Background:

The Integrated Canine Data Commons (ICDC) will receive data from many projects and provide the community with relevant access to that data. Not all requests to have ICDC receive data can be accommodated due to the ICDC’s focus and the effort and costs associated with bringing the data into the ICDC. Therefore, the ICDC must develop, document and adhere to a Data Governance Process.

Summary:

The ICDC will create a Data Governance Process to manage data requests. As part of the process the ICDC will develop a mechanism by which the community can request their project be added to the ICDC. Requests will be tracked, reviewed, and prioritized by the ICDC Data Governance Advisory Board. The prioritized list will be provided to NCI, for an NCI group to determine which data will be included in ICDC. Decisions will be tracked and communicated to all relevant stakeholders in a timely manner.

Process Details:

Request Initiation.

The ICDC will instantiate a system for researchers to submit requests for project data to be included in the ICDC. The submission system will provide guidance to requesters regarding the key evaluation criteria that will be used for evaluation. All requests will be captured and tracked in a system that will provide visibility to the request details and allow review of the requests progression through the ICDC Governance Process. The first step of the process is initiation where an ICDC team member will review requests for completeness. Complete requests will progress to an evaluation stage while incomplete requests will stay at the initiation stage with the requester contacted and asked to provide the relevant additional detail. Evaluation criteria will include, but may not be limited to, scientific impact to ICDC mission as well as more logistical areas such as type of data, size of data, access control, is there a shelf-life, and are other CRDC nodes involved.

Incoming submissions will be marked as "CONFIDENTIAL" with a watermark before forwarding out to DGAB members.  Members will be reminded at the start of each meeting that submissions are confidential until released (some may be embargoed prior to publication).

Evaluation.

All completed reviews will be sent for evaluation and adjudication by the ICDC Data Governance Advisory Board (DGAB).  The composition of the DGAB is listed below in the Roles and Responsibilities section.  The DGAB will review all completed requests and evaluate them based on the published evaluation criteria. The DGB will make a recommendation on the priority of the request and the recommendation will be provided to the NCI. The NCI will instantiate a group to make the final decision on the request. If a request is not accepted, feedback will be provided to the requester documenting the rationale for the decision. Requesters may, if they have addressed the DGAB comments, resubmit requests that were not initially approved. The DGAB will be responsible for establishing the recommendation Evaluation criteria. The FNL staff will provide logistical support to the DGAB and will also provide summary reports on the number of requests and their disposition. The FNL staff will ensure that the evaluation criteria are completed for each request before consideration by the DGAB. The DGAB and FNL staff will create and maintain the Evaluation criteria used by the DGAB for evaluation. The DGAB, FNL staff and NCI may also work together to develop any needed data policies, for example, data life cycle policy (will all data stay forever, or will data become less available over time).  For purposes of quorum, 3/5 members shall be considered sufficient.

Communication.

The FNL staff will communicate with all relevant stakeholders. In addition to ensuring the request system is working, the FNL staff will ensure any questions by requesters are answered, requests are reviewed and all decisions are communicated appropriately and in a timely fashion.

Roles and Responsibilities:

Data Governance Advisory Board.

The DGAB is composed of 4 external members (from ICDC Steering Committee), 2 NIH members (1 of which is from CBIIT) and supported by FNL staff. The DGAB will be chaired by a non-NIH member of ICDC Steering Committee. The DGAB will meet at least quarterly to review and adjudicate on all open and complete requests. They will use documented evaluation criteria to determine if a request is approved or declined. The DGAB will also determine the evaluation criteria (which will include considering scientific value of data for the ICDC) and may adjust those criteria. The DGAB is also responsible for providing input on the development and maintenance of data life cycle considerations.  The DGAB Chair will be responsible for ensuring each meeting has an agenda, defining if a quorum is present, confirming evaluation criteria are current, and ensuring discussions are unbiased. The DGAB Chair will also report to the ICDC Steering Committee the summary status of all data requests. Since the ICDC is a node in the Cancer Research Data Commons (CRDC), data requests may involve considering other CRDC components (for example, the CRDC-H data model or the Cancer Data Aggregator). The CBIIT representative will be responsible for representing CRDC considerations in discussing requests and in development and maintenance of any relevant evaluation criteria. DGAB meetings will not require in-person attendance.   The DGAB may decide, from time-to-time, that reprioritization of studies is necessary and will suggest such changes to the SAC.

Composition:

1. 1. Warren Kibbe - Chair 
   2. Matthew Breen 
   3. William Hendricks 
   4. Roel Verhaak 
   5. Greg Tawa (NIH) 
   6. Erika Kim (CBIIT)

NCI Senior Advisory Committee (SAC).

The NCI Senior Advisory Committee will serve as the final point of approval and prioritization for studies.  They will also serve as the final deciding point of any re-prioritization that becomes necessary.

Composition.

1. 1. Amy LeBlanc

   2. Connie Sommers
   3. Javed Kahn

FNL Staff.

FNL will manage the request process, ensure the evaluation criteria are made public and are current, ensure there is a tracking system, and monitor status for all requests. They will provide the DGAB reports on complete and open requests on a quarterly basis. They will document the data priority decisions made by the DGAB and provide those to the NCI. FNL staff will communicate NCI's inclusion decisions to the relevant stakeholders. FNL staff will also contribute to the generation of the evaluation criteria, contribute to development of data lifecycle policy, track any data lifecycle parameters assigned to a set of data, and provide summary data on requests and data life cycle status. The FNL staff will provide logistics support for the DGAB review sessions, including setting up meetings and ensuring all data priority decisions are documented.       

Contact:

1. 1. Kuffel, Gina (NIH/NCI) [C]
   2. Musk, Philip (NIH/NCI) [C]

Flow Chart:

Current Studies and Status