The confluence of the social justice movement to address racial inequalities and the Sars2-Covid-19 pandemic yielded powerful forces of change that led to unprecedented transformations in our country’s research enterprise. Manifested among them were the urgency for access to data and a new compact for collaboration among researchers to accelerate the closure of information gaps needed to support public health practices, policy development, research and development, public-private collaborations and more. The success stories, unexpected barriers, and unanticipated innovations that resulted over the last several years are now serving as catalysts for enduring policy changes that will accelerate progress from discovery to delivery of products, services, and technologies.
NIH is implementing new Data Sharing policies for the research projects it funds and supports. What are the hallmarks of this new policy? Effective January 23, 2023, nearly all proposals submitted to NIH for funding consideration will be required to submit a Data Management and Sharing Plan as a component of the research proposal. Under the Data Management & Sharing (DMS) Policy, NIH requires researchers to prospectively plan for how scientific data will be preserved and shared through submission of a Data Management and Sharing Plan. Researchers are will be required to: 1) submit a Data Management and Sharing plan outlining how scientific data and any accompanying metadata will be managed and shared, and 2) comply with the Data Management and Sharing plan approved by the funding NIH Institute or Center.
The implications are substantial and likely to be transforming for the academic research community, and beyond. We a taking a moment here to assess what’s unfolding and bring into focus the viewpoints of leaders from NIH and research institutions who spearhead the policy implementation.
This path towards democratizing research data to advance scientific progress has been years in the making. Many communities in science, such as physics, energy, and space science, have had open collaborations in science and public data repositories for generations. Biomedical and health services researchers have, in recent decades, expanded data use agreements for earlier sharing, and promoting large, inter-institutional collaborative programs. However, for many years, progress has been halting as pundits debated the pros and cons of open collaboration and sharing. The impact on intellectual property, academic career standing, and secured research funding were a few of the concerns raised about a large scale “commons” approach to the research enterprise. Then, in 2016, Congress passed the 21st Century Cures Act thereby taking a bold step forward in biomedical research by supporting the creation of an “Information Commons” - an ecosystem of separate but interconnected initiatives that facilitate open and responsible sharing of genomic and other data for research and clinical purposes.
What is behind the broadening of NIH’s data sharing policy now? A combination of experience with successful model data sharing programs, technologies that enable relatively low cost and rapid data collection and analysis, and the recognition that diversity of ideas contributes to greater access to data from non-traditional research fields. Together, systematic data sharing of research findings is widely viewed as a key to breaking down barriers to faster translation of basic science to meaningful impact on health.
What will NIH’s data sharing policy changes mean to researchers and institutions going forward? The good news is that there’s been a lot of thought and preparation about the supporting policies to enable researchers to comply and benefit from good data stewardship. Dr. Susan Gregurick is Associate Director for Data Science at NIH and the Director of the Office of Data Science Strategy for the past five years and has spurred progress in uses of data in research. “Across NIH, many of our Institutes and Centers have established working units to establish the practices, program management expertise, and infrastructure to enable the undertaking of these new policies,” Dr. Gregurick said.
A key resource that NIH features and has established as an information hub for researchers, institutions, and the public is the NIH Scientific Data Sharing website. This portal maps the key issues and program activities that underpin the policies. This resource is designed largely to help the research community connect for practical knowledge. The website offers resources to specific audiences through monthly seminar series on topics such as curation, data use agreements, data security, and use of cloud-based repositories and analytic tools, and provides information on in-person forums, electronic forms, and other project management tools.
Recently, NIH also announced program notices for how supplemental funding to research project grants can be requested and used to support data archiving, curation and maintenance. “For many years now, NIH has demonstrated the power of collaboration and data sharing in large genomic and proteomic projects and those experiences have given us the confidence to accelerate our path forward in data sharing and accelerate the pace of research overall,” Gregurick said.
The implementation of NIH policy brings important changes at academic research institutions where effective data management policies will among the keys to success. Dr. Sherine Gabriel, President of Rush University notes “the rapid and widespread sharing of a range of data, scholarly activities and outputs, across disciplines promotes inclusivity, transparent and trustworthy research, innovation, and collaboration. It will benefit investigators (especially new investigators) but more importantly, it will accelerate discovery benefiting society as a whole.”
Twenty years ago, when NIH’s open access policies for research publications were implemented, much of the infrastructure needs for compliance were addressed through publishing houses and professional societies. Now, the new data sharing policies place research institutions as a central focal point for implementation of repositories, cloud service agreements, education and training, and grant proposal development expertise. From basic science to clinical research, there are many implications for the administration of research programs.
How are research institutions planning for this transition? Gabriel points out that “Rush University supports open science and open scholarship, sharing discoveries and data, as openly as possible, in order to advance science and ultimately, save lives. Along with 60 other U.S. colleges and universities, we are a member of the Higher Education Leadership Initiative for Open Scholarship (HELIOS). This effort, emerging from the work of the National Academies of Sciences, Engineering, and Medicine's Roundtable on Aligning Incentives for Open Science, represents the largest, most carefully coordinated attempt to align higher education practice with open scholarship values.”
The scale and detail of implementing data sharing policies cannot be overstated. As the research enterprise embarks on this paradigm shift, there is much to be learned about the practices of data integrity assurances and how, in the future, NIH integrates data sharing plans into the evaluation process of research proposals in making award funding decisions. An exciting aspect of the policy will be the new research opportunities from new disciplines, novel partnerships, innovative cross-disciplinary programs, and training initiatives in computing and data science that will accelerate the translation of science into new services, products, and careers. Societal concerns regarding equity and unprecedented global emergencies, including the Sars2-Covid19 pandemic, have moved government, academia, and industry to new vistas for knowledge and technologies. How we adapt to these forces through data policy to overcome gaps in health equity and prepare for future pandemics remains to be seen.
Stay tuned for our next installment on the pioneering advances in data sharing as we listen to the ideas about the policy from investigators in leading laboratories and clinics. We’ll also hear from patient advocates on their perspectives about data sharing and what this means for eliminating speed bumps to a healthier future.