Final NIH Policy for Data Management and Sharing and Supplemental Information

As Enacted ( Federal Register)

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Published date	30 October 2020
Citation	85 FR 68890
Record Number	2020-23674
Section	Notices
Court	National Institutes Of Health

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Federal Register / Vol. 85, No. 211 / Friday, October 30, 2020 / Notices

HRSA specifically requests comments

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estimated burden; (3) ways to enhance

the quality, utility, and clarity of the

information to be collected; and (4) the

use of automated collection techniques

or other forms of information

technology to minimize the information

collection burden.

Maria G. Button,

Director, Executive Secretariat.

[FR Doc. 2020–24122 Filed 10–29–20; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Ninth Meeting of the National Clinical

Care Commission

AGENCY

: Office on Women’s Health,

Office of the Assistant Secretary for

Health, Office of the Secretary,

Department of Health and Human

Services.

ACTION

: Notice.

SUMMARY

: The National Clinical Care

Commission (the Commission) will

conduct its ninth meeting virtually on

November 17, 2020. The Commission is

charged to evaluate and make

recommendations to the U.S.

Department of Health and Human

Services (HHS) Secretary and Congress

regarding improvements to the

coordination and leveraging of federal

programs related to diabetes and its

complications.

DATES

: The meeting will take place on

November 17, 2020, from 1 p.m. to

approximately 5:30 p.m. Eastern

Standard time (EST).

ADDRESSES

: The meeting will be held

online via webinar. To register to attend

the meeting, please visit the registration

website at https://

kauffmaninc.adobeconnect.com/nccc_

9/event/event_info.html.

FOR FURTHER INFORMATION CONTACT

Clydette Powell, M.D., M.P.H., F.A.A.P.,

Designated Federal Officer, National

Clinical Care Commission, U.S.

Department of Health and Human

Services, Office on Women’s Health,

200 Independence Ave. SW 7th Floor,

Washington DC 20201. Phone: (240)

453–8239. Email: OHQ@hhs.gov.

SUPPLEMENTARY INFORMATION

: The

National Clinical Care Commission Act

(Pub. L. 115–80) requires the HHS

Secretary to establish the National

Clinical Care Commission. The

Commission consists of representatives

of specific federal agencies and non-

federal individuals who represent

diverse disciplines and views. The

Commission will evaluate and make

recommendations to the HHS Secretary

and Congress regarding improvements

to the coordination and leveraging of

federal programs related to diabetes and

its complications.

The ninth meeting will be held

virtually and will consist of updates

from the Commission’s three

subcommittees and a discussion of

public comments and outreach to

stakeholder organizations. Additionally,

the Commission will discuss the second

round of potential ‘‘action plans’’ from

the subcommittees (i.e.,

recommendations). The final meeting

agenda will be available prior to the

meeting at https://health.gov/our-work/

health-care-quality/national-clinical-

care-commission/meetings.

Public Participation at Meeting: The

Commission invites public comment on

issues related to the Commission’s

charge. There will be an opportunity for

limited oral comments (each no more

than 3 minutes in length) at this virtual

meeting. Virtual attendees who plan to

provide oral comments at the

Commission meeting during a

designated time must register prior to

the meeting at https://

kauffmaninc.adobeconnect.com/nccc_

9/event/event_info.html.

Written comments are welcome

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Written comments should not exceed

three pages in length.

Individuals who need special

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accommodations, should indicate the

special accommodation when

registering online or by notifying

Jennifer Gillissen at jennifer.gillissen@

kauffmaninc.com by November 9, 2020.

Authority: The National Clinical Care

Commission is required under the National

Clinical Care Commission Act (Pub. L. 115–

80). The Commission is governed by

provisions of the Federal Advisory

Committee Act (FACA), Public Law 92–463,

as amended (5 U.S.C., App.) which sets forth

standards for the formation and use of federal

advisory committees.

Dated: October 27, 2020.

Dorothy Fink,

Deputy Assistant Secretary for Women’s

Health, Office of the Assistant Secretary for

Health.

[FR Doc. 2020–24126 Filed 10–29–20; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Allergy and

Infectious Diseases; Notice of Closed

Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended, notice is hereby given of the

following meeting.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The contract proposals and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the contract

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would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Institute of

Allergy and Infectious Diseases Special

Emphasis Panel; Small Business Innovation

Research (SBIR) Phase II Program Contract

Solicitation (PHS 2019–1) Topic 74.

Date: November 24, 2020.

Time: 10:00 a.m. to 1:00 p.m.

Agenda: To review and evaluate contract

proposals.

Place: National Institute of Allergy and

Infectious Diseases, National Institutes of

Health, 5601 Fishers Lane, Room 3G62A,

Rockville, MD 20892, Bethesda, MD (Virtual

Meeting).

Contact Person: Eleazar Cohen, Ph.D.,

Scientific Review Officer, Scientific Review

Program, Division of Extramural Activities,

National Institute of Allergy and Infectious

Diseases, National Institutes of Health, 5601

Fishers Lane, Room 3G62A, Bethesda, MD

20892, (240) 669–5081, ecohen@

niaid.nih.gov.

(Catalogue of Federal Domestic Assistance

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and Transplantation Research; 93.856,

Microbiology and Infectious Diseases

Research, National Institutes of Health, HHS)

Dated: October 26, 2020.

Tyeshia M. Roberson,

Program Analyst, Office of Federal Advisory

Committee Policy.

[FR Doc. 2020–24081 Filed 10–29–20; 8:45 am]

BILLING CODE 4140–01–P

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.

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See also NIH Rigor and Reproducibility efforts

at https://www.nih.gov/research-training/rigor-

reproducibility.

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.

ACTION

: Notice of final Policy.

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

(sciencepolicy@od.nih.gov), 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.

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.

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.

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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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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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/

index.html.

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).

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.

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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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.

NIH Rigor and Reproducibility https://

www.nih.gov/research-training/rigor-

reproducibility.

Wilkinson, M., Dumontier, M. et al, The FAIR

Guiding Principles for Scientific Data Management

and Stewardship (March 2016) https://

www.nature.com/articles/sdata201618.

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.

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.

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,

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.

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

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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.

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.

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).

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NIH Strategic Plan for Data Science (June 2018)

https://datascience.nih.gov/sites/default/files/NIH_

Strategic_Plan_for_Data_Science_Final_508.pdf.

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.

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.

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.

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•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

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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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Neurological

Disorders and Stroke; Notice of Closed

Meetings

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended, notice is hereby given of the

following meetings.

The meetings will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

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Final NIH Policy for Data Management and Sharing and Supplemental Information

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