Frequently Asked Questions

Only relevant NIA-funded studies designated by NIA will be eligible to request biospecimens or data to the AgingResearchBiobank. NIH policy is that the unique resources developed through NIH funding are to be shared with the research community, to the extent that sharing of clinical data and materials is practical. Therefore, all current and complete multi-site NIA-funded studies should have a plan or should develop a plan for sharing data and biospecimens that complies with current NIH and NIA policies (https://sharing.nih.gov/data-management-and-sharing-policy/about-data-management-and-sharing-policies/data-management-and-sharing-policy-overview#after). Wherever appropriate, the AgingResearchBiobank should be used to facilitate sharing.

In general, the repository should receive all of the data being collected or created by the Study Data Coordinating Center, provided that the subject has consented to having his/her data included in the repository. However, no personal identifiers should be sent to the repository, and data may need to be transformed in some way to ensure that no personal identifiers are deposited.

A linkage file is a list that associates biological biospecimens with the relevant clinical data by matching the IDs that were used for the biospecimens to those that were used for the clinical records for all of the study subjects. The linkage file should be provided by the Study Data Coordinating Center at the time the clinical data are delivered to the AgingResearchBiobank for completed studies.

The AgingResearchBiobank will work with the Study Data Coordinating Center to prepare the data package for archiving. AgingResearchBiobank personnel will consult with the Study Data Coordinating Center to develop appropriate documentation that is comprehensive enough to allow investigators not familiar with the data to use them. In addition, they will familiarize themselves with the database and its architecture in preparation for archiving.

In general, the AgingResearchBiobank should only get limited datasets as defined under HIPAA regulations. In some cases, the AgingResearchBiobank personnel may provide advice to Study Data Coordinating Centers on how to transform data to prevent transmission of protected health information. Guidance is also available on methods to de-identify protected health information according to HIPAA (https://www.hhs.gov/hipaa/for-professionals/special-topics/de-identification/index.html)

In general, the AgingResearchBiobank should be used to store biospecimens that are not being used for the active conduct of the study. Whenever practical, part of each biospecimen should be designated for the AgingResearchBiobank and stored until the end of the study's lifespan or designated funding period.

Upon submission, the National Institute on Aging (NIA) assumes custodianship of the biospecimens. The NIA Official responsible for the biorepository is Rosaly Correa-de-Araujo, MD, MSc, PhD who serves as the Program Officer/Contracting Officer Representative (COR) for the AgingResearchBiobank. The AgingResearchBiobank likewise becomes the primary point of contact for requesting use of the biospecimens.

Yes, the biobank can aliquot biospecimens. There will be an additional charge for this service. (https://agingresearchbiobank.nia.nih.gov/costs/)

No. The AgingResearchBiobank is an archival repository. In general, each study should have its own plan for biospecimen processing. This can involve a central receiving laboratory that processes and analyzes biospecimens, and stores the biospecimens needed for the planned analyses. Alternatively, studies may have the biospecimens processed at the collection site.

No. The AgingResearchBiobank is not intended to serve as a clinical laboratory.

The list of studies and the associated biospecimens, images, and data available can be found at the Study Search page. (https://agingresearchbiobank.nia.nih.gov/studies/)

For any level of access to the data, you must have your institution's IRB approval. In some cases, institutions may provide a waiver.

NIA works with dbGaP to store the genotype data generated in NIA-sponsored studies whose clinical data are available through the AgingResearchBiobank. Please check the dbGaP Website for the study of interest. (https://www.ncbi.nlm.nih.gov/gap)

All qualified investigators will be allowed to apply for access to the stored materials.

Secondary use of biospecimens by a researcher from the original study group will follow the same guidelines and procedures as other researchers.

Yes. In general, all applications will be judged without regard to the geographical location of the applicant, although it is conceivable that there will be certain biospecimens collected in specific studies that are restricted to U.S. investigators by the terms of the study or of the participant's consent. At this time, there are no such biospecimens.

