Data Access Requests and Data Submissions

OSPA processes administers Data Access requests and agreements in the same manner as regular funding applications and awards. If the sponsor requires institutional certification of data safety and security, a written RUIT confirmation that RU complies with the sponsor’s IT standards must be obtained from the Head of RUIT or their designee. Data Access requests are typically submitted to sponsors who offer Genome Wide Association Studies (GWAS) and to other broad data resources and services.
  
Data Submission requests do not normally need OSPA sign-off unless the sponsor specifically requires institutional authorization.
 
I. NIH/dbGaP
The NIH DataBase of Genotypes and Phenotypes, dbGaP, archives and distributes the results of studies on the interaction of genotype and phenotype. dbGaP has two access levels that allow broad release of non-sensitive data while providing oversight and investigator accountability for sensitive data sets involving personal health information. dbGaP is an NCBI data distribution service and the control and management of the data housed in dbGaP is under the jurisdiction of the specific study's sponsoring NIH institute or center.
 
dbGaP DATA REQUESTS
dbGaP two access levels are:
Open-Access data can be browsed and/or downloaded freely and without prior approval.
Controlled-Access data requires a prior approval from an appropriate Data Access Committee (DAC). Users must obtain an IRB approval, complete an appropriate DAC's Data Use Certification (DUC) application, and have it co-signed by an institutional official (as with regular funding applications). Once a controlled-access data application is complete and approved it must be submitted by the applicant's institution (i.e. OSPA). Investigators should designate Kate Ross as the Institutional Official on the requests.  More>>

Pre-Award Investigators are required to submit their controlled-access data requests to OSPA, specifically, Kate Ross, for institutional review and approval. A full submission includes:
Sponsor guidelines or link to guidelines;
A complete and final version of your data request;
Compliance assurances as applicable (IRB, IACUC, IT, and/or other);
Completed Routing Form signed by PI and her/his Laboratory Head (if PI is not HOL);
Institutional commitment/support letters if applicable (for space, cost sharing, other).

More on our Pre-Award page.

Post-Award Reporting and other institutional and sponsor's post-award requirements are similar to those that apply to regular monetary awards. More on our Post-Award page.

dbGaP DATA SUBMISSIONS
Data submissions to dbGaP must be consistent with all applicable laws and regulations. Submitters must identify any limits that are specifically set by individual research participants on uses of the data, e.g., through their informed consent.

Submitting NIH-Funded Data When an investigator funded by an NIH Institute/Center (IC) is applying to submit data to the dbGaP, the application has to be sponsored by that IC, and the PI needs to contact their NIH grant's Program Official to start the process. If the grant has already expired, the dbGaP administrator advises that the PI contact the 'old' program official and start from there.

Submitting Non-NIH-Funded Data Submitters whose data was NOT funded by the NIH need to work with dbGaP staff to identify an appropriate sponsoring IC for the submission and the NIH DAC  that will guide and review their application. More in dbGaP’s Submission Process.
 
Notice of Online Data Submission and Access to the National Institutes of Health (NIH) database of Genotypes and Phenotypes (dbGaP), March 5, 2014

Notice for Use of Cloud Computing Services for Storage and Analysis of Controlled-Access Data Subject to the NIH Genomic Data Sharing (GDS) Policy, March 27, 2015
 
II. Other Database Resources
NIH/CGEMS The Cancer Genetic Markers of Susceptibility, CGEMS, project was launched to identify common inherited genetic variations associated with risk for breast and prostate cancer. In collaboration with extramural scientists, NCI's Division of Cancer Epidemiology and Genetics has developed the CGEMS initiative into a robust research program involving genome-wide association studies (GWASs) for a number of cancers, and more recently, exposures and survival.' More>>

Wellcome Trust Wellcome Trust Case Controlled Consortium, WTCCC, is another source for controlled data investigators may request for their studies. 'The primary purpose of the WTCCC is to accelerate efforts to identify genome sequence variants influencing major causes of human morbidity and mortality, through implementation and analysis of large-scale genome wide association studies. Additional objectives include the development and validation of informatics and analytical solutions appropriate to the scale and nature of the project, as well as use of the data generated to answer important methodological and biological questions relevant to association studies in general, and in the UK in particular (for example issues of population substructure). The Consortium anticipates that data generated from the project will be used by others, such as required for developing new analytical methods, in understanding patterns of polymorphism and in guiding selection of markers to map genes involved in specific diseases.'

When an investigator seeks access to data from the Wellcome Trust, s/he must complete a downloadable application from the sponsor’s data site and submit to OSPA using the same procedure as with regular monetary applications/award. Similarly, requests require IRB and other institutional approvals as applicable.
 
European Genome-phenome Archive The European Genome-phenome Archive (EGA) allows investigators to explore datasets from genomic studies, provided by a range of data providers. Access to datasets must be approved by the specified Data Access Committee (DAC). Users FAQ
 
More resources will be added as applicable.

For questions and clarifications contact Kate Ross, kross@rockefeller.edu, x7793.