For Researchers and Clinicians

The iCaRe2  provides secure, HIPAA-compliant, efficient and user-friendly mechanisms for standardized data collection. It aims to foster comprehensive clinical and epidemiological studies and accelerate the secondary use of cancer and health related data for translational research. Standardized multi-dimensional data collected by the iCaRe2 will help researchers to (i) better assess cancer risk factors, (ii) design new predictive mathematical models of carcinogenesis, and (iii) improve the pre-clinical diagnostic  methods for the early detection of cancer and and prognostic methods for estimation of personalized survival.

To prevent a court of law from being able to subpoena the iCaRe2 records, we obtained a multi-center Certificate of Confidentiality from the National Cancer Institute on behalf of the Secretary of the Department of Health and Human Services. The certificate protects the researchers from being compelled to reveal the personal identity of a participant in this registry in any federal, state, local, civil, administrative, legislative, or other proceedings. The Certificate of Confidentiality is intended to protect only the confidentiality of the medical history and genetic test result data collected as part of this research study. It does not protect information from this registry required for audit or program evaluation by the U.S. Department of Health and Human Services, requested by the Food and Drug Administration, placed in a health care provider’s medical records, or disclosed voluntarily by the study participant or someone with whom the study participant has shared this information. The protection afforded by the Certificate of Confidentiality is permanent and remains in effect after the death of the registry participant. It does not represent an endorsement of the research project by the Department of Health and Human Services.

How to Join:
The iCaRe2 operates under an IRB-approved protocol for data collection, storage and sharing at UNMC.  Each participating center will need to have all of the research activities and consent forms approved by their own Institutional Review Boards. As a participating center you will have access to templates that of an IRB application and patient informed consent form. Please contact our coordinator if you would like to join the iCaRe2 or click this link.


Governance:

To regulate day-to-day maintenance, support, and governance of the iCaRe2, we utilize a business model that is based on the confederation principle. According to this principle, data from multiple institutions (stakeholders) are stored in a central database, whereas, by default, individual stakeholders have access only to their own data. If needed, the stakeholder can allow other researchers to access specified data subsets for collaborative studies. To regulate this process, the Steering Committee has been formed for each individual cancer registry from the representatives of the institutions participating in data and tissue collection. The committee also includes the PI of this grant, the iCaRe2 coordinator, external advisors and a patient advocate. The steering committee operates in accordance with the bylaws describing the organizational structure, membership, standard operating procedures, and the quality assurance plan that we have developed previously. During its meetings, the committee reviews and prioritizes projects that utilize the collected data and determine whether the scientific goals justify the use of data and precious specimens. Through their representatives, the stakeholders decide which de-identified datasets collected by their institutions can be used internally, released only to the distinct collaborators, or opened to the whole research community.

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