Frequently asked questions about the AgingResearchBiobank can be found below:
About the Repository
- Submitting Resources from NIA Grants
- Obtaining Biospecimens and Data for Research
About the Repository
What is the purpose of having a central repository?
The National Institute on Aging (NIA) at the National Institutes of Health (NIH), U.S. Department of Health and Human Services (HHS), conducts and funds various longitudinal and clinical studies on aging that generate or have generated a collection of biospecimens and related phenotypic and clinical data. In 2018, the NIA's Division of Geriatrics and Clinical Gerontology established the AgingResearchBiobank to provide a state-of-the-art inventory system for the storage and distribution of these collections to the broader scientific community. Over the years, study collections have made significant contributions to public health and will continue to do so. Aging research will be expanded through the use of such collections to address new promising scientific questions targeting the development of prognostics, markers, and therapeutics for conditions related to aging and to provide a better understanding of the aging process. Collections included in the AgingResearchBiobank were built over many years from studies that carefully selected subjects and are available in a finite quantity. Each biospecimen is unique and cannot be replaced. Together with the opportunity to potentially pool data across study collections significantly increases the value and power of future research findings from the resources offered by the AgingResearchBiobank.
What are the components of the AgingResearchBiobank?
The AgingResearchBiobank includes two separate contract-funded components that work together to store data and biospecimens from relevant NIA-funded studies.
- Biologic Specimens (Biorepository) - Receives biospecimens from different study collections, stores the biospecimens under optimal conditions, and distributes them to qualified investigators.
- Data Repository - Serving as the data coordinating center for the AgingResearchBiobank, it receives, archives, maintains and distributes databases from different study collections. The Data Repository also analyzes stored data in response to inquiries, assists ongoing studies in preparing data for eventual archiving, coordinates cross-referencing between the two components of the AgingResearchBiobank, and manages the AgingResearchBiobank website.
Submitting Resources from NIA Grants
Eligibility for Submission
Who can request biospecimens and data?
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://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm). Wherever appropriate, the AgingResearchBiobank should be used to facilitate sharing. There is no cost to investigators to store biospecimens or data in the AgingResearchBiobank.
Submitting Data to the AgingResearchBiobank
What data should be sent to the Data Repository?
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.
When should the linkage file be provided?
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 is delivered to the AgingResearchBiobank for completed studies.
What interaction will the Study Data Coordinating Center have with the AgingResearchBiobank before data are sent?
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.
Should protected health information be sent to the AgingResearchBiobank?
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/privacy/special-topics/de-identification/index.html)
Submitting Biospecimens to the AgingResearchBiobank
Which biospecimens should be sent to the Biorepository and when should those biospecimens be sent?
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.
Who will be in charge of the biospecimens at the AgingResearchBiobank?
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.
Can the AgingResearchBiobank do aliquoting?
Yes, the biobank can aliquot biospecimens. There will be an additional charge for this service. (https://agingresearchbiobank.nia.nih.gov/costs/)
Can the AgingResearchBiobank serve as the primary receipt point for biospecimens, processing, aliquoting and shipping biospecimens out to various analysis laboratories during the study?
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.
Can the AgingResearchBiobank carry out biospecimen processing or routine clinical analyses?
No. The AgingResearchBiobank is not intended to serve as a clinical laboratory.
Obtaining Biospecimens and Data for Research
Available Biospecimens and Data
What types of data/biospecimens are available?
The list of studies or biospecimens/data available can be found at the Study Search page. (https://agingresearchbiobank.nia.nih.gov/studies/)
If my only goal is to use a dataset to demonstrate the statistical methodology and I do not plan to draw any scientific conclusions using the dataset, do I need to go through the IRB process?
For any level of access to the data, you must have your institution's IRB approval. In some cases, institutions may provide a waiver.
Do you have genotype data available? For which studies?
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)
Eligibility for Access
Who can access stored materials?
All qualified investigators will be allowed to apply for access to the stored materials.
Can the study group that collected the biospecimens retrieve some of the biospecimens stored in the AgingResearchBiobank?
Secondary use of biospecimens by a researcher from the original study group will follow the same guidelines and procedures as other researchers.
Can non-U.S. investigators apply to use biospecimens and data from the AgingResearchBiobank?
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.
Can commercial organizations apply to use biospecimens and data from the AgingResearchBiobank?
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.
Are there special provisions for biospecimens collected by international consortia?
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.
Cost for Access
Is there a charge for biospecimen requests or data requests?
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 over $5000 or being shipped internationally pre-pay prior to the AgingResearchBiobank beginning preparation of the shipment.
Data packages are generally provided at no cost.
I am an Ancillary Biospecimen Requestor, will I be charged for my biospecimen request?
Yes. All requestors are charged the same prices to receive biospecimens, regardless of their affiliations.
I have a request for 0.5ml of serum from every subject in a study at every time point. Will I be charged for data support?
No, this is a typical biospecimen request and is within the scope of support that the AgingResearchBiobank provides for free.
I need tables of demographic characteristics to submit along with my grant proposal for funding to use the biospecimens I'm requesting from the AgingResearchBiobank. Will I be charged for data support?
No, this is a typical data support request and is within the scope of support that the AgingResearchBiobank provides for free.
