NIH Public Access and Data Sharing Policies

Publications

The NIH Public Access Policy for publications has been in effect since April 7th, 2008.  It ensures that the general public has access to the published results of NIH-funded research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central (PMC). 

To ensure the manuscripts are archived in PMC, the process must start immediately upon acceptance for publication. The resources below are to assist in complying with the Policy.  PIs are responsible for ensuring that all peer-reviewed papers resulting from their NIH funding are submitted to PMC, including those authored by collaborators, students, postdocs, and subrecipients.

Data

NIH released their DRAFT Data Sharing Policy in November 2019. They are seeking comments through January 10, 2020. Several NIH Institutes have issued their own data sharing polices. More information on these requirements can be found below. 

NIH Publication Access

  • All investigators funded by NIH are required to submit final peer-review manuscripts to PubMed Central upon acceptance for publication
  • Publications are to be made public no later than 12 months after official publication date
  • Policy applies to any manuscript that:
    • Is peer-reviewed;
    • And, is accepted for publication in a journal on or after April 7, 2008;
    • And, arises from:
      • Any direct funding from an NIH grant or cooperative agreement active in Fiscal Year 2008 or beyond, or;
      • Any direct funding from an NIH contract signed on or after April 7, 2008, or;
      • Any direct funding from the NIH Intramural Program, or;
      • An NIH employee.

Sources:

What is the Public Access Policy
Public Access Policy Details
NIH Public Access Policy website
FAQs

PMID (PubMed ID) - A unique value assigned to every paper indexed in PubMed.1 It is not the same as the PubMed Central Identifier (PMCID). A PMID is not proof of compliance with NIH's Public Access Policy. 

PMCID (PMCID) - A unique value to assigned to every full-text paper in PubMed Central.2 PMCIDs are to be submitted to NIH as proof of compliance with Public Access Policy. When a PMCID is not yet available, investigators must submit the NIHMS ID number. 

PMID - PMCID Converter 

PMID vs PMCID

NIHMS - The NIH Manuscript Submission (NIHMS) system supports the deposit of manuscripts into PubMed Central (PMC), as required by the public access policies of NIH and other participating funders. If a publisher does not deposit manuscripts into PMC on behalf of the authors, then investigators must submit their final manuscript immediately upon publication acceptance

MyNCBI - My NCBI (National Center for Biotechnology Information) retains user information and database preferences to provide customized services for many NCBI databases. 

1: PubMed is a free search engine accessing primarily the MEDLINE database of references and abstracts on life sciences and biomedical topics. (source: https://en.wikipedia.org/wiki/PubMed)

2: PubMed Central a free digital repository that archives publicly accessible full-text scholarly articles that have been published within the biomedical and life sciences journal literature. (source: https://en.wikipedia.org/wiki/PubMed_Central) 

Authors (or someone they delegate) can submit the final peer-reviewed manuscript (not the final published version) to the NIH Manuscript Submission System (NIHMS).  Submitting to NIHMS is the only way an author can submit manuscripts to be added into PMC, if the journal publisher doesn't deposit it for them. Find out which journals will deposit into PMC. 

About NIHMS IDs:

At times, PI and/or authors will need to submit or approve papers in the NIH Manuscript System (NIHMS).  Upon submission, you will be given a NIHMS ID.  This ID should be used when referencing the paper.

The ID is only good to demonstrate compliance to the Policy for three months after the paper's publication date! After that date, you need a PubMed Central ID number (PMCID).  If you do not have a PMCID by the three month mark, NIH will consider the paper non-compliant.  That is why it is extremely important to start the process upon acceptance for publication.

NIHMS Resources:

PIs need to manage publications in My Bibliography of MyNCBI.

