Looking to Clinic, Community
“We’re hoping to get out and take the genome for test drives,” Dr. Brody told GEN. “We would hope that clinicians at all levels would be interested in participating in some of these test drives, in the form of research projects.”
Dr. Brody would not discuss upcoming projects, but did say they are envisioned as taking place beyond the large academic medical centers that have traditionally driven clinical research, into community institutions: “Most of the country probably does not receive its average healthcare from academic medical centers, so I think we would expect to be looking at other caregiver organizations as well.”
“What we want to do with genomic advances is try to do our homework either as we’re doing it, or ahead of time,” he said—to find out, for example, if people can be stratified for colon cancer screening based on biomarkers and other genetic data rather than simply age, then study how that could be implemented, and its effects on healthcare delivery and reimbursement.
“Genetics has that potential. I don’t think we’re exactly there for that example yet, because we’re not that great at predicting risk, but that would have the potential to change the system,” Dr. Brody said. “We’re not at the stage where we can just introduce more and more expensive technology into the healthcare system.”
In articulating a primarily research role to inform NIH policymakers at the intersection of science and society, Dr. Brody’s division differs from entities in and outside government that have recommended, or will recommend, more prescriptive answers.
The Presidential Commission for the Study of Bioethical Issues, for example, last year urged that individual genetic privacy interests be respected and secured—in part by Washington joining states in developing “a consistent floor of protections” ensuring security for whole-genome sequence data. Until now, federal action has been limited to the Genetic Information Nondiscrimination Act of 2008 (GINA), which bars employment discrimination based on genetic information.
This past November, Kaiser Permanente joined the University of California, San Francisco (UCSF), and UC Hastings College of Law in announcing the launch of the Center for Transdisciplinary ELSI Research in Translational Genomics.
Over three years, CT2G will study the ethical, legal, and social implications (ELSI) of translating genomic findings into clinical care, with an eye to educating professionals about the issues that underlie genomic data privacy. The importance of privacy, and how easily it can be breached, were illustrated earlier this year when Yaniv Erlich, Ph.D., and colleagues at the Whitehead Institute needed just a computer, an Internet connection, and publicly accessible online resources to identify nearly 50 individuals who had submitted personal genetic material for genomic studies.
CT2G, which is funded through a $780,000 NHGRI grant, will have working groups examine race/ethnicity and sex/gender in translational genomics, the boundary between genomics research and clinical care, and community governance and genomics. CT2G’s co-directors are Barbara A. Koenig, Ph.D., of UCSF and Carol P. Somkin, Ph.D., a research scientist with Kaiser Permanente.
“It is heartening to see increasing recognition of the importance of ELSI and wider considerations in preparing for the growth in genomic medicine internationally; increased knowledge and understanding of such issues can only be a good thing, and multidisciplinary input is vital,” the U.K.’s nonprofit PHG Foundation said in a statement, citing both CT2G and Dr. Brody’s appointment.