Final NIH Policy for Data Management and Sharing and Supplemental Information, 68890-68900 [2020-23674]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 85, Number 211 (Friday, October 30, 2020)]
[Notices]
[Pages 68890-68900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23674]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Final NIH Policy for Data Management and Sharing and Supplemental 
Information

AGENCY:  National Institutes of Health, HHS.

[[Page 68891]]


ACTION:  Notice of final Policy.

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SUMMARY: The National Institutes of Health (NIH) is issuing this final 
NIH Policy for Data Management and Sharing (DMS Policy) to promote the 
management and sharing of scientific data generated from NIH-funded or 
conducted research. This Policy establishes the requirements of 
submission of Data Management and Sharing Plans (hereinafter Plans) and 
compliance with NIH Institute, Center, or Office (ICO)-approved Plans. 
It also emphasizes the importance of good data management practices and 
establishes the expectation for maximizing the appropriate sharing of 
scientific data generated from NIH-funded or conducted research, with 
justified limitations or exceptions. This Policy applies to research 
funded or conducted by NIH that results in the generation of scientific 
data.

DATES: This final Policy is effective January 25, 2023.

FOR FURTHER INFORMATION CONTACT: If you have questions, or require 
additional background information about the DMS Policy, please contact 
Dr. Lyric Jorgenson, by email at ([email protected]), or 
telephone at 301-496-9838.

SUPPLEMENTARY INFORMATION: Sharing scientific data accelerates 
biomedical research discovery, in part, by enabling validation of 
research results, providing accessibility to high-value datasets, and 
promoting data reuse for future research studies.\1\ As a steward of 
the nation's investment in biomedical research, and in accordance with 
42 U.S.C. 282, of the Public Health Service Act, as amended, NIH has 
long championed policies that make research available to the public to 
achieve these goals. For example, the 2003 NIH Data Sharing Policy 
reinforced NIH's commitment to data sharing by requiring investigators 
to address data sharing in applications for large research awards. 
NIH's 2014 Genomic Data Sharing (GDS) Policy, initially preceded by the 
2008 Genome-Wide Association Studies Policy, set the expectation that 
researchers share large-scale genomic data, regardless of species, to 
enable the combination of large and information-rich datasets. In 2016, 
the NIH Policy on the Dissemination of NIH-Funded Clinical Trial 
Information (Clinical Trials Policy) further reinforced NIH's 
commitment to research participants and the research community by 
making the results of clinical trials accessible in a timely fashion.
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    \1\ See also NIH Rigor and Reproducibility efforts at https://www.nih.gov/research-training/rigor-reproducibility.
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    NIH recognizes that its data sharing policy efforts must flexibly 
evolve to keep pace with scientific and technological opportunities and 
notes that researchers' ability to generate, store, share, and combine 
data has never been greater. To capitalize on these advancements, NIH 
initiated the development of a more comprehensive data sharing policy 
alongside its efforts to modernize data sharing infrastructure in its 
2015 Plan for Increasing Access to Scientific Publications and Digital 
Scientific Data from NIH Funded Scientific Research. With policy and 
infrastructure modernization efforts working in tandem, NIH initiated a 
stepwise process for seeking feedback from the community to develop a 
robust data sharing policy capable of reflecting the diversity of its 
community's data sharing needs. In 2016, NIH requested public comments 
on data management and sharing strategies and priorities (NOT-OD-17-
015). In 2018, NIH solicited public input on proposed key provisions 
that could serve as a foundation for a future NIH policy for data 
management and sharing (NOT-OD-19-014). Using public feedback to inform 
its thinking, in 2019 NIH released a draft proposal for a future data 
management and sharing policy in the Federal Register (84 FR 60398).
    Along with the Draft Policy proposal, NIH sought feedback on 
supplemental materials that could help researchers integrate effective 
data management and sharing practices into research, including 
``Elements of an NIH Data Management and Sharing Plan'' and ``Allowable 
Costs for Data Management and Sharing.'' We note that a third document, 
``Supplemental Information to the NIH Policy for Data Management and 
Sharing: Selecting a Repository for Data Resulting from NIH-Supported 
Research,'' was developed in response to public comments received on 
both the Draft Policy and the ``Request for Public Comments on Draft 
Desirable Characteristics of Repositories for Managing and Sharing Data 
Resulting From Federally Funded Research,'' which was released for 
public comment by the White House Office of Science and Technology 
Policy (OSTP) to promote consistency across federal agencies and reduce 
researcher burden (85 FR 3085).
    In respect and recognition of Tribal sovereignty, NIH also 
initiated Tribal Consultation on its Draft Policy proposal, in 
accordance with the HHS Tribal Consultation Policy and the NIH Guidance 
on the Implementation of the HHS Tribal Consultation Policy. The NIH 
Tribal Consultation Report--NIH Draft Policy for Data Management and 
Sharing provides more detail on the Tribal Consultation process 
relative to the development of the final DMS Policy and NIH's response. 
Briefly, three themes emerged from Tribal Nations' input: (1) 
Strengthen engagement built on trust between researchers and Tribal 
Nations; (2) Train researchers to responsibly and respectfully manage 
and share American Indian and Alaska Native (AI/AN) data; and (3) 
Ensure research practices are aligned with the laws, policies, and 
preferences of AI/AN community partners. NIH intends to continue 
discussions to ensure appropriate implementation of the DMS Policy as 
it relates to these communities, and details about some of the 
implementation planning follows in the discussion below.

Overview of Public Comments

    NIH incorporated feedback over the course of several years to 
develop a data management and sharing policy proposal and released its 
Request for Comments on the Draft NIH Policy for Data Management and 
Sharing and Draft Supplemental Guidance on November 8, 2019 (84 FR 
60398, comment period closing on January 10, 2020). NIH held a public 
webinar on December 16, 2019, with over 580 people participating. In 
response to the Draft Policy, NIH received 203 responses from both 
domestic and international stakeholders, and the comments are publicly 
available.\2\ The largest group of respondents reported affiliation 
with universities, followed by nonprofit research organizations, 
professional associations (tied with ``other''), as well as small 
percentages of respondents affiliated with government agencies, 
healthcare delivery organizations, and patient advocacy organizations. 
Respondents typically identified themselves as scientific researchers, 
while another sizeable section self-identified as ``other.'' Remaining 
respondents identified as institutional officials, with smaller 
percentages self-identified as bioethicists or social science 
researchers, government officials, patient advocates, and members of 
the public. NIH considered all feedback in the development of the final 
DMS Policy, and a discussion of the public comments on topics follows 
below.
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    \2\ Compiled Public Comments on a DRAFT NIH Policy for Data 
Management and Sharing and Supplemental DRAFT Guidance (February 
2020) https://osp.od.nih.gov/wp-content/uploads/RFI_Final_Report_Feb2020.pdf.

