HEAL Public Access and Data Sharing

In response to the public health emergency of opioid misuse, addiction, and overdose, NIH has launched the Helping to End Addiction Long-term^® Initiative, or NIH HEAL Initiative^®. The NIH HEAL Initiative is a transagency effort focused on improving prevention and treatment strategies for opioid misuse and addiction and enhancing pain management. As part of its response to this crisis, NIH intends to maximize the availability of publications and the sharing of underlying data for NIH-Supported NIH HEAL Initiative Research Projects. Given the urgency of this crisis, as highlighted by the declared public health emergency, rapid availability of Publications and the primary data behind them promotes dissemination of new knowledge, enhances reproducibility and accelerates the ability of researchers to build upon NIH HEAL Initiative research to make new discoveries.

Through the NIH HEAL Initiative Public Access and Data Sharing Policy (the Policy), NIH seeks to create an infrastructure that addresses the need for researchers, clinicians, and patients to collaborate on sharing their collective data and knowledge about opioid misuse and pain to provide scientific solutions to the opioid crisis. Under the Policy, applicants for extramural research funding (grants, cooperative agreements, contracts, and other transactions; "Applicants") for NIH HEAL Initiative Research Projects are required to submit a Public Access and Data Sharing Plan that (1) describes their proposed process for making resulting Publications and, to the extent possible, the Underyling Primary Data immediately and broadly available to the public or (2), if applicable, provides a justification to NIH if such sharing is not possible. Underlying Primary Data should be made as widely and freely available as possible while safeguarding the privacy of participants and protecting confidential and proprietary data.

NIH understands that the content of a Public Access and Data Sharing Plan will vary depending on certain factors, including, for example, the size and complexity of the data set. However, the Public Access and Data Sharing Plan should, at a minimum, address the following general elements:

• Release of Publications
  • How publications will be made immediately available to the public
  • The methods through which the public, including other researchers, will locate and access the publication
  • Any anticipated limitations to the immediate and broad release of publications with an associated justification
• Sharing of Underlying Primary Data
  • The type of data that is expected to be generated by the research
  • The data that will be shared
  • Who will have access to the data
  • The timing and the medium for immediate sharing of the data
  • The methods through which the public, including other researchers, will locate and access the data
  • Any anticipated limitations to the immediate and broad sharing of data with an associated justification

Guidance for Appropriate Public Access and Data Sharing Plans

Applicants have the discretion to develop an appropriate Public Access and Data Sharing Plan that meets the requirements of the Policy. Although not prescriptive, NIH considers a Public Access and Data Sharing Plan with the following elements to be appropriate under the Policy:

1. Electronic copies of publications will be deposited within four weeks of acceptance by a journal in PubMed Central with proper metadata to be made discoverable and accessible upon publication.
2. Publications will be Published under the Creative Commons Attribution 4.0 Generic License (CC BY 4.0) or an equivalent license or otherwise dedicated to the public domain (e.g., Creative Commons public domain tool, CC0).
3. Publications will be made publicly available immediately without any embargo period.
4. Underlying Primary Data for the Publications will be made broadly available through an appropriate data repository, such as the NIH HEAL Initiative central data repository * , or a non-NIH repository that conforms to the principles articulated in this Policy.¹
5. To the extent feasible, Underlying Primary Data will be shared simultaneously with the publication and made immediately accessible through release under the CC BY 4.0 or an equivalent license or otherwise dedicated to the public domain (e.g., Creative Commons public domain tool, CC0).
6. To meet program goals under the NIH HEAL Initiative, the NIH requires broad and responsible sharing of Underlying Primary Data from NIH-Supported NIH HEAL Initiative Research Projects that protects and maintains the privacy and confidentiality of participant data. If the research involves human subjects, as defined by 45 C.F.R. 46², the Public Access and Data Sharing Plan should discuss how the privacy rights of participants and confidentiality of their data will be protected and maintained in accordance with 45 C.F.R. 46 and other applicable laws and regulations.
   • The Applicant should discuss the potential risks to research participants posed by data sharing and steps taken to address those risks, including the following:
     • Underlying Primary Data should be de-identified according to the standards set forth in the Department of Health and Human Services Regulations for the Protection of Human Subjects to ensure that the identities of research subjects cannot be readily ascertained with from the data.³ Underlying Primary Data should also be stripped of identifiers according to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule.⁴ Underlying Primary Data that are free of identifiers but contain sensitive information are  immediately released with no fee for access but are  deposited in controlled-access repositories with similar policies to those of the database of Genotypes and Phenotypes (dbGaP) (e.g., the controlled-access repository should have an independent data access committee and no financial incentives for limiting access to datasets).
     • Before submitting Underlying Primary Data, Awardees through their institutional review boards (IRBs)⁵, privacy boards⁶, or equivalent bodies⁷ will assess the informed consent materials to determine whether the Underlying Primary Data may be shared as contemplated in this Policy.
7. To meet program goals under the NIH HEAL Initiative, NIH requires broad sharing of Underlying Primary Data from NIH-Supported NIH HEAL Initiative Research Projects in a way that is responsive to concerns about protecting confidential and proprietary data and is consistent with other applicable laws and regulations. The Public Access and Data Sharing Plan should describe any anticipated confidentiality concerns and how they will be addressed in accordance with the requirements of the Policy and meet the program goals of the initiative. For example, the data will be shared under licenses that retain intellectual property for commercialization but should also have features that promote broad and immediate access (e.g., no embargo and no fee for access) to meet program goals.

