Data Use Certification

	Introduction and Statement of Policy
	Terms of Access
	Assurances/Checklist

Introduction and Statement of Policy

The Cancer Genetic Markers of Susceptibility (CGEMS) project is a strategic initiative in the National Cancer Institute (NCI) designed to identify common genetic variants that contribute to cancers of public health importance, breast and prostate cancer.  CGEMS is conducting a genome-wide association study (GWAS) with follow-up replication studies to identify genetic loci or regions associated with breast and prostate cancer. CGEMS is conducting the GWAS studies in two studies supported by the NCI, the Prostate, Lung, Colon and Ovarian Cancer Screening (PLCO) and the Nurses Health Study (NHS), an NCI-sponsored extramural trial. Following these genome-wide association studies (GWAS), CGEMS will conduct follow-up replication studies of subjects from independent populations using a subset of the genotypes identified in the GWAS.  These replication studies aim to specifically confirm genetic loci or regions associated with breast or prostate cancer.  Participants in the initial GWAS, as well as the replication studies, have been identified from existing, well-characterized cohort and case-control studies of breast and prostate cancer.  Each successive replication analysis will narrow the number of genetic variants for further evaluation. 

Once the data from the GWAS research is validated for quality, it will be publicly available to the entire cancer research community via the National Cancer Institute’s cancer Biomedical Informatics Grid™ (caBIG™) in two formats. Pre-computed summary data will be available freely at the CGEMS/caBIG™ portal (http://cgems.cancer.gov/data). Individual genotype data from PLCO and NHS participants, with case/control status and age of onset (in 5 year strata) will be available to registered users approved by the Data Access Committee (DAC) of CGEMS.

This broad data sharing is expected to further accelerate research in cancer and related fields as well as develop new analytical approaches for GWAS.  Access to the genome-wide scan data should provide many investigators an opportunity for discovery and hypothesis generation in the investigation of the genetic contributions to prostate and breast cancers. CGEMS data are also anticipated to stimulate research in biomarkers, preventive and interventional cancer studies. 

CGEMS datasets to be distributed under this certification process will have all identifying patient information redacted and only de-linked identifiers will be provided. However, due to the nature of the genotype data, and in even in the case of limited phenotype data, it may be possible, in principle, to use the genotypes to identify an individual research participant. Thus, these data will only be provided to investigators who, along with their institutions, have certified their agreement with the requirements and terms of access detailed below. It is the intent of the NCI that Approved Users of CGEMS Initiative Datasets should recognize the restrictions on data use imposed by the original informed consent agreements of contributing studies.

If a registered user attempts to identify and/or contact subjects and their relatives, it will be considered a violation of the agreement to pursue only scientific research with CGEMS data. Data that is identified may be 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 and their relatives in violation of this agreement may be subject to these rules, including any penalties there under 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.

To promote the responsible use of the CGEMS Initiative Datasets each investigator and their institutions seeking access shall acknowledge their agreement with the conditions for CGEMS data, which are articulated within this Data Use Certification. For collaborative projects, any independent collaborating investigator shall complete a separate Data Access Request (DAR) if that collaborating investigator is from a separate institution. If investigators are from the same institutions, multiple Data Use Certifications may be submitted under a single DAR.

Definitions of terminology used in these documents are found in the CGEMS Glossary.

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Terms of Access

1. Requesting Investigator ("Requester")

The Requester has reviewed and understands the guiding principles for responsible research use and data handling of the data included within CGEMS Initiative Datasets as described in the on-line material provided through the NCI Web site at  http://cgems.cancer.gov/data/.

2. Research Use

The Requester agrees that he/she shall use the CGEMS Project Dataset solely in connection with the research project described in the Data Access Request (DAR) submitted through the CGEMS Web site. The DAR includes the project title, the Requester’s name and institution. Major collaborators and their institutions will be listed separately but with the same project title. New uses of these data outside those described above will require submission of a new DAR; substantive modifications to the research project will require submission of an amendment to this application. The Requester further agrees that he/she shall use the CGEMS Project Dataset(s) only in accordance with the parameters described on the CGEMS Web site for appropriate research uses, and any limitations on such use. The Requester and his or her institution further acknowledge that they are responsible for ensuring that all uses of the data are consistent with federal, state, and local laws and regulations and any relevant institutional policies.

If the CGEMS Initiative Datasets will be updated with additional information and unless otherwise indicated, all statements herein are presumed to be true and applicable to the access and use of all versions of the CGEMS Initiative Datasets.

