If you have been following NIH grant announcements, you might also have heard about the new Data Management and Sharing policy coming into effect starting January 26, 2023. It’s a pretty big deal for anyone applying for NIH grants, and since it is new, there doesn’t seem to be as much practical information as we’d like, so our team at Labfront will try to break it down for you.
In our effort to make research logistics easier, in the coming year, we’ll also be working to make all Labfront projects automatically comply with the policy, making it super easy to both apply for your grant, and stay compliant with the policy. Stay tuned!
NIH Data Management and Sharing (DMS) policy, in a nutshell
Now in effect, the NIH’s DMS policy is a major step in the direction of data transparency.
For decades, the lack of access to primary data has led to two major problems. Firstly, the data collected and stored is locked up and forever inaccessible for integration with other datasets. In an era of internet of things and cloud computing, one-time use of data is a tremendously inefficient utilization of NIH resources. Secondly, without access to the original data, it becomes impossible to replicate a study and verify its accuracy, something that is particularly important in an era where science is often politicized and when public mistrust of science is at an all time high. Data sharing would help to ensure optimal use of resources and bring transparency to research.
DMS policy is an attempt to address these issues. To do so, the DMS policy draws from the FAIR (Findable Accessible Interoperable Reusable) Guiding Principles first published in 2016. The NIH has focused on 6 major DMS "elements" which are each sectioned in the required 2-page Data Management and Sharing Plan. Those elements are: (1) data type, (2) related tools, software, (3) standards, (4) data preservation, access, and timelines, (5) access, distribution or reuse, and (6) data oversight.
What does it mean for you?
If you are not an NIH-sponsored researcher, this may not affect you directly. However, it's worth noting that open data sharing is becoming a standard not only for the NIH but also for journals which are increasingly requiring authors to make data, code, and protocols available to readers.
If you are an NIH-sponsored researcher and have already submitted your proposal prior to January 26, 2023, this will only affect your next submission.
For the rest of you who may be in the process of submitting a new proposal and have just noticed that there is a new requirement for Data Management and Sharing Plan, this is an overview of what it means for you.
First, there are 3 parts to the DMS requirement: (1) the actual DMS Plan (max 2 pages), (2) Budget Line item in the budget form where you enter the numerical cost labeled "Data Management and Sharing Costs", and (3) Budget justification where you provide a brief description of the requested DMS costs.
Second, the DMS will not affect your overall NIH score. Peer reviewers may provide comments on reasonableness of budget but otherwise should not use this assessment to alter their score. Interestingly, reviewers will base this completely on the Budget Justification portion. The detailed 2-page DMS Plan goes only to the NIH program officers/staff who will assess the reasonableness of the detailed plan (for the time being).
Third, do not underestimate the importance of data management and miss this opportunity to allocate funds for storing/managing your data. Once your project gets awarded (we believe in you!), you cannot retrospectively request DMS funds. Being strategic about how you manage your data may markedly impact your future success. For one, shared data can be cited as products of NIH awards in your biosketch or progress reports. Furthermore, making your data findable and potentially accessible to other researchers can lead to collaborations and multiple authorships in subsequent studies that utilize your data.
Now, how much should be allocated to the DMS plan? The truth is, no one really knows, and the NIH has been intentionally vague about this since there are likely plenty of unforeseen costs (i.e., curating data, developing supporting documentation, formatting data to community standards, etc..). For digital health, the generated data tend to be large (think continuous heart rate for weeks to months), multimodal (multiple types of data - oxygen saturation, acceleration, heart rate, etc..), and messy/noisy. With the expectation that the data should also be stored for ~ 10 years after project completion, we anticipate the costs to be quite large - at least in the tens-of thousands of dollars. Of course, this is extremely project-dependent and worth a discussion with the people running the data repository.
Finally, don't miss out on the wonderful and free DMP tool which can assist you in filling out the DMS Plan.
What is Labfront doing to make this transition smoother?
We are on it! Everyone that knows us at Labfront knows that our goal is to make the research process easier, especially all the logistic parts that aren’t actually related to your real project. Over the next 6 months, we’ll be rolling out new features and services to help everyone easily comply with the Data Management and Sharing policy if you use Labfront to run your projects.
We’ll also be releasing a webinar with much more detailed information about DMS.
Finally, if you are stuck or need more advice on how best to conform with these policies within Labfront we will be offering consultations as well as support for our customers when dealing with wearable and physiological data especially during this transition period as resources can be limited around understanding how best to comply with the policy requirements.
We believe that open access research is critical during this time when science is often politicized and public trust in science is at an all time low - making sure our research is transparent can help restore confidence in science from all corners of society!
Join our list to receive updates on how to stay compliant with the NIH Data Management and Sharing (DMS) policy using Labfront, including webinars and consultation opportunities.
Dr. Ahn is an internal medicine physician with a background in physics/engineering and physiological signal analyses. He is the Chief Medical Officer at Labfront and an Assistant Professor in Medicine & Radiology at Harvard Medical School. Dr. Ahn is passionate about democratizing health sciences and exploring health from an anti-disciplinary perspective.