I Ethics, Law, and Policy

Undertaking a project such as The Cancer Genome Atlas (TCGA) raises existing as well as new and unique ethical, legal, and policy questions that will need to be considered and addressed during the course of this project.  As a result, a group of professionals and members of the public have been identified to oversee this task.  

An Ethics, Law, and Policy Group has been formed consisting of the following people:

Membership

William P. Bro, B.S. Kidney Cancer Association (KCA)
Catherine E. Ivy, M.S. The Ben and Catherine Ivy Foundation
Patricia King, J.D., Georgetown University Law Center

Staff Members

Elizabeth J. Thomson, D.N.Sc., R.N., National Human Genome Research Institute
Peter Good, Ph.D., National Human Genome Research Institute
Carolyn Compton, M.D., Ph.D., National Cancer Institute
Martin Ferguson, Ph.D., National Cancer Institute
Daniela S. Gerhard, Ph.D., National Cancer Institute

Purpose of the ELP Group :

To examine the ethical, legal, and policy issues that will need to be addressed in implementing The Cancer Genome Atlas, and to identify new issues that may arise as a result of the data generated by this project.  

Relevant issues will include but not be limited to:

(a) issues surrounding the informed consent process allowing for:

(i) the sequencing of DNA from both cancer and normal tissues

(ii) the collection and linking of family, health, and medical records to sequence, as well as other genomic information

(iii) the sharing of this information via a database that will be made widely accessible to researchers around the world

(b) unique data release and intellectual property issues

TCGA Human Subjects Protection and Data Access Policies:

The Cancer Genome Atlas Pilot Program Human Subjects Protection and Data Access Policies
TCGA Informed Consent Documents

TCGA Data Use Policy and Publication Guidelines:

The Responsible Use and Publication of Data Generated by the TCGA Pilot Project
Publication Guidelines for Members of the TCGA Network

Resources used by ELP Group Members:

Belmont Report
Research Regulations
Bioethics Resources
Fort Lauderdale Report