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Discussion of Public Comments on the Draft NIH Policy for Data 
Management and Sharing

Clarifying Expectations for Sharing Scientific Data

    Draft Policy: The Draft Policy did not explicitly set a default 
expectation of data sharing. Rather, it focused on requiring submission 
of and compliance with a Data Management and Sharing Plan (Plan) that 
outlines how data will be managed and shared. The Draft Policy also 
included recognition of that fact that certain factors (i.e., legal, 
ethical, or technical) may limit the ability to preserve and share 
data.
    Public Comments: While commenters were generally supportive of the 
overall scope of the Draft Policy, many requested NIH make an 
explicitly stronger commitment to expecting data sharing from the 
research community. Suggestions included requiring data sharing and 
indicating that data sharing should be the default, with well justified 
exceptions being permitted.
    Final Policy: The final DMS Policy does not create a uniform 
requirement to share all scientific data. Unlike a requirement for 
submission of Plans, which can be implemented across various funding 
mechanisms and types of research with little variation, appropriate 
data sharing is likely to be varied and contextual. Through the 
requirement to submit a Plan, researchers are prospectively planning 
for data sharing, which we anticipate will increasingly lead 
researchers to integrate data sharing into the routine conduct of 
research. Accordingly, we have included in the final DMS Policy an 
expectation that researchers will maximize appropriate data sharing 
when developing Plans. The final DMS Policy retains the Draft Policy's 
factors (i.e., ethical, legal, or technical) that may necessitate 
variations in the extent of scientific data preservation and sharing, 
and researchers should convey such factors in their Plans. The final 
DMS Policy has also been modified to clarify these factors are not 
limited to data derived from human research participants. We believe 
this will provide the necessary flexibility for researchers to 
accommodate the substantial variety in research fields, projects, and 
data types that this expectation will encompass.

Definition of ``Scientific Data''

    Draft Policy: The scope of which data will be shared relies on the 
definition of ``scientific data.'' This term was defined in the Draft 
Policy as: ``The recorded factual material commonly accepted in the 
scientific community as necessary to validate and replicate research 
findings, regardless of whether the data are used to support scholarly 
publications. Scientific data do not include laboratory notebooks, 
preliminary analyses, completed case report forms, drafts of scientific 
papers, plans for future research, peer reviews, communications with 
colleagues, or physical objects, such as laboratory specimens. NIH 
expects that reasonable efforts will be made to digitize all scientific 
data.''
    Public Comments: Commenters focused on a variety of aspects of the 
definition of ``scientific data.'' They suggested that the concept of 
data quality be included, as data that may otherwise meet the 
definition but, if uninterpretable, are not of value. Commenters also 
suggested the definition address null or negative findings (and 
indicate that these data should be shared). Commenters requested 
clarification about the sentence that NIH expects reasonable efforts 
will be made to digitize all scientific data, including whether NIH 
would cover costs to digitize data that are not collected in digital 
form.
    Final Policy: The final DMS Policy defines Scientific Data as: 
``The recorded factual material commonly accepted in the scientific 
community as of sufficient quality to validate and replicate research 
findings, regardless of whether the data are used to support scholarly 
publications. Scientific data do not include laboratory notebooks, 
preliminary analyses, completed case report forms, drafts of scientific 
papers, plans for future research, peer reviews, communications with 
colleagues, or physical objects, such as laboratory specimens.'' We 
agree that data quality is an important concept to convey to ensure 
that scientific data are useful and to prevent data sharing from 
becoming a perfunctory administrative requirement, but rather one that 
should be done with the understanding that these data are intended to 
be used by others. Therefore, we have added to the definition that the 
data should be of sufficient quality to validate and replicate research 
findings. Even those scientific data not used to support a publication 
are considered scientific data and within the final DMS Policy's scope. 
We understand that a lack of publication does not necessarily mean that 
the findings are null or negative; however, indicating that scientific 
data are defined independent of publication is sufficient to cover data 
underlying null or negative findings.
    We also note that while the final DMS Policy states that scientific 
data are those as of sufficient quality to ``validate and replicate,'' 
we anticipate that shared scientific data will be used for a variety of 
purposes (consistent with applicable laws, policies, and limitations) 
including subsequent analyses, as suggested in the Purpose section of 
the final DMS Policy. Therefore, the concepts of validation and 
replication provide a standard for determining what constitutes 
scientific data and are not intended to limit uses of shared data.
    Finally, we have removed the expectation for digitizing scientific 
data. We encourage reasonable efforts to digitize data, recognizing 
that digitizing data may be a technical factor that may limit the 
sharing of data.

Timing of Submission of Data Management and Sharing Plans

    Draft Policy: The Draft Policy proposed the submission of Plans at 
Just-in-Time for grants.
    Public Comments: While we received a range of comments about timing 
of Plan submission, the majority were opposed to or requested further 
clarification about Just-in-Time Plan submission. Commenters were 
concerned about not having sufficient time to develop Plans and 
expressed concerns about the Plan revision process leading to delays in 
issuing awards. Others indicated that institutions would want to review 
Plans because they would ultimately be responsible for compliance, but 
a Just-in-Time Plan submission would not afford institutions sufficient 
time. A key practical concern with Just-in-Time Plan submission was 
difficulty submitting a budget at application that included requests 
for allowable data management and sharing costs prior to actually 
drafting the Plan. Commenters who favored submitting Plans at Just-in-
Time frequently cited decreased burden on applicants, because with 
Just-in-Time, only those applicants likely to be funded would be 
required to submit Plans, rather than all applicants.
    Final Policy: The final DMS Policy requires submission of a Plan 
for extramural grants at application. This approach is more conducive 
to achieving NIH's goal of promoting a culture in which data management 
and sharing are recognized to be an integral component of a biomedical 
research project, rather than an administrative or additive one. While 
NIH is aware that this approach places the requirement on the general 
pool of grant applicants rather than on those likely to be funded, it 
is precisely this approach of prospective planning for data management 
and sharing that NIH hopes to promote and that a number of commenters 
suggested is crucial for ensuring more regular planning for data

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management and sharing. We were swayed by the logistical concerns 
expressed in comments, namely how applicants could submit budgets 
appropriately reflective of data management and sharing when not yet 
required to submit the Plan that is intended to help them consider 
these issues. In addition, the concerns about institutions having 
sufficient time to review Plans and potential logistical challenges in 
issuing timely awards was persuasive. This approach is also consistent 
with the 2018 Request for Information on Proposed Provisions of a Draft 
Data Management and Sharing Policy for NIH Funded or Supported 
Research, which proposed Plans be submitted with extramural grant 
applications. The responses to that proposal generally favored Plan 
submission at the time of application.

Assessment of Plans

    Draft Policy: The Draft Policy proposed that NIH Program Staff in 
the funding NIH ICO assess Plans from extramural grants.
    Public Comments: Many commenters supported peer review of Plans, 
noting their skill and that peer review of Plans would promote a 
cultural shift in favor of data sharing. Commenters also suggested that 
NIH Program Staff review may lead to more consistent Plan assessment 
and decrease peer reviewer burden.
    Final Policy: The final DMS Policy maintains NIH Program Staff 
assessments of Plans' merits. However, peer reviewers may comment on 
the proposed budget for data management and sharing, although these 
comments will not impact the overall score. This approach balances the 
benefit of consistency afforded by NIH Program Staff review of Plans, 
review of updates, and compliance monitoring, with the opportunity for 
peer reviewers to comment on the requests for data management and 
sharing costs. Over time, and through these reviews, we hope to learn 
more about what constitutes reasonable costs for various data 
management and sharing activities across the NIH portfolio of research.