MyNCBI Tips:
  • Login to MyNCBI using your eRA Commons ID and password. Do not sign in directly to NCBI.
  • Make sure your MyNCBI account is linked to your eRA Commons account.  After logging in, edit your account setting by clicking on your email address in the top right corner, change "Linked Accounts" and select NIH eRA Login.  This will ensure the bibliography pre-populates in the Research Performance Progress Report.
  • The NCBI account settings page is also where you can assign delegates. Just have their email addresses handy and they will receive alerts to accept the delegation.
  • Papers written by you should be added to your MyBibliography.  Papers written by others resulting from your NIH funding should be copied to a separate collection while you manage your citations.
Important Links and Resources:
  • FAQs on Reporting Publications in RPPRs - Go to Section E of the FAQs.
  • Guide to Categorizing Products (Section C) in the RPPR
  • RPPR Instruction Guide - Go to Section C, Chapter 6, for specific RPPR instructions on publications
  • Related NIH Notices:
    • NOT-OD-17-050 - Reporting Preprints and Other Interim Research Products
    • NOT-OD-16-079 - This Notice clarifies public access reporting requirements for publications arising from shared resources.
    • NOT-OD-15-091 - This Notice clarifies which publications should be included in progress reports and renewal applications for institutional training, career development, and related awards.
    • NOT-OD-12-160 - Contains links to many Notices related to NIH delaying the processing of non-competing continuation grant awards if publications arising from that award are not in compliance with the NIH public access policy. This began in the Spring 2013.
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Individual Institute and Center Data Sharing Policies and Guidance

Scope

Applies to all grant applications and awards that include human subject research submitted on or after 2019 Cycle I due date. (Exceptions: F, T, SBIR/STTR, R25) 

NIAAA-funded investigators conducting human subjects research are expected to submit de-identified, individual-level data to the NIAAA Data Archive (NIAAADA).

NOT-AA-19-020

Expectations
  • All applications must include a Data Archive Data Sharing Plan (NIAAADADSP) as part of the resource sharing plan. Applicants are encouraged to use the NIAAADA DSP template. 
  • Informed consent should include how data will be uploaded to NIAAADA and shared with research community.
  • Within 6 months of original award, a Data Submission Agreement  is to be signed by the principal investigator and an institutional business official.
  • It is expected that awardees will submit data to NIAAADA every 6 months. *This is distinct from sharing with research community*
  • Specific datasets that support a publication are to be submitted separately to NDA by creating a NDA Study. 
  • Data will be shared with the research community when the data supporting results have been accepted for publication or 2 years after the grant end date on the initial Notice of Award, whichever occurs sooner.
  • Does not supersede NIH Genomic Data Sharing Policy but does mandate the NIAAADA be the repository for genomic data funded by NIAAA unless NIAAA agrees to an alternative data archive.
  • Strongly encouraged to submit the full study or clinical trial protocol if one exists, alongside data.
  • A statement of progress on data sharing in non-competing renewals and progress reports is expected.
Applicable Data and Metadata Considerations
  • NIAAADA accepts electronic, de-identified data from human subject studies. Relevant data may include: data from clinical trials, epidemiological surveys, human laboratory investigations, and other studies that involve human participants. 
  • Physical biosamples will not be included in the NIAAADA , but reference numbers to biosamples will be included in the NIAAADA.
  • Awardees who are collecting human genomic data will register with dbGaP. After registration, all data (including but not limited to clinical, genomic, imaging, and phenotypic data) will be deposited in the NIAAA DA . A link to the NIAAA DA collection will be added to the dbGaP registration.
  • Strongly encouraged to use clinical and phenotypic data collection instruments/data dictionaries that have already been defined.
  • There are several required data collection instruments and standards that must be used.
  • Encouraged to use NDA validation tool frequently to ensure data standards are being followed.
  • Plan to collect the data needed to generate global unique identifiers (GUIDs) for each study subject.
    • PseudoGUIDs are an option when necessary data is missing or insufficient consent.
Budget Considerations
Resources
Scope

Applies to all grant applications and awards that involve human subject research submitted after 1/1/2020. (Exceptions: F, K, T, SBIR/STTR, R03, R25, AIDS applications).

All data including but not limited to clinical, genomic, imaging, and phenotypic data is to be deposited into the NIMH Data Archive (NDA).

