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The Genomic Ethics and Policy Group (GEPG) of the CGS provides consultation and advice in the areas of genomic research and the development of relevant research policy and public policy. CGS research projects, together with other ELSI efforts outside UNC have significant policy implications that address many of the challenges as genomic projects scale up and affect large communities and society-at-large. The GEPG is comprised of a team of CGS investigators (Bailey, Dressler, Evans, King, Nelson, Powell, and Rothschild (co-led by Bailey and Dressler. The GEPG is composed of three separate but interrelated functions:
- Research Ethics Consultation Service (Dressler & King); serving researchers whose studies involve a genetic or genomic component
- Research Policy Initiatives (Dressler & King); interacting mainly with local and national research ethics offices, agencies and organizations
- Public Policy Initiatives (Bailey); interacting mainly with professional organizations and advocacy groups
We envision the work of the GEPG as a central node for ELSI investigators’ and trainees’ education, including internship experiences for students, staff, and faculty interested in research ethics and policy, and in learning effective ways to disseminate information to policy makers.
Research Ethics Consultation Service (RECS)
The purpose of the consult service is to provide a scholarly, confidential environment to discuss and address ethical, legal and social issues (ELSI) related to the conduct of a broad range of human studies (behavorial/social science, epidemiologic, clinical/translational, other laboratory studies) involving genetic or genomic questions, methods and applications. We function not as a mediator or decision-maker, but to aid investigators and administrators in analyzing and addressing ethical and social challenges in the design, implementation and dissemination of research with a genetic or genomic component. All client interactions are strictly confidential and will not be shared.
RECS services include:
- General consultation: responding to general calls, questions, and concerns about ELSI aspects of genetic research involving genetics or genomics.
- Project-specific consultation: identifying and addressing ELSI issues specific to a particular project or program to assist researchers and others throughout the research process or at any stage of their work. Topics might include, but are not limited to, issues around subject recruitment, biobanking, disclosure of research results, sharing data with other investigators, description of risks and benefits in the informed consent process, dissemination of research data.
- Consultation for IRB and grant applications: prior to submitting IRB and/or grant applications, the service will assist researchers by reviewing ELSI-related sections, and will offer comment for revisions or additions. Areas for comment may include how well the consent form describes the nature, risks and benefits of study participation in non-technical language; models for protecting privacy and confidential information (honest broker or trusted intermediary); other issues to consider- intent for secondary and future use of samples; what to do if clinically relevant information is revealed during the course of the study.
Lynn Dressler and Nancy King will co-lead this service, supported by an extended consult team of experts. Dressler’s background spans translational laboratory research, policy and research ethics; King’s background spans law, policy and bioethics. Janell Markey will coordinate a rapid feedback system for the service. Evaluation forms from the client will be used to provide feedback and improve areas of the consult process.
Research Policy Initiatives
The Genomic Ethics and Policy Group, interacting with the UNC Office of Human Research Ethics (OHRE), UNC IRBs, relevant campus offices and the proposed TraCS institute, provide consultation for developing policies to guide the responsible conduct of genomic research locally at UNC, and when needed at the state and national level. Dressler and King, co-lead this initiative. Examples of these initiatives include on ongoing effort developing recommendations for collection and banking of human specimens research, part of the UNC Vice Chancellor’s Ad Hoc Committee on Biobanking and Specimen Research (Bailey, Dressler, King, Nelson); a regional Embryonic Stem Cell Research Oversight Committee (ESCRO; King) which could serve area universities; and an ongoing effort at the national level to revise the current NCI informed consent template for human specimen research to include DNA collection and genetic research (Dressler).
Public Policy Initiatives
In this initiative, we engage in activities that make it possible for us to be aware of emerging issues, provide opportunities for discussion and dissemination of this information and , importantly, to inform policy development at the local, state and national levels. Examples of these initiatives are summarized below.
Policy Boards and Advisory Groups. Local and national service on key policy boards and advisory groups: Dr. Evans, is a member of the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) and serves as an advisor to ASTAR (Advanced Science and Technology Adjudication Resource), a congressionally mandated organization funded in 2006 to educate state and federal judges about genetic science. Nelson, Director of OHRE, provides a bidirectional interface between proposed CEER activities and national discussions on policy and practice through his involvement on the Secretary’s Advisory Committee on Human Research Protections (SACHRP, DHHS) and several other national initiatives.
Newborn Screening Research. Although all of the proposed CGS projects have potential policy ramifications, our work on newborn screening is explicitly designed to provide information of direct relevance to policy makers. Decisions about expanded newborn screening are made at the state level, and the research by Bailey and colleagues is designed to help states consider a range of factors when making those decisions. During the planning period, Bailey served on a HRSA-funded task force to develop standards and criteria for a uniform screening panel. This task force work led to a major report on newborn screening, with a scale to evaluate candidate conditions for screening and a set of recommendations for more uniformity in screening across states.
ELSI Policy Roundtable for North Carolinians. This annual event will build on our experience at the 2007 Community Genetics Forum (CGF), where we held a policy roundtable involving many stake holders in genetic policy development, including state legislators, university officials, and local activists. Our plans are to have this as an annual event with attention to topics that affect North Carolinians.
Future Directions
We see the future role of the Genome Ethics and Policy Group to ensure that CGS work reflects and informs current thinking and policy development in the field. We will continue to develop our capacity, working with CEER and related non-CEER institutes, national and regional bodies and agencies to engage in advisory efforts and policy setting standards for genomic research and related areas.
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