BioLINCC FAQ

Access To BioLINCC Resources

  1. Do I need to register an account?
  2. Do you allow international requestors?
  3. Is there any cost to access BioLINCC data?
  4. Is there any cost to access BioLINCC biospecimens?
  5. Is funding required to access BioLINCC materials?
  6. What if my funding application is not successful?

Request Processing Requirements

  1. What are the requirements for requesting study datasets?
  2. I am a student. Can I use BioLINCC data?
  3. What are the requirements for requesting biospecimens?
  4. What are the components of IRB/EC documentation?
  5. What if I don't have an Institutional Review Board (IRB)?
  6. Who should sign as the authorized institutional business official for the Research Materials Distribution Agreement?
  7. My institution is requesting a modification to the Research Materials Distribution Agreement (RMDA). How do I facilitate this?

Data and Biospecimen Questions

  1. Are BioLINCC materials de-identified?
  2. Why is Institutional Review Board (IRB) review required for de-identified materials?
  3. Will you provide a custom dataset for my request?
  4. I know that certain data were collected for this study, why aren't these included in your data package?
  5. Why were certain data elements redacted? Can I obtain the un-redacted data?
  6. An NHLBI funded study is not available on BioLINCC. When will the data and/or specimens be released?
  7. I'm trying to replicate a publication. Will you have the data I need?

Request Timeline and Terms Of Use

  1. How long does the request process take?
  2. How long can I use the data?
  3. Can I allow other users to access my BioLINCC request?
  4. Can I share BioLINCC materials with other researchers?
  5. My request has been approved. Can I use the data for a different research question?
  6. What if I change institutions after completing the request, or need to transfer the project to a different Principal Investigator?
  7. Who should I contact with questions about the data?

Access To BioLINCC Resources

  1. Do I need to register an account?

    A BioLINCC account is not required to view most BioLINCC resources. This includes open BioLINCC study pages which will generally have key study documents, data dictionaries, and biospecimen availability information posted, where applicable. Registration through Login.gov will allow you to submit requests for biospecimens and/or data from Open BioLINCC Studies or teaching datasets, or to begin the application process for transferring a new NHLBI-funded study biospecimen collection to BioLINCC. You must register and log in using an institutional email; accounts using a free email provider will not be accepted. Once registered and logged in, you will be able to access your request or incoming study application at any time to check its status, add comments, or upload attachments.

  2. Do you allow international requestors?

    In support of current security directives, NIH is implementing a technical update to enhance security measures focused on protecting data provided by NIH Controlled-Access Data Repositories (CADRs). Specifically, as of April 4, 2025, NIH is prohibiting access to and ending any remaining ongoing projects involving NIH CADRs and associated data by researchers and institutions located in countries of concern. Please see Guide Notice NOT-OD-25-083 for more details.

    For remaining international investigators, the request requirements are currently the same. Most institutions will have an Ethics Committee that serves a similar function to U.S. Institutional Review Boards. NHLBI requires original and English translated copies of the IRB/EC documentation, where applicable. The translated copy should be in the same format as the original and with the official's signature or seal/stamp and on institutional letterhead.

  3. Is there any cost to access BioLINCC data?

    There is no cost to access BioLINCC datasets.

  4. Is there any cost to access BioLINCC biospecimens?

    There is no cost to access BioLINCC biospecimens, other than the cost to physically ship any biospecimens to your lab. The NHLBI Biorepository can provide estimated shipping costs based upon request parameters (e.g., number of aliquots, vial size, special requirements, shipping destination, etc.). Please contact BioLINCC for more information. See also Is funding required to access BioLINCC materials.

  5. Is funding required to access BioLINCC materials?

    Funding is not required for data requests. Funding is required for requests that include biospecimens, to cover the costs of both shipping and proposed assays. 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. See also the Funding Opportunities web page for some funding opportunities that may be applicable to research using BioLINCC resources.

    You may submit a request for biospecimens if you do not have funding currently available, but plan to apply to an open 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. BioLINCC 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.

  6. 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 BioLINCC request. Due in part to the dynamic nature of the biospecimen inventory, any letter of biospecimen availability provided by BioLINCC is only valid for your original grant application. BioLINCC will re-assess biospecimen availability in the new request.

Request Processing Requirements

  1. What are the requirements for requesting study datasets?

    Principal Investigators (i.e., Senior Investigators or other individuals with the authority to sign the RMDA for the research being proposed) must register for a BioLINCC account in order to submit a data request form, which can be initiated from any open BioLINCC study listed on the studies page. The request form must include a description of your research plan/protocol, and documentation of review and approval from an Institutional Review Board (IRB) or Ethics Committee (EC). For most studies, an IRB/EC determination that the research is exempt from review, or considered "not human subjects research", is sufficient to proceed. Some studies may require full or expedited IRB/EC review and approval, and this will be noted on the study page. IRB/EC documentation should be provided in PDF format. Once these requirements are met and your request is approved by the NHLBI, BioLINCC staff will provide a Research Materials Distribution Agreement (RMDA) to be signed by the Principal Investigator and an authorized business official from your institution, prior to data release.