NOT-MH-19-033

NIMH Data Sharing Infographic 

Expectations
  • All applications must include a resource sharing plan
  • Informed consent should include how data will be uploaded to NDA and shared with research community.
  • Within 6 months of original award, a Data Submission Agreement  is to be signed by the principal investigator and an institutional business official.
  • It is expected that awardees will submit data to NIMH Data Archive (NDA) every 6 months. *This is distinct from sharing with research community*
  • Specific datasets that support a publication are to be submitted separately to NDA by creating a NDA Study. 
  • Data will be shared with the research community when the data supporting results have been accepted for publication or at the end of the award period (including the first no cost extension), whichever occurs sooner.
  • Does not supersede NIH Genomic Data Sharing Policy but does mandate the NDA be the repository for genomic data funded by NIMH unless NIMH agrees to an alternative data archive
  • Strongly encouraged to submit the full study or clinical trial protocol if one exists, alongside data.
  • A statement of progress on data sharing in non-competing renewals and progress reports is expected.
Data and Metadata Considerations
  • Strongly encouraged to use clinical and phenotypic data collection instruments/data dictionaries that have already been defined.
  • There are several required data collection instruments and standards that must be used.
  • Awardees who are collecting human genomic data will register with dbGaP. After registration, all data (including but not limited to clinical, genomic, imaging, and phenotypic data) will be deposited in the NDA. A link to the NDA collection will be added to the dbGaP registration.
  • Encouraged to use NDA validation tool frequently to ensure data standards are being followed.
  • Plan to collect the data needed to generate global unique identifiers (GUIDs) for each study subject.
    • PseudoGUIDs are an option when necessary data is missing or insufficient consent.
Resource Sharing Plan

The portion of that plan dealing with data must include:

  1. A summary of the data that will be shared
  2. A description of the standard(s) and/or data dictionaries that will be used to describe the data set, and
  3. The proposed schedule to validate that the data are compliant with the data dictionary that is being used.

Compliance with this data sharing plan will become a special term and condition in the Notice of Award.

Budget Considerations
Resources
Scope

Applies to all grant applications and awards that involve human subject research related to autism submitted after 9/1/2020. (Exceptions: F, K, T, SBIR/STTR, R03, R25) for the following institutes: NIMH, NICHD, NIDCD, NIEHS, and NINDS.

NIMH investigators will abide by data sharing timeline in NOT-MH-19-033

All raw and analyzed data (including, but not limited to, clinical, genomic, imaging, and phenotypic data) are to be deposited into the NDA infrastructure.

NOT-MH-20-010

Expectations
  • Applicants should review the NDA submission requirements
  • Informed consent should include how data will be uploaded to NDA and shared with research community.
  • Within 6 months of original award, a Data Submission Agreement  is to be signed by the principal investigator and an institutional business official.
  • It is expected that awardees will submit data to NDA every 6 months.
    *This is distinct from sharing with research community*
  • Specific datasets that support a publication are to be submitted separately to NDA by creating a NDA Study. 
  • Data will be shared with the research community when the data supporting results have been accepted for publication or at the end of the award period (including the first no cost extension), whichever occurs sooner.
  • Strongly encouraged to submit the full study or clinical trial protocol if one exists, alongside data.
Data and Metadata Considerations
  • Strongly encouraged to use clinical and phenotypic data collection instruments/data dictionaries that have already been defined.
  • There are several required data collection instruments and standards that must be used.
  • Encouraged to use NDA validation tool frequently to ensure data standards are being followed.
  • Plan to collect the data needed to generate global unique identifiers (GUIDs) for each study subject.
    • PseudoGUIDs are an option when necessary data is missing or insufficient consent.budget
Budget Considerations
Resources
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Definitions and Resources

A central function of the NDA is to store and to link together clinical, omics, neuro-signal recordings, and other data derived from individuals who participate in research studies. Depending on the goals of the research, investigators may collect any combination of data from research participants during a single study. Review NDA Policy. 

Contributing Data

Below are the basic steps and necessary considerations for uploading data to NDA. For complete overview see NDA website on contributing data and the NDA training video.

