Data Sharing, Intellectual Property, and Publication Policy

MIDAS (Models of Infectious Disease Agent Study) creates computational models that will be useful to policymakers, public health professionals, and the research community. In order to maximize the utility and distribution of information and technology, MIDAS has developed policies that will

• Minimize administrative barriers to the conduct of collaborative research,Encourage open and free interchange of information among all program participants,
• Facilitate the rapid dissemination of information into the public domain, and
• Protect data and technology from inappropriate uses, especially with respect to national security.

The Research Groups and Informatics Group will work to proactively address issues relating to data and material sharing and intellectual property.

MIDAS Research Groups, the Informatics Group, and non-MIDAS participants and their institutions agree to the following policy:

DATA SHARING

The policies for information and material sharing encompass research conducted by funded Research Groups, the Informatics Group, and non-MIDAS researchers.

Data used in MIDAS research will be collected and stored in database servers, and will be accessible by MIDAS-funded researchers and registered non-MIDAS researchers through the MIDAS Portal.

MIDAS uses existing or simulated data. Data suppliers must be informed of and agree to MIDAS policies concerning data sharing. Once collected, data will be put into computable form and will become available to MIDAS Research and Informatics Groups. Data will become available to the public within 6 months of being released to MIDAS investigators. Institutional reviews of data related to intellectual property, if any, must be conducted within the 6 month window.

The MIDAS Data Group will review all data sets before they are accepted to ensure that

• They are of sufficient completeness and quality,
• They are of value with respect to the MIDAS mission and goals,
• They have appropriate agreements and consents (e.g., intellectual property, human subjects, animal welfare), and
• They are restricted if there are national security or privacy concerns.

Restricted data. MIDAS may receive data that are critical to the program's mission and that must be confidential for national security or privacy reasons. These data may be restricted to MIDAS-funded investigators. Restriction of data is expected to be an exception and will be determined by the Data Subgroup in consultation with NIGMS staff.

MIDAS Investigators. MIDAS investigators will deposit annotated data sets to the shared database when they are complete. Except in the case of an emergency, it will be a MIDAS community standard that the MIDAS research group which first obtained the data will be afforded sufficient time to analyze the set before other MIDAS groups conduct analyses of that set.

The Informatics Group has the responsibility of ensuring the data are in computable format and making them available to MIDAS investigators through the Portal.

Non-MIDAS investigators. A key strategy for achieving the MIDAS's scientific goals is that data and information collected by and generated by MIDAS investigators will be broadly available. As a condition of using MIDAS data, ancillary investigators will agree to conduct experiments consistent with MIDAS's aims and to deposit documented results (data, tools, models, analyses, or other intellectual property) into the MIDAS database at least once every 90 days. Publications of research that uses MIDAS data should cite MIDAS. The dissemination of these results and information to the public will be done according to each institution's publication policy and published NIH guidelines for dissemination of research results (http://grants.nih.gov/grants/policy/nihgps_2001/part_iia_6.htm).

Public data. Information deposited in MIDAS databases prior to publication or presentation at scientific meetings will be coded as non-public and will be accessible to registered users through use of an access code. Data which has been made public through publication or presentation at scientific meetings will be coded as public and will then be accessible to both program participants and the public.

Data collected in an emergency. In the event of a public health emergency involving an infectious disease, MIDAS resources may be diverted to address the emergency. In this situation, it may be impractical or unwise to release incoming data in the usual timeframe. Once the emergency is past, data will be released as soon as possible.

MODEL SHARING

MIDAS will achieve its goals most rapidly if there is extensive collaboration and if models and tools are available to MIDAS investigators. This allows for testing and verifying models, comparisons of model performance, and statistical analyses of MIDAS outcomes.

MIDAS analytic and simulation software tools will be made available to all MIDAS investigators through the secure MIDAS website. Each Research Group is responsible for regularly updating and documenting its code.

The public release of simulations and models raises the possibility of national security concerns. It would be unwise to release information or software that could be used to endanger the public. Therefore, the developer, the Steering Committee, and NIGMS staff will be involved in decisions to release models publicly.

PUBLICATIONS AND PRESENTATIONS

The MIDAS Principal Investigators, along with the NIGMS Scientific Director, will constitute the Publications and Presentations Committee.

All publications that cite MIDAS support should be submitted to the Publications and Presentations Committee simultaneously with submission for publication. The Publications and Presentations Committee (and other investigators as deemed appropriate by the Principal Investigator) will review the draft document for concerns and convey their concerns and suggested changes directly to the submitting author. For publications and presentations that deal with MIDAS-wide activities (e.g., public release of a MIDAS-endorsed influenza model or a manuscript covering work from MIDAS researchers at-large), the Publications and Presentations Committee may designate the lead author, recommend co-authors, and require appropriate representation of contributing teams.

Concurrent with publication, data and results, as well as detailed specifications on analytic and simulation software tools, will be made accessible to MIDAS investigators on the MIDAS portal. As soon as possible after publication, results and software will be made publicly available.

Disputes will be referred to the Publications and Presentations Committee for resolution.

A secretariat for the Publications and Presentations Committee will manage scheduling, standard operating procedures, record-keeping, and staffing.

INTELLECTUAL PROPERTY CONSIDERATIONS

Inventions. Working within the timing constraints of placing program information into the public domain, member institutions may seek intellectual property protection for technology and data obtained in this project. Participating Investigators who file invention disclosures which result from collaborative research are expected to disclose the collaborative nature of the research and the names of the other participating investigators and their institutions. Inventorship will be determined by U.S. Law. Title to inventions will be determined by the inventor's obligation to assign rights to his or her employers. In accordance with 37CFR401, no member institution shall assign its rights to any third party.

Research license. Each member institution will grant to participating institutions and any other not-for-profit institution a non-exclusive, non royalty bearing, non-transferable license for purposes of non-commercial research, to all intellectual property developed in performance of this program. Title holders to intellectual property will be encouraged to license their intellectual property rights, when appropriate, and in compliance with the NIH guidelines, to non-participating third parties for purposes of developing commercial products and public benefit.

Resolution of disputes. All disputes between participating institutions involving intellectual property will be resolved by alternative dispute resolution. The arbitrators shall be mutually agreed upon by the parties involved in the dispute.

Disputes between participating institutions and NIGMS on scientific or program matters will be resolved by arbitration as described in the Request for Applications (http://grants.nih.gov/grants/guide/rfa-files/RFA-GM-01-004.html).

USER AGREEMENT TO COMPLY WITH MIDAS INFORMATION POLICY

MIDAS (Models of Infectious Disease Agent Study) creates computational models of emerging infectious diseases that will be useful to policymakers, public health professionals, and the research community.

All users of MIDAS data, information, software, or technology (i.e., retrieved from the MIDAS Portal) agree to the following:

• Users will employ the data to conduct experiments consistent with MIDAS's aims,
• Users will deposit documented results (data, tools, models, analyses, or other intellectual property) into the MIDAS database at least once every 90 days,
• Publications and presentations will cite MIDAS,
• The dissemination of results and information will be in accordance with published NIH guidelines for dissemination of research results.