  2. I am a student. Can I use BioLINCC data?

    Yes, if your faculty advisor or supervisor agrees to act as the Principal Investigator for your research and submits the request for you. They will need to register with BioLINCC, submit the request, and name you as an Authorized User.

  3. What are the requirements for requesting biospecimens?

    Principal Investigators (i.e., Senior Investigators or other individuals with the authority to sign the RMDA as the responsible party for the research being proposed) must register for a BioLINCC account in order to submit a data request form and submit a complete specimen request form. BioLINCC will then identify suitable specimens based on the submitted criteria. Once we have search results that meet your approval, your request will be formalized and you will be asked to provide the following documentation:

    • Documentation of review from an Institutional Review Board or Ethics Committee (EC)*
    • A comprehensive study protocol that addresses all of the following topics: summary of proposed research aims, analytes or parameters to be tested, type of assay(s)/platforms(s) to be used, scientific background and rationale, and sample size rationale and calculations
    • Curriculum Vitae of the Principal Investigator
    • If non NIH grant funds will be used to support the research, documentation demonstrating that funds are available is required. This can be in the form of a letter of award or letter of support from your department chair

    * If a study collection is considered anonymized, as specified on the study page, institutional documentation or policy statements regarding the use of anonymized specimens may be sufficient for this requirement.

    Documentation should be provided in PDF format. Once these requirements are met and your request is approved by the NHLBI, BioLINCC staff will provide a Research Materials Distribution Agreement (RMDA) to be signed by the Principal Investigator and an authorized business official from your institution, prior to specimen release.

  4. What are the components of IRB/EC documentation?

    Requirements for the IRB/EC documentation include:

    • Official institutional or IRB/EC letterhead (name, logo, website, and address in the header)
    • Name and title of Principal Investigator, name of institution, and affiliated institution contact information (address, email, or phone)
    • Title of research project
    • Name and title of IRB/EC signing official
    • IRB protocol ID, federal-wide assurance number
    • Level of review (expedited, full, exempt)
    • Determination of review
    • Date of approval and expiration, if applicable
    • An official stamp/seal, if applicable
    • The original document and a copy translated into English, both meeting the above requirements and in the same format as the original, if applicable

  5. What if I don't have an Institutional Review Board (IRB)?

    IRB documentation is required. If your institution does not have an IRB, you may consider obtaining review from an independent IRB. Typically, such IRBs will charge a fee for service. NHLBI/BioLINCC does not endorse any particular independent IRB.

  6. Who should sign as the authorized institutional business official for the Research Materials Distribution Agreement?

    The authorized official (may be referred to as the business official or other title) is an individual at the institution/entity that has authority to enter into a contract on behalf of the institution. If applicable, your Office of Sponsored Programs or contract department may be of assistance. NHLBI requires that the legal signatory for the institution be an individual other than the Principal Investigator.

  7. My institution is requesting a modification to the Research Materials Distribution Agreement (RMDA). How do I facilitate this?

    NHLBI rarely accepts modifications to the RMDA. For example, the Principal Investigator cannot be removed as a legal party to the agreement. Your Administrative office is welcome to contact BioLINCC directly at biolincc@imsweb.comwith additional questions.

Data and Biospecimen Questions

  1. Are BioLINCC materials de-identified?

    Yes, all BioLINCC data and biospecimens are de-identified so such that participant identifiers (e.g., name, addresses, social security numbers, place of birth, city of birth, contact data) have been redacted. Under no circumstances will BioLINCC provide participant identifiers, or a link to such information, to recipients of coded materials. See also the Guidelines for Preparing Clinical Study Data Sets for Submission to the NHLBI Data Repository web page for a description of the typical data redaction process.

    Some specimen-only collections may be considered anonymized, as specified on the study page. Specifically, the link between the specimen and donor has been destroyed and only limited data are available to investigators.

  2. Why is Institutional Review Board (IRB) review required for de-identified materials?

    An IRB reviews research projects to determine whether the proposed research minimizes the risk to research participants. Although this usually has to do with research that involves treatment or invasive procedures, it also includes additional risk assessment from, in this case, potential harm to individuals through their identification.

  3. Will you provide a custom dataset for my request?

    No. BioLINCC provides a standard data package upon fulfillment of a request that includes data. Be sure to review the Data Dictionary, data collection forms, and other documentation posted to the study page to ensure that we have the data necessary for your research.

  4. I know that certain data were collected for this study, why aren't these included in your data package?

    The data may not be subject to data sharing requirements, or they may not yet be ready for release. Please contact BioLINCC for more information regarding the specific study and data.

