Human subjects approval
• Billing and shipping addresses
• P.O. Box # and FedEx account numbers are optional.

Required Credentials for Requesters

Requesters must meet the following criteria:

1. Is a permanent employee of their institution at a level equivalent to, but not limited to, that of an academic professor (e.g., assistant, associate, or non-tenure or tenure-track professor) or senior researcher. This does not include lab technicians or trainees, e.g., post-docs or graduate students.
2. Uses an email address affiliated with their self-identified institution or corporation.
3. Has direct oversight of laboratory staff and trainees.
4. Is accountable for ensuring that the terms of access (through agreements such as DUA, DUC agreement, DTA, etc.) and institutional policies are followed.
5. Only occupies one role at a time. Requests in which the requester, or any other Key Personnel, occupy more than one role (e.g., Institutional Signing Official or IT Director) are not allowed.

Research Use Statement

The approval of project requests depends on a carefully written Research Use Statement (250 words maximum).  The statement should include the following components:

• Objectives of the proposed research
• Study design
• Analysis plan, including phenotypic characteristics that will be evaluated in association with genetic variants.
• Brief description of any planned collaborations with researchers at other institutions, including the name of the collaborator(s) and their institutions

Data use is limited to non-profits and is only for substance use and addiction research. Other data for substance use research that can be used in other studies may be found in dbGaP. Research should not deviate from the description in the approved Research Use Statement.  If the scope is expanded, investigators must submit another research statement.  Conducting research not described in the Research use statement is violation of the terms of the Data Use Certification.

Data Use Agreement

If you are requesting phenotypic and/or genotypic datasets, you just upload a digitally signed PDF to indicate that you agree to the terms of the NIH Data Use Certification Agreement. You may use the following file as a template.

Distribution Agreement

A digitally signed distribution agreement is required if you are requesting samples. Please follow the instructions on the template below to create a digitally signed PDF on institutional letterhead.

Institutional Certification

Requests must be certified by the institution as represented by an Institutional Signing Official (SO) who meets all the following criteria:

1. Is affiliated with the requester’s institution or corporation.
2. Has institutional authority to legally bind the institution or corporation in administrative matters.
3. Uses an email affiliated with the requester’s institution or corporation. When a request is submitted an email with be sent to the SO, via the SO email address field on the form, requesting confirmation that the SO approved the submission of the request.

Institutional Signing Official (SO) Attestation of requester Affiliation Requests must include an attestation by the SO that all listed requesters fulfill the criteria below:

1. Are affiliated with their listed institution or corporation.

2. Meet the minimum criteria to qualify as a requester. Is a permanent employee of their institution at a level equivalent to, but not limited to, that of an academic professor (e.g., assistant, associate, non-tenure or tenure-track professor) or senior researcher. This does not include lab technicians or trainees, e.g., post-docs or graduate students.

3.  Is accountable for ensuring that the terms of access (through agreements such as DUA, DUC agreement, DTA, etc.) and the requester institutional policies are followed.

4.  Only occupies one role at a time. Requests in which the requester, or any other Key Personnel, occupy more than one role (e.g., Institutional Signing Official or IT Director) are not allowed.

The certification must be provided by the requester in the form of a PDF on institutional letterhead that is digitally signed by the SO. You may use the following Word document as a template.

Biomaterial Access Request Form

When you have gathered the required documents, please submit the form here.