Grants & Research

Nanodiagnostics and Nanotherapeutics: Building Research Ethics and Oversight
Sponsor: National Institutes of Health (NIH) and the National Human Genome Research Institute (NHGRI)
Award #: 1RC1HG005338-01
Project Dates: 10/1/09-9/30/11
Principal Investigator: Prof. Susan M. Wolf
Co-Investigators: Profs. Jeffrey McCullough, Ralph Hall, and Jeffrey Kahn
Award Amount: $914,044

This project will produce the first systematic and comprehensive recommendations on how to protect human participants in research on nanodiagnostics and nanotherapeutics, including drugs, devices, and gene therapy using nano-vectors. Research in nano-medicine is burgeoning, with research on human participants under way, but current research ethics and oversight have not yet adequately addressed key concerns including uncertainty about how to assess risks. The project group will use normative, empirical, and policy analysis to evaluate current approaches to nanomedicine research ethics and oversight, generating much-needed recommendations on ethics standards and oversight processes.

Managing Incidental Findings and Research Results in Genomic Biobanks and Archives
Sponsor: National Institutes of Health (NIH) and the National Human Genome Research Institute (NHGRI)
Award #: 2R01HG003178-03
Project Dates: 9/25/09-7/31/11
Principal Investigator: Prof. Susan M. Wolf
Co-Investigators: Profs. Jeffrey Kahn, Frances Lawrenz, Brian Van Ness
Award Amount: $911,559

The new 2-year project will convene a multidisciplinary working group of national experts in order to analyze and generate recommendations on managing incidental findings and individual research results in genomic research using biobanks and large archives. In order to understand the genetic contribution to a host of diseases and conditions of great importance to public health, scientists are increasingly assembling large biobanks, archiving many individuals' DNA and health information for scientific reanalysis over time. However, there is no clarity about what individual health information, if any, should be given back to those people generous enough to participate by contributing their DNA and health information. Some prominent biobanks are giving back none at all. This project will convene leading experts on bioethics, genomics, biobanking, and law to recommend policies and practices on return of both incidental findings and individual research results that may have importance for the donor.

Cutting-Edge Policy Issues in Reprogenomics: Revamping the Law, Ethics & Policy Governing Genomic Biobanks and Assisted Reproductive Technology
Sponsor: Robina LaPPS Research Funding
Project Dates: 7/1/09-6/30/11
Principal Investigator: Prof. Susan M. Wolf
Award Amount: $87,546

This funding encompasses work on two related projects addressing cutting-edge issues posed by the latest advances in biomedical science in the linked domains of genomics and reproductive technologies. Both raise high-profile issues of immediate concern to federal and state government, scientists, and physicians. Both projects address how legal and ethical obligations to those who are most vulnerable (participants in genomic research and children produced using reproductive technologies) should fundamentally change policy and practice. Outcomes will include:

• a major legal article on incidental findings and return of individual research results
• a major bioethics publication
• visits to biobanks and archives to get a deeper sense of how they work and emerging issues
• an article on ART, and
• a book proposal on ART.

NIRT: Evaluating Oversight Models for Active Nanostructures and Nanosystems: Learning from Past Technologies in a Societal Context
Website: http://lifesci.consortium.umn.edu/nirt
Sponsor: National Science Foundation (NSF)
Award # : SES-0608791
Project Dates: 9/1/06 to 8/31/10
Principal Investigator: Prof. Susan M. Wolf
Co-Principal Investigators: Prof. Efrosini Kokkoli, Department of Chemical Engineering and Materials Science; Prof. Jennifer Kuzma, Center for Science, Technology and Public Policy; Jordan Paradise, Consortium on Law and Values in Health, Environment & the Life Sciences; Prof. Gurumurthy Ramachandran, Environmental Health Services.
Award Amount: $1,220,765

This project aimed to identify oversight models for nanotechnology by assessing 6 historical oversight models: for drugs, devices, gene transfer, genetically engineered organisms in the food supply, chemicals in the workplace, and chemicals in the environment. The project brought together a multidisciplinary group of Investigators and senior personnel from the University of Minnesota, with strengths in nanotechnology research and development, public policy, law, health, environment, economics, and bioethics and involves outside collaborators representing a range of perspectives. The project team evaluated oversight models using a historical and comparative approach and integrated findings to glean lessons for emerging applications of nanotechnology.

Project outcomes include:

• publication of individually authored papers analyzing the 6 historical oversight models
  
• publication of comparative work examining oversight models across the 6 models
  
• publication of a group-authored consensus paper on lessons for nanotechnology oversight
  
• wide dissemination of policy analysis and normative oversight recommendations through hard-copy and web-based resources
  
• a public conference hosted at the University of Minnesota to present papers and seek public feedback
  
• presentation of project work by Investigators at outside conferences

A workshop series was developed as a course option for both undergraduates and graduate students within the Hubert H. Humphrey Institute of Public Affairs, with cross-registration from the Law School and other programs. The PIs worked to link this project with science education needs in the K-12 community.

How Should Neuroscience Change Law? Lessons from the Impact of Genetics and Emerging Convergence of Genomics and Neuroscience
Sponsor: Subaward from the University of California, Santa Barbara (MacArthur Foundation Law and Neuroscience Project)
Project Dates: 12/1/2008 to 11/30/2009
Principal Investigator: Prof. Susan M. Wolf
Award Amount: $10,000

This project analyzes highly related and convergent science to see how law has already been affected. It then normatively evaluates changes and adaptations in legal doctrine and practice already under way. Ultimately, this project aims to influence the future development of legal practice, doctrine, and theory on neuroscience and Neurogenomics via the publication of a major paper. Core issues to analyze include:

• The lessons of offering, introducing, and using genetic evidence (especially behavioral genetics) in the criminal process and courtroom-admissibility, weight, understandability, probative vs. prejudicial value, can the evidence be disregarded upon instruction, statistical issues
• The lessons of genetics defenses ("my genes made me do it")-when are these defenses offered, what science are they based upon, how has law adapted to the emergence of this type of defense
• The lessons of police and prosecutorial uses of genetics-problems of DNA investigation, efforts to compel DNA examination of the defendant, DNA identification, issues of defendant privacy, positive and negative impacts of this science and practice, critique of emerging legal doctrine affecting these practices
• What do we know about how law has influenced the science (not just science affecting the law)?
• To what extent are we seeing convergence of genetics and neuroscience in the criminal process already and what should we expect to see, including how will the linked genomic and neuroscience databases already being established (in part due to NIH, NSF, and journal data-sharing requirements) affect the issues above?