Yes. The data and biospecimen request process is open to all organizations interested in using biospecimens or data for research, although it is conceivable that there will be certain biospecimens collected in specific studies that are restricted from commercial use by the terms of the study or of the participant's consent.

For biospecimens collected by international consortia, applications for use of biospecimens and data will be considered regardless of the geographical location of the applicant institution or researcher.

All requestors will be invoiced for biospecimens according to the prices outlined on our costs page. (https://agingresearchbiobank.nia.nih.gov/costs/) This page also contains the policies for submitting payment, including a requirement that all requests pre-pay prior to the AgingResearchBiobank beginning preparation of the shipment.

Data packages are generally provided at no cost.

Yes. All requestors are charged the same prices to receive biospecimens, regardless of their affiliations.

No, this is a typical biospecimen request and is within the scope of support that the AgingResearchBiobank provides for free.

No, this is a typical data support request and is within the scope of support that the AgingResearchBiobank provides for free.

Yes, you are likely to need to pay for additional support in order to define and complete your tables. An estimate will be provided once the work is defined.

Yes. This is not a typical biospecimen selection and will require additional support. An estimate will be provided once the work is defined.

To request data, images, and/or biospecimens, go to the Request for Materials page: https://agingresearchbiobank.nia.nih.gov/requests/request-for-materials/create/

Requestors will need to provide the following:

1. AgingResearchBiobank Online Request Form
2. Protocol (See Glossary for more information)
3. IRB Approval (or waiver)
4. CV
5. Proof of Funding
6. Signed copy of the Outgoing Human Resources Transfer Agreement (OHRTA) or Outgoing Human Data Transfer Agreement (OHDTA) provided to you by AgingResearchBiobank staff after submission of the Online Form

A Signing Official (SO) from your institution should provide this signature. An SO has institutional authority to legally bind the institution in grants administration matters. The individual fulfilling this role may have any number of titles in the grantee organization. For most institutions, the Signing Official (SO) is located in its Office of Sponsored Research or equivalent.

Funding is required for requests that include biospecimens. This can include NIH grant funds, institutional/departmental funds, NIH intramural funds, private foundation funds, funding outside of the United States, industry funds, non-NIH federal funds, state funding, etc.

You may submit a request for biospecimens if you do not have funding currently available, but plan to apply to a funding opportunity. Once suitable specimens have been identified, the request will be put on hold until the outcome of your funding application has been determined. AgingResearchBiobank can provide a letter of biospecimen availability for inclusion in grant applications. Please note that these letters should not be viewed as endorsements of the proposed research.

If your application is not funded and you wish to pursue a re-application for specimens with alternative funding, you must submit a new AgingResearchBiobank request. Due in part to the dynamic nature of the biospecimen inventory, any letter of biospecimen availability provided by AgingResearchBiobank is only valid for your original grant application. AgingResearchBiobank will re-assess biospecimen availability in the new request.

All applications are reviewed by the Biobank Scientific Review Committee (BSRC) and judged on numerous criteria, including the qualifications of the researcher and the research environment, the significance and appropriateness of the proposed research, design of the proposed research and ethical considerations including consistency with the terms of the informed consent obtained from the subjects. Final approval is determined by the NIA COR.

No. Each request is reviewed independently and all information is considered. If you want to include information that you are working with a Study investigator, the reviewers would consider that in the request. The information alone should not be a deciding factor for access to data or biospecimens.

During the lifespan of the study, investigators should apply directly to the study group to propose an ancillary study.

Please submit a request for the additional materials, providing a justification and the original request number. In some cases, the documents submitted for the original request can be used for the new request as long as they are still current (e.g. IRB approval).

In general, biospecimens and data stored at the AgingResearchBiobank are consented for additional research; however, some consents are conditional and/or may require further review by the AgingResearchBiobank staff prior to approved release. All requests for biospecimens and data are carefully reviewed against the consent forms by the AgingResearchBiobank and NIA staff members to ensure adherence.

