Notice Number: NOT-AA-17-005
Release Date: May 26, 2017
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIAAA seeks public comments on a proposed data-sharing initiative to create a repository of all future NIAAA-funded studies that include human subjects. With such an initiative, all NIAAA-funded researchers would be expected to make individual-level data obtained from NIAAA-funded human subjects research available to the general research community.
Access to individual-level data from human-subject studies has numerous advantages (Gøtzsche 2011; Ross et al. 2012). Secondary data analysis of existing datasets offers a low-cost, high-yield approach for further investigation. Researchers can pose and test new and creative research hypotheses that go beyond those of the initial studies. And importantly, when datasets are harmonized, they can be combined to provide the large sample sizes that are particularly useful in this era of Precision Medicine and Big Data. By increasing statistical power, these combined datasets can increase the reliability and confidence of the study findings with regard to the scientific processes and effects (e.g., meta-analysis), and create the large sample sizes necessary for applying advanced statistical methods. Combined datasets also enable us to identify certain subgroups of patients for whom treatment (or other scientific processes) may be particularly beneficial or harmful. Additionally, data can be linked across studies for individuals who participate in more than one experiment, enabling researchers to draw conclusions that otherwise might be missed. Making data available to the general research community also helps mitigate delays in (or the failure to) publish the results of Federally-funded studies. Finally, because raw data are shared, the integrity of study results can be verified and reproduced by outside parties.
NIAAA is seeking information from the public on a proposed data-sharing initiative for NIAAA-funded studies that include human subjects.
The National Institutes of Health (NIH) views data sharing as essential for translating research into knowledge, leading to improved products and procedures and, ultimately, benefiting human health (https://grants.nih.gov/grants/NIH-Public-Access-Plan.pdf). The agency has a long and ongoing commitment to making the results of Federally-funded scientific research available to a broad audience, including members of the general public, industry, and the scientific community (https://grants.nih.gov/policy/sharing.htm). NIH also has a history of promoting good data management and sharing practices, including ensuring that data adhere to the “FAIR” (Findable, Accessible, Interoperable, and Reusable; https://www.nature.com/articles/sdata201618) principles.
In 2003, the Final NIH Statement on Sharing Research Data first required applicants requesting funding of $500,000 or more in direct costs for any one year to include a data sharing plan or to state why data sharing is not possible (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). In 2013, the White House Office of Science and Technology Policy (OSTP) released a memorandum, entitled Increasing Access to the Results of Federally Funded Scientific Research (https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/ostp_public_access_memo_2013.pdf), directing Federal agencies and offices to develop plans to ensure that peer-reviewed publications and digital scientific data from Federally-funded scientific research are accessible to the public, industry, and the scientific community to the extent feasible and consistent with applicable laws and policies. In coordination with the U.S. Department of Health and Human Services (HHS) (http://www.hhs.gov/open/public-access-guiding-principles/index.html), NIH responded to that memorandum by developing the National Institutes of Health Plan for Increasing Access to Scientific Publications and Digital Scientific Data from NIH Funded Scientific Research (i.e. the NIH Plan), released in February 2015 (https://grants.nih.gov/grants/NIH-Public-Access-Plan.pdf). To implement the NIH Plan and move forward with the data sharing initiative, NIH is further refining its data management and sharing policy (e.g., determining which data types have the greatest value for sharing and the costs and value of sharing different data types, including the long-term resource implications), and examining how best to expand the initial 2003 Data Sharing Policy. Finally, the 21st Century Cures Act, signed into law on December 2016, gives the NIH Director the authority to require data sharing from NIH-supported research, making data available to scientists and further advancing biomedical research (Hudson and Collins, 2017).
In support of these NIH policies on data sharing, a number of NIH Institutes have taken the initiative to develop large repositories to make human subjects data available to the larger research community (https://www.nlm.nih.gov/NIHbmic/nih_data_sharing_repositories.html). For example, the National Heart Lung and Blood Institute (NHLBI) makes their epidemiological and clinical trial data available via the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) (https://biolincc.nhlbi.nih.gov). That repository of individual level data includes more than 580,000 participants from over 110 Institute-supported clinical trials and observational studies (Coady and Wagner, 2013). Similarly, the National Institute on Drug Abuse (NIDA) makes data available from more than 50 clinical trials (N=30,000) via the NIDA Data Share Web site (https://datashare.nida.nih.gov/). And, more recently, the NIH common fund program All of Us (formerly the Precision Medicine Initiative Cohort Program) began developing a repository of 1 million human subjects (https://www.nih.gov/allofus-research-program).
