Biologic Specimen and Data Repository Information Coordinating Center
Home > Frequently Asked Questions

Frequently Asked Questions

Table of Contents

Please select one of the categories below to view the corresponding questions. You may then select your question and view its answer.

I. BioLINCC
II. Grants and Cooperative Agreements
III. Contracts
IV. Ancillary Studies
V. Genetic and Pedigree data
VI. Requesting NHLBI Data Repository Data Sets through BioLINCC
VII. Submitting and preparing biospecimen collections for inclusion in the NHLBI Biorepository
VIII. Requesting samples with or without accompanying characterization data from the NHLBI Biorepository
IX. General Questions
X. Other Questions


I. BioLINCC

Back to Table of Contents

II. Grants and Cooperative Agreements

Back to Table of Contents

III. Contracts

Back to Table of Contents

IV. Ancillary Studies

Back to Table of Contents

V. Genetic and Pedigree data

Back to Table of Contents

VI. Requesting NHLBI Data Repository Data Sets through BioLINCC

Back to Table of Contents

VII. Submitting and preparing biospecimen collections for inclusion in the NHLBI Biorepository

Back to Table of Contents

VIII. Requesting samples with or without accompanying characterization data from the NHLBI Biorepository

Back to Table of Contents

IX. General Questions

Back to Table of Contents

X. Other Questions

Back to Table of Contents


I. BioLINCC

What is BioLINCC?
BioLINCC is the Biologic Specimen and Data Repository Coordinating Center. The center coordinates data and biospecimens from NHLBI-funded studies that are available for use in other approved studies. The center also creates teaching data sets from NHLBI-funded studies for use in training future biostatisticians.

Back to Table of Contents

Who can use the BioLINCC Web site?
The BioLINCC Web site can be used by any member of the public. Members of the public can search the BioLINCC database for information on studies and have access to the BioLINCC documentation. You must be registered user, however, to request data and biospecimens or add study data and information to the database. Teaching data sets are now available for use in undergraduate and graduate biostatistics programs.

Back to Table of Contents

How do I become a registered user?
You can apply to register from the Register link in the upper right of each BioLINCC Web page. The NHLBI will determine your eligibility to access further information and contact you concerning your approval.

Back to Table of Contents


II. Grants and Cooperative Agreements

Which grants and cooperative agreements are subject to the data set policy?
For grants, studies requesting $500K or more in direct costs in one or more years and identified as being of high programmatic interest to NHLBI are subject to the policy. For cooperative agreements, clinical trials or epidemiology studies that are supported by the U01 mechanism and have 500 or more participants are subject to the policy.

Back to Table of Contents

Is there standard language that will be added to the grant award?
The Grants Operations Branch, working with program staff, will ensure that the following language is included in the Notice of Grant Award:

"Data will be released under this study. Data refers to study data, with certain deletions and recoding, that are released to requesting institutions and investigators for specific purposes and with certain restrictions and conditions. data will be made available to the public in accordance with the NHLBI Policy for Data Sharing from Clinical Trials and Epidemiological Studies as revised on June 27, 2005."

Back to Table of Contents

A study funded by a grant (e.g., R01 or cooperative agreement) that was not required under the previous policy to provide a data set is undergoing a competitive renewal. Does the new policy now apply to previously collected data?
Studies will not be required to include previously collected data in the data set; however, since the intent of the policy is to make data available to the research community, every effort should be made to release previously collected data. The added burden of documenting and cleaning previously collected data should be considered when developing budgets for the renewal period.

Back to Table of Contents

A study funded by a grant is using population samples from existing contract studies that are already required to provide data sets. What data would be released by each funding mechanism through the process?
In this specific situation, the grant is also an ancillary study to more than one contract study. In order to avoid releasing an implied identifier for the contract studies, the data that belong to the grant (e.g., special labs, imaging studies or procedures) would only be released from the grant. For completeness, the grant would also need to release some parent study data regarded as an integral part of the grant analyses; however, the data from the grant should not contain any contract study identifiers. The contract studies that provided the population samples would not release data collected by the grant even if it is ancillary to the contract study (see Ancillary Study question #7).