3. Non-Identification

The Requester agrees not to use CGEMS Project Datasets, or any other information, to identify or contact individual participants or their relatives from whom phenotype data and DNA samples were collected.

4. Non-Transferability

The Requester agrees to retain control over the data, and further agrees not to distribute the individual data in any form to any entity or individual other than his or her research staff, who also agree to the terms within this Data Use Certification, subject to applicable laws and regulations.

The Requester agrees to store CGEMS data only on computers with adequate security controls, to adhere to practices that ensure that only authorized individuals can gain access, and to maintain appropriate control over any copies of the data. The Requester and his or her institution acknowledge responsibility for ensuring appropriate use of these data and agreement to the terms of this document by research staff.

In the event of a breach of confidentiality, Approved Users are required to report the breach on the same day it is discovered. Reports can be made by contacting the NCI Center for Bioinformatics (NCICB) Application Support by phone (toll free 888-478-4423 or 301-451-4384) or by email to both NCICB (ncicb@pop.nci.nih.gov) and DAC of CGEMS ( NCI_CGEMS_DAC@mail.nih.gov). The report must include all known information regarding the breach as well as a description of plans for further investigation and immediate remediation.

The NCI, or other entity designated by the NCI may also investigate such breaches.  Approved Users and their associates will be required to support such investigations and provide information, within the limits of applicable local, state and federal laws and regulations.

The Requester agrees that if he or she changes institutions, a new Data Access Request and appended Data Use Certification must be submitted and must be approved before data use resumes.

5. Intellectual Property

By requesting access to CGEMS Initiative Dataset(s), the Requester and his or her home organization (Requesting Institution) accept the intent of the NCI to see that Approved Users follow the NCI/CGEMS intellectual property policy as summarized below:

• Achieving maximum public benefit is the ultimate goal of CGEMS. NCI is committed to pre-competitive availability of datasets, and urges users to avoid making IP claims on the data. However, NCI also recognizes the importance of the later development of IP on downstream discoveries, especially in therapeutics, which will be necessary to support full investment in products that the public needs.
  
  
• In this spirit, it is expected that the CGEMS data and conclusions derived therefrom will remain freely available, without requirement for licensing, for applications such as, but not necessarily limited to, the following: the use of markers in developing assays and diagnostic tools utilizing a variety of single or multiple technical platforms; the use of combinations of variants in multiplex assays; and the use of variants as guides toward identification of new drug targets.
  
  
• The NCI encourages consistency with the recommendations cited in NIH's Best Practices for the Licensing of Genomic Inventions and in the NIH Research Tools Policy.

6. Publication

There are no restrictions on the publication of work based on analysis of the CGEMS Initiative Dataset. Approved Users are asked to apply the normal standards of scientific etiquette when deciding to publish results (association of a variation with phenotype) based substantially on unpublished data. CGEMS recommends that the following citations be used for the two data sets:

Breast Cancer

When referencing the breast cancer data set including the pre-computed analyses or the individual genotype data, please cite both the website (http://cgems.cancer.gov/data/) and the following reference:

Hunter DJ, Kraft P, Jacobs KB, Cox DG, Yeager M, Hankinson SE, Wacholder S, Wang Z, Welch R, Hutchinson A, Wang J, Yu K, Chatterjee N, Orr N, Willett WC, Colditz GA, Ziegler RG, Berg CD, Buys SS, McCarty CA, Feigelson HS, Calle EE, Thun MJ, Hayes RB, Tucker M, Gerhard DS, Fraumeni JF Jr, Hoover RN, Thomas G, Chanock SJ. A Genome-Wide Association Study Identifies Alleles in FGFR2 Associated with Risk of Sporadic Postmenopausal Breast Cancer. Nat Genet, 39(7):870-874, 2007.

Prostate Cancer

When referencing the prostate cancer data set including the pre-computed analyses or the individual genotype data, please cite both the website (http://cgems.cancer.gov/data/) and the following reference:

Yeager M, Orr N, Hayes RB, Jacobs KB, Kraft P, Wacholder S, Minichiello MJ, Fearnhead P, Yu K, Chatterjee N, Welch R, Staats BJ, Calle EE, Spencer Feigelson H, Thun MJ, Rodriguez C, Albanes D, Virtamo J, Weinstein S, Schumacher FR, Giovannucci E, Willett WC, Cancel-Tassin G, Cussenot O, Valeri A, Andriole GL, Tucker M, Gerhard DS, Fraumeni Jr. JF, Hoover R, Hunter DJ, Chanock SJ, Thomas G. Genome-Wide Association Study of Prostate Cancer Identifies a Second Locus at 8q24. Nat Genet, 39(5):645-649, 2007.

