From “Nice to Have” to “Need to Have”: Essential Data Management Best Practices and Tools for NIH Compliance

“Demands are mounting on researchers to have data management and sharing plans, with the National Institutes of Health (NIH) being the latest government funder to implement a mandate in the form of the 2023 NIH Data Management and Sharing Policy. This webinar features a panel discussion from experts on how research teams can implement best-practice data management, with particular emphasis on the NIH’s requirements. The panelists will also discuss the emerging space of tooling designed to make adhering to best practices and funder guidelines easy for researchers.”

New Resources Available on Protecting Participant Privacy When Sharing Scientific Data – NIH Extramural Nexus

“NIH’s scientific data sharing site now offers information and resources on the following topics:

Principles and Best Practices for Protecting Participant Privacy
Designating Scientific Data for Controlled Access
Considerations for Obtaining Informed Consent
Considerations for Researchers Working with American Indian/Alaska Native (AI/AN) Communities…”

Administrative Supplements to Support Collaborations to Improve the AI/ML-Readiness of NIH-Supported Data | Data Science at NIH

“Artificial intelligence and machine learning (AI/ML) are a collection of data-driven technologies with the potential to significantly advance biomedical research. The National Institutes of Health (NIH) makes a wealth of biomedical data available and reusable to research communities however, not all of these data are able to be used efficiently and effectively by AI/ML applications.

To address these issues, National Institutes of Health (NIH) Office of Data Science Strategy (ODSS) announced “Administrative Supplements to Support Collaborations to Improve the AI/ML-Readiness of NIH-Supported Data” on March 6, 2023. ODSS has also posted Frequently Asked Questions (FAQs) for this funding opportunity. The goal of this notice is to make the data generated through NIH-funded research AI/ML-ready and shared through repositories, knowledgebases, or other data sharing resources….”

Administrative Supplements to Support Enhancement of Software Tools for Open Science | Data Science at NIH

“As part of their research projects, investigators often produce innovative, scientifically valuable software tools. Frequently, these valuable tools cannot be supported long-term or are developed under conditions that aren’t optimal for reuse. In an effort to address this, the National Institutes of Health (NIH) Office of Data Science Strategy (ODSS), along with other institutes and centers (ICs) at NIH, announced a renewal of the notice for administrative supplements to enhance software tool development for open science (NOT-OD-23-073) on March 7, 2023.

These supplements will:

support robustness, sustainability, and scalability of existing biomedical research software tools and workflows.
invest in research software tools with recognized value in a scientific community to enhance their impact by leveraging best practices in software development and advances in cloud computing.
support collaborations between biomedical scientists and software engineers to enhance the design, implementation, and “cloud-readiness” of research software….”

March 2023 Librarian Community Call, OpenCon

“As both agencies and institutions prepare for the implementation of the 2022 OSTP Memo, there are a variety of ways libraries can support this work—both on campus and in advocacy to ensure agency plans lead to strong policies. Join the next OpenCon Library Community Call on Tuesday, March 14th, at 12pm ET / 9am PT to discuss how libraries are preparing for the 2022 memo to take effect, what additional types of support could help in this preparation, and the important role libraries can play in advocacy around implementation. Katie Steen-James, SPARC’s Manager of Public Policy & Advocacy, will join the discussion and walk through the first opportunity for libraries to help shape the implementation of the memo in the NIH’s recently announced Request for Information on their plan to implement the 2022 memo. 

Note: This call is open to those working in libraries and academic institutions rather than vendors, who are asked to respect the purpose of these calls for candid discussion….

You can find all the proposed agendas and notes from the Librarian community calls in one place, right here….”

Data Sharing Enters a New Era | Annals of Internal Medicine

“On 25 August 2022, the White House Office of Science and Technology Policy (OSTP) directed all federal agencies to develop or update their policies to ensure that peer-reviewed publications and the underlying data resulting from federal funds are freely available and publicly accessible on the day of publication (1). The OSTP action intends to stimulate innovation, restore faith in science, and renew commitment to open science. Although public availability of peer-reviewed publications may spur innovation, data sharing has greater potential but is complex and challenging. Yet, the OSTP announcement provided limited details regarding data sharing….

As the NIH develops new policies as mandated by OSTP, it should consider several issues. First, the 27 institutes and centers of the NIH should have a single approach to data sharing, which is more likely to result in consistent and effective data sharing. Second, NIH should fund centers of excellence for data sharing and training to assist investigators who desire to analyze shared data but need assistance in acquiring and analyzing data. Third, the NIH (and all federal agencies) should enforce its data sharing policy. It has been lax in enforcing its existing policies regarding sharing trial data and the posting of trial results on (7). Although entities that receive federal awards or the journals that publish the results of those awards could help ensure data are shared, they have less influence than the NIH….

