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Grants & Research

The Consortium competes for grants to originate leading work on the societal implications of biomedicine and the life sciences. We thank the National Institutes of Health (NIH) and its National Human Genome Research Institute (NHGRI) and National Cancer Institute (NCI), the National Science Foundation (NSF), the Robert Wood Johnson Foundation, Robina LaPPS Research Funding, MacArthur Foundation Law and Neuroscience Project, and The Greenwall Foundation for supporting our research.

Below, please find information on the Consortium’s funded research relating to:

The Consortium also has a long history of helping and consulting with investigators at the University of Minnesota and other institutions on interdisciplinary and multi-institutional grant proposals. We welcome this opportunity to further research and collaboration. Please see selected grant proposals aided by the Consortium.

Links to further information:  

  


Consortium research 
 

Return of Research Results & Incidental Findings

Translating Research Into Health Benefits: Returning Research Results & Incidental Findings
Sponsor: The Robert Wood Johnson Foundation Investigator Awards in Health Policy Research
Award # 69763
Project dates: 8/1/12 - 7/31/14
Principal Investigator: Prof. Susan M. Wolf (Consortium on Law and Values in Health, Environment & the Life Sciences)
Award Amount: $333,133

This 2-year project will use multiple research methods to generate the first book on the question of how to handle incidental findings (IFs) and individual research results (IRRs). The question of whether researchers should return IFs and IRRs of clinical significance challenges the traditional line drawn between research and clinical care, a line fundamental to the structure of research practice, health law, and bioethics. At stake is how we conduct human subjects research, its relationship to clinical care, and whether we can harvest the potential health benefits to individuals flowing from research without unduly burdening that research effort.

Project outcomes will include:

  • a book;
  • journal articles on the public health, public policy, legal, and ethical implications; and
  • presentations in a range of high-profile venues to shape policy and practice.

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Disclosing Genomic Incidental Findings in a Cancer Biobank: An ELSI Experiment
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: 9/12/11 - 7/31/16
Principal Investigators: Prof. Gloria Petersen (Mayo), Prof. Barbara Koenig (UCSF), and Prof. Susan Wolf (University of Minnesota)
Award Amount: $2.4 million
National Working Group
Bibliography (password-protected for project members only)
Project Materials (password-protected for project members only)
Brocher Workshop on "Returning Genetic Results in Biobanks: Opening an International Dialogue"

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.

Project outcomes will include:

  • a public conference scheduled for the Spring 2014;
  • publication of consensus recommendations;
  • publication of individual papers including analyses of the legal and ethical issues raised; and
  • web-based materials available to the public

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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 # 2-R01-HG003178
Project Dates: 9/25/09 - 7/31/11
Principal Investigator: Prof. Susan M. Wolf (Consortium on Law and Values in Health, Environment & the Life Sciences
Co-Investigators: Prof. Jeff Kahn (Center for Bioethics), Prof. Frances Lawrenz (Dept. of Educational Psychology), Prof. Brian Van Ness (Dept. of Genetics, Cell Biology & Development)
Award Amount: $911,559
National Working Group
Bibliography
Project Materials (password-protected for project members)

This 2-year project convened a multidisciplinary working group of national experts 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 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:CONSORTLV 2011 ifbb sm GIF

  • a national conference on "Should We Return Individual Research Results and Incidental Findings from Genomic Biobanks & Archives?" held in Bethesda, MD on May 29, 2011;
  • a symposium published in Genetics in Medicine in April 2012;
  • a symposium published in the Minnesota Journal of Law, Science & Technology in Spring 2012; and
  • web-based materials available to the public.  
     

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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 - 6/30/13
Principal Investigator: Prof. Susan M. Wolf (Consortium on Law and Values in Health, Environment & the Life Sciences)
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.

Project 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.

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Managing Incidental Findings in Human Subjects Research
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, Consortium on Law and Values in Health, Environment & the Life Sciences
Co-Investigators: Prof. Jeff Kahn (Center for Bioethics); Prof. Frances Lawrenz (Depart. of Educational Psychology); Prof. Charles Nelson (Children's Hospital Boston and Harvard University)
Award Amount: $587,559
National Working Group
Bibliography
Project Materials (password-protected for project members)

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 non-paternity 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?

