1. 4. The Planning Committee was composed of ELSI researchers, both CEER and non-CEER affiliated. It also included two individuals from outside the U.S. and members of the ELSI program staff. The following were members: Bernhardt, Barbara Boyer, Joy Caulfield, Tim Chung, Wendy Cook-Deegan, Bob Goldenberg, Aaron Henderson, Gail Juengst, Eric Kaye, Jane King, Nancy Lee, Sandra McEwen, Jean Press, Nancy Royal, Charmaine Thomson, Elizabeth , and Van Riper, Marcia .
2. 11 NHGRI issued a press release on September 26, 2011, announcing seven grants awarded under a new call for research on return of results in genomic research: The National Human Genome Research Institute (NHGRI) today awarded seven grants, totaling $5.7 million, aimed at untangling one of the knottiest ethical issues facing genomic researchers. Under the microscope are issues around if, when and how researchers should return to study participants information about their risk for diseases or conditions discovered during studies of their genomes… Researchers have widely varying opinions on the ‘return of results’ issue. Some believe that they have an ethical or legal obligation to reveal to study participants their genomic information – especially if it is medically significant and interventions can prevent or reduce the risk of a disorder. Others consider sharing such information unethical – especially if the research participant was told he or she would not be re-contacted, if the information relates to a disorder for which there is no known intervention, or if the precise medical significance of the information is unclear. Researchers on both sides of the question must also consider regulatory and policy issues related to bringing genome sequencing to clinical applications. Until now, researchers have had very little data to guide their decisions, except for research that asks people hypothetically whether they want incidental findings returned to them. An incidental finding is a health finding about a research participant that is discovered in the course of conducting research but is not the central aim of the study. What people want in the abstract may be very different from what they want in an actual genomic research setting. See (last visited December 7, 2012). On December 6, 2011, they issued a press release for Clinical Sequencing Exploratory Research Projects. To help speed up the application of genomic science to medical care, NHGRI will invest $40 million over four years to support five Clinical Sequencing Exploratory Research Projects, in which new multi-disciplinary research teams will explore the ways in which healthcare professionals may use genome sequencing information in a medical care setting. Physicians, ethicists, genomic scientists, patients and families will work together to learn important lessons about the use of genome sequencing in medical care and to develop methods to improve its use in the future…Clinical Exploratory Research Projects will answer questions such as how to incorporate genomic data into medical records, what tools are needed to extract relevant information from a patient's genome sequence, and how the availability of genome sequence data affects a physician's recommendations regarding treatment. The research will include important ethical and psycho-social elements, such as how patients should be counseled and educated before having their genome analyzed, the best way to acquire patient consent to participate in a study, and when to return findings to patients that are not related to the primary medical condition for which the test was done. The program will also provide a forum for the development and dissemination of innovative and best practices for clinical genome sequencing. At (last visited December 7, 2012).
3. 17. A typology also anticipated by the research plan that currently frames the work of our CGREAL colleagues at Case Western Reserve University. Juengst, E. , NIH Grant Application # 2 P50-HG003390–06, “Center for Genetic Research Ethics and Law,” April 15, 2009.
4. A Collaboratively-Derived Science-Policy Research Agenda
5. 19. Note how early-phase melanoma research is described and discussed in Harmon, A. , “Target Cancer’ Series,” New York Times, available at (last visited December 7, 2012).