Back to Table of Contents

A grant includes cohorts from populations explicitly excluded from the policy (i.e., American Indian or Alaskan Native). Should a data set still be provided to NHLBI?
Participants from populations excluded from the policy should be removed from the data set. If the contribution of the excluded participants is so large as to seriously compromise the value of the data set for scientific purposes, then program officials, with concurrence of program or division directors, will decide if the grant should be excluded from the policy

Back to Table of Contents

What is the role of the NHLBI program official in ensuring the data set from a grant is properly prepared and documented?
The program official will ensure that a study prepares the data set and appropriate documentation. The project official (currently Sean Coady) is available to staff and investigators for consultations on strategies for the review and preparation of the data set and appropriate documentation. General guidelines for the preparation of the data set can be found in the Guidelines for NHLBI Data Set Preparation. Once the data have been reviewed (and, if necessary, modified) and documentation assembled, the material should be sent to the program official. The program official will then inform the project official that the data and documentation from the study have been prepared. The data and documentation are then reviewed for acceptability for release through the program. If specific revisions are needed to the data or documentation, the program official serves as the point person for all communications with the study.

Back to Table of Contents

Data from a grant are scheduled for release after funding expires. Should the data be prepared potentially years in advance of the scheduled release? Will funds in the estimated amount of the data preparation budget be restricted so that the data can be prepared closer in time to the actual release date?
The data could be prepared prior to the end of funding even though this may be several years prior to the scheduled release date. The data and documentation should be delivered to NHLBI for review with sufficient lead time to ensure that any revisions can be completed while funding is still in place. Once a final data set has been prepared, either the study or NHLBI can hold the data until the appropriate release date or any time prior if the principal investigator approves an earlier release. The advantage of preparing the data early is that study investigators are familiar with data and documentation issues and may therefore be able to prepare the data and documentation more efficiently. Another option would be to restrict funding in the amount of the expected preparation budget and the study could complete the data and documentation preparation at any time prior to the scheduled release date.

Back to Table of Contents

How will NHLBI track which grants are required to prepare data sets and when the data should be delivered to NHLBI?
Working with appropriate staff, NHLBI will develop checkboxes to the competing (new) awards checklist indicating whether a data repository data set is required for the grant. The project official (currently Sean Coady) will periodically generate reports to develop a list of grants required to provide data sets. Program officials will periodically be asked to update certain relevant dates regarding the progress of the study such as when recruitment is expected to be completed, anticipated dates of final data cleaning for analysis, and for clinical trials, the anticipated date of publication of the primary results.

Back to Table of Contents

What is the expected budget for preparation of a data set, and what components should be included in it?
The budget for preparation of a data set is dependent on the size and complexity of the study data. In general, the staff involved would include a statistical programmer to review the data and perform any actions needed to conform to the NHLBI policy, support or other staff to review documentation and create electronic versions suitable for new investigators to use to conduct analyses, and a biostatistician or other investigator to manage the overall effort. In brief, informed consents would need to be reviewed to determine patients or subjects eligible for inclusion in a data set and whether or not commercial/noncommercial use versions of the data are required (see Other Questions #2). The review of the data would include looking at frequency distributions of data fields that involve visually identifiable traits (such as height and weight) or traits that are reasonably discernible through a casual knowledge of a study subject (such as education, marital status, income), traits of a sensitive or potential legal nature (such as illicit drug use, sexual behaviors), long comment fields with potentially identifiable information, other potentially identifying traits with low frequencies (such as specific causes of death), and data fields that may have validity issues (such as a test or procedure found to not provide reliable data). Modifications to the data would include replacing the original IDs with new random IDs, recoding all dates to a time interval such as time since randomization or enrollment, top/bottom coding of visual traits such as height and weight, removing any geographic identifiers, grouping variables such as race, marital, status, education, and removing invalid fields or long comment fields. The documentation to prepare would include items such as forms, data dictionaries, descriptions of variables that were derived, study protocols and manuals, and publication lists. For a study with approximately 2,000 participants, 30-40 baseline and follow-up forms, and outcome data a rough estimate of time would be 0.25-0.40 annual FTE for staff and 0.05-0.15 FTE for project management.