CONSORTLV thumb jlme summer 08 JPG

Project outcomes include:

  • a symposium on "Managing Incidental Findings in Human Subjects Research" published in the Journal of Law, Medicine & Ethics, Summer 2008;
  • publication of the empirical analysis;
  • publication of the consensus report;
  • a public conference on "Managing Incidental Findings in Human Subjects Research: From Imaging to Genomics" held on May 1, 2007; and
  • web-based materials available to the public.

    

 

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Nanobiotechnology Research Ethics and Oversight;
 

DNA Nanotechnology: Developing and Analyzing a New Tool for Sensing and Targeting Disease
Sponsor: MnDRIVE Transdisciplinary Research
Award #1000014863
Project Dates: 7/1/14-6/30/16
Principal Investigators: Prof. Efie Kokkoli, (Chemical Engineering and materials Science), Prof. Karen Ashe, (Neurology), Scott McIvor, (Genetics, Cell Biology and Development), Walter Low, (Neurosurgery), Ted La Buza, (Food Science and Engineering), and Susan Wolf (Consortium on Law and Values in Health, Environment & the Life Sciences)
Award Amount: $500,000

This 2-year project will use breakthrough DNA nanotechnology to engineer and evaluate materials to address major health challenges and food system issues. We propose to use aptamer-amphiphiles as DNA nanotubes to target and treat Alzheimer’s disease and brain tumors, and as sensors to detect food allergens such as milk. DNA nanotubes have the potential to deliver compounds - such as nucleic acids - to the brain safely and efficiently, while aptamer-amphiphiles can detect milk with potentially ultrafast response time. Such research involving DNA and nanotechnology raises controversial questions of ethics, law, and policy that we will analyze to generate recommendations. 

Project goals and outcomes include:

  • To engineer and evaluate DNA nanotubes both in vitro and in vivo for the delivery of nucleic acids as part of a targeted antitumor strategy against glioblastoma multiforme.
  • To engineer and evaluate DNA nanotubes both in vitro and in vivo for the specific delivery of ASOs to neurons in the brain with the goal of lowering APPs and preventing Alzheimer’s disease.
  • To develop an aptamer-amphiphile-based LC assay for the rapid and sensitive in-plant detection of dairy proteins by detecting β-lactoglobulin from surface swabs of typical processing equipment.
  • To map the ethical, legal, and societal issues raised by DNA nanotechnology and generate consensus recommendations. Generate and publish more detailed analyses of particular dimensions of these problems, such as occupational health implications, environmental assessment, human subjects concerns, concerns raised by use in food production, oversight design, and public concerns. Assemble a full bibliography on the ELSI issues raised by DNA nanostructures

Nanodiagnostics and Nanotherapeutics: Building Research Ethics and Oversight

Sponsor: National Institutes of Health (NIH) and the National Human Genome Research Institute (NHGRI)
Award # 1-RC1-HG005338-01
Project Dates: 9/30/09 - 7/31/12
Principal Investigator: Prof. Susan M. Wolf (Consortium on Law and Values in Health, Environment & the Life Sciences
Co-Investigators: Prof. Jeffrey McCullough (Dept. of Laboratory Pathology), Prof. Ralph Hall (Law), and Prof. Jeffrey Kahn (Center for Bioethics)
Award Amount: $914,044
National Working Group
Bibliography
Project Materials (password-protected for project members)

This project produced 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 used normative, empirical, and policy analysis to evaluate current approaches to nanomedicine research ethics and oversight and generated much-needed recommendations on ethics standards and oversight processes.

Project outcomes include:

  • a national conference on "Nanodiagnostics and Nanotherapeutics: Building Research Ethics and Oversight;"
  • recommendations for researchers, research universities and institutions, private industry, NIH, FDA, OHRP, policymakers, and stakeholders including research participants themselves, published in the Winter 2012 issue of the Journal of Law, Medicine & Ethics; and
  • a symposium published in the Winter 2012 issue of the Journal of Law, Medicine & Ethics.

