Biologic Specimen and Data Repository Information Coordinating Center

Q: What are the requirements for requesting study datasets?

A: You must submit a data request form, which can be initiated from any open BioLINCC study listed on the studies page. The request must include a description of your research plan/protocol, preferably in the body of the request or attached as a separate document, as well as documentation of review 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. 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 a designated Principal Investigator and an authorized business official from your institution, prior to data release.

Q: What are the requirements for requesting biospecimens?

A: After submitting a complete specimen request form, BioLINCC will identify suitable specimens based on your 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, such as 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.

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 a designated Principal Investigator and an authorized business official from your institution, prior to specimen release.

Q: Are BioLINCC materials de-identified?

A: Yes, all BioLINCC data and biospecimens are de-identified. That is to say that obvious subject identifiers (e.g., name, addresses, social security numbers, place of birth, city of birth, contact data) have been redacted from all BioLINCC datasets and biospecimens, and under no circumstances would BioLINCC provide subject 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.

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

A: An IRB reviews research projects from the point of view of determining whether the proposed research minimizes the risk to research subjects. 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. Although the NHLBI datasets have been redacted to remove personal identifiers such as name, address, etc., they also contain such a wealth of individual data such that there is a possibility of determining identity. The Data Repository operates under an NIH IRB-reviewed protocol which requires that datasets may only be released to researchers who are themselves under the oversight of an IRB.

Q: What if I don't have an Institutional Review Board (IRB)?

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

Q: Who should sign as the authorized institutional business official for the Research Materials Distribution Agreement?

A: The authorized official is an individual at the institution that can enter into a contract on behalf of the institution. The title of this individual varies greatly. If applicable, your contract department may be of assistance. NHLBI requests that the legal signatory for the institution be a different individual than the Principal Investigator except in circumstances where it is the only option (e.g. small businesses where they are truly the same).

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

A: NHLBI rarely accepts modifications to the RMDA. For example, the Principal Investigator cannot be removed as a legal party to the agreement. Your contracts/MTA office is welcome to contact BioLINCC directly at biolincc@imsweb.com.

Q: 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 can 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, and biospecimen preparation. We typically advise that investigators allow at a minimum three months for completion of a biospecimen request, assuming that funds are immediately available and all request requirements are met in a timely manner.

Q: I am a student. Can I use BioLINCC data?

A: Yes. We recommend using one of the teaching or public use datasets. These have been redacted in such a way that they do not require review from an Institutional Review Board. You may obtain them simply by submitting a request. Users are cautioned that teaching datasets are completely unsuitable for publication purposes since specific statistical measures were used to create anonymous versions.

If a teaching or public use dataset is not sufficient, you may submit a request for any of the BioLINCC datasets. In addition to the usual request requirements, you will be required to designate a faculty advisor or supervisor as the Principal Investigator.

Q: Do you allow international requestors?

A: Yes. The request requirements are the same. Most institutions will have an Ethics Committee that serves a similar function to U.S. Institutional Review Boards.

Q: How long can I use the data?

A: A Research Materials Distribution Agreement for data is valid for three years once signed. BioLINCC will contact you once the expiration date is approaching. If your project is complete, please notify BioLINCC that any data residing on personal computers, portable media, or institutional servers have been permanently deleted and any data CDs have been destroyed. If you require more time to work with the data, you may submit a data renewal request.

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

A: Minor changes to the proposed project (changes in exclusion/inclusion criteria, follow-up length, covariates, general analytic approach, etc.) without a change in the research aims or hypothesis do not require additional review by NHLBI. Substantial changes in the project (different outcome, additional research aims, etc.) would require that you submit a new protocol/description of the research which will be sent to NHLBI to review as an additional project or project revision.

Q: What if I change institutions after completing the request, or need to transfer the project to a different principal investigator?

A: 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 must notify BioLINCC that any data residing within your previous institution have been destroyed.

Q: Will you provide a custom dataset for my request?

A: 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.

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

A: 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.

Q: Why were certain data elements redacted? Can I obtain the un-redacted data?

A: 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 for studies that are still active.

Q: Who should I contact with questions about the data?

A: 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, and generally the data and documentation provided in the data package would encompass 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. Collaboration with the original study investigators outside of BioLINCC may be an option for studies that are still active.

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

A: Not all NHLBI funded studies are released on BioLINCC. Generally speaking, the earliest timeframes for the release of eligible studies are three years after the end of the clinical activity (final patient follow-up, etc.) or two years after the main paper of the trial has been published. More information on the release may be found on the NHLBI Policy for Data Sharing from Clinical Trial and Epidemiological Studies web page. Please contact BioLINCC for more information regarding a specific study.

Q: Is there any cost to access BioLINCC materials?

A: There is no cost to access BioLINCC materials, 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.

Q: Can I share BioLINCC materials with other researchers?

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

If your project involves collaborators from an outside institution, the collaborator(s) must submit and complete their own 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 such that the biospecimens remain within the purview of the Principal Investigator and his/her institution.

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

A: 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, subjects are sometimes excluded from the BioLINCC dataset, for example if they did not provide informed consent for future use of their data. We also cannot guarantee that all data elements needed to replicate a publication can be made available through BioLINCC.

Q: Is funding required to access BioLINCC materials?

A: 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. 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 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. 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.

Q: What if my funding application is not successful?

A: 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.

For any other questions not answered here or in the BioLINCC Handbook, please contact BioLINCC.