NIH’s DRAFT Data Management and Sharing Policy: We Need to Hear From You!

Around this time last year, I wrote about a request for information (RFI) on potential key elements that could comprise a future NIH data management and sharing policy.  Not surprisingly, we received a lot of helpful feedback. Most commenters supported data sharing and the importance of prospectively planning for where, when, and how scientific data should be managed and shared.  There were, however, concerns about how one policy could fit all sizes and types of data across the biomedical research universe as well as potential burden on the research community.

Over the course of the last year, NIH has been incorporating many of these suggestions into our thinking and continuing to engage the community on their thoughts about data management and sharing. We’ve also been working with sovereign Tribal Nations through consultation sessions held across the U.S which have been vital in shaping NIH’s perspective on the potentially unique data sharing needs of those communities.

Today, NIH has released for public comment in the Federal Register a Draft NIH Policy for Data Management and Sharing along with supplement draft guidance. The draft policy furthers NIH longstanding commitment to making available the results and products of the research we fund and conduct.

To facilitate public comments, NIH has established a web-portal where folks can easily and securely provide their feedback.  The portal can be accessed by clicking here. To ensure that your comments are considered, responses must be submitted no later than January 10, 2020.

I recognize that there is a perception that a Draft policy represents a finished product, that NIH has already made up our mind. I want to assure you that this is not the case.  It is very important that we hear from the stakeholder community about what you think works and doesn’t work with respect to what we have proposed. We are also eager to hear your thoughts on the utility of the supplemental draft guidance or recommendations for any other guidance materials that would be helpful. I previously wrote a blog on best practices for public comments that you might find useful.

Finally, to further engage stakeholders, NIH will be hosting a webinar on the draft policy in the near future. Please stay tuned for the details. We look forward to hearing what you think about the draft policy and supplemental draft guidance and encourage you to broadly share its availability and our request for comments.  With your help, we can ensure that the draft policy maximizes the myriad benefits of data management and sharing while minimizing the burden to the research community.

Posted by Dr. Carrie D. Wolinetz, November 6, 2019

Comments (15):

    My only concern about this policy is that it doesn’t seem to account for the fact that, for extramural grants that are proposing making their data extensively available, there would likely be substantial costs to the project. Yet, the plan only needs to be submitted and approved during the JIT phase. If the plan needed to be developed when the application was submitted, then the investigator could budget for data sharing costs.

    I agree with the policy of broad data sharing that respects subject privacy but also makes data available to a broad range of investigators. HOWEVER, there are serious barriers to accessing data generated in other countries, particularly the EU, but also countries like Iceland. Currently, EU investigators can get US data but in most situations, US investigators cannot get EU data. NIH is aware of this disparity but has not come up with a solution. This puts US investigators at a severer disadvantage which will persist until equal sharing with other countries is resolved. US tax payers are funding science and sharing data but US scientists are at a disadvantage.

    A second issue is that within NIH-funded science, there are data that are also not broadly available. Specifically, TOPMed data are sequestered and not broadly available. This internal NIH problem needs to be resolved. Again, this is a situation that many investigators who work in human genetics are aware of but NIH has not addressed for reasons that are not obvious.

    We should share data in a way that does not put US investigators are a disadvantage.

    thanks for the post. I Also pasted this on the feedback portal.

    NIH provides no justification for its statement (in supplemental DRAFT Guidance pdf): “Note, NIH does not expect researchers to share all scientific data generated in a study.”
    I suggest instead: “All data from research funded partially or entirely by NIH is expected to be publicly available. the only exceptions are with respec to HIPAA compliance, similar protected personal informationm, and U.S. national security.

    Copyright: The DRAFT Guidance and Supplemental Draft Guidance fail to mention copyright. The NIH funded scientific community is already stuck with for profit companies charging access for much of the publications funded by NIH. NIH’s failure to address copyright simply invites publishers — and researchers — hiding their data behind a paywall. I strongly urge NIH to update its Guidance with text consistent with the following logic:

    Data are facts. Facts cannot be copyrighted.

