Genomic Data Sharing

Division Of Basic Sciences - Nci

Investigators

Abstract

The Data Management and Sharing (DMS) Policy applies to all NIH-funded research generating data of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications and is no longer limited to genomic data or thresholds. Genomic data includes public access to Genomic Summary Results. For Intramural Research Program a DMS plan is required for scientific data from research associated with a ZIA (human and non-human research); Clinical protocol that will undergo IC Initial Scientific Review; Genomic Data Sharing (GDS) project. The DMS Plan incorporates the requirements of both the DMS and GDS policies and addresses six core elements: Data type; Related Tools, Software and/or Code; Data Standards; Data Preservation, Access, and Associated Timelines; Access, Distribution, or Reuse Considerations; and Oversight of Data Management and Sharing. There is also an option to include other elements as applicable. Laboratory scientists complete DMS plans using the Annual Report System. Clinical investigator protocols are required to comply at the time of quadrennial review (which CCR does not currently have in place) or as specified by CCR or OIR. New protocols must submit their plan during Scientific Review Committee (SRC) using the CCR Data Sharing Portal. SRC-reviewed plans are revised if applicable, finalized, and approved for submission at the time of Study Initiation. The NCI Office of Data Sharing did not establish a procedure for policy exceptions which can occur because of limitations specified in Tech Transfer agreements. After input from the Office of Science Policy, the NCI Office of Data Sharing, and legal counsel in the Office of Intramural Research, the final determination was that CCR leadership could determine whether to grant a data-sharing waiver. A CCR waiver mechanism has been implemented with the current approver the CCR Director or Acting Director. Investigator Resources-Data Sharing Portal: Critical to the infrastructure needed to facilitate investigators is maintaining the CCR Data Sharing Portal (https://service.cancer.gov/gds/). The DMS Policy mandates a DMS Plan (DMSP) and an Institutional Certification (IC) to be completed based on whether the study involves human versus non-human organisms or cell lines in which the IC is not required. The Data Sharing Portal has experienced multiple problems following the 8/2023 update. This year we worked with Jason Levine who navigated with CBIIT the funding they were requesting to address portal functionality. CBIIT has since instituted a number of changes which have improved portal functionality and we continue to track problems that arise and CBIIT has been more responsive to problems we report. As part of CBIIT's efforts to support system performance, scalability, and security, they are migrating the application to a new ServiceNow instance, called EZapps. EZapps is a new platform for teams across NIH to use for ServiceNow development. The portal application's hosting location is changing, but the user experience and overall look and feel of the application should not be be affected. Support Documents: To support the DMS policy and the portal, in addition to the CCR Data Management and Sharing Website, we have a DMSP waiver SOP and Data Mangement and Sharing Plan SOP. Otherwise, we transistioned to a Data Management and Sharing Portal User Manual, which allows revision as needed without delays associated with the review/approval process for CCR SOPs. The data sharing has moved to sharepoint which is where Data Sharing information and instructions are stored. Staff: Dr. Calzone is the Genomic Program Administrator (GPA). The GPA Administrator (GPA-A) position is held by Dr. Abid Al Reza. Both GPA and GPA-A serve as primary contacts for CCR investigators. The GPA-A is the primary contact for CBIIT and assists with data pulls, study registrations, refining the portal, and assisting with SOPs and the Portal User Manual. The GPA and GPA-A attend Office of Science Policy, Office of Data Sharing, Expert Panel meetings and workgroup meetings to learn about new policy developments and contribute to new form development. The GPA works with the GDS regulatory aspects. The GPA-A facilitates the CCR Sensitivity Review committee with the assistance of the GPA, who reviews all entered determinations and discusses with the committee if there are issues. Final sensitivity determinations are provided to the Protocol Support Office staff in time for scientific review. The GPA serves as the interface when the need arises to engage ODS and the GPA-A handles any CCR Waiver Requests. The GPA-A serves as the lead for logistical, computer, and portal issues. He works under GPA's supervision to: complete the initial reviews of DMSP and Institutional Certifications if a human study submissions in the portal, provide timely feedback to investigators if modifications are required, and support investigators in the data sharing process; enter studies into the Genomic Summary Result online system for review by the CCR Sensitivity Review committee; maintains the CCR GDS Wiki page, the online data sharing key information source for CCR investigators; and enters tracking data and responds to investigator queries. Both the GPA and GPA-A enter dbGaP study registrations and respond to PI and other staff queries. Statistics 7/4/2024-7/3/2025: Data Sharing Portal-635 records in the GDS Tracking portal, an increase of 27 studies since the last review. 45 Data Management and Sharing Plans were reviewed in this reporting period: 36 are completed, reviewed and approved; 3 are actively undergoing SRC review; 4 are awaiting the PI review; 2 are pending Scientific Director review. 40 Institutional Certifications were reviewed in this reporting period: 31 ICs were reviewed and approved; 6 are waiting for the PI to sign; 3 are in a standby mode not otherwise defined; 0 are waiting for a GPA review; and 0 are waiting for the Clinical Director approval. The GPA-A continues to audit the entries for incomplete documents never submitted for review/approval, revisions never resubmitted, and eliminating duplicates and follows up with the investigator(s) as indicated. Waivers: Five waivers were submitted and approved from 7/4/2024 to 7/3/2025. This is down from 29 in last reporting period and we hypothesize this may be because Tech Transfer had integrated data sharing language into agreements they negotiate and/or the result of a reduction in new protocols. We do not have access to CRADA's or CTA's to determine whether the agreement language is or is not an influencing factor in the reduction in waivers. New Study Genomic Sensitivity Determinations are specific to genomic data sharing only for public sharing of summary results which could identify a patient, i.e. if a rare disease or other factors deemed senstive: 63 studies were reviewed, 18 Sensitive, 44 Not Sensitive, 1 was found not to be GDS applicable. 16 studies underwent a second review because of an amendment that could alter the sensitivity determination. Data Sharing: 501 studies are registered in dbGaP, 15 in the last year. Overall there are 96 complete registrations, and 405 minimal registrations (discontinued minimal registration activity in 2023). In total, data was submitted and released on 66 studies in this reporting period. There are 26 studies actively involved in some aspect of data submission: 20 studies have data submitted but are late on release; one study with data submitted but no target release date, 2 are late on data submission, with the remaining in process. CCR Data Sharing Website: We have worked with Ronya Taylor who is updating the CCR Data Sharing Website. This has included recommended revisions largely associated with providing intramural specific resources as opposed to extramural.