Back to Table of Contents

What points should be discussed in the =$500K request letter and the grant application about data sets?
The general points to discuss include: a general statement addressing expected compliance with the policy, brief statement on plans for preparation of the data set, and a statement indicating that the budget reflects inclusion of resources for the data set. In the $500K letter, this could be relevant to the acceptance criterion about a dissemination plan. However, both a data plan and a dissemination plan for results should be discussed. Below is an example of addressing the policy in a recent $500K request letter:

Back to Table of Contents


III. Contracts

Is there standard language that will be incorporated in the RFP and subsequent contract for delivery of a data repository data set?
The Contracts Operation Branch will ensure that the following language is included in each RFP and contract:

Back to Table of Contents

Are existing contracts expected to comply with the new policy in terms of the timing for release of a data set, or continue to follow the previous policy until the study is renewed?
Existing studies are encouraged but not required to comply with the new policy. There may be potential benefits to migrating to the new policy, such as simplifying timelines for the study. For example, it is possible that a new ancillary study would have a release date far earlier than the contract data.

Back to Table of Contents

For an existing study to comply with the new policy, the study will need to provide one or more years worth of catch-up data at the time of their next scheduled release, creating a burden on study staff. Should the additional burden and, therefore costs, be considered by program staff?
Providing the catch-up data does create at least some additional burden. Program or contract staff should be consulted on possible cost reimbursement options.

Back to Table of Contents


IV. Ancillary Studies

Are all ancillary studies required to submit a data set?
An ancillary study is expected to provide a data set for the data repository only if the parent study is subject to the policy.

Back to Table of Contents

Currently, there is no provision in the [parent study's] ancillary study policy for an ancillary investigator to provide data to the coordinating center. Is there standard language that should be added to the ancillary study policy?
Ancillary study policies should make clear that ancillary study data are to be included in the data set submitted to NHLBI. Although this may require tailoring to the policies of individual studies, the following language should be added in the section related to return of ancillary study data to the main study:

It may be worthwhile to add a statement to the ancillary study proposal form or agreement, if the parent study has one, stating:

"...the ancillary study investigator understands that data from this ancillary study will be made available to the public in accordance with the NHLBI Policy for Data Sharing from Clinical Trials and Epidemiological Studies as revised on June 27, 2005, and that adequate funds will be designated for this purpose."

Back to Table of Contents

Are the coordinating centers expected to produce and appropriately document ancillary study data or should this be the responsibility of the ancillary study investigator?
The parent study will need to consider how it should implement the policy. Since the coordinating centers are more familiar with the guidelines, it may be advantageous for the coordinating center to review and, if necessary, revise the ancillary data (based on NHLBI guidelines) and add the ancillary study data to the parent study database. The coordinating center would need to request that the ancillary study investigator provide appropriate documentation. The coordinating center should require appropriate compensation either through the ancillary study award or directly as part of the study's contract or grant award.

Back to Table of Contents

If the ancillary study timeline differs from the parent study timeline, will the data set release date relate to the timeline of the ancillary study or the parent study exam cycle? For parent studies with many ancillary studies, there may be lots of timelines to track. Are the coordinating centers responsible for this as well? Note this further increases the burden on coordinating centers.
To the extent possible, ongoing observational studies will be updated only on an annual basis and ancillary study data should be delivered to NHLBI during the annual update that most closely approximates the timeline as described in the policy. For some ancillary studies, this may mean a slight delay in when the data are actually released through the data repository. One possible approach would be to track ancillary studies on a 'fiscal year' basis, i.e. ancillary studies funded within a given time frame will be released at a prescribed date. For clinical trials for which the publication date of the main study results will differ from that of the ancillary study, the ancillary study data should be delivered to NHLBI according to the timeline as described in the policy. Regardless, the added burden to coordinating centers should be taken into account when budgeting costs for the ancillary study.

