Genomic Datasets for Cancer Research
Data Access Request Process
This page contains instructions for submitting a Data Access Request for dataset(s) under the purview of the Extramural National Cancer Institute (NCI) Data Access Committee (DAC) and an overview of the review process.
- Applying for Access to Extramural National Cancer Institute (NCI) Data Access Committee (DAC) Datasets
- Data Access Review Process
- Log in through eRA Commons
- Select datasets (review Data Use Certificate (DUC) and Data Use Limitations or DUL)
- Input project information
- Approval by your Institute's Signing Official
- Submit DAR through database of Genotypes and Phenotypes (dbGaP)
Review of DAR by DAC
- Intended use complies with DUL
- Data type is appropriate for research
- Project approval or rejection: Rejected projects can be revised and resubmitted
Data Request Granted
- Receive data
- Conduct secondary analyses
- Report on progress annually (requests must be renewed after one year)
Applying for Access to Extramural National Cancer Institute (NCI) Data Access Committee (DAC) Datasets
Investigators should use the Database of Genotype and Phenotype (dbGaP) online application process to request access to data. All investigators must complete the Application for Federal Assistance (SF 424 [R&R]) to request data access.
- Extramural Investigators must be full-time faculty members (or equivalent government/private sector employees) at the requesting institution and have a User ID for the National Institutes of Health (NIH) Electronic Research Administration (eRA) Commons. Learn more about eRA Commons.
- NIH Staff must obtain one-time permission from their Supervisor, Scientific Director, or Division Director (or other senior Institute/Center official) and their Institute/Center Director before submitting an SF 424 to request data access. View NIH Staff Request for Permission to Access GWAS Data form [PDF]. This form can be saved and edited by NIH staff. However, to e-mail the form with data inputs, the user must first save the document. The Acrobat Reader File menu includes a selection titled, "Attach to e-mail", but the user must save the file with the inputs BEFORE attaching the form to an e-mail message. The completed NIH Staff Request for Permission to Access GWAS Data form should be sent to Laura Rodriguez, Rosann Wise, and GWAS@nih.gov.
The SF 424 [R&R] from dbGaP includes instructions for requesting access to dbGaP authorized access datasets. View video describing how to apply for dbGaP controlled data access. A complete Data Access Request includes the following items:
- Information about the applicant's institution, including contact information for the applicant and their Institutional Signing Official.
- Brief descriptions of the applicant's research objectives, study design, and analysis plan to be included in the Research Use Statement section of the SF 424 [R&R]. See section on preparing the Research Use Statement below for specific details.
- A non-technical summary of the applicant's proposed research to communicate to the general public the purpose and objectives of the research. Tip: Language at an eighth grade reading level is recommended. Learn more about plain language guidelines and tools.
- A list of collaborators at the applicant's institution in the "Collaborators" section of the request. Collaborators at other institutions must submit separate Data Access Requests for access to data. At a minimum, the "name," "position/title," and "organization name" fields for each collaborator listed must be completed.
- Information about the Information Technology (IT) Director, or his/her designee at the applicant's institution should also be included in the "Collaborators" section of the request. The IT Director, or his/her designee, has the authority to vouch for the IT capacities at the applicant's institution or a higher level division of the institution (e.g., School of Medicine). The inclusion of the IT Director or designee is required for access to NCI Extramural DAC data, as described in the NCI Extramural DAC Data Use Certification(s) Agreement that the applicant and their Institutional Signing Official sign when submitting the data access request.
- Review of and agreement to the terms and statements outlined in the NCI Extramural DAC Data Use Certification Agreement (appended to the SF424 [R&R]). Tip: The Data Use Certifications are unique to each dataset and are accessed through dbGaP for the respective datasets.
- Review and approval of the Data Access Request by the applicant's Institutional Signing Official. The items listed above are included in the SF424 [R&R] generated by the dbGaP online application.
Tip: Prepare and save the Research Use Statement and non-technical summary in a word processing application. This information can be copied and pasted into the respective form boxes when completing the online dbGaP request process. The Research Use Statement is to be inserted on page 3 of the SF424 [R&R] application form.
The Research Use Statement should be one to two paragraphs in length and include:
- research objectives;
- study design;
- analysis plan (including the phenotypic characteristics that will be tested for association with genetic variants);
- explanation of how the proposed research is consistent with Data Use Limitations for the requested dataset(s);
- acknowledgement of the Data Use Limitations and intention to abide by them; and
- if relevant, a brief description of any planned inter-institutional collaborative research, including the name(s) of the collaborator(s) and/or their institutional affiliation(s). (Note: Data cannot be shared with collaborators from other institutions until they have submitted a similar application to use the dataset(s) from their institution(s) and have received approval.) See examples of research use statements and non-technical summaries.
The Extramural NCI DAC will compare an applicant's Research Use Statement to the Data Use Limitations for the dataset(s) when they evaluate Data Access Requests to confirm that the purpose(s) for which the data are being requested are consistent with the purpose(s) for which the data are authorized to be used.
Particularly if the proposed research addresses outcomes or hypotheses that were not the primary focus of the original study that collected the data, the applicant should describe how the proposed use is consistent with any Data Use Limitations for the requested dataset(s).
If the applicant intends to use a dataset or multiple datasets to develop or evaluate performance of new analytical methods, a sentence indicating how this work is relevant to the specific disease datasets being requested should be included, especially if the dataset has a disease-specific Data Use Limitation (e.g., "This methodological work will advance the understanding of the genetic basis of each of the primary conditions included in the requested datasets").
The data requested should be used solely for the research project described in the Data Access Request. New uses of these data outside those described in the Data Access Request will require submission of a new application.
If, in addition to requesting Extramural NCI DAC datasets, the applicant is requesting access to other datasets that are under the purview of other National Institutes of Health (NIH) DACs, the Data Access Request also will be reviewed by the other responsible DAC(s). Those NIH Institute and Centers may have additional requirements for requesting data or different terms of access. Application instructions and Data Use Certification Agreement documents for all requested datasets should be carefully followed.
- Special care should be taken when requesting datasets from more than one study. When multiple datasets are requested, applicants must clearly specify the intended use of each dataset.
Data Access Request Review Process
The Extramural National Cancer Institute (NCI) Data Access Committee (DAC) will review and approve or disapprove all requests from the research community for data access requests of cancer and other genotype-phenotype studies (including sequencing and molecular diagnostic assays) for which it is responsible. The Committee evaluates whether the request conforms to NIH policies and procedures including consistency of the proposed research use with Data Use Limitations stipulated by the submitting institution for each study. "Research community" includes NIH staff who request access to datasets for research purposes.
The NCI DAC will also maintain records of all NCI employees requiring access to those controlled datasets for programmatic oversight and research purposes.
It is anticipated that applicants will receive a DAC decision within 21 days from the submission of their Data Access Request.