NIH ICO Consistency of Data Sharing Expectations

    Draft Policy: The Draft Policy noted that NIH ICOs may supplement 
the Policy's expectations for Plans with their own complementary 
requirements to further advance their specific program or research 
goals. In addition, the Draft Policy stated the funding NIH ICOs may 
request additional or specific information to be included within Plans 
to meet expectations for data management and sharing in support of 
programmatic priorities or to expand the utility of the scientific data 
generated from the research.
    Public Comments: In light of various existing NIH ICO data sharing 
policies, commenters expressed confusion around having potentially 
varying expectations in data sharing policy implementation across NIH. 
There were concerns about insufficient direction to NIH ICO and around 
a potentially uncoordinated variety of approaches. Commenters suggested 
guidance to facilitate NIH ICO consistency and suggested that NIH 
provide a centralized location of NIH ICO-specific expectations to help 
researchers navigate variations, particularly when subject to more than 
one NIH ICO's data sharing policies.
    Final Policy: While the final DMS Policy's language on this issue 
has not substantively changed from that of the Draft Policy, we have 
heard the concerns and intend to address them during the period of 
implementation planning prior to the DMS Policy's Effective Date. NIH 
ICOs can, within certain bounds, meet their scientific, policy, and 
programmatic goals in different ways. As such, this Policy affords NIH 
ICOs the opportunity to meet the goals of this Policy in ways that 
enhance their respective science. However, we intend to promote 
consistency on some key tenets of the final DMS Policy, such as the 
requirement for submission of Plans and the timing of their submission. 
The DMS Policy represents the minimum requirements for the NIH, but NIH 
ICOs may expect more specificity in Plans. For example, NIH ICOs and 
Programs may wish to promote, via specific Funding Opportunity 
Announcements (FOAs) or across their research portfolios, the use of 
particular standards to enable interoperability of datasets and 
resources. We are appreciative of the suggestion about how to organize 
NIH ICO-specific expectations and will be working to ensure clear 
implementation materials for applicants and awardees.

Data Derived From Human Participants

    Draft Policy: The Draft Policy acknowledged the applicability of 
laws, regulations, guidance, and policies that govern the conduct of 
research with human participants and how data derived from human 
participants should be used. It also described that Plans should 
indicate how human participants and data derived from them would be 
protected. Finally, the Draft Policy acknowledged that certain factors 
may limit the ability to share data and proposed that these factors be 
described in the Plan. Importantly, the Draft Policy did not propose 
any new expectations for the conduct of research with human 
participants.
    Public Comments: Commenters expressed concerns about how to 
safeguard participant privacy and confidentiality when sharing data, 
with some requesting information on de-identification practices. 
Commenters also requested guidance on best practices in communicating 
data sharing in informed consent. They also stressed the importance of 
data sharing to maximize the contributions of those who volunteer to 
participate in NIH-funded studies. Some pointed to special populations 
with preferences on data sharing issues, such as AI/AN populations, and 
asked how sharing of data from these participant populations is 
expected to be handled.
    In addition to the public comments submitted during the comment 
period, NIH received input from the Secretary's Advisory Committee on 
Human Research Protections (SACHRP).\3\ SACHRP provided a set of 
recommendations relating to applying the DMS Policy to research with 
human participants, some of which we have incorporated into the final 
DMS Policy and are discussed below.
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    \3\ Attachment A--NIH Data Sharing Policy (September 2020) 
https://www.hhs.gov/ohrp/sachrp-committee/recommendations/august-12-2020-attachment-a-nih-data-sharing-policy/.
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    AI/AN communities provided input through various channels, 
including through letters sent to NIH as part of government-to-
government communications. The Tribal Consultation process also led to 
valuable input that is informing NIH's implementation efforts, 
described further below.
    Final Policy: As with the Draft Policy, the final DMS Policy does 
not introduce new requirements for protections for research with human 
participants. Existing laws (e.g., Certificates of Confidentiality), 
regulations (e.g., the Common Rule), and policies (e.g., the NIH 
Genomic Data Sharing Policy) continue to apply. However, through this 
Policy and associated supplemental information and other activities, 
NIH promotes thoughtful practices regarding the treatment of data 
derived from human participants.
    In response to public comments and SACHRP's recommendations on the 
Draft Policy, we have included in the final DMS Policy three concepts 
that we believe are important to emphasize for investigators as they 
think through how to engage prospective participants

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regarding what is expected to happen with the data they contribute and, 
downstream, how best to respect these contributions. First, we 
encourage investigators to consider, while developing their Plans, how 
to address data management and sharing in the informed consent process, 
such that prospective participants will understand what is expected to 
happen with their data. This planning will serve investigators as they 
develop their Plans, because some of the Plan elements prompt 
investigators to outline anticipated factors that might affect the 
ability to share and preserve scientific data, such as any limitations 
arising from the informed consent process. NIH also intends to develop 
resources to help researchers and institutions in communicating the 
intent to share data with prospective research participants. Second, we 
note that any limitations on subsequent use of data (which may apply to 
non-human data as well) should be communicated to those individuals or 
entities preserving and sharing the scientific data. This ensures that 
factors that may affect subsequent use of data are properly 
communicated and will travel with the data. Finally, we highlight the 
importance of researchers considering whether, in choosing where and 
how to make their data available (if not already specified by an FOA or 
funding NIH ICO expectation), access to scientific data derived from 
humans should be controlled, even if de-identified and lacking explicit 
limitations on subsequent use.
    We note that data carrying explicit limitations on subsequent use 
require access controls to manage such limitations. This approach 
honors the wishes and autonomy of the participants who contributed 
their data and is important to uphold, even if the data are de-
identified. In addition, investigators should consider whether access 
to data even without such limitations should be controlled. SACHRP 
identified concerns regarding re-identification of otherwise de-
identified data, and indeed technological advances and increasing 
interoperability among data resources, while providing opportunities 
for new analyses, present identifiability concerns that are widely 
acknowledged. In response to concerns expressed in public comments and 
by SACHRP, NIH may support development of resources to assist 
researchers and institutions in determining how to appropriately de-
identify data from human participants, as well as for communicating 
data sharing in informed consent.
    The final DMS Policy does not preclude the open sharing of data 
from human participants in ways that are consistent with consent 
practices, established norms, and applicable law. For example, open 
sharing of a compilation of a population's genotype at a particular 
locus may be an acceptable and established practice if consistent with 
informed consent. And importantly, we are aware that some patient 
communities prioritize openness to speed scientific progress and 
discovery. Nothing in the final DMS Policy is intended to prevent these 
approaches, as long as participants are appropriately informed and 
prospectively agree to them.
    We emphasize that respecting participant autonomy and maintaining 
privacy of participants and confidentiality of their data can be 
consistent with data sharing. Through the final DMS Policy, we outline 
a balance that accommodates various responsible approaches that meet 
data sharing expectations and honor appropriate limitations in sharing. 
In addition, while the DMS Policy sets the expectation that, through 
their Plans, researchers maximize the appropriate sharing of scientific 
data (acknowledging factors that may limit such sharing, as discussed 
above), the DMS Policy does not expect that the informed consent given 
by participants to be obtained in any particular way, such as through 
broad consent.
    In response to input from Tribal Nations, the final DMS Policy 
clarifies agency respect for Tribal sovereignty in the absence of 
written Tribal laws or polices. To address some of the other themes and 
comments we heard from both AI/AN communities as well as public 
commenters who expressed interest in agency efforts to promote 
responsible and respectful engagement of AI/AN populations, we are 
developing supplemental information for researchers who wish to work 
with AI/AN communities. Such guidance is expected to encourage 
researchers to (among other topics): thoughtfully consider the unique 
data sharing concerns of AI/AN communities; respectfully negotiate 
agreements for data use with Tribal Nations; and enhance researcher 
awareness of processes Tribal Nations use to review prospective 
research. NIH will seek input from AI/AN communities on the development 
of the guidance, to ensure it serves the goals of guiding researchers 
while taking into account Tribal preferences and values.

