Grants & Research

The Consortium competes for grants to originate important work on the societal implications of the life sciences. We are gratified that National Institutes of Health (NIH)--National Human Genome Research Institute (NHGRI) and National Cancer Institute (NCI), National Science Foundation (NSF), Robina LaPPS Research Funding, MacArthur Foundation Law and Neuroscience Project, and The Greenwall Foundation have supported our research.

Current Grants

Completed Grants

Disclosing Genomic Incidental findings in a Cancer Biobank: An ELSI Experiment
Website: http://www.lifesci.consortium.umn.edu/gifd (requires login)
Sponsor: National Institutes of Health (NIH), the National Cancer Institute (NCI), and the National Human Genome Research Institute (NHGRI)
Award #1-R01-CA154517
Project Dates: 9/6/11 - 6/30/16
Principal Investigators: Profs. Barbara Koenig (UCSF), Gloria Petersen (Mayo), and Susan Wolf
Award Amount: $2.4 million

This empirical and normative bioethics research project will guide policy and practice about the disclosure of genomic incidental findings (GIFD), a much-debated topic. With ethical guidance from a multidisciplinary ELSI Working Group, we will conduct an experiment designed to develop strategies for offering incidental findings to family members of probands in a biobank for pancreatic cancer. Our approach will be informed by studying the preferences of biobank research participants (including kin). Given that the majority of the pancreatic cancer probands are deceased, many concerns arise: Who should be offered the findings, given that notification of the proband’s legal next of kin may not assure that biologically at-risk family members are informed? Since relatives were not involved in the original biobank informed consent process, how should re-contact be managed? What disclosure procedures best meet family members’ concerns? Is there an ethical threshold for determining when the researcher is obligated to offer GIFD? A partnership among 3 PIs—a genetic epidemiologist who directs the SPORE biobank (Gloria Petersen), an empirical researcher (Barbara Koenig), and a bioethics and law scholar (Susan Wolf)—combines the strengths of Mayo Clinic and the University of Minnesota (UMN). This project will generate much-needed data on proband and family preferences, produce detailed analyses of the legal and ethical issues raised, create consensus recommendations, devise methods for honoring preferences, and advance sound biobank governance.

Managing Incidental Findings and Research Results in Genomic Biobanks and Archives
Website: http://lifesci.consortium.umn.edu/ifbb (requires login)
Sponsor: National Institutes of Health (NIH) and the National Human Genome Research Institute (NHGRI)
Award #2-R01-HG003178
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 2-year project has convened 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 has convened 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.

Project outcomes include:

  • a national conference on "Should We Return Individual Research Results and Incidental Findings from Genomic Biobanks & Archives?" For video please visit the conference website.
  • a symposium published in Genetics in Medicine in April 2012
  • a symposium to be published in the Minnesota Journal of Law, Science & Technology
  • a project website for the use of project members
  • a public website to aid public understanding

Nanodiagnostics and Nanotherapeutics: Building Research Ethics and Oversight
Website: http://lifesci.consortium.umn.edu/nanomedicine (requires login)
Sponsor: National Institutes of Health (NIH) and the National Human Genome Research Institute (NHGRI)
Award #1-RC1-HG005338-01
Project Dates: 10/1/09 - 7/31/12
Principal Investigator: Prof. Susan M. Wolf
Co-Investigators: Profs. Jeffrey McCullough, Ralph Hall, and Jeffrey Kahn
Award Amount: $914,044

This project is producing 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.

Project outcomes will include:

  • a national conference in Sept. 2011 on "Nanodiagnostics and Nanotherapeutics: Building Research Ethics and Oversight" For video please visit the conference website;
  • recommendations for researchers, research universities and institutions, private industry, NIH, FDA, OHRP, policymakers, and stakeholders including research participants themselves, scheduled to be published in the Fall 2012 issue of the Journal of Law, Medicine & Ethics;
  • a symposium scheduled to be published in the Fall 2012 issue of the Journal of Law, Medicine & Ethics; and
  • a public website to aid public understanding.

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.

 


Project investigators at April 15, 2010 conference on "Governing Nanobiotechnology: Reinventing Oversight in the 21st Century."

