NIH continues to work with the research community to ensure we address resource needs associated with the NIH Data Management and Sharing Policy. Today the NIH Office of Science Policy is releasing a new set of FAQs on questions we have heard over the past year, and are also seeking public comment on a new resource for researchers that promotes responsible management and sharing of American Indian/Alaska Native (AI/AN) participant data.
NIH is committed to ensuring that study participants are equal partners in research and have input into how their data and biospecimens are collected and used in the future. At the heart of any research effort lies the need for transparent and clear conversations between researchers and prospective participants about mutual goals and expectations regarding sharing practices.
To assist in facilitating this dialogue, NIH has been working with stakeholders to identify informed consent language “best practices” capable of effectively describing how data and biospecimens will be stored and shared for future research. From these conversations, NIH has developed a new resource that we are seeking the community’s feedback on. The resource describes points to consider when addressing this issue, and provides sample consent language that researchers can tailor based on their own unique study needs…read on for more…
Common Data Elements (CDEs) are a type of health data standard that is commonly used and reused in both clinical and research settings. CDEs provide a way to standardize data collection—ensuring that data are collected consistently, and otherwise-avoidable variability is minimized.
Common Data Elements foster rigor, facilitate data sharing, and allow multiple datasets to be integrated. They also help make data more FAIR (Findable, Accessible, Interoperable, and Reusable). Many different CDEs are currently in use and can vary across research disciplines, so we would encourage researchers check out databases like the NIH CDE Repository for examples, tools, and other related resources. Through a recently released Request for Information (NOT-LM-21-005), we seek your thoughts on how you use CDEs, potential challenges to their adoption, and how NIH might facilitate and incentivize their use to help us plan future CDE-related efforts.
Today, nearly twenty years after the publication of the Final NIH Statement on Sharing Research Data in 2003, we have released a Final NIH Policy for Data Management and Sharing. This represents the agency’s continued commitment to share and make broadly available the results of publicly funded biomedical research. We hope it will be a critical step in moving towards a culture change, in which data management and sharing is seen as integral to the conduct of research. Responsible data management and sharing is good for science; it maximizes availability of data to the best and brightest minds, underlies reproducibility, honors the participation of human participants by ensuring their data is both protected and fully utilized, and provides an element of transparency to ensure public trust and accountability.
Opportunity knocks for NIH researchers, who will be able to leverage clinical data from electronic health record (EHR) systems with increased frequency and consistency. The recently published final rule, which went into effect on June 30, 2020, and requires electronic health record (EHR) systems to provide the clinical data necessary for nationwide, interoperable health information exchange through the adoption of the U.S. Core Data for Interoperability (USCDI) standard.
NIH has released for public comment a Draft NIH Policy for Data Management and Sharing along with supplemental draft guidance. Let the NIH know what you think works and what doesn’t in the proposed policy by submitting your comments through the web-portal no later than January 10, 2020.
When world famous cellist, Yo-Yo Ma, visited the NIH campus, he shared a story from the history of music, in which the peak of stringed instrument quality occurred in the late 17th century at a time of great collaboration and sharing of knowledge. When instrument makers began to compete, all of that changed: secrets of craftsmanship were held close and the quality of instruments plummeted. This decline lasted, according to Ma, until the 20th century, when again the free-flow of knowledge resumed. NIH Director Francis Collins noted, “There’s a lesson here about science.”
Genomic research produces incredibly large amounts of valuable data, often more than one lab can feasibly interrogate. Every day, genomic sequencing costs decrease, and high-throughput technologies advance, allowing scientists to generate large-scale genomic data faster than before. Thus the sharing of these data not only is practical and efficient, it also maximizes the scientific potential of valuable data. This is why it’s important for you to know about the release of the final NIH Genomic Data Sharing Policy.
In 1951, biomedical research took a leap forward when it was announced that cancer cells taken from a patient, Henrietta Lacks, could not only be grown in a lab, but also grown in perpetuity, creating the first immortal human cell line. This cell line – “HeLa” – is the most widely used human cell line to this day. However, at the time ….