External Data Use Agreement SenNet Consortium
Approved by the SenNet Consortium Steering Committee June 15, 2022
This policy governs data access and data release by the SenNet Consortium to the public. We begin by articulating the guiding principles that the SenNet Program will strive to adhere to. We then outline the public data release, data access and software release policies, and finish with appropriate use and requested acknowledgment statements. Section IV of this document sets policy for sharing SenNet data outside the Consortium (presentation, publication, collaboration) prior to its public release by SenNet.
- Guiding Principles
The SenNet Consortium will strive to support;
- FAIR principles: Findable, Accessible, Interoperable, and Reusable:
- Rapid data release: Data will be released by SenNet after a verification step which is understood to mean that the SenNet lab considers the experiment to have produced usable data. It is expected that data may continue to be collected by improving SOPs and other QA/QC metrics and may be replaced in future releases.
- No embargos: There will be no publication embargo placed on the non-SenNet community once SenNet data has been publicly released.
- Data will be released under a permissive license, such as CC-BY 4.0 (for open data; https://creativecommons.org/licenses/by/4.0/).
- Open source software release (this document covers only the software that is used in processing data for release) using a permissive open-source license like MIT or BSD. The SenNet project will endeavor to not use closed-source (e.g., vendor) software, but that may not always be possible.
- Release both raw and processed data. The definition of raw data will reflect community input and needs. The specific processing level will be agreed upon by the SenNet data release and QC teams, who will also be collecting input from the broader research community.
SenNet, like many other NIH programs, will follow “rapid data release” policies to the community. We will publish data release schedules (with a minimum frequency of every six months after the first release) on our website for the community’s benefit. Working papers and/or white papers generated by the SenNet consortium will be used to inform the research community, and we will accept feedback on all aspects of the data release process. It is expected that SenNet data will be released after “data verification”, which is defined as assessing the usability of the data. That is, the data has sufficient quality to support its use in follow up experiments. The working/white papers will provide additional and assay specific details at the time of data release.
- Public Data Release
All public releases of SenNet data will be associated with working/white papers or publications that describe the choices made in the experimental design, data collection and processing workflows and will assess the potential impact on the research community. As a general guideline, these papers will describe how we implemented our guiding principles described above and will include the following aspects:
(1) how we implement FAIRness;
(2) choice of data formats;
(3) definition of raw data for each assay;
(4) description of the data processing;
(5) minimum QA/QC criteria;
(6) analytical software including parameters; etc.
The SenNet program will endeavor to correct errors identified in released data in subsequent releases using an appropriate versioning processes.
- Data Access
The SenNet Data Portal will provide access to both open and restricted access data and will be guided by the rules set forth by existing NIH GDS Policy and other applicable laws. There may be both controlled and uncontrolled access data available through the Data Portal. Permission to access controlled data will be reviewed and granted by a designated NIH Data Access Committee. Controlled access data available on the SenNet web portal will be handled according to the NIH Security Best Practices document. As of this writing, we only expect controlled access to be relevant to the following datatypes: DNA and RNA sequencing raw data. Controlled access is not applicable to other data types that are part of SenNet consortium assays. It is also not applicable to higher level processed data. SenNet consent groups (consent codes) under which data and metadata will be released will include two kinds (1) “no restrictions for research use” or (2) General Research Use (GRU).
- Appropriate Use Statement
Users of SenNet open-data or processed data agree not to use the requested datasets, either alone or in concert with any other information, to identify or contact individual participants (or family members) from whom data and/or samples were collected. This provision does not apply to research investigators operating with specific IRB approval, pursuant to US 45 CFR 46, to contact individuals within datasets or to obtain and use identifying information under an IRB approved research protocol. All investigators conducting “human subjects research” within the scope of US 45 CFR 46 must comply with the requirements contained therein.
Appropriate Sharing Statement
All data (raw, processed, analyzed, numerical or image) and related resources anticipated to be released by SenNet as part of a data release or a Consortium publication can be shared as follows:
- If the data has already been published or officially released by SenNet, then the data can be openly
shared and used broadly with appropriate acknowledgement.
- If the data has not been published or officially released by SenNet, then the data can be “shared confidentially” outside the Consortium, with an expectation that the information will not be shared further – e.g., confidential grant review, confidential commercial planning – and that it will be denoted as “preliminary” or “unpublished”.
- If the data has not been published or officially released by SenNet and the PI wishes to disclose information publicly (without the expectation of confidentiality) – e.g., as part of a presentation or as part of a collaboration outside the Consortium – the PI must disclose this to the SenNet Steering Committee Chairs. The shared data should be denoted as “preliminary” or “unpublished” or “confidential.”
- the PI submits a short, written description of what (data), when (date) and where (medium in which the disclosure will happen) to the SC chairs at least 2 weeks in advance of the disclosure.
- The SC chairs will discuss by email and meet in person with the PI if needed to clarify details.
- The SC chairs will consider the extent to which the public disclosure would impact the Consortium.
- The SC chairs will respond to the PI with its recommendation within 2 weeks.
- If there are significant concerns or scenarios that the Consortium has not considered previously, the SC chairs will refer the matter to the full SenNet Steering Committee.
Generated data not anticipated to be released officially by SenNet is left to the discretion of the Principal Investigator to share in agreement with the Publication Policy.
All SenNet publications need to acknowledge funding through the NIH Common Fund and cite all appropriate grant numbers using the specific language: “This research is supported by the NIH Common Fund, through the Office of Strategic Coordination/Office of the NIH Director under awards X, Y, Z”.