    Attribution is not a problem: I do note that attribution of data source (i.e. original author’s publication, with complete methods can be handled by the simple expectation: “give credit where credit is due”.

    I published in 2006 The principle that data is not subject to copyright provides a framework in which all scientific data should be made freely accessible.
    In addition to obtaining numerical data on request, the U.S. Supreme Court’s observation hat data is not subject to copyright (14) provided
    the rationale to digitize spectra from published graphs.
    Data Is Not Copyrightable
    During the course of developing this data, one of us had an epiphany while reading in Lessig (18) about a U.S. Supreme Court decision: data is not subject to copyright (14). Text and commentary about Feist can be found on many legal web sites by doing a Google search. Indeed,
    the broad availability of the text of Supreme Court decisions is because they are not subject to copyright. The Feist decision reaffirmed the U.S. Copyright act of 1976 that “there can be no copyright in facts”. The basis for the Feist decision can be found in the U.S. Constitution.
    14. Feist Publications, Inc. v. Rural Tel. Serv. Co. 1991;499 U.S. 340.
    18. Lessig L. The Future of Ideas. New York: Random House; 2001. p 368.

    Data is knowledge and availabilities of knowledge lakes of data might helps to generate valuable pre-cognition system of any events to help human to use less brainstorm effective and accurate descriptive results as well as generate predictive scenarios for decisive conclusion and executions.

    If Data is Facts then Facts are just Facts belongs to history line for future references.
    Different Categories of Datasets (exp: Health, Accidental, Weather, Disaster, Population, Education etc.) should be available to access for researcher or data analyser personal with less privacy policies to interact to help human society.

    someone advised: “We should share data in a way that does not put US investigators are a disadvantage.”
    In 2019, in AI Time, ML(Machine Learning Artificial Intelligence with Deep Learning) should know the Data Pattern, Data DNA etc. of illegal words or lines or slogans or classified datasets suppose to go through MLAI Processes before retrieve/share publicly on NIH Web platform.

    Data is not knowledge. Data is information…knowledge is what evolves when available data can be coalesced into accurate predictions & reasonable and/or workable interpretations of the meaning represented by the data.

    Where are we going to put all this data? How is it going to be uniformly posted? How will investigators know how and where to find it? was established to foster transparency and dissemination of information about clinical trials: will something similar be developed for individual participant data, with a format that is easy to understand and navigate? Scientists are fairly sophisticated people and know their own data, but we still are going to need help navigating registries and wading through the flood of information this requirement will create.

    It is true that it is sometimes not easy to get data generated in other countries. However, this is an area where NIH leads. Often, other countries look to NIH as a model of good biomedical policy. So do journals when seeking to set policies that apply to authors from all countries. We should not seek to have NIH policy as the least common denominator.

    Your answer still does not address the problem. Right now, European investigators are obtaining data from US repositories, combining it with European data that US investigators do not have access to, and publishing papers based on the combined data. Thus gaining an unfair advantage at the expense of US tax payer. Nothing in your response addresses this issue. This is not only unfair, it is not good science since the investigators who generate the data have the best knowledge about the data. A more equitable data sharing landscape would promote US-European collaborations.

    NIH has done nothing to resolve this situation and expecting journal editors to solve this problem is naïve and really is NIH shirking its responsibility to solve this problem.

    Short of saying “data for US citizens only”, im not sure what you expect them to do. That’s a slippery slope that we probably shouldn’t start down.

    Unless we are going to get rid of the entire concept of impact factor, which although that would be great will not happen in my lifetime, NIH would never mandate publication in freely accessible journals.

    you have to better than that. With EU investigators, the Spanish have been very good about sharing genetic data and they are under GDPR. Data sharing needs to be reciprocal, not one sided. The optics of this to the public are awful.

    This is a really good idea — it could be added as a required section for all applications, and added to the required review criteria.

    Full transparency is always ideal when possible. However, I also understand that obtaining consistent and accurate data comes with guidelines for the collection of said data and therefore oversight and funding. If the data being shared is accurate, it should be made accessible to everyone. Checks and balances to this system are paramount.

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