What is the NIH Developmental Studies Biospecimens Access Program?
The NIH Developmental Studies Biospecimens Access Program provides the research community access to biospecimens collected from the Adolescent Brain Cognitive DevelopmentSM Study (ABCD Study®) participants. The ABCD Study is the largest longitudinal study of brain development and child health in the U.S., collecting data from nearly 12,000 children across the country beginning when they were 9-10 years old and continuing for a decade. The ABCD Study cohort approximates the U.S. population on several demographic factors (see below).
Figure 1. Demographic distribution of participants in the ABCD Study
*The American Community Survey is a demographics survey program conducted by the U.S. Census Bureau. Note that the ABCD Study participant race/ethnicity distribution closely resembles the American Community Survey distribution.
Stored biospecimens from the ABCD Study include DNA from either saliva or blood, saliva, deciduous teeth, whole blood, and serum. Deciduous teeth and DNA from saliva were collected at baseline only. Oral fluids are collected annually. Blood and serum collection began at the 2-year follow up and will continue every other year for the duration of the program. Biospecimen collection was disrupted for the 2, 3, and 4-year follow up visits and may be incomplete due to COVID-19. See the ABCD Study site for detailed protocols.
No funds are available through this FOA. Applicants must have funding from another source and provide proof of funding to carry out the research, including costs for shipment of samples to the investigator, in their X01 application. Applicants must identify their funding source and include relevant documentation.
Applicants seeking biospecimens may want to consider the following funding opportunities:
- RFA-DA-22-037 - Accelerating the Pace of Drug Abuse Research Using Existing Data (R01 Clinical Trial Optional)
- RFA-DA-22-038 - Accelerating the Pace of Drug Abuse Research Using Existing Data (R21 Clinical Trial Optional)
- PAR-22-137 - Accelerating the Pace of Child Health Research Using Existing Data from the Adolescent Brain Cognitive Development (ABCD) Study (R01-Clinical Trial Not Allowed)
- PAR-22-138 - Accelerating the Pace of Child Health Research Using Existing Data from the Adolescent Brain Cognitive Development (ABCD) Study (R21-Clinical Trial Not Allowed)
- The Human Health Exposure Analysis Resource (HHEAR) laboratories for chemical analyses of banked biological samples to support characterization of environmental exposure.
- Maximizing the Scientific Value of Existing Biospecimen Collections for exploratory research relevant to the mission of the Center for Tobacco Products using existing, publicly available biospecimens.
- NIH parent announcements
For inquiries regarding the NIH Developmental Studies Biospecimen resource and procedures for access, contact the NIH Developmental Studies Team.
Applying for access to biospecimens
- Submit a Biospecimen Availability Request - Interested applicants are encouraged to submit a letter of intent in the form of a Biospecimen Availability Request to the NIH Developmental Studies Team 6 weeks in advance of their X01 submission to determine whether there is sufficient quantity of the sample required for the proposed study, the impact it will have on the resource, and whether the proposed use of samples is consistent with the limitations of the participants’ informed consents. Biospecimen Availability Requests may be submitted on a rolling schedule.
Download and complete the NIH Developmental Studies Biospecimen Availability Request form. You will be asked to provide:
- Your institutional affiliation and contact information
- Detailed information on the samples you are requesting, including:
- the type and quantity of biospecimen requested
- the biospecimen collection visit(s) from which you are requesting samples
- You may apply for access to samples from multiple timepoints if you are proposing a longitudinal design and can demonstrate adequate storage capabilities.
- relevant demographic variables (i.e. race/ethnicity, sex at birth)
- additional specimen requirements (i.e. storage conditions, additives or preservatives, etc.)
Applicants interested in specimens from future collection timepoints should contact the NIH Developmental Studies team.
- Biospecimen Availability Request Review - The NIH Developmental Studies Team will complete a review of your Biospecimen Availability Request. Upon receipt of your Biospecimen Availability Request, the NIH Developmental Studies Team will determine whether your requested samples are available and will work with you to update your Biospecimen Availability Request as needed. You will be provided with an Availability and Impact Report that may be included when applying for funding from other sources. Reports will be sent within 30 days of request submission.
- X01 Application Submission - Review the NIH Developmental Studies Biospecimen Application Submission Schedule and plan your submission accordingly, once available. The FOA is expected to be published in early 2023 with an expected application due date in Spring 2023. Please refer to the NOITP for details.
Frequently Asked Questions
- Do I have to have funding before I apply?
Yes. You will be required to provide proof of funding in your X01 application that will cover all associated costs of conducting the research and shipping the biospecimens to the investigator. You will need to identify your funding source and provide related documentation (e.g. grant number, summary statement).
- Who can apply for access?
Please see the NOITP for more information about eligibility. Both foreign (non-U.S.) and domestic (U.S. based) investigators from eligible institutions as specified in the FOA may apply. Investigators with proof of funding for studies consistent with research priorities for child or adolescent health and development will be given priority.
- Can a non-US based investigator apply for access to samples from these studies?
Yes, samples are available to U.S. – and non- U.S. - based investigators. However, you will need to pay for costs associated with shipping samples outside the US. If the shipment is intended for a foreign country, the researcher is responsible for obtaining the required documents for entry of biohazardous material.
- Do I need IRB approval prior to submitting my Biospecimen Availability Request?
You do not need IRB approval prior to submitting a Biospecimen Availability Request or an application to apply for access to ABCD Study samples. You will be required to submit proof of IRB approval or exemption for your proposed use of samples after your application is approved and before your samples will be shipped
- What is the timetable for review of a Biospecimen Availability Request?
Biospecimen Availability Request review takes approximately one month. Review process will include checking for availability of requested samples, impact to the resource, and consistency with the limitations of the participants’ informed consents. An Availability and Impact Report will be e-mailed to you at the end of the review period.
- Do I need to pay for retrieving or shipping the ABCD Study samples?
Investigators will need to pay for shipping samples, but there is no cost for the samples themselves.
- Am I required to submit or share the results from my study?
You are required to share the data, consistent with the NIH Data Sharing Policy and the policies set forth by the project funding agency(ies). You are expected to create a study in the ABCD data repository in the NIMH Data Archive (NDA), linking your analyses, including any derived measures, to the ABCD collection. For assistance with the data sharing process, contact the NDA help desk.
- Are there limitations to the data sharing process or to the types of data that can be shared?
All data must be de-identified before uploading to the NDA. You may not transfer data, with or without charge, to any other entity or any individual. This applies to all versions of ABCD Study data (including any individual-level data derived from the original data). More information is in the Data Use Certification on the NDA website.