Cancer Genetic Markers of Susceptibility (CGEMS) Data Access Policies

This page describes the Data Access Policies for the CGEMS data

	Registered Data Access Overview
	CGEMS Data Access Request Process
	Frequently Asked Questions

Registered Data Access Overview

Investigators seeking to register for access to controlled-access CGEMS data must complete a Data Access Request (DAR)/SF 424 form. The Requester and a Signing Official (SO) authorized to represent the Requester’s organization must agree to the terms and conditions for data use as specified in the Data Use Certification (DUC). Submission of a completed DAR/SF 424 serves as acceptance of the DUC and binds the Requester and organization to the terms and conditions stated therein. Access to controlled-access CGEMS data will be granted with the express understanding that the data will be used in accordance with the conditions described in Data Use Certification for appropriate research uses, including any limitations on such use, of a given dataset.

Application to the CGEMS Data Access Committee can be made by fax, mail, or as an electronic Adobe Acrobat (PDF) email attachment sent to:

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CGEMS Data Access Request Process

Data Access Request Resources: Data Use Certification (DUC) Data Access Request Instructions Data Access Request Form (PDF)

Requests for access to the genome-wide association genotype data are made to the CGEMS Data Access Committee, which grants permission for accessing one genome-wide association study per request.

Requests for access to the genome-wide association genotype data are made to the CGEMS Data Access Committee, which grants permission for accessing data for the Breast cancer (NHS) and Prostate cancer (PLCO) genome wide association studies. Separate requests should be made for each study.

Requesters can submit a signed DAR/SF 424 by mail, or fax or email with a scanned copy of the SF 424 as an Adobe Acrobat (PDF) attachment to the CGEMS Data Access Committee (DAC).

To complete the DAR/SF 424, the requester and the authorized institution signing official (SO) must have an active NIH electronic Research Administration (eRA) User ID and password. NIH intramural investigators may utilize their NIH directory User ID and password. For information on creating an NIH eRA account, visit http://era.nih.gov/.

The CGEMS Data Access Committee (DAC) will meet biweekly to review the requests for registered access. The DAC will review each DAR/SF 424 and render a decision a soon as possible. The committee is comprised of nine NCI voting employees, two non-voting consultants and two ex-officio members.

Within two weeks of acknowledging receipt of the completed DAR/SF 424 submitted by the SO, the DAC will either 1) Approve, 2) Disapprove, or 3) Postpone data access for the requesting investigator. Requesters approved and authorized by the DAC are designated Approved Users. Approved Users certify that they will abide by the terms and conditions specified in the DUC, including the provision not to distribute CGEMS controlled-access data in any form to third parties other than those of their own research staff who have agreed to the terms of the DUC. For collaborative projects, any independent collaborating investigator from a separate institution involved in the use of the CGEMS data is required to submit a separate DAR/SF 424. All Approved Users and their institutions will be required to acknowledge responsibility for ensuring that all uses of the data are consistent with federal, state, and local laws and regulations and with any relevant institutional policies.

It is the intent of the NCI to provide rapid access to the genotype data to any investigator for biomedical research; non-routine requests will be considered on a case-by-case basis. Requests from research organizations unfamiliar to the NIH may utilize a signing official with the authority to represent the organization, with prior approval by the CGEMS DAC, although all Requesters who can meet the conditions for obtaining an account with the NIH eRA will be asked to do so. The CGEMS DAC can be contacted by email at NCI_CGEMS_DAC@mail.nih.gov.

Approved Users will utilize their NIH eRA User ID and password to authenticate their identity and gain access to the controlled-access datasets. Access is granted to only the requested study, access to other studies will require the submission of a separate DAR for each. In the case that the requester moves, he/she must obtain a new DAR/SF 424 from the new institution. The DAR/SF 424 for the old institution is not transferable and thus, a new Requester must apply for access to the controlled-access dataset(s).

If it is not possible for your organization to complete a DAR/SF 424 submission, contact the CGEMS DAC at NCI_CGEMS_DAC@mail.nih.gov.

Data access granted by the DAC is only for research purposes and can not be used under any circumstance to identify subjects. Study subjects or their relatives will not be contacted at any time. If a registered user attempts to identify subjects or their relatives, it will be considered a violation of agreement to pursue only scientific research with CGEMS data. If the data are used to identify individuals, the action is subject to the HHS Human Subjects Regulations found at 45 C.F.R. Part 46, and the Health Insurance Portability and Accountability Act Privacy and Security Rules found at 45 CFR Parts 160, 162 and 164. Users who identify or attempt to identify subjects in violation of this agreement may be subject to these rules, including any penalties thereunder for misuse of identifiable data. NCI/CGEMS will report any suspected violations to the appropriate authorities, which may include the U.S. Department of Justice, the U.S. Department of Health and Human Services Office for Civil Rights and the U.S. Department of Health and Human Services Office of Human Research Protections. NIH-funded users may also be subject to suspension or termination of awards.

Frequently Asked Questions

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Last Updated: October 04, 2007