Cohort Metadata Repository Researcher Agreement
Electronic Certification (E-Certification) and Agreement For use of the Cohort Metadata Repository (CMR) and Transfer of Data
Epidemiology and Genomics Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
DEFINITIONS:
NCI: Epidemiology and Genomics Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, National Institutes of Health (NIH), an agency of the United States Public Health Service (PHS) within the Department of Health and Human Services (DHHS)
RESEARCHER: An organization, as represented by its academic or clinical researchers conducting observational studies with human subjects. “RESEARCHER” may also include individual academic or clinical researchers who conduct observational studies with human subjects under their own legal authority independent of an employer or parent organization.
METADATA: metadata collected by the NCI under auspices of Cancer Epidemiology Cohort initiative. “METADATA” does not mean participant collected METADATA, associated databases, or software used to create and run the CMR website.
RECITALS:
WHEREAS, the NCI has constructed a research tool in the form of an Cohort Metadata Repository (CMR), and this database is intended to assist RESEARCHERs with harmonization of data among cohorts; and
WHEREAS, the RESEARCHER intends to collaborate with other cohorts to and,
WHEREAS, the NCI wishes the RESEARCHER to have access to METADATA describing the human subjects under RESEARCHER’s supervision;
In consideration of the above, the RESEARCHER and NCI agree to the following:
- The Researcher will be responsible for directing human subjects under its supervision to submit METADATA to the NCI. NCI will store the METADATA in the NCI’s CMR. NCI will maintain the METADATA in the absence of identifying information.
- METADATA and harmonization codes submitted to the NCI are the property of the NCI for distribution purposes and shall be made available as a service to the research community.
- The METADATA will be used only for research, clinical and academic purposes. THIS METADATA WILL NOT BE USED BY NCI TO TREAT OR DIAGNOSE HUMAN SUBJECTS. In the event that: (a) a party to this agreement is able to deduce the identity of an individual human subject whose information is a component of the METADATA; And, (b) the human subject is not being supervised by or under care of the party, then that party agrees it will not attempt to identify or contact such human subject and, furthermore, will notify the other party of its ability to make such identification.
- Neither NCI nor the RESEARCHER will use the METADATA unless it has obtained all appropriate clearances to use the METADATA, including but not limited to clearance by an Institutional Review Board or equivalent governing body. The use and handling of the METADATA by either party will be performed in compliance with all applicable statutes and regulations.
- The RESEARCHER may redistribute METADATA to third parties for research, clinical, and academic purposes under conditions of use no less restrictive than those of this Agreement.
- The RESEARCHER agrees to acknowledge the source of the METADATA in any publications reporting use of it.
- NCI shall have the right to conduct quality assurance measures of the METADATA including, but not limited to, reviews of system logic, evaluation of missing METADATA, and summary statistics based on METADATA across the entire system. No evaluation of, or publication based on, a single registered study will be performed by NCI. The NCI represents that its role in managing the METADATA shall be primarily archival, and that the NCI will not conduct investigative activities with the METADATA.
- Any METADATA delivered pursuant to this Agreement is understood to be experimental in nature. THE NCI MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OF THE METADATA WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER PROPRIETARY RIGHTS.
- 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 said party's activities under this agreement, except that the NCI, as an agency of the United States, assumes liability only to the extent as provided under the Federal Tort Claims Act (28 U.S.C. Chapter 171). If the RESEARCHER is a component of or an agency of a State government then RESEARCHER assumes liability only to the extent authorized under the laws of the State or Commonwealth.
- RESEARCHER agrees not to claim, infer, or imply endorsement of the RESEARCHER by the NCI and by the Government of the United States of America.
- Upon request by the NCI, the RESEARCHER will perform any of the following as directed by the NCI: (a) immediately cease use of the METADATA; (b) dispose of METADATA provided by the NCI that is in the RESEARCHER's possession. Any false or misleading statements made, presented, or submitted to the Government, including any relevant omissions, under this Agreement are subject to all applicable civil and criminal statutes including Federal statutes 31 U.S.C. §§ 3801 3812 (civil liability) and 18 U.S.C. § 1001 (criminal liability including fine(s) and/or imprisonment).
By accepting the terms of this agreement, the RESEARCHER certifies that the information submitted by the RESEARCHER is true, complete and accurate to the best of RESEARCHER's knowledge. The person accepting the terms of this agreement for the RESEARCHER has the requisite power and authority to accept the terms of this Agreement.