When Data Are Expected To Be Shared

    Draft Policy: The Draft Policy proposed that shared scientific data 
should be made accessible in a timely manner for use by the research 
community and the broader public.
    Public Comments: While commenters appreciated the flexibility 
afforded by this approach, they also expressed concern about its 
ambiguity. Some suggested timing of data sharing be connected to 
publication. Commenters also suggested NIH should specify outer bounds 
for timing of data sharing in the absence of a publication. Overall, 
commenters expressed the desire for more clarity.
    Final Policy: The final DMS Policy states that ``[s]hared 
scientific data should be made accessible as soon as possible, and no 
later than the time of an associated publication, or the end of the 
award/support period, whichever comes first.'' This statement provides 
more clarity than the Draft Policy through outer bounds to guide 
researchers in when to make the scientific data available. It clarifies 
that publication triggers release of the data that underlie that 
publication (indeed, publishers often require the same). But it also 
recognizes that research does not always lead to a publication that 
would itself trigger the release of data. Importantly, the final DMS 
Policy is designed to increase the sharing of scientific data, 
regardless of whether a publication is produced. Important research may 
never be published for a variety of reasons, not least of which because 
the results did not prove the hypothesis. However, we believe the 
scientific data underlying all NIH-funded research to be of importance, 
particularly to serve the purposes of accountability and transparency. 
Data that do not form the basis of a publication produced during the 
award period should be shared by the end of the award period. A single 
research project may take advantage of both approaches. Namely, 
researchers may share data underlying publication during the period of 
award but may share other data that have not yet led to a publication 
by the end of the award period.

How Long Data Should Be Available

    Draft Policy: The Draft Policy stated that ``NIH encourages shared 
scientific data to be made available as long as it is deemed useful to 
the research community or the public.''
    Public Comments: Commenters expressed uncertainty about how the 
concept of usefulness would be

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determined, and who would determine usefulness.
    Final Policy: We have indicated a framework for helping researchers 
think through a minimum time period for data availability. Providing 
this framework is anticipated to help researchers both develop Plans 
and also budget accordingly for data management and sharing costs, when 
needed. Existing requirements and expectations set forth through, for 
example, applicable record retention requirements, repository policies, 
and journal policies may guide researchers as they seek to define 
minimal periods for data availability. However, we encourage 
researchers to propose longer time periods that may be informed by 
other factors, such as anticipated value of the dataset for the 
scientific community and the public.

Where To Share Scientific Data

    Draft Policy: The Draft Policy stated that ``NIH encourages the use 
of established repositories for preserving and sharing scientific 
data.''
    Public Comments: Commenters supported the use of established 
repositories for preserving and sharing scientific data.
    Final Policy: The final DMS Policy strongly encourages the use of 
established repositories to the extent possible. This reflects NIH's 
preference that scientific data be shared and preserved through 
repositories, rather than kept only by the researcher or institution 
and provided on request, with the recognition that this is not always a 
practical or even a preferred approach. For example, we recognize and 
respect that AI/AN communities, in particular, may wish to manage, 
preserve, and share their own data. We support efforts that enable AI/
AN communities to prioritize research opportunities and to ensure 
sufficient protections on scientific data generated from such research. 
In addition, we have released the Supplemental Information to the NIH 
Policy for Data Management and Sharing: Selecting a Repository for Data 
Resulting from NIH-Supported Research, which will aid researchers as 
they choose suitable repositories for the preservation and sharing of 
data. This supplemental information is discussed in more detail below.

Discussion of Public Comments on the Draft Supplemental Information: 
Elements of an NIH Data Management and Sharing Plan

Page Limit and Template for Plans

    Draft Supplemental Information: The Draft Supplemental Information 
suggested a limit for Plan length of two pages or less. It did not 
indicate whether template Plans would be provided.
    Public Comments: Commenters expressed that two pages is 
insufficient to describe approaches for data management and sharing, 
particularly for larger, more complicated projects, such as those 
involving consortia. In addition, commenters suggested that NIH provide 
a template for Plans, with Plans being machine-readable.
    Final Supplemental Information: We understand the concern about 
describing plans for data management and sharing in two pages. In the 
final supplemental information, we have noted the elements to be 
addressed in two pages or less, indicating that these descriptions need 
not be long narratives. In addition, short Plans are anticipated to 
limit researcher burden.

The Acceptability of ``To Be Determined'' as a Response to Plan 
Elements

    Draft Supplemental Information: The Draft Supplemental Information 
proposed that if certain elements of a Plan have not been determined by 
the time of Plan submission, an entry of ``to be determined'' may be 
acceptable if a justification is provided along with a timeline or 
appropriate milestone at which a determination will be made.
    Public Comments: Commenters disagreed with allowing responses of 
``to be determined'' at initial Plan submission.
    Final Supplemental Information: The final Supplemental Information 
eliminates the language that a response of ``to be determined'' is 
acceptable. We do not expect researchers to necessarily have all 
details at the application stage, but we encourage researchers to fill 
out Plans to the best of their knowledge and ability, so the Plans may 
be appropriately assessed. We also note that adherence with NIH ICO-
approved Plans is a requirement of the final DMS Policy. As indicated 
in the final DMS Policy, researchers will have opportunities to update 
their Plans throughout the course of their awards, subject to NIH ICO 
approval.

The Use of Persistent Unique Identifiers (PIDs)

    Draft Supplemental Information: The Draft Supplemental Information 
asked for researchers to indicate how data will be findable and whether 
a persistent unique identifier or other standard indexing tools will be 
used.
    Public Comments: Commenters expressed support for PIDs, explaining 
that researchers are incentivized to use PIDs because they enable 
effective citation. They also noted PIDs are a way to track data 
sharing compliance.
    Final Supplemental Information: The final Supplemental Information 
asks researchers to describe how the scientific data will be findable 
and identifiable, i.e., via a persistent unique identifier or other 
standard indexing tools. This wording change is meant to highlight the 
importance of using a PID or other standard indexing tool so the data 
are findable, which is a key component of the FAIR (Findable, 
Accessible, Interoperable, and Re-usable) Principles. PIDs are also 
listed as a desirable characteristic of data repositories in the 
Supplemental Information to the NIH Policy for Data Management and 
Sharing: Selecting a Repository for Data Resulting from NIH-Supported 
Research.

Data Security

    Draft Supplemental Information: The Draft Supplemental Information 
proposed that researchers address provisions for maintaining the 
security and integrity of the scientific data, such as through 
encryption and back-ups. It also noted that data sharing should be 
consistent with security as well as other factors.
    Public Comments: Commenters emphasized the importance of data 
security.
    Final Supplemental Information: We have removed the prompt for 
researchers to address provisions related to the security of scientific 
data. While we agree with the importance of appropriate data security 
measures, we believe that technical provisions regarding data security 
are more appropriately addressed by the institutions and repositories 
preserving and sharing the scientific data. The Supplemental 
Information to the NIH Policy for Data Management and Sharing: 
Selecting a Repository for Data Resulting from NIH-Supported Research 
(discussed in more detail below) outlines characteristics of suitable 
repositories, and we do not wish to burden the funded community with 
describing in-depth the data security processes of the data 
repositories preserving and sharing the data generated by their 
research. While data may remain with an institution prior to submission 
to a data repository, the DMS Policy is not designed to set any new 
standards for institutional data security practices.

