A project symposium will appear in the Journal of Law, Medicine & Ethics (Winter 2009) on Developing Oversight Approaches to Nanobiotechnology: The Lessons of History. Symposium guest editors are Susan M. Wolf, JD, Gurumurthy Ramachandran, PhD, Jennifer Kuzma, PhD, and Jordan Paradise, JD.
Paradise J, Wolf SM, Kuzma J, Ramachandran G, Kokkoli E. Symposium Introduction: The Challenge of Developing Oversight Approaches to Nanobiotechnology. Journal of Law, Medicine & Ethics. (forthcoming 2009).
I. Case Studies of Oversight Systems
- Kuzma J, Najmaie P, Larson J. Evaluating Oversight Systems for Emerging Technologies: A Case Study of Genetically Engineered Organisms. Genetically Engineered Organisms Survey
- Johnson R. Commentary: Emerging Technologies Oversight: Research, Regulation and Commercialization.
- Hurley T. Commentary: Using Expert Elicitation to Evaluate Oversight of Genetically Engineered Organisms: Is It Possible to Determine the Extent to Which Informational Asymmetries and Prejudice Bias Responses?
- Paradise J, Tisdale AW, Hall R, Kokkoli E. Evaluating Oversight of Human Drugs and Medical Devices: A Case Study of the FDA and Implications for Nanobiotechnology. Human Drugs & Medical Devices Survey
- Frankel MS. Commentary: Public Outreach by the FDA.
- Foote SB. Commentary on Evaluating Oversight of Human Drugs and Medical Devices.
- Choi JY, Ramachandran G. Review of the OSHA Framework for Oversight of Occupational Environments. Workplace Chemicals Survey
- Maynard AD. Commentary: Oversight of Engineered Nanomaterials in the Workplace.
- Wolf SM, Gupta R, Kohlhepp P. Gene Therapy Oversight: Lessons for Nanobiotechnology. Gene Therapy Survey
- Kahn JP. Commentary: Who’s Afraid of the RAC? Lessons from the Oversight of Controversial Science.
II. Comparing Across Case Studies
- Paradise J, Wolf SM, Kuzma J, Kuzhabekova A, Tisdale AW, Kokkoli E. Developing U.S. Oversight Strategies for Nanobiotechnology: Learning from Past Oversight Experiences.
III. Cross-Cutting Ideas
- Kimbrell G. Governance of Nanobiotechnology and Nanomaterials: Principles, Regulation, and Renegotiating the Social Contract.
- Marchant G. What Does the History of Technology Regulation Teach Us About Nano Oversight?
- Nelson KC, Andow DA, Banker MJ. Problem Formulation and Option Assessment (PFOA) Linking Governance and Environmental Risk Assessment for Technologies: A Methodology for Problem Analysis of Nanotechnologies and Genetically Engineered Organisms.
- Hogle L. Science, Ethics and the “Problems” of Governing Nanotechnologies.
- Priest SH. Risk Communication for Nanobiotechnology: To Whom, About What, and Why?
- Fauss E, Gorman ME, Swami N. Using Expert Elicitation to Prioritize Resource Allocation for Risk Identification for Nanosilver. Yawson R. Regionalism and Africa’s Science, Technology, and Innovation Nanofuture.
- Liao N. Combining Instrumental and Contextual Approaches: Nanotechnology and Sustainable Development.
NIH-funded grant #1 R01 HG003178-01A1, on "Managing Incidental Findings in Human Subjects Research," resulted in a major symposium issue in the Journal of Law, Medicine & Ethics. Principal Investigator: Prof. Susan M. Wolf. Co-Investigators: Adjunct Assoc. Prof. Jordan Paradise; Prof. Jeffrey Kahn, Center for Bioethics; Prof. Frances Lawrenz, Department of Educational Psychology; Prof. Charles Nelson, Children's Hospital Boston, Harvard University. Click on the article title below to read the article (pdf):
- Wolf SM, Paradise J, Nelson CA, Kahn JP, Lawrenz F, eds. Symposium: Incidental Findings In Human Subjects Research: From Imaging to Genomics. Journal of Law, Medicine & Ethics. 2008;36(2):2-383.
- Wolf SM. Introduction: The Challenge of Incidental Findings. Journal of Law, Medicine & Ethics. 2008;36(2):216-18.
- Wolf SM et al. Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations. Journal of Law, Medicine & Ethics. 2008;36(2):219-48.
- Lawrenz F, Sobotka S. Empirical Analysis of Current Approaches to Incidental Findings. Journal of Law, Medicine & Ethics. 2008;36(2):249-55.