Back to Table of Contents

Does the new policy apply to ancillary study applications reviewed or funded prior to October 1, 2005?
The new policy will not be applied retrospectively. Unless NHLBI required otherwise, only ancillary study applications reviewed by the parent study on or after October 1, 2005 are expected to provide data suitable for the repository to the coordinating center.

Back to Table of Contents

Are there situations in which an ancillary study is exempt from the policy?
There may very well be situations where data from an ancillary study will not be subject to the policy. For example, an ancillary study on a very small subgroup of participants may not have sufficient value to the research community to justify a data set, or the data collected may have identifiable properties that cannot be modified without compromising scientific value, or provisions in the informed consent may prohibit release through the program. There may also be situations in which the ancillary study is a component of a larger grant or cooperative agreement that includes participants/specimens/data from other studies that are not required to produce a data set. Program officials, with concurrence from program or division directors, will make the decision on when an ancillary study is exempt from the policy.

Back to Table of Contents

An ancillary study is using participants from a parent study along with participants from other contract studies as part of a large grant or cooperative agreement. Will the parent study and the large grant/cooperative agreement both be required to provide a data set?
In this situation, the ancillary data (for example, special labs, imaging studies or procedures) collected as part of the grant/cooperative agreement would only be released from the grant or cooperative agreement and not from the parent study. Although the parent study would not be releasing the ancillary data, the grant/cooperative agreement would release the parent study data that is regarded as an integral part of the grant/cooperative agreement. The grant/cooperative agreement would not release any identifiers that associate a subject with a specific parent study (See Grants and Cooperative Agreements question #4).

Back to Table of Contents

If an NHLBI funded parent study has an ancillary study funded by another NIH institute or some other entity, is a data set from the ancillary study still expected?
Since provisions for an NHLBI data set should be incorporated into the ancillary study policy, there is an expectation that regardless of funding source, NHLBI will receive an ancillary study data set. If the ancillary study funding is from an NIH institute with similar data sharing policies, then it is possible that the ancillary study data will be released by more than one institute; however, parent study data can only be released by NHLBI.

Back to Table of Contents

Ancillary studies may be 'generational', that is, the ancillary study itself may have ancillary studies. How far down the line does the policy apply? How would 'offspring' ancillary study data be coordinated?
If the ancillary study uses parent study data or specimens from the parent study, then the data should be subject to the policy.

Back to Table of Contents


V. Genetic and Pedigree data

Should studies provide to NHLBI both a self-reported and a genetic pedigree?
Although there are scientific benefits to both types of pedigree data, only genetic pedigrees should be sent to NHLBI for distribution through the program due to the sensitivity of non-paternity.

Back to Table of Contents

How should non-paternity be masked in genetic pedigrees?
One approach would be to replace the self-reported paternal ID with a phantom or 'dummy' ID. The study should ensure that the paternal 'dummy' ID is unique, but indistinguishable from other IDs (the ID cannot be linked with any phenotype data, but the format of the ID should not reveal it as a 'dummy' ID).

Back to Table of Contents

Should large pedigrees be masked?
In a single center study, a large pedigree may be considered an identifying characteristic and a study may wish to consider removing such pedigrees from the data set or truncating pedigrees at a certain size (limit pedigrees to size 6 or less). What constitutes a 'large' pedigree is entirely subjective, and a study should carefully consider the scientific value of large pedigrees and the protections NHLBI has in place (investigators must sign a data distribution agreement and obtain IRB approval) in deciding when large pedigrees should be removed. In multicenter studies with no clinic or center identifier and no special sample selection criteria by center (for example, race as a criteria for a specific site), large pedigrees may be kept.

