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== NCI Cancer Moonshot℠ Public Access and Data Sharing Policy ==

Consistent with the critical goals of the National Cancer Institute’s (NCI) Cancer Moonshot℠ to accelerate cancer research by enhancing data sharing and making evidence-based approaches to cancer therapy more broadly available to patients, NCI recognizes that the full value of NCI-Supported Cancer Moonshot Research Projects can only be realized if Publications and Underlying Primary Data (as defined below) are disseminated as promptly and broadly as possible. Much of the urgency highlighted by the Cancer Moonshot and in the Blue Ribbon Panel’s recommendations to the National Cancer Advisory Board (NCAB) in 2016 emphasizes that the rapid availability of cancer publications and the primary data behind it promotes dissemination of new knowledge, enhances reproducibility, and accelerates the ability of researchers to build upon cancer research to make new discoveries.

Through the Cancer Moonshot Public Access and Data Sharing Policy (the "Policy"), NCI seeks to create an infrastructure that addresses the recommendation of the Blue Ribbon Panel’s Enhanced Data Sharing working group to the NCAB that researchers, clinicians, and patients collaborate in sharing their collective data and knowledge about cancer to accelerate progress towards improving cancer outcomes. The NCAB subsequently accepted this recommendation and recommended it to the NCI.

=== 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 a Cancer Moonshot Research Project.

:*NCI-Supported: "NCI-Supported" means all Cancer Moonshot Research Projects financially supported—whether in whole or in part—by NCI.

:*Cancer Moonshot Research Projects: "Cancer Moonshot Research Projects" refers to the initiatives funded as part of the Cancer Moonshot beginning in fiscal year 2018 including projects conducted by NCI researchers, contractors, and recipients of extramural Cancer Moonshot funding.

:*Publication: A "Publication" includes (a) published research results in any manuscript that is peer-reviewed and acceptbed by a journal1 or (b) a complete and public draft of a scientific document (commonly referred to a s preprint).2

:*Publish: To "Publish" means to 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 NCI-Supported Cancer Moonshot℠ 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.

Specifically, this Policy applies to:

:*Competing grant and cooperative agreement applications3 that are submitted to NCI in response to a Cancer Moonshot Research Project Funding Opportunity Announcement on or after October 1, 2017.

:*Proposals for contracts for Cancer Moonshot Research Projects that are submitted on or after October 1, 2017.

:*NCI intramural Cancer Moonshot Research Projects generating Publications and Underlying Primary Data on or after October 1, 2017.

=== Public Access and Data Sharing Plan Requirement ===

NCI intends to maximize the availability of Publications and the sharing of underlying data for NCI-Supported Cancer Moonshot Research Projects. Under the Policy, applicants for extramural research funding (grants, cooperative agreements, and contracts) (collectively, "Applicants"), for Cancer Moonshot 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 Underlying Primary Data immediately and broadly available to the public; (2) if applicable, provides a justification to NCI 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.

=== 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 a Cancer Moonshot Research Project, a Public Access and Data Sharing Plan will be required to be submitted with contract proposals starting in fiscal year 2018 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 Cancer Moonshot℠ funding for grants and cooperative agreements, starting in fiscal year 2018, NCI will give funding priority to those Applicants that submit an appropriate Public Access and Data Sharing Plan that ensures maximal sharing of the Publications and Underlying Primary Data arising from the award. 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, NCI researchers engaged in intramural Cancer Moonshot Research Projects that generate Publications or Underlying Primary Data will be required to comply with this Policy.

=== NCI Office of Data Sharing ===

The NCI Office of Data Sharing (ODS) advocates for the proper balance of open-access, open-source, open-data sharing policies. ODS respects the rights of the public to participate in and benefit from publicly funded research while considering the critical importance of intellectual property concerns for individuals and organizations to support a healthy commercial marketplace.

=== Elements of a Public Access and Data Sharing Plan ===

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

#Electronic copies of Publications will be deposited in PubMed Central with proper tagging of metadata to ensure online discoverability and accessibility within four weeks of acceptance by a journal.
#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).
#Publications will be made publicly available immediately without any embargo period.
#Underlying Primary Data for the Publications will be made broadly available through an appropriate data repository such as the Genomic Data Commons, dbGaP, TCIAExit Disclaimer, or a non-NIH repository that conforms with the principles articulated in this Policy.
#To the extent feasible, Underlying Primary Data will be shared simultaneously with the Publication and made immediately accessible through release 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).
#NCI requires broad and responsible sharing of Underlying Primary Data from NCI-Supported Cancer Moonshot 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. 465, 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 HHS Regulations for the Protection of Human Subjects to ensure that the identities of research subjects cannot be readily ascertained with the data.6 Underlying Primary Data should also be stripped of identifiers according to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule.7 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 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)8, privacy boards9, or equivalent bodies10, will assess the informed consent materials to determine whether the Underlying Primary Data may be shared as contemplated in this Policy.
:NCI requires broad sharing of Underlying Primary Data from NCI-Supported Cancer Moonshot Research Projects but is responsive to concerns with protecting confidential and proprietary data. 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. For example, the data will be shared under licenses that retain intellectual property for commercialization but also have features that promote broad and immediate access (e.g., no embargo and no fee for access).

'''Selected References'''

#In accordance with the NIH Public Access Policy, NCI 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 NIHMS. For further information, please see the Frequently Asked Questions about the NIH Public Access Policy.
#See NIH Notice NOT-OD-17-050: Reporting Preprints and Other Interim Research Products
#Competing grant and cooperative agreement applications include but are not limited to the following: Research Grants (Rs), Program Projects (Ps), Cooperative Research Mechanisms (Us), Career Development Awards (Ks), and SCORs and other S grants with a research component.
#Although not comprehensive, the U.S. National Library of Medicine provides a list of NIH Data Sharing Repositories.
#Under 45 C.F.R. 46.102(f), "human subject" is defined as "a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information."
#See 45 CFR 46.102(f).
#See 45 CFR 164.514(b)(2) in the list of HIPAA identifiers that must be removed.
#See 45 C.F.R. &sect; 46.102(g).
#See 45 C.F.R. Part 164.
#For those primary studies that may be conducted outside of the U.S. then 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 cancer research projects.

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