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TCGA Ethics & Policies

TCGA was among the first to address many ethical and logistical considerations associated with collecting, analyzing, and providing access to data from human tissue specimens. To this end, TCGA formed an Ethics, Law and Policy Group with the goal of identifying and addressing critical ethical, legal and social questions faced by researchers and patients participating in the program. The group established informed consent guidelines for effective and fair use of cancer genomic information.

The ultimate goal was to develop research policies maximizing public benefit from the data that were in accordance with these ethical and legal guidelines, ensuring:

  • 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 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 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. 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. August, 2014

Suggested Informed Consent Language for Prospective Collections
An example informed consent document that TCGA suggested Tissue Source Sites use when collecting specimens from prospective project participants. This document helps ensure that patients considering donating tissue specimens to human genomics research programs such as TCGA recognize the risks and benefits of participation and understand the nature of their inclusion in the project. November, 2011

Sharing Data from Large-scale Biological Research Projects 
Principles for sharing and publishing genomic data in order to maximize public benefit developed at a meeting in Fort Lauderdale sponsored by the Wellcome Trust. These “Fort Lauderdale Principles” informed the original TCGA publication guidelines, which balance making genomic data immediately available for research use with protecting the initial publication rights of the original owner. January, 2003

Considerations for Open Release of Genomic Data from Human Cancer Cell Lines 
An explanation of the factors considered in the decision by NCI and NHGRI to release genomic data and information from the Cancer Cell Line Encyclopedia as open-access data. 2013

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