NOT-OD-23-180: Request for Information (RFI): Inviting Comments and Suggestions on Opportunities and Challenges for the Collection, Use, and Sharing of Real-World Data (RWD) including Electronic Health Records, for NIH Supported Biomedical and Behavioral Research

“The purpose of this Request for Information (RFI) is to solicit public comments on the use of Real-World Data (RWD), including Electronic Health Records, for Biomedical and Behavioral Research…. 

Researchers are increasingly using data collected in real-world settings to augment traditional research studies as well as develop more effective treatments and interventions for patients. These “real-world data (RWD)”, defined by the U.S. Food and Drug Administration, are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Examples of RWD include data derived from electronic health records, medical claims data, data from product or disease registries, and data gathered from other sources (such as digital health technologies) that can inform on health status. While these data hold tremendous promise for biomedical and behavioral research, they can be collected from a variety of sources through multiple mechanisms, creating challenges for researchers and questions for those whose data are being shared.

Importantly, the National Institutes of Health (NIH) is committed to ensuring participant privacy and autonomy are protected in all NIH supported research. As NIH establishes health-related research data platforms that include access to RWD, NIH continues to prioritize maximizing data access while upholding participant preferences regarding the collection and use of their data. Most recently, through an NIH Director Advisory Committee, NIH met with stakeholders to understand their perspectives on benefits and risks of combining and using human datasets, particularly from disparate sources (e.g., research and non-research settings) and how their data should be used in biomedical research. NIH will continue working to incorporate these perspectives in its research studies to build trust and honor participant preferences. Input requested on this RFI will be used to inform NIH’s continuing development of guidance on the use of RWD for research and assist in the planning for appropriate mechanisms and programs for research with RWD….”

NOT-LM-20-015: Request for Information (RFI): Strategic Opportunities and Challenges for the National Library of Medicine, National Institutes of Health.

“NLM is requesting public comment on major opportunities or challenges relevant to the NLM mission that have arisen or become more important in the last five years and that have implications for the future of NLM in its capacity both as an institution conducting and supporting research and as a national library providing biomedical information products, services, training, capacity-building, and other resources to the world. This information will be used to guide NLM’s continuing implementation of its strategic plan. Response to this RFI is voluntary. Respondents are free to address any or all topics listed below and are encouraged for each topic addressed to describe the opportunity or challenge and how NLM might address it.

Major opportunities or challenges that have emerged over the last five years and that have implications for the future of NLM in the area of:

Science (including clinical health sciences, biomedical science, information science, informatics, data analytics, data science, etc.)
Technology (including biotechnology, platforms, hardware, software, algorithms, processes, systems, etc.)
Public health, consumer health, and outreach (including epidemic disease surveillance, culturally competent engagement, optimizing the experience of resource users, etc.)
Library functions (including collection development, access, preservation, indexing, library metadata, service agreements with other libraries, etc.)
Modes of scholarly communication (including researchers’ use of social media, preprints, living papers, changes in the roles and practices of publishers, data-driven approaches to studying historical medical texts, images, and datasets, etc.)
Perspectives, practices, and policies (including those related to open science, the need for diversity, equity, and inclusion in research, algorithmic bias, expectations of reproducibility of research, etc.)
Workforce needs (including data science competencies, effective strategies for recruitment and retention of underrepresented minorities, opportunities for training and continuing education for middle- and late-career researchers and librarians, etc.)

Major opportunities or challenges that have emerged in the last five years and that have implications for the future of NLM in other areas or areas not well captured above.
Opportunities or challenges on the horizon over the next five years that fall within the purview of the NLM’s mission….”

NLM Strategic Opportunities and Challenges: We Want to Hear from You! – NLM Musings from the Mezzanine

“To make sure that our strategic plan implementation activities remain relevant and attuned to the needs of the public, NLM released a Request for Information (RFI) to learn from you about any related major opportunities or challenges that have arisen or become significantly more important since the plan was created.

While NLM has been advancing its strategic goals, there have been many changes in science, technology, and society that are relevant to our mission. For example, the use of artificial intelligence in research and health care has greatly increased, biomedical scientists are increasingly using nontraditional channels to share their research results, and, of course, there is an urgent need to understand the novel coronavirus and figure out how to quell the pandemic that has affected so many lives around the world. 

Your feedback will help us ensure that the implementation of NLM’s strategic plan remains current. Responses to the RFI will be accepted through October 19, 2020….”

Federal Register :: Request for Information: Public Access to Peer-Reviewed Scholarly Publications, Data and Code Resulting From Federally Funded Research

“OSTP, and the National Science and Technology Council’s (NSTC) Subcommittee on Open Science (SOS), are engaged in ongoing efforts to facilitate implementation and compliance with the 2013 memorandum Increasing Access to the Results of Federally Funded Scientific Research?[1] and to address recommended actions made by the Government Accountability Office in a November 2019 report.[2] OSTP and the SOS continue to explore opportunities to increase access to unclassified published research, digital scientific data, and code supported by the U.S. Government. This RFI aims to provide all interested individuals and organizations with the opportunity to provide recommendations on approaches for ensuring broad public access to the peer-reviewed scholarly publications, data, and code that result from federally funded scientific research.

Interested persons are invited to submit comments on or before 11:59 p.m. ET on March 16, 2020….”

NOT-OD-19-014: Request for Information (RFI) on Proposed Provisions for a Draft Data Management and Sharing Policy for NIH Funded or Supported Research

“The purpose of this Notice is to solicit public input on proposed key provisions that could serve as a foundation for a future NIH policy for data management and sharing….”