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Discussion of Public Comments on the Draft Supplemental Information: 
Allowable Costs for Data Management and Sharing

Timelines for Using Funds for Data Management and Sharing Activities

    Draft Supplemental Information: The Draft Guidance noted that 
budget requests to the NIH may include costs for preserving and sharing 
data through repositories that charge recurring fees, however it did 
not specify timelines by which funds allotted for data management and 
sharing must be spent or how to account for paying fees to data 
repositories storing data after the end of the performance period.
    Public Comments: Commenters generally supported the proposal but 
sought clarification on whether funds may be used to pre-pay fees for 
long-term data availability. Commenters also asked whether these funds 
could cover personnel expenses.
    Final Supplemental Information: Personnel costs required to perform 
the types of data management and sharing activities described in the 
final Supplemental Information are allowable. Regarding the 
availability of data beyond the end of the project, which is crucial to 
achieving the goals of the DMS Policy, the final Supplemental 
Information clarifies that fees for long-term data preservation and 
sharing are allowable, but funds for these activities must be spent 
during the performance period, even for scientific data and metadata 
preserved and shared beyond the award period. NIH funds cannot legally 
be spent after the award period.

Discussion of Requests for Additional Guidance and Information

    Public commenters requested more clarity not only on information in 
provided materials, but about issues key to implementation. One common 
theme was a request for guidance about how to choose a data repository, 
with some requesting a list of suitable repositories. NIH does not 
intend to provide a comprehensive list of suitable repositories outside 
of those supported or stewarded by NIH.\4\ However, NIH recognizes the 
need for providing a way to help researchers determine what 
characteristics make for a suitable repository for the preservation and 
sharing of data from NIH-funded research. As such, we are releasing the 
Supplemental Information to the NIH Policy for Data Management and 
Sharing: Selecting a Repository for Data Resulting from NIH-Supported 
Research. This document stems in part from an interagency effort led by 
the White House OSTP to outline desirable characteristics of preserving 
and sharing data from federally funded research, released as the 
Request for Public Comment on Draft Desirable Characteristics of 
Repositories for Managing and Sharing Data Resulting From Federally 
Funded Research (85 FR 3085). The purpose was also to promote 
consistency across federal agencies to reduce researcher burden. The 
public comments on this document also informed the development of the 
Supplemental Information.
---------------------------------------------------------------------------

    \4\ For an example of NIH-supported or -stewarded repositories 
see Open Domain-Specific Data Sharing Repositories (September 2020) 
https://www.nlm.nih.gov/NIHbmic/domain_specific_repositories.html.
---------------------------------------------------------------------------

    The Supplemental Information to the NIH Policy for Data Management 
and Sharing: Selecting a Repository for Data Resulting from NIH-
Supported Research includes a process to help researchers determine 
suitable repositories by providing relevant characteristics, noting 
that NIH ICOs may have identified preferred repositories in FOAs or 
through other announcements.

Concluding Points

    As the DMS Policy is released, the world is in the midst of the 
COVID-19 pandemic. The recognition that more open sharing can lead to 
faster advances and treatments has led to an unprecedented worldwide 
effort to openly share publications and data related to both SARS-CoV-2 
(the novel coronavirus that causes COVID-19) and coronaviruses more 
generally. While this is a specific example of an urgent public health 
need, patients, families, and patient advocacy groups consider the 
diseases and conditions that affect them to be of equal urgency, as do 
those who research these diseases and conditions and treat affected 
patients. With public input, NIH has worked to develop and refine this 
DMS Policy, the goal of which is to increase the sharing of scientific 
data generated from NIH-funded research to ultimately enhance health, 
lengthen life, and reduce illness and disability.
    In addition to the Supplemental Information discussed here, we 
intend to provide frequently asked questions and other information to 
aid in implementation, prior to the DMS Policy's Effective Date. We 
recognize that some fields and researchers plan for sharing and prepare 
data for preservation and sharing as a regular practice. For others, 
these activities may be new. We anticipate a period of learning and an 
evolution of implementation practices. Further, it is important to 
acknowledge that NIH recognizes that expectations for robust data 
management and sharing practices will need to be met with investments 
in and evolution of accompanying data infrastructure. We look forward 
to working with applicants and the funded community as they prepare to 
meet the DMS Policy's requirements and expectations, as we all move 
toward a future in which data sharing is a community norm.
    The final DMS policy is set forth below. Upon its Effective Date, 
the DMS Policy replaces the 2003 NIH Data Sharing Policy.

NIH Policy for Data Management and Sharing

Section I. Purpose

    The National Institutes of Health (NIH) Policy for Data Management 
and Sharing (herein referred to as the DMS Policy) reinforces NIH's 
longstanding commitment to making the results and outputs of NIH-funded 
research available to the public through effective and efficient data 
management and data sharing practices. Data sharing enables researchers 
to rigorously test the validity of research findings,\5\ strengthen 
analyses through combined datasets, reuse hard-to-generate data, and 
explore new frontiers of discovery. In addition, NIH emphasizes the 
importance of good data management practices, which provide the 
foundation for effective data sharing and improve the reproducibility 
and reliability of research findings. NIH encourages data management 
and data sharing practices consistent with the FAIR data principles.\6\
---------------------------------------------------------------------------

    \5\ NIH Rigor and Reproducibility https://www.nih.gov/research-training/rigor-reproducibility.
    \6\ Wilkinson, M., Dumontier, M. et al, The FAIR Guiding 
Principles for Scientific Data Management and Stewardship (March 
2016) https://www.nature.com/articles/sdata201618.
---------------------------------------------------------------------------

    Under the DMS Policy, NIH requires researchers to prospectively 
plan for how scientific data will be preserved and shared through 
submission of a Data Management and Sharing Plan (Plan). Upon NIH 
approval of a Plan, NIH expects researchers and institutions to 
implement data management and sharing practices as described. The DMS 
Policy is intended to establish expectations for Data Management and 
Sharing Plans, which applicable NIH Institutes, Centers and Offices 
(ICO) may supplement as appropriate.

Section II. Definitions

    For the purposes of the DMS Policy, terms are defined as follows:
    Scientific Data: The recorded factual material commonly accepted in 
the

[[Page 68897]]

scientific community as of sufficient quality to validate and replicate 
research findings, regardless of whether the data are used to support 
scholarly publications. Scientific data do not include laboratory 
notebooks, preliminary analyses, completed case report forms, drafts of 
scientific papers, plans for future research, peer reviews, 
communications with colleagues, or physical objects, such as laboratory 
specimens.
    Data Management: The process of validating, organizing, protecting, 
maintaining, and processing scientific data to ensure the 
accessibility, reliability, and quality of the scientific data for its 
users.
    Data Sharing: The act of making scientific data available for use 
by others (e.g., the larger research community, institutions, the 
broader public), for example, via an established repository.
    Metadata: Data that provide additional information intended to make 
scientific data interpretable and reusable (e.g., date, independent 
sample and variable construction and description, methodology, data 
provenance, data transformations, any intermediate or descriptive 
observational variables).
    Data Management and Sharing Plan (Plan): A plan describing the data 
management, preservation, and sharing of scientific data and 
accompanying metadata.