Definitions/Terms

Public Access and Data Sharing Plan: A Public Access and Data Sharing Plan describes the plan for releasing Publications and sharing the Underlying Primary Data (as defined below) for an NIH HEAL Initiative Research Project.

NIH HEAL Initiative-Supported: Refers to all NIH HEAL Initiative Research Projects financially supported — whether in whole or in part — by NIH.

NIH HEAL Initiative Research Projects: Projects funded as part of NIH HEAL Initiative beginning in fiscal year 2019, including projects conducted by NIH researchers, contractors, and recipients of extramural NIH HEAL Initiative funding.

Publication: Either (a) published research results in any manuscript that is peer reviewed and accepted by a journal⁸ or (b) a complete and public draft of a scientific document (commonly referred to as a preprint).⁹

Publish: Report in a publicly accessible manner.

Underlying Primary Data: For the purposes of this Policy, "Underlying Primary Data" means recorded factual material commonly accepted in the scientific community as necessary to document and support research findings in Publications.

Scope and Applicability

The Policy applies to all NIH-Supported NIH HEAL Initiative Research Projects with resulting Publications and Underlying Primary Data, to the extent feasible. The requirements of this Policy are in addition to those requirements and expectations specified under other applicable NIH public access and data sharing policies, including but not limited to the NIH Public Access Policy, the NIH Data Sharing Policy, and the Genomic Data Sharing Policy. For additional information, see NIH Sharing Policies and Related Guidance on NIH-Funded Research Resources.

Implementation of the Policy

The specifics of implementation of the Policy will depend on the mechanism through which the funding is being obligated or awarded. With respect to contracts involving an NIH HEAL Initiative Research Project, a Public Access and Data Sharing Plan will be required to be submitted with contract proposals starting in fiscal year 2020 and will be incorporated as a contract deliverable. Review of the contract proposals will include an evaluation of the Public Access and Data Sharing Plan.

With respect to extramural NIH HEAL Initiative funding for grants and cooperative agreements, starting in fiscal year 2019, NIH will give funding priority to those Applicants that provide an appropriate Public Access and Data Sharing Plan that ensures maximal sharing of the Publications and Underlying Primary Data arising from the award. The NIH HEAL Initiative program leads will work with grantees and the Public Access and Data Sharing Plan will become a term and condition of the award, as detailed in the Notice of Award.

Applicants may include anticipated charges for Publication or data sharing and resources that may be needed to support a proposed Public Access and Data Sharing Plan in the budget plan of their application/proposal. These charges may include but are not limited to article or author fees charged by open-access journals, the Creative Commons or other equivalent copyright license fees, or similar fees.

Finally, NIH researchers engaged in intramural NIH HEAL Initiative research projects that generate Publications or Underlying Primary Data will be required to comply with this Policy.

* The HEAL Data Platform does not store data. See implementation guidance:

• https://heal.nih.gov/data/complying-heal-data-sharing-policy
• https://www.healdatafair.org/resources/road-map

[1] Although not comprehensive, the U.S. National Library of Medicine (NLM) provides a list of NIH Data Sharing Repositories.

[2] Under 45 C.F.R. 46.102(e)(1), "human subject" is defined as "a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens."

[3] See 45 C.F.R. 46.102(e).

[4] See 45 C.F.R. 164.514(b)(2) in the list of HIPAA identifiers that must be removed pdf  156 KB.

[5] See 45 C.F.R. 46.102(g).

[6] See 45 C.F.R. Part 164 pdf  502 bytes.

[7] For those primary studies that may be conducted outside of the U.S., an analogous review committee to an IRB or privacy board may be asked to participate in this review of informed consents and proposed data disclosures for NIH HEAL Initiative research projects.

[8] In accordance with the NIH Public Access Policy, NIH will consider the following to be journals: (a) journals included in the journal section of the NLM catalog; (b) for policy purposes, manuscripts that meet the requirements for ISSN assignment, have content that is issued over time under a common title, are a collection of articles by different authors, and are intended to be published indefinitely; and (c) manuscripts determined to be journals upon review by the NIH Manuscript Submission (NIHMS) system. For further information, please see the Frequently Asked Questions about the NIH Public Access Policy.

[9] See NIH Notice NOT-OD-17-050: Reporting Preprints and Other Interim Research Products.

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