Completed Grants

NIRT: Evaluating Oversight Models for Active Nanostructures and Nanosystems: Learning from Past Technologies in a Societal Context
Public Website: http://www.lifesci.consortium.umn.edu/nirt-public
Working Group Website: http://lifesci.consortium.umn.edu/nirt (requires login)
Sponsor: National Science Foundation (NSF)
Award #SES-0608791
Project Dates: 9/1/06 - 8/31/10
Principal Investigator: Prof. Susan M. Wolf
Co-Investigators: Prof. Efrosini Kokkoli, Department of Chemical Engineering and Materials Science; Prof. Jennifer Kuzma, Center for Science, Technology and Public Policy; Prof. Jordan Paradise, Seton Hall Law School; 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:

A workshop series was also 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 - 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?
Emerging Problems in Neurogenomics: Ethical, Legal & Policy Issues at the Intersection of Genomics & Neuroscience
Conference website: http://lifesci.consortium.umn.edu/conferences/neuro_agenda
Sponsor: The Greenwall Foundation
Award: Presidential Grant
Project Dates: 11/21/07 - 5/31/08
Principal Investigator: Prof. Susan M. Wolf
Co-Principal Investigators: Prof. Harry Orr, PhD, Tulloch Professor of Genetics and Director of Institute for Translational Neuroscience and the Institute of Human Genetics, and Jordan Paradise, JD, Associate Director of Research & Education at the Consortium.
Award Amount: $25,000

This award helped fund a project on "Emerging Problems in Neurogenomics: Ethical, Legal & Policy Issues at the Intersection of Genomics & Neuroscience" involving top experts from around the country. The project featured a day-long public conference on 2/29/08 exploring issues in neurogenomics (co-funded by the Academic Health Center, ITN, and the Consortium), a published symposium, and a follow-on proposal to NIH.

Managing Incidental Findings in Human Subjects Research
Website: http://lifesci.consortium.umn.edu/conferences/incidentalfindings/
Sponsor: National Institutes of Health (NIH)/National Human Genome Research Institute (NHGRI)
Award #1-R01-HG003178-01A1
Project Dates: 9/26/05 - 7/31/07
Principal Investigator: Prof. Susan M. Wolf
Co-Investigators: Profs. Jordan Paradise; Jeffrey Kahn, Center for Bioethics; Frances Lawrenz, Department of Educational Psychology; Charles Nelson, Children's Hospital Boston, Harvard University.
Award Amount: $587,559

This project, led by researchers in the University of Minnesota's Consortium on Law and Values in Health, Environment & the Life Sciences, collaborating with a Working Group of prominent national scholars, tackled how researchers should handle incidental findings identified during research. Incidental findings are defined as unexpected findings beyond the domain of key interest in the research that have potential clinical significance, such as a suspicious mass revealed in a functional MRI (fMRI) study or an incidental finding of nonpaternity in genetic research. What should consent forms say about this and how should IRBs consider the potential for incidental findings in their review of protocols?

Project outcomes include:

Colliding Categories: Haplotypes, Race & Ethnicity
Sponsor: National Human Genome Research Institute
Award #1-R01-HG002818
Project Dates: 7/01/03 - 7/01/04
Principal Investigator: Dr. Jonathan D. Kahn
Co-Investigators: Prof. Jeffrey Kahn, Prof. Susan Wolf
Award Amount: $191,654

This project explored the impending collision between biological and regulatory classifications of population subgroups in American society. We focused on the interaction between biological categories emerging from the effort to create a haplotype map of the human genome and preexisting categories specifying race and ethnicity embodied in the U.S. Office of Management and Budget's Directive 15, which governs collection of data by all federal agencies and in federally funded research. This project involved an eminent national group of scholars including: Profs. Troy Duster PhD, (New York University and University of California, Berkeley); Phyllis Griffin Epps, JD (University of Houston); Evelynn Hammonds, PhD (Harvard University); Jonathan Marks, PhD (University of North Carolina, Charlotte); Michael Omi, PhD (University of California, Berkeley); Kim Fortun, PhD (Rensselaer Polytechnic Institute); Dorothy Roberts, JD (Northwestern University); and Charmaine Royal, PhD (Howard University); and University of Minnesota Profs. Donna Arnett, PhD; Rose Brewer, PhD; Colin Campbell, PhD; Jeffrey Kahn, PhD, MPH; Vivek Kapur, PhD; Harry Orr, PhD; William Toscano, PhD; and Susan Wolf, JD.

 

Genetics & Disability Insurance: Ethics, Law & Policy
Sponsor: National Human Genome Research Institute
Award #1-R01-HG02089
Project Dates: 7/01/00 - 12/31/03
Principal Investigator: Prof. Jeffrey Kahn
Co-Investigators: Prof. Susan Wolf, Dr. Dianne Bartels
Award Amount: $413,912

This grant was awarded to the Center for Bioethics and Joint Degree Program in Law, Health & the Life Sciences to complete a comprehensive investigation of the ethical, legal, and policy issues in the use of genetic information in private and public disability insurance and to recommend policies based on the findings.

Project outcomes include:

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