Section III. Scope

    The DMS Policy applies to all research, funded or conducted in 
whole or in part by NIH, that results in the generation of scientific 
data. This includes research funded or conducted by extramural grants, 
contracts, Intramural Research Projects, or other funding agreements 
regardless of NIH funding level or funding mechanism. The DMS Policy 
does not apply to research and other activities that do not generate 
scientific data, including training, infrastructure development, and 
non-research activities.

Section IV. Effective Date(s)

    The effective date of the DMS Policy is January 25, 2023, including 
for:
     Competing grant applications that are submitted to NIH for 
the January 25, 2023 and subsequent receipt dates;
     Proposals for contracts that are submitted to NIH on or 
after January 25, 2023;
     NIH Intramural Research Projects conducted on or after 
January 25, 2023; and
     Other funding agreements (e.g., Other Transactions) that 
are executed on or after January 25, 2023, unless otherwise stipulated 
by NIH.

Section V. Requirements

    The DMS Policy requires:
     Submission of a Data Management and Sharing Plan outlining 
how scientific data and any accompanying metadata will be managed and 
shared, taking into account any potential restrictions or limitations.
     Compliance with the awardee's plan as approved by the NIH 
ICO.
    The NIH ICO may request additional or specific information to be 
included within the Plan in order to meet expectations for data 
management and data sharing in support of programmatic priorities or to 
expand the utility of the scientific data generated from the research. 
Costs associated with data management and data sharing may be allowable 
under the budget for the proposed project (see Supplemental Information 
to the NIH Policy for Data Management and Sharing: Allowable Costs for 
Data Management and Sharing).

Section VI. Data Management and Sharing Plans

    Researchers planning to generate scientific data are required to 
submit a Plan to the funding NIH ICO as part of the Budget 
Justification section of the application for extramural awards, as part 
of the technical evaluation for contracts, as determined by the 
Intramural Research Program for Intramural Research Projects consistent 
with the objectives of this Policy, or prior to release of funds for 
other funding agreements. Plans should explain how scientific data 
generated by research projects will be managed and which of these 
scientific data and accompanying metadata will be shared. If Plan 
revisions are necessary (e.g., new scientific direction, a different 
data repository, or a timeline revision), Plans should be updated by 
researchers and reviewed by the NIH ICO during regular reporting 
intervals or sooner. Plans from NIH-funded or conducted research may be 
made publicly available and should not include proprietary or private 
information.\7\
---------------------------------------------------------------------------

    \7\ NIH Grants Policy Statement 2.3.11 Availability and 
Confidentiality of Information (October 2019) https://grants.nih.gov/grants/policy/nihgps/html5/section_2/2.3.11_availability_and_confidentiality_of_information.htm.
---------------------------------------------------------------------------

    Plan Elements: NIH has developed Supplemental Information to the 
NIH Policy for Data Management and Sharing: Elements of an NIH Data 
Management and Sharing Plan that describes recommended elements to 
address in Plans.
    Plan Assessment: The NIH ICO will assess the Plan, through the 
following processes:
     Extramural Awards: Plans will undergo programmatic 
assessment by NIH as determined by the proposed NIH ICO. NIH encourages 
potential awardees to work with NIH staff to address any potential 
questions regarding Plan development prior to submission.
     Contracts: Plans will be included as part of the technical 
evaluation performed by NIH staff.
     Intramural Research Projects: Plans will be assessed in a 
manner determined to be appropriate by the Intramural Research Program.
     Other funding agreements: Plans will be assessed in the 
context of other funding agreement mechanisms (e.g., Other 
Transactions).

Section VII. Managing and Sharing Scientific Data

    NIH expects that in drafting Plans, researchers will maximize the 
appropriate sharing of scientific data, acknowledging certain factors 
(i.e., legal, ethical, or technical) that may affect the extent to 
which scientific data are preserved and shared. Any potential 
limitations on subsequent data use should be communicated to 
individuals or entities (e.g., data repository managers) that will 
preserve and share the scientific data. The NIH ICO will assess whether 
Plans appropriately consider and describe these factors.
    Considerations for Scientific Data Derived from Human Participants: 
NIH prioritizes the responsible management and sharing of scientific 
data derived from human participants. Applicable federal, Tribal, 
state, and local laws, regulations, statutes, guidance, and 
institutional policies govern research involving human participants and 
the sharing and use of scientific data derived from human participants. 
NIH also respects Tribal sovereignty in the absence of written Tribal 
laws or polices. The DMS Policy is consistent with federal regulations 
for the protection of human research participants and other NIH 
expectations for the use and sharing of scientific data derived from 
human participants, including the NIH's 2014 Genomic Data Sharing (GDS) 
Policy, 2015 Intramural Research Program Human Data Sharing Policy, and 
45 CFR 46. Researchers proposing to generate scientific data derived 
from human participants should outline in their Plans how privacy, 
rights, and confidentiality of human research participants will be 
protected (i.e., through de-identification, Certificates of 
Confidentiality, and other protective measures).

[[Page 68898]]

    NIH strongly encourages researchers to plan for how data management 
and sharing will be addressed in the informed consent process, 
including communicating with prospective participants how their 
scientific data are expected to be used and shared. Researchers should 
consider whether access to scientific data derived from humans, even if 
de-identified and lacking explicit limitations on subsequent use, 
should be controlled.
    Data Repository Selection: NIH strongly encourages the use of 
established repositories to the extent possible for preserving and 
sharing scientific data.\8\ The Supplemental Information to the NIH 
Policy for Data Management and Sharing: Selecting a Repository for Data 
Resulting from NIH-Supported Research assists researchers in selecting 
a suitable data repository(ies) or cloud-computing platform.
---------------------------------------------------------------------------

    \8\ NIH Strategic Plan for Data Science (June 2018) https://datascience.nih.gov/sites/default/files/NIH_Strategic_Plan_for_Data_Science_Final_508.pdf.
---------------------------------------------------------------------------

    Data Preservation and Sharing Timelines: Shared scientific data 
should be made accessible as soon as possible, and no later than the 
time of an associated publication, or the end of performance period, 
whichever comes first. Researchers are encouraged to consider relevant 
requirements and expectations (e.g., data repository policies, award 
record retention requirements, journal policies) as guidance for the 
minimum time frame that scientific data should be made available, which 
researchers may extend.

Section VIII. Compliance and Enforcement

During the Funding or Support Period

    During the funding period, compliance with the Plan will be 
determined by the NIH ICO. Compliance with the Plan, including any Plan 
updates, may be reviewed during regular reporting intervals (e.g., at 
the time of annual Research Performance Progress Reports (RPPRs)).
     Extramural Awards: The Plan will become a Term and 
Condition of the Notice of Award. Failure to comply with the Terms and 
Conditions may result in an enforcement action, including additional 
special terms and conditions or termination of the award, and may 
affect future funding decisions.
     Contracts: The Plan will become a Term and Condition of 
the Award, and compliance with and enforcement of the Plan will be 
consistent with the award and the Federal Acquisition Regulations, as 
applicable.
     Intramural Research Projects: Compliance with and 
enforcement of the Plan will be consistent with applicable NIH policies 
established by the NIH Office of Intramural Research and the NIH ICO.
     Other funding agreements: Compliance with and enforcement 
of the Plan will be consistent with applicable NIH policies.