Back to Table of Contents

Will genetic/pedigree data be provided to all investigators requesting data from a particular study?
Genetic/pedigree data will only be provided to investigators specifically requesting them. The genetic/pedigree data and documentation should be sent to NHLBI as stand-alone data since not all investigators will receive genetic/pedigree data. For example, if a large population study also has ancillary data on specific SNPs, then an investigator requesting the genetic data would be required to complete a data distribution agreement for both the clinic/follow-up data and a separate agreement for the genetic data. The IRB approval would need to indicate that the proposed project included the use of genetic data.

Back to Table of Contents


VI. Requesting NHLBI Data Repository Data Sets through BioLINCC

How do I obtain data from the NHLBI data repository?
The process is the same for either datasets and/or biospecimens.

Detailed instructions can be found in Section 3.0 of the Handbook

Back to Table of Contents

What is the cost for study datasets?
There is no monetary cost to the researcher for the preparation or receipt of a study dataset.

Back to Table of Contents

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. However, two teaching data sets are available and were designed to be suitable for use in an undergraduate or graduate level biostatistics instruction program. IRB approval is not required for these data sets.

Users of the teaching data sets are cautioned that these datasets are completely unsuitable for publication purposes since specific statistical measures were used to create anonymous versions.

Back to Table of Contents


VII. Submitting and preparing biospecimen collections for inclusion in the NHLBI Biorepository

When should I contact NHLBI about my interest in submitting a collection for inclusion in the NHLBI Biorepository?
The investigator should contact the NHLBI through BioLINCC as early in the planning stages of the study as possible. The NHLBI Biorepository Oversight Committee (BioROC) will review the proposed collection to determine if it meets the standards related to the intrinsic value as an addition to the existing collections. If the proposed collection adds value to the existing collections then the NHLBI biorepository staff can work with the investigator to assure that the standards (protocols, procedures, informed consent) are in place prior to the initiation of the study.

Back to Table of Contents


VIII. Requesting samples with or without accompanying characterization data from the NHLBI Biorepository

How do I obtain samples from the NHLBI Biorepository?

Detailed instructions can be found in Section 3.0 of the Handbook

Back to Table of Contents

Do I have to develop a full study plan and get IRB approval before determining if appropriate samples even exist in the repository?
At the initial request, the researcher can provide a simplified study plan describing the goals of the research alone with the as much information as possible (i.e., requirements for specimen type, minimum volumes etc.) to help BioLINCC determine if and how many specimens meet the requirements of the researcher. A full study plan and IRB approval are required before the application can be considered by the Repository Allocation Committee.

Back to Table of Contents

What are the costs for receiving biospecimen samples?
Researchers receiving biospecimen samples must pay for shipping costs. In some circumstances, the researcher may be requested to assist in the cost of aliquoting the requested biospecimens.

Back to Table of Contents

Once my request for samples is submitted, how long will it take for me to receive the samples?
The length of the review process can be influenced by the complexity of the request, particularly as it relates to legal issues and consideration of the importance of the study, when very limited quantities of biospecimen are involved. The minimal time between submission of the full study plan, with appropriate documentation and identified biospecimens, to shipment of samples is three months.

Back to Table of Contents

To obtain funding for the proposed studies on the samples from the biorepository I must document approved access to the samples. However, BioLINCC requires demonstration of adequate funding prior to considering my proposal. How do I resolve this issue?
This issue will be dealt with on a case-by-case basis.

Back to Table of Contents


IX. General Questions

Who owns the biospecimens submitted to the repository?
The NHLBI Biorepository is the custodian of samples from designated studies. For biospecimens housed in the NHLBI biorepository during an agreed-upon proprietary period, the study group submitting the samples controls their distribution. Once the proprietary period ends and the study transitions to the Open Access period, the NHLBI Repository Allocation Committee (RAC) assumes responsibility for distributing the samples in accordance with applicable NIH policies and procedures.

Back to Table of Contents

What is a linkage file?
A linkage file is a list that associates biological samples with the relevant clinical data. It is used to match the IDs that were used for the biosamples to those that were used for the clinical records for all of the study subjects. Note that these IDs must be masked or otherwise constructed so as not to identify subjects.