In order to receive biospecimens, images, or data, the institution will have to sign an Outgoing Human Resources Transfer Agreement (OHRTA) for biospecimens or an Outgoing Human Data Transfer Agreement for data with NIA (https://sharing.nih.gov/data-management-and-sharing-policy/about-data-management-and-sharing-policies/data-management-and-sharing-policy-overview#after). The agreement will include certification that the project has IRB approval, that the investigators will only conduct the research consistent with the subjects' informed consent, and that researchers will not attempt to identify any individuals. In addition, the Agreement will forbid any redistribution of the materials by the investigator or institution.

If necessary, special processing requests may be taken into consideration. You will always be contacted before shipment of the biospecimens to verify shipping details and ensure availability to receive the shipment.

A biospecimen request can take up to several months to fulfill once the fully completed request is approved by NIA. Biospecimen turnaround time depends on many factors, including:

• Does the request require relabeling of vials?
• How many biospecimens are being requested?
• Do they need to be aliquoted?
• Are the biospecimens stored in one freezer or scattered in several freezers?
• Are biospecimens being pulled from -80C freezers or liquid nitrogen freezers?
• Where will the biospecimens be shipped?
• Does the request require payment by the recipient before the request may be processed?

Once approved, you will receive a secure link through your data request where you can download the data package. You may not share the data with any other researcher not named in the Outgoing Human Data Transfer Agreement and will be required to either destroy the data or apply for an extension at the end of 3 years.

Yes, you can use the same letter of extension, but you will need to list all of the datasets in the letter.

Please review the following questions. Send the answers via the Comments tab of your data request or through the Contact Us page (https://agingresearchbiobank.nia.nih.gov/contact/).

1. Which study's data are you having problems with?
2. Did you receive this data set from the AgingResearchBiobank?
3. Are you having problems with any other data sets?
4. Are you working with Windows PC or another operating system?
5. What version of SAS are you using?
6. Do you know the nature of the problem? Example: Cannot open because SAS format is missing; incompatible SAS version; or another specific error message.
7. Are you trying to work with a different software tool such as R, SPSS, etc.?

For any level of access to the data you must have your institution's IRB approval or waiver. If you do not have an IRB, you must use an external IRB. This IRB step is required whether or not you publish your findings. Since the data we offer is provided in limited datasets and the data have been de-identified so there is no direct human-subject interaction, sometimes your IRB will consider a waiver. You may want to approach it from that standpoint.

All co-investigators who will receive the data need IRB approval to work with it. Similarly, each institution needs its own signed Agreement.

NIA policy is that documents aside from the AgingResearchBiobank's own agreement will not be signed by NIA officials. Additionally, the AgingResearchBiobank provides limited datasets rather than completely de-identified data. One of the AgingResearchBiobank's tasks, as defined by NIA, is to develop systems to help ensure protection of the human subjects who contributed research biospecimens and/or data by maintaining the confidentiality of these subjects and by maintaining a searchable inventory of informed consents and NIA Approval Letters from biospecimen contributors.

Datasets have been received without personal identifiers and thus are unlinked to the subjects. We do not accept any information, nor use any information collected, that would permit us as the keeper of a record system to establish the identity of a given subject or query the databases and retrieve information for an individual subject whose identity is known from some other source.

Traditional personal identifiers that may be utilized to establish the identity of individual subjects (e.g., surname, address, social security number, etc.) are never accepted by us when we receive materials from a study. Instead, we work with study's Data Coordinating Center and biospecimen repositories to develop an identifier code for each subject that will link the clinical and descriptive data to stored biospecimens. All data received by us is untraceable to the original subjects.

Researchers producing manuscripts using NIA data and/or biospecimens are required to use the general AgingResearchBiobank acknowledgement.