Post Funding or Support Period

    After the end of the funding period, non-compliance with the NIH 
ICO-approved Plan may be taken into account by NIH for future funding 
decisions for the recipient institution (e.g., as authorized in the NIH 
Grants Policy Statement, Section 8.5, Special Award Conditions, and 
Remedies for Noncompliance (Special Award Conditions and Enforcement 
Actions)).

Supplemental Information to the NIH Policy for Data Management and 
Sharing: Elements of an NIH Data Management and Sharing Plan

    The final NIH Policy for Data Management and Sharing requires 
applicants to submit a Data Management and Sharing Plan (Plan) for any 
NIH-funded or conducted research that will generate scientific data. 
This supplemental information outlines the elements to be addressed in 
a Plan within two pages or less. A Plan should reflect the proposed 
approach to data management and sharing at the time it is prepared and 
be updated during the course of the award/support period to reflect any 
changes in the management and sharing of scientific data (e.g., new 
scientific direction, new repository option, timeline revision). For 
some programs and data types, NIH and/or NIH ICOs have developed 
specific data sharing expectations (e.g., scientific data to share, 
relevant standards, repository selection, timelines) that apply and 
should be reflected in a Plan. When no additional NIH and/or NIH ICO 
data sharing expectations apply, researchers should propose their own 
approaches to data management and sharing in a Plan. NIH encourages 
data management and sharing practices to be consistent with the FAIR 
(Findable, Accessible, Interoperable, and Reusable) data principles and 
reflective of practices within specific research communities. NIH 
recommends addressing all elements described below.
    Data Type: Briefly describe the scientific data to be managed, 
preserved, and shared, including:
     A general summary of the types and estimated amount of 
scientific data to be generated and/or used in the research. Describe 
data in general terms that address the type and amount/size of 
scientific data expected to be collected and used in the project (e.g., 
256-channel EEG data and fMRI images from ~50 research participants). 
Descriptions may indicate the data modality (e.g., imaging, genomic, 
mobile, survey), level of aggregation (e.g., individual, aggregated, 
summarized), and/or the degree of data processing that has occurred 
(i.e., how raw or processed the data will be).
     A description of which scientific data from the project 
will be preserved and shared. NIH does not anticipate that researchers 
will preserve and share all scientific data generated in a study. 
Researchers should decide which scientific data to preserve and share 
based on ethical, legal, and technical factors that may affect the 
extent to which scientific data are preserved and shared. Provide the 
rationale for these decisions.
     A brief listing of the metadata, other relevant data, and 
any associated documentation (e.g., study protocols and data collection 
instruments) that will be made accessible to facilitate interpretation 
of the scientific data.
    Related Tools, Software and/or Code: An indication of whether 
specialized tools are needed to access or manipulate shared scientific 
data to support replication or reuse, and name(s) of the needed tool(s) 
and software. If applicable, specify how needed tools can be accessed, 
(e.g., open source and freely available, generally available for a fee 
in the marketplace, available only from the research team) and, if 
known, whether such tools are likely to remain available for as long as 
the scientific data remain available.
    Standards: An indication of what standards will be applied to the 
scientific data and associated metadata (i.e., data formats, data 
dictionaries, data identifiers, definitions, unique identifiers, and 
other data documentation). While many scientific fields have developed 
and adopted common data standards, others have not. In such cases, the 
Plan may indicate that no consensus data standards exist for the 
scientific data and metadata to be generated, preserved, and shared.
    Data Preservation, Access, and Associated Timelines: Plans and 
timelines for data preservation and access, including:
     The name of the repository(ies) where scientific data and 
metadata arising from the project will be archived. NIH has provided 
additional information to assist in selecting suitable repositories for 
scientific data resulting from funded research.

[[Page 68899]]

     How the scientific data will be findable and identifiable, 
i.e., via a persistent unique identifier or other standard indexing 
tools.
     When the scientific data will be made available to other 
users (i.e., the larger research community, institutions, and/or the 
broader public) and for how long. NIH encourages scientific data be 
shared as soon as possible, and no later than time of an associated 
publication or end of the performance period, whichever comes first. 
Researchers are encouraged to consider relevant requirements and 
expectations (e.g., data repository policies, award record retention 
requirements, journal policies) as guidance for the minimum time frame 
scientific data should be made available. NIH encourages researchers to 
make scientific data available for as long as they anticipate it being 
useful for the larger research community, institutions, and/or the 
broader public. Identify any differences in timelines for different 
subsets of scientific data to be shared.
    Access, Distribution, or Reuse Considerations: NIH expects that in 
drafting Plans, researchers maximize the appropriate sharing of 
scientific data generated from NIH-funded or conducted research, 
consistent with privacy, security, informed consent, and proprietary 
issues. Describe any applicable factors affecting subsequent access, 
distribution, or reuse of scientific data related to:
     Informed consent (e.g., disease-specific limitations, 
particular communities' concerns).
     Privacy and confidentiality protections (i.e., de-
identification, Certificates of Confidentiality, and other protective 
measures) consistent with applicable federal, Tribal, state, and local 
laws, regulations, and policies.
     Whether access to scientific data derived from humans will 
be controlled (i.e., made available by a data repository only after 
approval).
     Any restrictions imposed by federal, Tribal, or state 
laws, regulations, or policies, or existing or anticipated agreements 
(e.g., with third party funders, with partners, with Health Insurance 
Portability and Accountability Act (HIPAA) covered entities that 
provide Protected Health Information under a data use agreement, 
through licensing limitations attached to materials needed to conduct 
the research).
     Any other considerations that may limit the extent of data 
sharing.
    Oversight of Data Management and Sharing: Indicate how compliance 
with the Plan will be monitored and managed, frequency of oversight, 
and by whom (e.g., titles, roles).

Supplemental Information to the NIH Policy for Data Management and 
Sharing: Allowable Costs for Data Management and Sharing

    NIH recognizes that making data accessible and reusable for other 
users may incur costs. To assist individuals and entities subject to 
the final NIH Policy for Data Management and Sharing, this supplemental 
information outlines categories of allowable NIH costs associated with 
data management and sharing.
    All allowable costs submitted in budget requests must be incurred 
(e.g., curation fees, data repository fees) during the performance 
period, even for scientific data and metadata preserved and shared 
beyond the award period. Consistent with 45 CFR 75.403 and the NIH 
Grants Policy Statement Section 7.4, budget requests must not include 
infrastructure costs that are included in institutional overhead (e.g., 
Facilities and Administrative costs) or costs associated with the 
routine conduct of research. Costs associated with collecting or 
otherwise gaining access to research data (e.g., data access fees) are 
considered costs of doing research and should not be included in 
scientific data management and sharing budgets. Costs may not be double 
charged or inconsistently charged as both direct and indirect costs.
    Reasonable, allowable costs may be included in NIH budget requests 
when associated with:
    1. Curating data and developing supporting documentation, including 
formatting data according to accepted community standards; de-
identifying data; preparing metadata to foster discoverability, 
interpretation, and reuse; and formatting data for transmission to and 
storage at a selected repository for long-term preservation and access.
    2. Local data management considerations, such as unique and 
specialized information infrastructure necessary to provide local 
management and preservation (e.g., before deposit into an established 
repository).
    3. Preserving and sharing data through established repositories, 
such as data deposit fees necessary for making data available and 
accessible. For example, if a Data Management and Sharing Plan proposes 
preserving and sharing scientific data for 10 years in an established 
repository with a deposition fee, the cost for the entire 10-year 
period must be paid prior to the end of the period of performance. If 
the Plan proposes deposition to multiple repositories, costs associated 
with each proposed repository may be included.