Another well-developed, comprehensive program is the National Institute on Mental Health (NIHM) Data Archive (NDA)—a very large Federal data repository of NIMH-funded human studies (https://data-archive.nimh.nih.gov/). Started in 2008, the repository now includes approximately 4,200 registered users and 530 studies (N=135,000 human subjects). The NDA program collects human subject study data from NIMH-funded grantees, performs data quality checks, standardizes data elements (i.e., variables) for harmonization across studies and, then, after a predetermined period, makes the de-identified data available to the general research community. Researchers then must apply for access to conduct secondary data analysis studies. NIMH strongly encourages grantees to submit study data every 6 months from the start of the study until its conclusion and training is provided on how to submit that data. NIMH makes study data available to the general research community no later than 1-year after the grant termination date. Thus, grantees have 1 year to publish exclusively before the study data are available for publication by other researchers. Costs associated with providing data to the NDA are generally included within the grant application and thus are not absorbed by the grantee’s institution.
Recently, NIAAA and NIMH discussed partnering on the NDA, which would give NIAAA the opportunity to leverage the NDA infrastructure, experience, and expertise for archiving future NIAAA-funded studies involving human subjects. This partnership would allow NIAAA to implement a full-scale data repository program at relatively low cost.
Feedback obtained through this RFI will be used to inform the development of NIAAA policies related to the creation, management, and sharing of individual-level human subject data generated from NIAAA-supported human subjects research through the NDA program.
NIAAA recognizes that many factors must be considered when determining what, when, and how individual-level data should be managed and shared. These factors include, for example, the purpose for sharing, how best to support data re-use and reproducibility, how long the data should be embargoed before distribution, as well as security and ethical considerations. Because NIAAA proposes to join the NDA program, the ultimate final data sharing policies and processes likely will similar to those of the NDA program (https://data-archive.nimh.nih.gov/s/sharedcontent/about/policy).
NIAAA seeks comment on any or all of the following topics to help formulate strategic approaches for prioritizing its data management and sharing activities:
1. Types of data that should receive the highest priority when considering data sharing and what will be gained from sharing that data.
2. Extent grantees maybe required to submit data to the data repository and how should this requirement be enforced.
3. The length of time data should be embargoed before being made available to the general research community.
4. Extent that would be useful to have an independent organization (i.e., NDA) perform data checks throughout the course of the grant cycle and to make this information available to grantees for correction of erroneous data.
5. Maintenance by NDA of archived individual-level data and the long-term resource implications for managing these data.
6. List the barriers (and burdens or costs) to data stewardship and sharing, and mechanisms for overcoming these barriers.
7. List of additional topics respondents believe are important for NIAAA to consider.
Submitting A Response
Responses to this RFI must be submitted electronically to firstname.lastname@example.org by July 21, 2017, 11:59:59 PM EST. Please include the Notice number NOT–AA–17–005 in the subject line.
Answers must be sufficiently brief (short paragraphs) so that NIAAA may group similar responses. Each paragraph should be labeled with a number corresponding to the numbered points addressed above.
All stakeholders are invited to provide information. If you choose to submit, please categorize your area of expertise by including all that apply:
You also may also include details on your role within industry, government, or academia, and your experiences with other relevant repositories.
Responses to this RFI are voluntary. Responses will be compiled, reviewed by NIAAA staff, and may appear in reports and shared publicly in an unedited form after the close of the comment period. However, any information shared publicly will be de-identified and will not be attributed to any individual. Please do not include any proprietary, classified, confidential, or sensitive information in your response. NIAAA will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder's submission.
This RFI is for planning purposes only and should not be construed as a policy, solicitation for applications, or as an obligation on the part of the Government to provide support for any ideas identified in response to it. The NIAAA may use information gathered by this RFI to inform development of future funding opportunity announcements and policy development. Please note that the U.S. Government will not pay for the preparation of any information submitted or for its use of that information.
We look forward to your input and hope that you will share this RFI document with your colleagues.
Coady SA and Wagner E: Sharing individual level data form observational studies and clinical trials: a perspective from NHLBI. Trials 2013, 14:201:1–3.
Gøtzsche PC: Why we need easy access to all data from all clinical trials and how to accomplish it. Trials 2011, 12:249.
Hudson KL and Collins FS: The 21st Century Cures Act – A view from the NIH. N Engl J Med 2017, 376:2:111–113.
Ross JS, Lehman R, Gross CP: The importance of clinical trial data sharing toward more open science. Circ Cardiovasc Qual Outcomes 2012, 5:238–240.
Please direct all inquiries to:
Daniel Falk, Ph.D.
Division of Medications Development
National Institute on Alcohol Abuse and Alcoholism