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An ELSI Case Study Analysis of Large NIH Genetic Research Studies: Common Threads and Lessons Learned to Inform Policy Development (Dressler, Henderson, Juengst, Fishman)
Significance: Large-scale genomic studies are shifting their research focus from families to populations. As this happens, scientists, their sponsors, and their ELSI advisors must decide how best to navigate the competing claims of individuals and groups on matters of consent and consultation, benefit-sharing and results reporting, and protection from potential research risks. Many policies have been developed and much experience gained in conducting large-scale studies, but the process of policy development is often sui generis to each new initiative. Although several national efforts have attempted to address this need, including the intramural and extra mural ELSI programs at NIH; ethics advisory groups to specific studies; and policy and education activities by OHRP and DOE, no one has yet examined the first wave of large-scale genomic initiatives for their research policy lessons. This project examines this early experience to anticipate the policy development needs of future studies.
Large-scale NIH genetics studies:. The Single Nucleotide Polymorphism (SNP) ;the International Haplotype (HAPMAP); and the Environment Genome Project (EGP) will be the focus of this analysis. Using a case-study approach, this project will analyze concerns, challenges, and policy guidance relevant to these early genomic scale-up studies at NIH. It will seek input and perspectives from researchers, program officers, and ethics advisors. Data from the SNP/ HAPMAP, and EGP studies are now being accessed by scientists for more widespread use, providing the opportunity to identify a spectrum of ELSI-related experiences, and how the issues of recruitment, biobanking, disclosure, benefit-sharing and risk protections have been addressed in practice when both group and individual interests are at stake. This project is a collaborative effort between the UNC CEER and the Case CEER, building on UNC’s P20 efforts regarding biobanking, ownership, and control, and the Case CEER’s analysis and review of policy and practices relevant to family and community genetic research studies.
Research Question 1: What are the ELSI issues relevant to early scale-up genetic variation studies sponsored by NIH, NHGRI SNP/ HAPMAP and the NIEHS EGP study?
Research Question 2: What are the perspectives of extramural researchers, NIH research administrators, and ELSI advisors regarding the common threads and lessons learned related to informed consent and biobanking?
Research Question 3: How have these common threads and lessons learned been translated into policy for the design of future large-scale NIH genetic research studies and what next steps are needed to translate evidence-based data into policy?
Outcomes: The information gained in this analysis will be used to evaluate how the common threads and lessons learned can be translated into policy to aid in the design of future large-scale NIH genetic research studies. We anticipate expanding this pilot to include ongoing studies across NIH (not limited to genetic variation studies) and additional stakeholders. The ultimate goal is to produce information that will lead to the development of national, harmonized, evidence-based policy to guide future genomic research studies.
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