The OSTP states that the data underlining the peer-reviewed report must be made available at the time of publication, but it does not indicate when or whether the entire data set must be deposited in a publicly available repository or what happens if there is no publication….

Data sharing is more challenging than the OSTP memorandum suggests. As the United States enters a new era of mandated data sharing, federal agencies need to be cognizant of and address the important questions that arise from this mandate. Data sharing has the potential to stimulate innovation but only if the administrative structure for data sharing is efficient; is financially supported; and is respectful of the time, effort, and intellectual investment of individuals who collected the data.”

Grynoch | Show me the data! Data sharing practices demonstrated in published research at the University of Massachusetts Chan Medical School | Journal of eScience Librarianship

Abstract:  Objective: In the interest of making data findable, accessible, interoperable, and reusable (FAIR), the National Institutes of Health (NIH) will institute a new Data Management and Sharing Policy in January 2023. This policy will require researchers applying for NIH funding to submit a Data Management and Sharing Plan. As 63% of grant dollars received by University of Massachusetts Chan Medical School (UMass Chan) researchers comes from the NIH, we explored whether UMass Chan researchers are currently sharing data associated with their published research and how they shared their data. 

Methods: PubMed was searched for articles published in 2019 with a UMass Chan researcher as either the first or last author. These articles were examined for evidence of original or reused data, the type of data, whether the article stated that data was available, and where and how to find that data. 

Results: Of the 361 articles with original data, 26% had a data availability statement. However, most articles (71%) did not mention where data could be accessed. The data storage location of the estimated 1551 original datasets was similarly not mentioned for 74% the datasets with the next largest category being available upon request (8.6%). Genomic data repositories such as the Gene Expression Omnibus were among the top repositories used by authors. Similar areas for improvement were noted for permanent identifier use (46% had a permanent identifier), using non-proprietary file formats (most popular format was Excel), and citing reused data. Authors who published open access were more likely to share their data. 

Conclusions: While some researchers at UMass Chan have embraced data sharing, particularly genomic data sharing, we expect there will be more data shared in the coming years with the implementation of the new NIH Data Management and Sharing Policy.

Advancing the Promise of Open Science: We Want to Hear from You! – Office of Science Policy

“Today, we are pleased to announce that the “NIH Plan to Enhance Public Access to the Results of NIH-Supported Research” (NIH’s Public Access Plan) is now available for public review and comment. We are issuing this Plan in response to the OSTP memo and also because it is consistent with NIH’s longstanding commitment to open science. This Plan builds upon the strong foundation of the NIH Public Access Policy which, since 2008, has made over 1.4 million articles describing NIH-supported research available to the public through PubMed Central. As you will see, the Plan builds on what we currently do, and we expect to maintain many current practices. But importantly, we ultimately plan to institute a zero-embargo period on publications so that research results are freely available to the public without delay.

It is important to keep in mind that this Plan is not a proposed policy, but a roadmap of steps NIH will take to enhance access to research products.  Any future updates to the NIH Public Access Policy will, in turn, be released as a draft for public comment. Also, to loop back to the DMS Policy—we expect that the DMS Policy will meet all expectations related to data sharing in the OSTP memo….”

NOT-OD-23-091: Request for Information on the NIH Plan to Enhance Public Access to the Results of NIH-Supported Research

“NIH seeks public input on the “NIH Plan to Enhance Public Access to the Results of NIH-Supported Research” (NIH Public Access Plan). NIH has a decades-long history of providing public access to scholarly publications and data resulting from the research it supports, including through the 2008 NIH Public Access Policy and the 2023 Data Management and Sharing Policy. In 2022, the White House Office of Science and Technology Policy (OSTP) released a memorandum on “Ensuring Free, Immediate, and Equitable Access to Federally Funded Research” that establishes new guidance for improving public access to scholarly publications and data resulting from Federally supported research. The NIH Public Access Plan outlines the proposed approach NIH will take to implement the new guidance, consistent with its longstanding commitment to public access. …”

NIH Preprint Pilot Expands to Include Preprints Across NIH-funded Research – NIH Extramural Nexus

“To prepare for Phase 2, we’ve reviewed user feedback from Phase 1 and are taking steps to more clearly communicate what preprints are, their peer review status, and why they are included in NLM literature resources. We have also been exploring new strategies for presenting the record of versions in our literature databases and reviewing filter options to support different search and discovery workflows. We continue to develop materials to increase awareness of preprints and to consolidate resources of interest in our Librarian Toolkit.

