Genomic Data Sharing

Division Of Basic Sciences - Nci

Investigators

Abstract

This year the NIH Office of Science Policy (OSP) launched the new Data Management and Sharing (DMS) Policy effective January 25, 2023. The DMS Policy mandates sharing of scientific data generated from NIH-funded or conducted research and went into effect 1/25/2023 for laboratory scientists and clinical research protocols going in for Scientific Review. For the 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 GDS policy applies to all NIH-funded research generating large-scale human or non-human genomic data. Large-scale data including genome-wide association studies (GWAS), single nucleotide polymorphism (SNP) arrays, genome sequence, transcriptomic, metagenomic, epigenomic, and gene expression data. The GDS Policy expanded on November 1, 2018 to include public access to Genomic Summary Results. At that time, the Office of Science Policy (OSP) mandated dbGaP minimal registration for all studies as a means for OSP to communicate with all investigators with policy-applicable studies. OSP has since backed off this mandate, so minimal registrations have been discontinued. Guidance issued from the CCR Director also mandates genomic data sharing for rare diseases/cancers with no minimum thresholds. The Trans-NCI Genomic Data Sharing Working Group adopted the definition of rare disease - a disease that affects less than 200,000 persons in the United States. 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 completed DMS plans by 1/25/2023 using the Annual Report System. Plans that involved genomics were reviewed by K. Calzone in addition to either Brenda Boersma or Kelly Haskins, with their focus predominately on non-genomic plan elements. Plans were approved, or the investigator was provided with written comments on items to address. DMS plans completed by 1/25/2023 were submitted electronically to OIR in the NIDB. Existing clinical 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). SRC-reviewed plans are revised if applicable, finalized, and approved during Study Initiation. In contrast to the GDS policy, 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 Dr. Misteli or his designee. Investigator Resources Data Sharing Portal: Critical to the infrastructure needed to facilitate investigators is developing and 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 or non-human organisms or cell lines. DMS plans for new clinical protocols began using the OIR intramural pdf template until the existing Data Sharing portal was modified to create the new DMS plan. Several delays occurred in this process, including a delay in receiving the budget from CBIIT and a delay in CCR rendering a budget decision to move forward. Usability testing was completed by the deadline, and revisions based on the user testing were completed when one CCR leader submitted changes deemed essential. CBIIT had already reallocated Staff to other projects with budget and staffing implications. After an additional delay, the final determination was to launch the portal in its present condition because these items, such as the API for ZIA numbers, CBIIT was not clear that they could even build in the Service Now platform that houses the portal. The permission to launch the portal as is was shared with me on 6/16/2023. However, at that same time, NCI ODS notified us that new Institutional Certification memo templates were established and mandated for use, effective 7/1/2023. CBIIT immediately began that portal revision and investigating how to update each existing Institutional Certification. At the same time, the portal resubmit function was not functioning. As such, CBIIT asked that the launch be delayed until that resubmit fix was made, and the Institutional Certification update was completed. As of July 21, 2023, CBIIT expects to launch the week of August 7, 2023. Brenda Boersma has an email prepared for clinical protocol PI distribution once the launch date is finalized. Support Documents: To support the DMS policy and the new portal, in addition to the CCR Data Management and Sharing Website, we have established the following Standard Operating Procedures (SOPs): 1-RPS 21-Establishing a Data Management Sharing Plan; 2-RPS 22-Requesting a Data Management and Sharing Waiver; 3-RPS 23-Registering a Clinical Trial in dbGaP In addition, the Office of Education and Compliance recommended that instead of integrating portal-specific functionality into the SOPs, those details be put into a Data Management and Sharing Portal User Manual, which could be revised as needed without delays associated with the review/approval process for SOPs. The three SOPs and the Manual are currently on the CCR SOP website. Lastly, we have revised the data sharing WIKI page, renaming it to Data Management and Sharing and reflecting the current Data Sharing landscape and associated resources. Statistics from July 3, 2022-July 4, 2023 Tracking Portal: 565 studies are in the GDS Tracking portal. 26 GDSPs were reviewed, and 23 were approved. 35 ICs were reviewed, and 31 were approved. The GPA Administrator has been auditing the entries for incomplete documents never submitted for review/approval, revisions never resubmitted, and eliminating duplicates. Waivers: One waiver was submitted and approved, IRB001578, ceding data sharing to the Children's Oncology Group. PSO indicates two additional waivers to be submitted: IRB001529-Gulley and IRB01583-Annunziata. Lastly, Dr. Aldape has been notified about the new waiver option as he was considering submitting an Exception. New Study Sensitivity Determinations: GSR Sensitivity Determinations: 52 studies were reviewed, 19 Sensitive, 33 Not Sensitive. Data Sharing: 473 studies are registered in dbGaP, 70 complete registrations, and 403 minimal registrations (discontinued activity). Data was submitted on 19 studies this year and 3 new versions of existing studies. There are 67 studies with some aspect of data submission: 3 additional studies have complete registrations with no data submission. Specifically, 2 are late on submission, and one with no target release date. Lastly, there are 15 studies with data submitted but late on release.