Back to Table of Contents

What types of data/samples are available?
The list of studies available can be found here. You may search using keywords or you may review the list of available studies. Descriptions of the studies and number and type of biospecimens, when applicable, can be viewed by clicking on the study name.

Back to Table of Contents


X. Other Questions

A study's informed consent is very detailed and includes several checkboxes for how the participant's data can be used. For example, there are checkboxes for: type of research (i.e., the participant can consent to using their data for research on any disease, or for cardiovascular disease and risk factors only), investigators who are allowed to do research on their data (i.e., any qualified investigator or study investigators only), and whether or not commercial interests can have access to the data. How should the data set be prepared in terms of which participants are included?
The data set must be prepared in a manner consistent with each participant's informed consent. Since NHLBI cannot restrict the type of research conducted on a data set, participants requesting that their data be used only for a specific research purpose (CVD only research, for example) should be removed from the repository version of the data. The NHLBI policy also requires that for studies in which the informed consent allows participants to request that their data not be used for commercial purposes, the data should include a 'commercial purpose' and a 'non-commercial purpose' version. In preparation for the data set, the coordinating center will need to enter data on the level of consent for each study participant.

Back to Table of Contents

The terms "Commercial Purpose" and "Non-Commercial Purpose" seem confusing. Are they named for an intended purpose or for the type of investigators that are eligible to receive them?
The terminology is based on what the participant indicated on the informed consent. A participant indicating on the informed consent that his or her data may be shared with investigators developing commercial products will be included in the commercial purpose data set. Therefore, the commercial purpose data set may be used by either academic or commercial entities developing commercially viable products. If a participant indicated that his or her data may not be shared with investigators developing commercial products, then that data will not appear in the commercial purpose data set, but will be in the non-commercial purpose data set providing the informed consent does not prohibit sharing of data beyond the study itself. Investigators from both academic and commercial institutions may receive the non-commercial data set; however, the investigator must indicate a non-commercial use of the data in the data distribution agreement.

Back to Table of Contents

Why should investigators provide a list of participant IDs to the NHLBI?
Study IDs should be replaced with new randomized IDs. Since NHLBI serves as the data repository, the link between the randomized IDs and the original study IDs is requested as a backup for the study in case delinking the data is needed for an unforeseen purpose. Participant IDs may be sent to NHLBI in several formats. One is to include all participant IDs with indicators for 'permission to share data' and 'permission to share data for a commercial purpose'. Another approach is to supply separate files of IDs. One file would list only the IDs for which the data can be shared for the purpose of non-commercial research (non-commercial purpose) and one file for which the participants indicated that their data could be shared for any reason (commercial purpose).

Back to Table of Contents

Must all of the data be reviewed for either truncation at the extremes (continuous traits) or grouping so that all counts are 20 or greater (categorical traits)?
The guidelines for modifying data are general and therefore not universally applicable. In general, only traits that have features that may be identifiable visually (e.g., height, weight, waist circumference) or could be ascertained through a casual knowledge of a subject (e.g., race, Hispanic status, marital status, employment status, education, income, significant outcomes of low frequencies such as cancers or specific causes of death) should be reviewed for possible modification. In general, multicenter studies have more leeway in performing fewer modifications since the removal of study center (geography) will, by itself, help to resolve many of the data modification issues.

Back to Table of Contents

How should image files or imaging data be transferred to NHLBI for distribution through the data repository?
If possible, summary scores or other reduced data are preferred from imaging studies such as MRIs, carotid ultrasounds, or CT scans. If a study prefers to release raw image data, then the project official should be consulted for options in releasing image data

Back to Table of Contents

Is the process the only mechanism for sharing data?
In addition to the mechanism, study investigators may want to establish a process for collaborations. Study investigators have a particular expertise regarding the study and in some situations may be willing to collaborate with other investigators. Coordinating centers may wish to consider establishing a website to describe the study and mechanisms for collaboration.

Back to Table of Contents