  5. Why were certain data elements redacted? Can I obtain the un-redacted data?

    Data may have been redacted or modified prior to release as a measure to protect the identity of participants. For example, dates will typically be coded as number of days from a particular reference point, such as study baseline. Study site information may be redacted or coded. Extreme values may be winsorized or values with low frequencies may be grouped together. See also the Guidelines for Preparing Clinical Study Data Sets for Submission to the NHLBI Data Repository web page for a description of the typical data redaction process. Generally, BioLINCC cannot share un-redacted data. In many cases, the redactions occurred prior to BioLINCC receiving the data. If un-redacted data are required for your research, collaboration with the original study investigators, outside of BioLINCC, may be an option.

  6. An NHLBI funded study is not available on BioLINCC. When will the data and/or specimens be released?

    Not all NHLBI funded studies are released on BioLINCC but may be released on other data sharing platforms such as BioData Catalyst (BDC), dbGaP, other NIH repositories, or a non-Federal repository. NIH and NHLBI data sharing policies have evolved significantly over time. Current NIH and NHLBI data sharing policies can be found at https://sharing.nih.gov/data-management-and-sharing-policy and at https://www.nhlbi.nih.gov/grants-and-training/policies-and-guidelines/nhlbi-policy-for-data-sharing, respectively.

  7. I'm trying to replicate a publication. Will you have the data I need?

    Although BioLINCC datasets are intended to encompass the primary outcomes of a study, they may not perfectly match study publications. In general, BioLINCC data would have been prepared by the study more recently than the primary outcome paper or other publications, and thus some additional adjudication or data correction may occur resulting in small discrepancies with a publication. Furthermore, participants are sometimes excluded from the BioLINCC dataset if they did not provide informed consent for future use of their data. We cannot guarantee that all data elements needed to replicate a publication can be made available through BioLINCC.

Request Timeline and Terms Of Use

  1. How long does the request process take?

    The request timing varies significantly, and often is dependent on how quickly you are able to provide the required documentation or respond to questions from BioLINCC staff. Data requests may be completed in as little as one week. Requests that include biospecimens require additional time for evaluation of the biospecimen inventory and suitability, formal reviews of the request, biospecimen preparation and your position in the request queue. We typically advise that investigators allow at a minimum three to six months for completion of a biospecimen request, assuming that funds are immediately available and all request requirements are met in a timely manner.

  2. How long can I use the data?

    A Research Materials Distribution Agreement for data is valid for twelve months once signed. BioLINCC will contact you once the expiration date is approaching. If your project is complete, you and your Institutional Signing Official will be required to attest that any data residing on personal computers, portable media, or institutional servers have been permanently deleted. If you require more time to work with the data, you may submit a data renewal request.

  3. Can I allow other users to access my BioLINCC request?

    Yes. The other users will first need to register a BioLINCC account through Login.gov. Then, while you are logged into your account, open the desired request via the My BioLINCC page. From the drop down menu or under the "More" tab in the request header, select "Add Approved Users" to search for and add users based on email address. Once added, Approved Users can view and comment on the request, and will be included on subsequent request update notifications. Please note that users added in this manner by default will not have permission to download approved datasets within the request. Please refer to information on sharing BioLINCC materials and contact BioLINCC if data download permissions are needed.

  4. Can I share BioLINCC materials with other researchers?

    The Principal Investigator (PI) is responsible for oversight of Approved Users of BioLINCC materials, and may add additional Approved Users within his/her institution at his/her discretion. The Research Materials Distribution Agreement (RMDA) holds the PI and the Institutional Signing Official at the recipient institution responsible for adhering to the terms of the agreement, including maintaining BioLINCC materials in a secure manner within the institution.

    If your project involves collaborators from an outside institution, the collaborator(s) must complete a separate BioLINCC request prior to accessing any BioLINCC data and/or biospecimens. For biospecimens, the use of testing labs outside of the recipient institution is in compliance with the terms of the RMDA as long as the lab is under a contractual, non-disclosure agreement stating that the biospecimens remain within the purview of the Principal Investigator and his/her institution.

  5. My request has been approved. Can I use the data for a different research question?

    Minor changes to the proposed project (changes in exclusion/inclusion criteria, follow-up length, covariates, general analytic approach, etc.) without a change in the original research aims or scope do not require additional review by NHLBI. Substantial changes in the project (different outcome, additional research aims, etc.) require prior approval from NHLBI. This process involves submission of a new protocol/description of the research which will be sent to NHLBI for review as an additional project or project revision.

  6. What if I change institutions after completing the request, or need to transfer the project to a different Principal Investigator?

    In both cases, a new request will be required in order to establish a new Research Materials Distribution Agreement. In the case of changing institutions, you and your Institutional Signing Official will be required to attest that any data residing within your previous institution have been destroyed prior to receiving data for your new request.

  7. Who should I contact with questions about the data?

    You may send your questions to BioLINCC and we will do our best to assist you. Please note that BioLINCC staff were not involved in the original data collection. Generally, the data and documentation provided in the data package encompasses all available materials that were provided by the study for public release. Please be aware that scientific interpretation and statistical support services for the analysis of requested data are out of scope of the BioLINCC program.

For any other questions not answered here, please contact BioLINCC.