Versions:

Since different versions of the data have been released for Prostate Scan 1A, Prostate Scan 1 and Breast Scan, please be sure to cite the specific version of the data set. Additional versions of datasets may be released as new advances and discoveries are made.

7. Research Use Reporting

In order to ensure that the NCI CGEMS policies and procedures for participant protection and data use are adhered to at a later time, Approved Users agree to provide feedback on how the CGEMS data have been used and any results such as publications and patents that have been generated as a result of access to the data.

Approved Users are encouraged, but not required to provide brief reports on their research using CGEMS Datasets. In the future, Approved Users may be asked to provide general comments regarding the effectiveness of CGEMS, such as ease of access and use, appropriateness of data format, challenges in complying with CGEMS policies, and suggestions for improving CGEMS data access or the program in general.

8. Dissemination of Research Results and Acknowledgments

It is the intent of NCI to promote the dissemination of analyses of CGEMS Initiative Dataset(s) as widely as possible. Requesters are strongly encouraged to publish their results in peer-reviewed journals.

The Requester agrees to acknowledge CGEMS and NCI, the primary funding organization that supported the contributing studies in all oral and written presentations, disclosures, and publications resulting from any analyses of the data. The Requester further agrees that the acknowledgment shall include a reference to the specific version of the CGEMS Initiative analyzed.

9. Non-Endorsement, Indemnification

The Requester and his/her institution acknowledge that although all reasonable efforts have been taken to ensure the accuracy and reliability of the CGEMS data. NCI does not and cannot warrant the results that may be obtained by using any data included therein. NIH, NCI and all contributors to the CGEMS dataset disclaim all warranties as to performance or fitness of the data for any particular purpose.

No indemnification for any loss, claim, damage or liability is intended or provided by any party under this agreement. Each party shall be liable for any loss, claim, damage, or liability that said party incurs as a result of its activities under this agreement, except that the NIH, as an agency of the United States, assumes liability only to the extent provided under the Federal Tort Claims Act, 28 U.S.C. 2671 et seq.

By signing and dating this Data Use Certification the Requester and his/her Signing Official represent and warrant the Requester’s qualifications for access to and use of CGEMS Initiative Dataset(s) and certify their agreement to the NCI principles, policies and procedures for the use of CGEMS Initiative Datasets as articulated in this document. Requestors further confirm that they have shared this document and the CGEMS policies and procedures with any research staff that will participate in their use. Institutional Business Officials also acknowledge that they have shared this document and the relevant CGEMS policies and procedures with appropriate institutional organizations, such as the Office of Technology Transfer and the Office for Human Subjects Research.

10. Termination and Violations

The Data Use Certification is without a time limit. However, for the protection of the study participants, when an investigator no longer requires CGEMS data then all copies of the CGEMS Initiative data set(s) should be deleted from all computers under the supervision of the Approved User.

NCI may terminate this agreement and immediately revoke access to all CGEMS Initiative Datasets at any time if the Requester is found to be no longer in agreement with the policies, principles and procedures of CGEMS. If a registered user attempts to identify subjects, it will be considered a violation of the agreement to pursue only scientific research with CGEMS data. If the data is 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 there under 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.

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Assurances/Checklist

Please Read the Statements Below

The Principal Investigator and this Institution make the following assurances:

• The CGEMS dataset will be used solely in connection with the research intent.

• The Institution has considered any participant protection issues and agrees that the research can go forward.
• No efforts will be made to attempt to identify the participants and their relatives in this Research.
• There will be no transfer of restricted CGEMS data to any other investigators/institutions (except research assistants, students, post-doctoral fellows, etc., who answer directly to the PI and are bound by this DUC).
• To prevent accidental transfer of restricted CGEMS data, adequate security controls (e.g. no network accessibility, secure lap tops and mass storage devices) are in place.
• To immediately any reportable events to the CGEMS DAC in writing: unintentional identification of research participant; unauthorized release of data; accidental compromise of data security.
• To respect the pre-competitive nature of CGEMS datasets in considering claims of intellectual property derived from use of these data and to adhere to the tenets of NIH’s Best Practices for the Licensing of Genomic Inventions.
• To report publications on an annual basis.  
• To acknowledge the CGEMS dataset in any publication or presentation resulting from the use of the dataset.

By entering name and date, and submitting this form, I certify agreement to the terms and conditions specified in the Data Use Certification.

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Last Updated: July 23, 2007