Supplemental Information to the NIH Policy for Data Management and 
Sharing: Selecting a Repository for Data Resulting from NIH-Supported 
Research

    This supplemental information is intended to help researchers 
choose data repositories suitable for the preservation and sharing of 
data (i.e., scientific data and metadata) resulting from NIH-funded and 
conducted research. NIH promotes the use of established data 
repositories because deposit in a quality data repository generally 
improves the FAIRness (Findable, Accessible, Interoperable, and Re-
usable) of the data.
    While NIH supports many data repositories, it will not necessarily 
provide data repositories to preserve and share all data resulting from 
the research it funds. The broader repository ecosystem for biomedical 
data includes data repositories supported by other organizations, both 
public and private. NIH anticipates that the broader repository 
ecosystem will continue to evolve over time, providing different 
options for researchers as their data sharing needs continue to evolve.
    Similarly, while discipline or data-type specific repositories may 
not exist for every type of data resulting from NIH-funded or conducted 
research, the broader repository ecosystem provides suitable data 
repositories to accommodate scientific data generated from all of NIH's 
funded or conducted research projects. Researchers may wish to consult 
experts in their own institutions (e.g., librarians, data managers) for 
assistance in selecting among data repositories.
    NIH encourages researchers to select data repositories that 
exemplify the desired characteristics (see lists I. and II. below 
relating to data repository characteristics), including when a data 
repository is supported or provided by a cloud-computing or high-
performance computing platform. These desired characteristics aim to 
ensure that data are managed and shared in ways that are consistent 
with FAIR data principles.

Selecting a Data Repository

    1. For some programs and types of data, NIH and/or NIH ICO 
policy(ies) and FOAs identify particular data repositories (or sets of 
repositories) to be used to preserve and share data. For data generated 
from research subject to such policies or funded under such FOAs, 
researchers should use the designated data repository(ies).
    2. For data generated from research for which no data repository is 
specified by NIH or the NIH ICO (as described

[[Page 68900]]

above), researchers are encouraged to select a data repository that is 
appropriate for the data generated from the research project and is in 
accordance with the desired characteristics, taking into consideration 
the following guidance:
    A. Primary consideration should be given to data repositories that 
are discipline or data-type specific to support effective data 
discovery and reuse. NIH makes a list of such data repositories 
available (see https://www.nlm.nih.gov/NIHbmic/domain_specific_repositories.html).
    B. If no appropriate discipline or data-type specific repository is 
available, researchers should consider a variety of other potentially 
suitable data sharing options:
    i. Small datasets (up to 2 GB in size) may be included as 
supplementary material to accompany articles submitted to PubMed 
Central (see https://www.ncbi.nlm.nih.gov/pmc/about/guidelines/#suppm).
    ii. Data repositories, including generalist repositories (see 
https://www.nlm.nih.gov/NIHbmic/generalist_repositories.html) or 
institutional repositories, that make data available to the larger 
research community, institutions, or the broader public.
    iii. Large datasets may benefit from cloud-based data repositories 
for data access, preservation, and sharing.

I. Desirable Characteristics for All Data Repositories

    The characteristics in this section are relevant to all 
repositories that manage and share data resulting from Federally funded 
research:
    A. Unique Persistent Identifiers: Assigns datasets a citable, 
unique persistent identifier (PID), such as a digital object identifier 
(DOI) or accession number, to support data discovery, reporting (e.g., 
of research progress), and research assessment (e.g., identifying the 
outputs of federally funded research). The unique PID points to a 
persistent landing page that remains accessible even if the dataset is 
de-accessioned or no longer available.
    B. Long-Term Sustainability: Has a plan for long-term management of 
data, including maintaining integrity, authenticity, and availability 
of datasets; building on a stable technical infrastructure and funding 
plans; and having contingency plans to ensure data are available and 
maintained during and after unforeseen events.
    C. Metadata: Ensures datasets are accompanied by metadata to enable 
discovery, reuse, and citation of datasets, using schema that are 
appropriate to, and ideally widely used across, the community(ies) the 
repository serves. Domain-specific repositories would generally have 
more detailed metadata than generalist repositories.
    D. Curation and Quality Assurance: Provides, or has a mechanism for 
others to provide, expert curation and quality assurance to improve the 
accuracy and integrity of datasets and metadata.
    E. Free and Easy Access: Provides broad, equitable, and maximally 
open access to datasets and their metadata free of charge in a timely 
manner after submission, consistent with legal and ethical limits 
required to maintain privacy and confidentiality, Tribal sovereignty, 
and protection of other sensitive data.
    F. Broad and Measured Reuse: Makes datasets and their metadata 
available with broadest possible terms of reuse; and provides the 
ability to measure attribution, citation, and reuse of data (e.g., 
through assignment of adequate metadata, unique PIDs).
    G. Clear Use Guidance: Provides accompanying documentation 
describing terms of dataset access and use (e.g., particular licenses, 
need for approval by a data use committee).
    H. Security and Integrity: Has documented measures in place to meet 
generally accepted criteria for preventing unauthorized access to, 
modification of, or release of data, with levels of security that are 
appropriate to the sensitivity of data.
    I. Confidentiality: Has documented capabilities for ensuring that 
administrative, technical, and physical safeguards are employed to 
comply with applicable confidentiality, risk management, and continuous 
monitoring requirements for sensitive data.
    J. Common Format: Allows datasets and metadata downloaded, 
accessed, or exported from the repository to be in widely used, 
preferably non-proprietary, formats consistent with those used in the 
community(ies) the repository serves.
    K. Provenance: Has mechanisms in place to record the origin, chain 
of custody, and any modifications to submitted datasets and metadata.
    L. Retention Policy: Provides documentation on policies for data 
retention within the repository.

II. Additional Considerations for Repositories Storing Human Data (even 
if de-identified)

    The additional characteristics outlined in this section are 
intended for repositories storing human data, which are also expected 
to exhibit the characteristics outlined in Section I, particularly with 
respect to confidentiality, security, and integrity. These 
characteristics also apply to repositories that store only de-
identified human data, as preventing re-identification is often not 
possible, thus requiring additional considerations to protect privacy 
and security.
    A. Fidelity to Consent: Employs documented procedures to restrict 
dataset access and use to those that are consistent with participant 
consent (such as for use only within the context of research on a 
specific disease or condition) and changes in consent.
    B. Restricted Use Compliant: Employs documented procedures to 
communicate and enforce data use restrictions, such as preventing 
reidentification or redistribution to unauthorized users.
    C. Privacy: Implements and provides documentation of appropriate 
approaches (e.g., tiered access, credentialing of data users, security 
safeguards against potential breaches) to protect human subjects' data 
from inappropriate access.
    D. Plan for Breach: Has security measures that include a response 
plan for detected data breaches.
    E. Download Control: Controls and audits access to and download of 
datasets (if download is permitted).
    F. Violations: Has procedures for addressing violations of terms-
of-use by users and data mismanagement by the repository.
    G. Request Review: Makes use of an established and transparent 
process for reviewing data access requests.

    Dated: October 19, 2020.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2020-23674 Filed 10-29-20; 8:45 am]
BILLING CODE 4140-01-P