I The Cancer Genome Atlas Human Subjects Protection and Data Access Policies
During the process of establishing The Cancer Genome Atlas (TCGA) human subjects protection and data access policies, National Cancer Institute (NCI) and National Human Genome Research Institute (NHGRI) staff and subject matter experts sought input from diverse constituencies and reviewed dozens of informed consent protocols and forms used by investigators implementing tissue and clinical data collections for genomic studies. In addition, a workshop was held to bring key stakeholders together and identify the breadth of human subjects protection and data access issues relevant to TCGA (view TCGA Data Release Workshop Report).
Following the workshop, NCI and NHGRI gathered additional input, and in March 2007 finalized the human subjects protections and data access policies (view The Cancer Genome Atlas Pilot Program Human Subjects Protection and Data Access Policies).
One of the main issues addressed in the human subjects protection and data access policies is the observation that consent processes for existing studies rarely convey to donors adequate descriptions of modern, high-throughput genetic and genomic studies. Specifically, the reviewed consents did not relay the unprecedented scale of data being generated from such genomic studies, nor how those data can be quickly and widely shared on the Internet. Additionally, most consent documents did not describe the potential risks associated with such wide data sharing. On the basis of these findings, NCI and NHGRI management determined that existing informed consent documents were inadequate for TCGA, and that all living donors would have to consent specifically to participate in TCGA.
Model language for two consent forms was developed in conjunction with outside ethics and legal subject matter experts. One consent form is for re-consenting patients who have already contributed samples and data as research participants in other studies; the other form is for consenting new research participants for TCGA.
The overall purpose of The Cancer Genome Atlas informed consent process is to seek permission for tissue and data collection from potential participants after informing them of the data protection plans and the potential risks inherent in TCGA’s plan to make data widely available to investigators.
TCGA management has created draft text for these documents. However, it is expected that the specific process and exact wording of the consent process will be finalized by investigators and their institutional review boards (IRBs). NCI and NHGRI only require that the consent form includes all of the above concepts.
Please click the links below to download TCGA informed consent documents:
Please click the links below to download TCGA Human Subject Protection and Data Access Policy documents:
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