I do not have an analyst but I need to prepare complex tables of multiple characteristics I plan to explore using biospecimens I'm requesting from the AgingResearchBiobank. Will I be charged for data support?
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.
I have a specific set of subject and specimen IDs that I would like to request from the AgingResearchBiobank. Will I be charged for data support?
Yes. This is not a typical biospecimen selection and will require additional support. An estimate will be provided once the work is defined.
Applying for Access
How do I obtain data or biospecimens from the Repository?
To request data only, go to the Request Data Only page: https://agingresearchbiobank.nia.nih.gov/requests/data-request/create/
To request biospecimens and accompanying data, go to the Request Biospecimens and Data page: https://agingresearchbiobank.nia.nih.gov/requests/samples-and-data/create/
Requestors will need to provide the following:
- AgingResearchBiobank Online Request Form
- Protocol (See Glossary for more information)
- IRB Approval (or waiver)
- Proof of Funding
- 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
On the Outgoing Human Resources Transfer Agreement (OHRTA) or Outgoing Human Data Transfer Agreement (OHDTA) forms, who should provide the Authorized Signature for my institution?
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.
Is funding required to access AgingResearchBiobank materials?
Funding is not required for data requests. 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.
What if my funding application is not successful?
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.
Obtaining Approved Biospecimen Requests
Who makes the decision about granting access to biospecimens?
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.
If we were working together with a Study investigator, would this affect our situation and chances of accessing the data or biospecimens?
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.
While a study is ongoing, how do investigators gain access to biospecimens?
During the lifespan of the study, investigators should apply directly to the study group to propose an ancillary study.
I would like to receive more of the biospecimens that I have requested or additional biospecimens. What process should I follow?
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).
How do you interpret the following section in Funding Opportunity Announcements: "Applicants must include in this section a statement of how the proposed research fits within the limitations of the subjects'' informed consent. Information about the informed consents for each study can be obtained from the AgingResearchBiobank."?
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.
Under what conditions are biospecimens distributed?
In order to receive biospecimens 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://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm). 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.
Once my request for biospecimens is approved, before pulling the biospecimens, will I be contacted regarding the method of biospecimen processing and shipment method?
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.
Once my request for biospecimens is approved, how long will it take for me to receive the biospecimens?
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?
Obtaining Approved Data Requests
How will data packages be sent to me?
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.
If I have received several datasets, may I use one extension letter to cover all of them?
Yes, you can use the same letter of extension, but you will need to list all of the datasets in the letter.
I am unable to open a dataset I received from the AgingResearchBiobank, what do I do next?
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/).
- Which study's data are you having problems with?
- Did you receive this data set from the AgingResearchBiobank?
- Are you having problems with any other data sets?
- Are you working with Windows PC or another operating system?
- What version of SAS are you using?
- Do you know the nature of the problem? Example: Cannot open because SAS format is missing; incompatible SAS version; or another specific error message.
- Are you trying to work with a different software tool such as R, SPSS, etc.?
Is IRB approval required for internal analysis in an organization, or is IRB approval required only if the data analysis will be published?
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 has 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.
I will have co-investigators from other institutions working with me on the dataset I am requesting. Does NIA need IRB approval from each institution separately, or do you just need the IRB approval from the Principal Requestor's institution?
All co-investigators who will receive the data need IRB approval to work with it. Similarly, each institution needs its own signed Agreement.
My IRB requires confirmation that all AgingResearchBiobank data is deidentified. Can the AgingResearchBiobank sign a Confidentiality Agreement so I can move forward with my request for NIA biospecimens and data?
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.
Producing Manuscripts using NIA Biospecimens
If I produce a manuscript using NIA data and/or biospecimens, am I required to acknowledge this?
Researchers producing manuscripts using NIA data and/or biospecimens are required to use the general AgingResearchBiobank acknowledgement.
What provisions should be included about the repository in the informed consent for subjects?
NIA has developed model language for use in informed consents that describes the repository and explains what will happen to the biospecimens and data that are collected. The most important point is that the repository will not accept any personal identifiers on biospecimens or in the datasets. Your NIA Project Officer can provide you with a copy of the model language.
What subject or biospecimen identification code will the AgingResearchBiobank use?
The repository can use the study's assigned ID for each participant. In situations where this would be inappropriate, because the ID contains potential personal identifiers, the study should assign a different, masked, identifier and a link between this new ID and any stored biospecimens.
Does the AgingResearchBiobank maintain a Certificate of Confidentiality?
No. The Repository does not have a Certificate of Confidentiality because we do not accept any personally identifying information.
When biospecimens or data are made available to requestors, will the actual name of the study clinic be released?
No. The study clinic is considered personally identifying information that could be used to identify subjects, especially when enrollment from a center was low or when used in combination with other characteristics. If a scientific need arises, a coded center may be released but the centers would not be identified by name or geographic location.
Who owns the biospecimens submitted to the AgingResearchBiobank? Does the Institution submitting the biospecimens maintain ownership or are they owned by NIA once they have been submitted?
The AgingResearchBiobank does not address its biospecimen holdings in terms of "ownership", It is more a matter of control of the biospecimens. The National Institute on Aging (NIA) is the custodian of biospecimens from deposited studies. 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 Repository and the Biobank Scientific Review Committee (BSRC) assume responsibility for distributing the biospecimens in accordance with applicable NIH policies and procedures.