Tfie Changing Landscape of Genomic Research Regulation

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Research Questions and Specific Aims: One important constellation of stakeholders Involved in the conduct of TGR is the triad composed of the researcher/investigator, the research participant, and members of the regulatory community. Large-scale genomic studies using banked population samples are changing the regulatory framework first developed for smaller family genetic studies of rare diseases. New federal regulations requiring the sharing of de-Identified coded genotypic information from these studies is but one challenge to the system, as new guidelines must be developed that balance the needs of research agenda with those of society. The rapid development of new genetic and genomic technologies has also increased the pressure to improve the speed and efficiency of entire research process, particularly when translating research findings into industry or the clinic. Understanding the views of each stakeholder in the biomedical TGR "triad" is paramount in order to harmonize and balance the needs of society with the needs of the research community. The major research agenda for this CGREAL research group focuses on a normative and empiric analysis of the changing regulatory landscape resulting from the advances In large-scale genetic and genomic studies. In particular, the obligation of the public to participate in genetic and genomic research, the evolving beliefs of researchers, regulators and participants about genomic research technologies and the access and use of genomic data that produces unique identifiers (known hereafter as GUIR for Genomic Unique Identifier Research) will be examined by the following specific aims: 1. Determine the knowledge and beliefs of researchers, regulators, and participants about; ¿ genomic technologies that produce unique identifiers (GUIR) ¿ the types of information that may be generated or result from GUIR ¿ how this information could be used in society 2. Determine the beliefs of researchers, regulators, and participants about; ¿ duties and social obligations to participate in genomic research ¿ correlating factors that may increase or decrease participation in genomic research ¿ implications for the design and regulation of genomic research ¿ potential risks and benefits from participation in genomic research, particularly GUIR 3. Conduct a normative, ethical and regulatory analysis of the social obligations and duties to participate in genomic research. These analyses will explore; ¿ whether all genomic research creates unique identifiers (GUIR). ¿ whether the current "social contract" for biomedical research pertains to genomic research and GUIR. ¿ the implications of the concept of solidarity on the perceived obligation for participation. ¿ implications of GUIR on regulatory guidelines and policy.