I The Cancer Genome Atlas Human Subjects Protection and Data Access Policies
During the process of establishing TCGA human subjects protection policies, the NCI and NHGRI staff and subject matter experts sought input
from diverse constituencies and reviewed dozens of protocols and informed consent documents used by investigators and other groups implementing
tissue and clinical data collections for genomic studies. This review led to the critical observation that many protocols and consent
processes for existing studies did not adequately describe modern, high-throughput genetic and genomic studies. Specifically, the reviewed consents
did not convey the unprecedented scale of data generated from such genomic studies, nor the risks to privacy and confidentiality when such data can
be quickly and widely shared on the internet.
These findings led NCI and NHGRI management to initially decide that living donors of tissue specimens and data to TCGA would need to be consented
specifically for TCGA and be provided with specific information about the project, the types of data being generated, and the potential risks
to them. It was understood that this policy would necessitate that still living donors who had in the past contributed samples to existing
collections (i.e. retrospective collections) would need to be recontacted. Over the course of the first 20 months of the pilot, NCI/NHGRI
received considerable feedback on this policy and also identified several informed consent documents that, while not TCGA specific, did address
many of the concerns about a project with this scope of data generation and distribution.
During March and April 2008, project management revisited this consent policy and modified the policy as follows: for candidate biospecimen collections,
the NCI/NHGRI will review the informed consent document that was used to collect the specimens and issue a non-binding opinion memo to the contributing
PI that describes the degree to which the existing consent document is consistent with the goals and activities of TCGA. Specifically,
the memo will review if the informed consent document includes key concepts related to TCGA participant risks such as genetic research, broad sharing of
biospecimens and clinical data, the possibility of future research use, the deposition of genomics data into electronic database with partial public access
and the risk of loss of privacy.
Principal Investigators (PI) may choose to use this memo as supporting documentation in their application to their local IRB. Ultimately, the local IRB will determine if the existing consent document is sufficient for submission of specimens and data to TCGA.
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: