As a pioneering large-scale genomics project, The Cancer Genome Atlas (TCGA) was among the first to address several ethical and logistical considerations associated with collecting, analyzing, and providing access to data from human tissue specimens. Seeking to maximize the public benefit of the TCGA data, the National Cancer Institute (NCI) and the National Human Genome Research Institute (NHGRI), with help from the Ethics, Law and Policy Group, developed policies that ensure the following:
- Protection of human participants in the project, including their privacy
- Secure and compliant access of TCGA data
- Timely data release to the research community
- Initial scientific publication by the data producers
These policies have influenced the development of the field of cancer genomics and will continue to serve as a guide for future genomic research projects.
Human Subjects Protection and Data Access Policies: a set of policies developed by the NCI and NHGRI to protect the privacy of participants donating specimens to TCGA. Included are TCGA’s informed consent policy, data access policy and information about HIPAA Privacy Rule compliance.
Last Updated: January, 2014
Data Use Certification Agreement: a set of policies that researchers must agree to before gaining access to TCGA data. This agreement ensures that researchers who are pursuing a research question that requires Controlled-access data will comply with TCGA policies such as maintaining participants’ privacy, accessing the data securely and following TCGA publication guidelines.
Last Updated: August, 2014
TCGA Suggested Informed Consent Language for Prospective Collections: a sample informed consent document that TCGA suggested tissue source sites use when collecting specimens from prospective project participants. This document ensures that patients considering donating tissue specimens to TCGA recognize the risks and benefits of participation and understand the nature of their inclusion in the project.
Last Updated: November, 2011
Sharing Data from Large-scale Biological Research Projects: A System of Tripartite Responsibility: these principles for sharing and publishing genomic data in order to maximize public benefit were developed at a meeting in Fort Lauderdale sponsored by the Wellcome Trust. The “Fort Lauderdale Principles” informed the TCGA publication guidelines, which balance making genomic data immediately available for research use with protecting the initial publication rights of the original owner.
Last Updated: January, 2003
Considerations for Open Release of Genomic Data from Human Cancer Cell Lines: an explanation of the factors considered in the decision by the NCI and NHGRI to release cell-line information from the Cancer Cell Line Encyclopedia as open-access data.
Last Updated: 2013