The following prerequisites must be met before submitting data:

  1. Obtain Informed Consent.
  2. Collect from participants the PII needed to create an NDA GUID.
  3. Estimate the cost of data sharing (see Cost Estimation).

Following prerequisites, these are the preliminary steps necessary for uploading data to NDA:

  1. Review NDA Policy
  2. Complete Data Submission Agreement. Data cannot be contributed until this document is completed and received by NDA. 
  3. Create NDA account. All team members working on project needs to create their own account. 
  4. Create a list of data expected to collect and anticipated share date within the "Data Expected" tab

Prepare data for submission:

  1. Generate GUIDs or PsuedoGUIDs 
  2. Follow data harmonization standards
  3. Format data as CSV or txt (tab delimited) files with two header rows. The first row must contain the data structure name and version number. The next header record is the element name. Ensuring all rows contain data. Templates are available in Data Dictionary. 
  4. Validate data for harmonization using validation tool
  5. Share Data - Unless a specific schedule for data sharing has been defined in advance, raw data submitted to NDA are generally shared within 4 months of submission. See below on more information on how data are shared and accessed.
Creating NDA Study - For Sharing Data Supporting Publications

The NDA study is distinct from the data being uploaded to NDA during award period. 

Each NDA Study is issued a Digital Object Identifier (DOI), which is expected to be referenced in the publication as a persistent link to the supporting dataset. A NDA Study should be created before a manuscript is submitted and data will be shared following acceptance of manuscript. 

View the NDA Study tutorial for step-by-step instruction on how to create and link a NDA Study to a publication.

About Shared Data
  • Submitted data will generally be held in a private enclave open only to the awardee until the data are shared with the research community. Unless the data are part of a NDA Study, then the NDA Study data are released upon acceptance of manuscript. 
  • Data are shared with research community based upon information provided by awardee in the "Data Expected" tab.
Access to Shared Data

The following information is accessible without NDA account:*

  • Summary information of shared data
  • Able to build queries and view summary information

To request an NDA account to gain access to detailed datasets, the following are required:

  1. Be sponsored by an NIH recognized institution with a Federalwide Assurance
  2. Have a research related need to access NDA data
  3. Complete Data Use Certification
  4. The request is reviewed by Data Access Committee

*Other Federated Repositories may impose additional access requirements.

What Does NOT go into NDA?
  • Electronic medical records will not be submitted to NDA. De-identified data derived from electronic medical records may be submitted.
  • Physical biospecimens will not be submitted to NDA, but reference numbers to biosamples will be submitted.
  • Videos and pictures of faces or other external body parts (i.e. parts that could potentially compromise a participant’s identity) will not be submitted to NDA.
  • Participants who do not consent to share data through NDA are not excluded from the study, but their data cannot be uploaded to NDA.
Resources

The Global Unique Identifier (GUID) is an alphanumeric code generated by the NDA GUID tool for research participants. 

GUIDs are required for all submitted data. If insufficient information is collected to generate GUIDs, a pseudo-GUID can be created. 

How a GUID is generated is outlined below. Visit NDA's using the GUID website for complete information. 

  1. Enter research participant's PII* into GUID tool
  2. The information entered never leaves your computer to generate a series of one-way hash codes
  3. The encrypted hash codes are sent to GUID system at NDA
  4. If codes match an existing GUID, the GUID is returned to researcher
  5. If the code is unique, a new GUID is created and sent back to researcher

To create a GUID, the following PII is needed:

  • First Name
  • Middle Name
  • Last Name
  • Sex
  • Date of Birth
  • City/Municipality of Birth

If the above information is missing or insufficient consent is obtained, a pseudo-GUID can be created. 

*Informed consent needs to include information on how and when data will be submitted to NDA. NDA offers resources for developing informed consent language.

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Contact:

For questions regarding the NIH Public Access Policy, you may contact Stephanie Scott in SPA at [email protected].  You may also reach out to the Health Sciences Library at [email protected] for assistance.