- Richardson HS. Incidental Findings and Ancillary-Care Obligations. Journal of Law, Medicine & Ethics. 2008;36(2):256-70.
- Miller FG, Mello MM, Joffe S. Incidental Findings in Human Subjects Research: What Do Investigators Owe Research Participants? Journal of Law, Medicine & Ethics. 2008;36(2):271-79.
- Cho MK. Understanding Incidental Findings in the Context of Genetics and Genomics. Journal of Law, Medicine & Ethics. 2008;36(2):280-85.
- Clayton EW. Incidental Findings in Genetics Research Using Archived DNA. Journal of Law, Medicine & Ethics. 2008;36(2):286-91.
- Van Ness B. Genomic Research and Incidental Findings. Journal of Law, Medicine & Ethics. 2008;36(2):292-97.
- Illes J, Chin VN. Bridging Philosophical and Practical Implications of Incidental Findings in Brain Research. Journal of Law, Medicine & Ethics. 2008;36(2):298-304.
- Royal JM, Peterson BS. The Risks and Benefits of Searching for Incidental Findings in MRI Research Scans. Journal of Law, Medicine & Ethics. 2008;36(2):305-14.
- Nelson CA. Incidental Findings in Magnetic Resonance Imaging (MRI) Brain Research. Journal of Law, Medicine & Ethics. 2008;36(2):315-19.
- Siddiki H et al. Incidental Findings in CT Colonography: Literature Review and Survey of Current Research Practice. Journal of Law, Medicine & Ethics. 2008;36(2):320-31.
- Wilfond BS, Carpenter KJ. Incidental Findings in Pediatric Research. Journal of Law, Medicine & Ethics. 2008;36(2):332-40.
- Parker LS. The Future of Incidental Findings: Should They Be Viewed As Benefits? Journal of Law, Medicine & Ethics. 2008;36(2):341-51.
- Keane MA. Institutional Review Board Approaches to the Incidental Findings Problem. Journal of Law, Medicine & Ethics. 2008;36(2):352-55.
- Milstein AC. Research Malpractice and the Issue of Incidental Findings. Journal of Law, Medicine & Ethics. 2008;36(2):356-60.
- Wolf SM, Paradise J, Caga-anan C. The Law of Incidental Findings in Human Subjects Research: Establishing Researchers' Duties. Journal of Law, Medicine & Ethics. 2008;36(2):361-83.
Investigators on our NSF-funded grant #SES-0608791 on "NIRT: Evaluating Oversight Models for Active Nanostructures and Nanosystems: Learning from Past Technologies in a Societal Context" published several articles including:
- Kuzma J. Nanotechnology Oversight: Just Do It. Environmental Law Reporter. 2006;12:10913-23.
- Kandlikar M, Ramachandran G, Maynard AD, Murdock B, & Toscano WA. Health Risk Assessment for Nanoparticles: A Case for Using Expert Judgment. Journal of Nanoparticle Research. 2007;9:137- 56.
- Kuzma J. Moving Forward Responsibly: Oversight for the Nanotechnology-Biology Interface. 9 Journal of Nanoparticle Research. 2007;9:165-82.
- Paradise J, Wolf SM. Ramachandran G, Kokkoli, E, Hall R, Kuzma J. Developing Oversight Frameworks for Nanobiotechnology. Minnesota Journal of Law, Science & Technology. 2008;9(1):187-203.
- Paradise J, Diliberto GM, Tisdale AW, Kokkoli E. Exploring Emerging Nanobiotechnology Drugs and Medical Devices. Food and Drug Law Journal. 2008;63(2):407-20.
- Kuzma J, Romanchek J, Kokotovitch A. Upstream Oversight Assessment for Agrifood Nanotechnology: A Case Studies Approach. Risk Analysis. 2008;28(4):1081-98.
- J. Kuzma J, Besley JC. Ethics of Risk Analysis and Regulatory Review: From Bio-to Nanotechnology. Nanoethics. (forthcoming 2008)(Published online May 13, 2008, DOI: 10.1007/s11569-008-0035-x).
- Kuzma J, Paradise J, Ramachandran G, Kim J, Kokotovich A, Wolf SM. An Integrated Approach to Oversight Assessment for Emerging Technologies. Risk Analysis. (forthcoming 2008) (Published online July 9, 2008, DOI: 10.1111/j.1539-6924.2008.01086.x).
- Wolf SM et al. Developing Oversight Approaches to Nanobiotechnology: The Lessons of History. Journal of Law, Medicine & Ethics. (forthcoming Winter 2009).
Publications that resulted from an NIH, National Human Genome Research Institute-funded grant #5R01HG02089, on “Genetics & Disability Insurance: Ethics, Law & Policy,” include: