|
Our CEER planning grant (1P20 HG03387) was motivated by the observation that “the rapid expansion of large sample gene discovery and disclosure projects raises major ethical, legal, social, and policy challenges, to such an extent that it constitutes a significant and urgent public health need.” We sought to determine how such large-scale projects may amplify or raise important ELSI issues, and whether such projects create the need for additional oversight. From this preliminary research, four critical ELSI issues requiring research have emerged: (1) “Scale-up” could change the implications of genetic information for individuals, families, or populations, particularly when genetic findings are ascribed to individuals by virtue of their membership in socially defined groups. (2) Large-scale genomic research could alter challenges to informed consent in response to shifting estimations of risk and benefit. (3) New technologies and data collection and storage capacities could pose unique ELSI issues as investigators, subjects, and institutions grapple with regulating the use of DNA samples, control of data, and dissemination of results. (4) All of these concerns are also integral to understanding the most efficient and judicious translation of genomic research findings into clinical or public health practice. Therefore, the Center for Genomics and Society is conducting an integrated set of research, policy, and education projects to fill this gap in knowledge about new or heightened ELSI issues, and developing policy-relevant recommendations that will address translation to practice.
- Center Aim 1: Conduct Integrated Research on ELSI Issues Raised by Large-Scale Genomic Studies
The Center is implementing transdisciplinary studies that explore these four ELSI questions to help ensure that genomic advances result in maximum benefit and minimal harm to individuals, families, groups, and society. Five focused and interrelated projects examine scale-up issues that impact the subjects of large-scale genomics studies; research investigators and university and NIH administrators involved in DNA sample collection and analysis; and clinicians and patients engaged in novel pharmacogenetic testing. These five projects all focus on genomic research in which a variety of gene discovery techniques are used, and which create a wide range of issues through the disclosure and dissemination of genetic information. Three cross-cutting ethical, legal, and social analyses utilize data from these projects to address major questions raised by large-scale genomics.
- Center Aim 2: Use ELSI Expertise to Inform Genomic Research and Policy
The Center is developing a set of mechanisms to inform genomic research, research policy, and public policy. The Genomic Ethics and Policy Group (GEPG) provides consultation to three communities: researchers engaged in genomic research, research administrators responsible for establishing research policies, and policy makers or other groups who must translate or interpret genetic research when making public policy decisions. The GEPG works to advise and develop research and public policy, seeking input from diverse research and community groups.
- Center Aim 3: Provide Training, Education and Outreach, Particularly Focused on Underrepresented Minorities, to Foster Continued ELSI Research on Large-Scale Genomics that is Informed by Diverse Perspectives
Training efforts focus on a core group of diverse graduate students, post-doctoral fellows, and young investigators from a variety of disciplines who work on research, consultation and policy initiatives. Training activities provide the experiences and knowledge that promote engagement in ELSI research, and the skills essential to interdisciplinary collaboration. The Center also provides education and outreach activities that increase awareness of ELSI research and career opportunities for students at different stages (from high school through post-graduate); for administrators and faculty at area universities and colleges, and for non-academic communities. Primary aims of outreach activities are to develop a pipeline for increasing the diversity of ELSI researchers, to increase research collaborations between the University of North Carolina (UNC) and minority-serving institutions, and to gain diverse perspectives on ELSI research and policy.
|
