THE CENTER FOR GENETIC RESEARCH ETHICS & LAW

ABOUT THE PROGRAM

Specific Aims

Urgent Issues from the Four Corners of Genetic Research Ethics

The research fostered by the CGREAL will be investigator-initiated and open-ended, in order to take advantage of the creativity our investigators can bring to the Center's mission. One of the first examples of that creativity is the conceptual framework we have developed for the Center's work. This framework divides the domain of genetic research ethics into quarters, demarcating four elements important to the ethical assessment of any genetic research project: 1. the cultural meaning ascribed to the research by its subjects; 2. the social values that influence scientists' interest in the project; 3. the moral imagination that informs the project's design; 4. the policies through which the project attempts to live up to its responsibilities to the people it describes (Fig.1, below). We discuss this framework further in Section II., below. While it is an innovation and as yet untested, this framework does allow us to articulate four specific Center-Wide aims for our work that can produce products of practical use to the scientific and policy-making communities.

Center-Wide Aim #1: Cultural Meaning.

To improve our understanding of the relationship between human genetic research and the humans it seeks to benefit by elucidating the culturally-mediated personal values and beliefs that influence different people's reactions to and experience of genetic research participation.

What does it mean to participate in human genetic research?

As genomics makes possible increasingly fine-grained studies of human genetic variation, both globally and locally, it will become more important for genome researchers and science policy makers to become sophisticated students of human cultural, social and political variation as well. Understanding research participants' beliefs and attitudes about themselves, their family relations, lineage, community, and ethnic identity will be critical to the success of this science. These beliefs and attitudes shape the participants' interpretation of the research experience and lay the foundation for any research risks or possible benefits that might emerge. The research collaborations we propose will be able to fill important gaps in our understanding of this changing landscape, enabling us to produce the cultural equivalent of a haplotype map for the diversity that exists in the meanings people give to genetic research.

Center-Wide Aim #2. Social Values.

To improve our understanding of the relationship between human genetic research and the human benefits it promises by elucidating the influence of translational incentives, ranging from commercial prospects and benefit-sharing agreements to long-term public health goals on the design and conduct of basic genetic research.

What social values should help steer genomic research?

Questions about the translation of new genetic knowledge into practical health benefits sometimes get relegated "downstream" from genetic research ethics, as issues in the clinical delivery or dissemination of genetic discoveries. However, studies of academic/industry relationships in genomics make it clear that entrepreneurial thinking about the prospect for application occurs quite early in the human genetic and genomic research process. The increasing interest in "benefit-sharing" arrangements with research participant communities is also encouraging basic scientists to design research with practical outcomes in mind. Finally, behind these incentives, most scientists are motivated by more or less well formed public health goals. Building on our previous studies of benefit-sharing, the commercialization of cutting-edge science, the regulatory system that governs the translational pathway in the U.S., and the public health goals of genetic medicine, our research collaborations with local scientists involved in such "technology transfer" will provide empirical and policy studies that will allow us to provide useful perspectives on regulatory regimes at the institutional, governmental, and international levels.

Center-Wide Aim #3. Moral Imagination.

To anticipate the research ethics and science policy issues raised by new advances in genetic research by analyzing the confluence of human variation research, computational genomics, sequencing technologies, and gene transfer techniques through the lenses of contemporary research regulations and norms.

What challenges will the $1,000 genome raise as a research tool?

The CWRU Center for Computational Genomics will be on the forefront of advances in genome-wide analysis, which will increase the speed and scope of genetic research exponentially, making it possible for clinical investigators to take genomic approaches to complex traits and conditions that have been hitherto beyond their reach. New sequencing technologies promise to propel this work even further by dramatically lowering research costs, and their combination with improved gene transfer technology will open up new horizons for molecular medicine. Novel issues will be generated for clinical investigators and research participants when these tools begin to used in human studies, challenging current conventions regarding individual informed consent, research participant privacy, research risks, and research aimed at "genetic enhancement." Anticipating and identifying these new issues in advance is the exercise of scientific moral imagination. Through our collaborations, we will build on our ongoing work on the different elements converging into "genomic medicine" to imagine as many of these issues as we can in order to provide the scientific community and science policy makers with a road map to the challenges ahead..

Center-Wide Aim #4: Responsible Policy.

To harness ongoing scholarship on genetic research ethics for practical application by providing evidence-based policy options for use by the scientific community, institutional review boards, and national research regulatory bodies in seeking to improve participant protections in the design and conduct of human genetic research.

What are responsible options in designing and conducting human genetic research?

As genetic and genomic approaches to human biology have gained wider biomedical use over the last decade, concerns for the rights and welfare of the individuals, families, and communities have prompted new examinations of conventional genetic research practices, including questions about family-facilitated recruitment, third party information disclosure, pedigree publication, stored tissue management, community engagement, and benefit sharing. Our research collaborations with scientists conducting genetic research with families, communities, and populations in fields untutored in conventional approaches to these issues, from cardiology to parasitology, will provide empirical evidence of researchers' and participants' actual experience of these issues and careful ethical and legal critiques of alternative approaches to addressing them.

Figure 1. Elements of a Genetic Research Ethic