The Genomics Policy Process w/Notes


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  • The Genomics Policy Process w/Notes

    1. 1. The Genomics Policy Process: Forming Partnerships Between Citizens, Experts, and Policy Makers G. Fowler PhD K.C. Allison PhD M. Garland DScRel University of Minnesota Oregon Health and Science University Translating “ELSI”: Ethical, Legal and Social Implications of Genomics, Case Western Reserve University, May 3, 2008
    2. 2. <ul><li>“ Science can only ascertain what is, but not what should be, and outside its domain value judgments of all kinds remain necessary.” (Einstein, 1941) </li></ul><ul><li>“ Doing the Genome Project in the real world means thinking about these outcomes from the start, so that science and society can pull together to optimize the benefits of this new knowledge to human welfare and opportunity.” (Watson and Juengst, 1992) </li></ul><ul><li>“ Given the profundity of the challenges thus brought into public and policy debates, democratic theory in the era of the knowledge society must take on board the involvement of citizens in the production, use and interpretation of knowledge for public purposes.” (Cantley, 2005) </li></ul>Slide The Genomics Policy Process
    3. 3. Geneforum’s 3-Level Strategy <ul><li>“ ...the means by which problem identification, technical knowledge of possible solutions, and societal [ELSI] values join to set a course of action.” (IOM, 1988) </li></ul>Slide The Genomics Policy Process Education Engagement Consultation
    4. 4. An Overview of the Geneforum Process Slide The Genomics Policy Process QOL Community Justice Geneforum Dialogue Genetic Science Genetic Policy Development Democratic Process Public Knowledge Policy Outcome Public Obtains Facts Obtains Values Transmits Facts Transmits Values Provides Facts
    5. 5. Strategies for Promoting Dialogue and Building Community <ul><li>Geneforum Offline </li></ul><ul><li>Community talks </li></ul><ul><li>Public forums </li></ul><ul><li>Focus groups </li></ul><ul><li>Public opinion surveys </li></ul><ul><li>Programs with schools and educational institutions </li></ul><ul><li>Media outreach </li></ul><ul><li>Geneforum Online </li></ul><ul><li>Surveys and polls </li></ul><ul><li>Online forums </li></ul><ul><li>Consumer guides </li></ul><ul><li>“ Genetizen” experts’ blog </li></ul><ul><li>Interviews with thought leaders </li></ul><ul><li>User participation tools </li></ul><ul><li>Knowledge warehouse for offline activities (e.g., past public forums, survey summaries and analyses) </li></ul>Slide The Genomics Policy Process
    6. 6. Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) Request for public comment on draft report: Realizing the Promise of Pharmacogenomics: Opportunities and Challenges Slide The Genomics Policy Process
    7. 7. SACGHS Comment Solicitation <ul><li>Total comments received: 58 </li></ul><ul><ul><li>Subject-matter experts: 53 (91%) </li></ul></ul><ul><ul><li>Public at large: 5 (9%) </li></ul></ul><ul><ul><li>(Input ratio: Expert to Public-at-Large 9:1) </li></ul></ul><ul><li>U.S. policy formation regarding genome-based research and applications remains remote from the public. </li></ul>Slide The Genomics Policy Process
    8. 8. The Geneforum Fact-Value Separation Process <ul><ul><li>Citizens: Articulate community values </li></ul></ul><ul><ul><li>Experts: Identify relevant facts and probabilities </li></ul></ul><ul><ul><li>Policy Makers: Combine community values and the best available data in choosing among various alternatives </li></ul></ul>Slide The Genomics Policy Process
    9. 9. Partnership Model for Genomic Policy <ul><li>Some points about the model: </li></ul><ul><li>Citizens, Experts, and Policy Makers are all members of the same community </li></ul><ul><li>Policy Makers initiate action (A) by asking about community values (V) and facts data (F). </li></ul><ul><li>The questions from Policy Makers focus on the questions that Citizens and Experts ask. </li></ul><ul><li>The new policy (P) affects the community. </li></ul><ul><li>Policy Makers ask: </li></ul><ul><ul><li>How can we best apply science to maximize public values and create new policy? </li></ul></ul><ul><li>Citizens ask: </li></ul><ul><ul><li>What’s really important to us? </li></ul></ul><ul><li>Experts ask: </li></ul><ul><ul><li>What are the facts about present knowledge and technology? </li></ul></ul><ul><ul><li>What is feasible based on the current state of knowledge? </li></ul></ul>Slide The Genomics Policy Process
    10. 10. Oregon’s Committee on Genetic Privacy and Research <ul><li>Mandated to ... </li></ul><ul><li>“ Create opportunities for public education on the scientific, legal, and ethical development within the fields of genetic privacy and research and shall…elicit public input…(and)…take into consideration public concerns and values related to these matters.” (ORS 192.549(8); Fowler 2002) </li></ul>Slide The Genomics Policy Process
    11. 11. The Need for Policy <ul><li>Informed consent for obtaining genetic information; Individual’s rights in genetic protecting genetic information; Retention and destruction of information; Disclosure of genetic information; Use of deceased individual’s DNA sample or genetic information for research (ORS 192.531-540) </li></ul><ul><li>Employer/insurance genetic discrimination (ORS 743.730) </li></ul><ul><li>Retention for the purpose of newborn screening procedures (OAR 333-025-0155) </li></ul><ul><li>Provider notification and opt out for genetic information (OAR 333-025-0165) </li></ul>Slide The Genomics Policy Process
    12. 12. New Era of Genomic Science <ul><li>Replace one-directional information and decision flow with citizen dialogue, robust engagement and partnership with experts and policy makers; </li></ul><ul><li>Discovering and respecting public values; </li></ul><ul><li>Developing structures to more effectively engage the public in the discussion of genomic science…beyond simply education. </li></ul>Slide The Genomics Policy Process
    13. 13. The Translation of Genomics Into Public Health Policy: Core Functions <ul><li>Formulation of standards and guidelines, in collaboration with stakeholders, which promote the appropriate use of genetic information and the effectiveness, accessibility, and quality of genetic tests and services. </li></ul><ul><li>(Beskow et al . Community Genetics 2001) </li></ul>Slide The Genomics Policy Process
    14. 14. THANK YOU