What do authors and investigators need to know about Phase 2?

For a preprint to be included in the pilot, it must be posted to a participating preprint server: bioRxiv, medRxiv, arXiv, or Research Square.
Preprints must acknowledge direct NIH support or have an NIH-affiliated author. Investigators should follow guidance NIH released in March 2017 (NOT-OD-17-050) to enable identification of preprints with NIH support, including clearly acknowledging NIH support. Preprints that do not clearly acknowledge direct NIH support or only acknowledge indirect support will not be included in the pilot.
NIH encourages investigators to select a Creative Commons Attribution (CC-BY) license or dedicate their work to the public domain. All preprints made available under a Creative Commons license will undergo full-text indexing in PMC to support preservation and greater discovery.
New preprint records are identified by NLM staff and added to PMC weekly. However, it may take up to two weeks for a preprint to be added to PMC and PubMed. Preprints do not fall under the NIH Public Access Policy and therefore should not be deposited via the NIH Manuscript Submission (NIHMS) system. NIHMS is only for peer-reviewed author manuscripts that have been accepted for publication in a journal.
Preprints can be reported to NIH as products of an award. NLM simplified the steps to add preprint citations to My Bibliography. See this video for details….”

Moving From Idealism to Realism With Data Sharing | Annals of Internal Medicine

Only these opening sentences are OA: “Significant efforts have been made in the past decade to promote open science and data sharing in clinical research. The moral and scientific arguments are clear: If data are shared, it could promote transparency and understanding of the results, honor the participation of individuals, and enable new discoveries (1).

The White House Office of Science and Technology Policy recently updated guidance requiring that results of federally funded research be made immediately available, and federal agencies have drafted a series of policies that outline expectations of their awardees. For example, the National Institutes of Health (NIH) has released a new Policy….”

Harvard Library Responds to the NIH Data Management and Sharing Policy | STAFF PORTAL

“Beginning with the first funding deadlines in January, all NIH grant proposals will be required to include a formal, two-page Data Management and Sharing Plan (DMSP), which must include the following elements….

Crucially, in addition to adding a required DMSP, the data management strategies stated in the plan will be audited and monitored externally, and compliance with stated plans may affect the funding status of grants.


Fortunately, here at Harvard affiliates have access to a variety of computing infrastructure and systems to effectively manage and steward a wide range of research outputs associated with modern, data-driven, computational research.

Harvard’s libraries, Harvard University Information Technology (HUIT), Research Computing, and Sponsored Programs offices have all been adding services and building capacity to support researchers complying with this new policy next year.

In the resources section below, we’ve included links to an executive summary of the policy and a collection of FAQs that we created specifically for Harvard users. We’ve also included resources from the NIH designed to support researchers writing and implementing a DMSP for the 2023 funding cycles.

Along with the requirement to make research data publicly available, in its new policy the NIH strongly encourages the use of established data repositories. When selecting an appropriate repository, researchers should plan to utilize subject- or domain-specific repositories for their data types if possible. When a disciplinary repository does not exist, researchers should use generalist repositories that accept all data types. We’ve included information on Harvard Dataverse and other generalist repositories in the resources section below….”

[Open letter to US FDA and NIH]

“I write regarding concerns about the lack of compliance by medical product sponsors with requirements to report certain clinical trial results information to the database. The law requires that certain clinical trial sponsors report results to to expand the knowledge base, support additional research, and provide important safety and efficacy information to health care providers and researchers. These important goals depend on adequate compliance with applicable requirements and appropriate enforcement.”

US congress committee calls for tougher action on trial sponsors who fail to meet reporting deadlines | The BMJ

“A US congress committee has criticised the Food and Drug Administration (FDA) and National Institutes of Health (NIH) for taking “only modest compliance action” against clinical trial sponsors who have not published results.1

Under US law, clinical trial sponsors are required to submit their results within one year of the completion date. Research looking at compliance in recent years found, however, that over 5000 trials were in “violation of applicable reporting requirements,”2 while over half (37 of 72) of reviewed trials that were funded by the NIH had failed to comply with applicable reporting requirements.3

The US Congressional Committee on Energy and Commerce has written to ask why the FDA and NIH have failed to sanction trial sponsors who break reporting rules….”