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NIRT: Evaluating Oversight Models for Active Nanostructures and Nanosystems: Learning from Past Technologies in a Societal Context
Sponsor: National Science Foundation (NSF)
Award # SES-0608791
Project Dates: 9/1/06 - 4/30/11
Principal Investigator: Prof. Susan M. Wolf (Consortium on Law and Values in Health, Environment & the Life Sciences)
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); and Prof. Gurumurthy Ramachandran (School of Public Health Environmental Health Services).
Award Amount: $1,220,765
National Working Group
Bibliography
Project Materials (password-protected for project members only)

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:

  • CONSORTLV thumb jnr april 11 JPGa project symposium entitled "Special Focus: Governance of Nanobiotechnology" published in the Journal of Nanoparticle Research;
  • 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;
  • CONSORTLV thumb jlme winter 09 JPGa published symposium on "Developing Oversight Approaches to Nanobiotechnology: The Lessons of History" in the Journal of Law, Medicine & Ethics, Winter 2009 issue;
  • a public conference on "Governing Nanobiotechnology: Reinventing Oversight in the 21st Century" hosted at the University of Minnesota on April 15, 2010;
  • web-based materials available to the public; and
  • 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. 
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Neuroscience 

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 - 9/30/2010
Principal Investigator: Prof. Susan M. Wolf
Award Amount: $10,000

This project analyzed highly related and convergent science to see how law has been affected. It then normatively evaluated changes and adaptations in legal doctrine and practice already under way. This project aimed to influence the future development of legal practice, doctrine, and theory on neuroscience and neurogenomics via the publication of a major paper. Core issues analyzed included:

  • 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? 

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Emerging Problems in Neurogenomics: Ethical, Legal & Policy Issues at the Intersection of Genomics & Neuroscience
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,  Consortium on Law and Values in Health, Environment & the Life Sciences.
Award Amount: $25,000
Conference website

This award helped fund a 1-day conference on "Emerging Problems in Neurogenomics: Ethical, Legal & Policy Issues at the Intersection of Genomics & Neuroscience" involving top experts from around the country. The conference was held on February 29, 2008 and explored issues in neurogenomics (co-funded by the Academic Health Center, ITN, and the Consortium). The conference was used in preparation of a follow-on proposal to NIH on Managing Incidental Findings and Research Results in Genomic Biobanks and Archives.

    

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Other Grants 

Oscar M. Ruebhausen Visiting Professorship in Bioethics
Sponsor: The Greenwall Foundation
Project Dates: 10/08/07-10/11/07
Principal Investigators: Profs. Jeff Kahn (Center for Bioethics); Barbara Koenig (Mayo Clinic); and Susan Wolf (Consortium on Law and Values in Health, Environment & the Life Sciences)
Award Amount: $25,000
MJLST article

This collaborative project involving the Center for Bioethics and the Consortium on Law and Values in Health, Environment & the Life Sciences at the University of Minnesota and the Biomedical Ethics Research Program of the Mayo Clinic and Mayo College of Medicine, hosted Prof. Zach W. Hall, PhD, founding President of the California Institute for Regenerative Medicine (CIRM) as the Oscar M. Ruebhausen Visiting Professorship in Bioethics. Dr. Hall visited both institutions for one week, providing two major lectures ("Stem Cell Research: At the Intersection of Science, Politics, Law and Culture" at the University of Minnesota and Grand Rounds at the Mayo Clinic). He participated in a number of additional events at both institutions, including a live hour-long interview with Minnesota Public Radio (MPR); meetings with University of Minnesota Stem Cell Advisory Board, and faculty, administrators, and law and graduate students at the University of Minnesota. At the Mayo Clinic, Dr. Hall met with stem cell researchers, medical students, graduate students, and institutional leadership. In addition, Mayo Clinic collaborated with the University of Minnesota—Rochester in an evening public panel, including commentators from disability law, bioethics, and a Minnesota state legislator. Dr. Hall published an article in our journal, the Minnesota Journal of Law, Science & Technology in Winter 2009 based on these presentations.
 

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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 (Consortium on Law and Values in Health, Environment & the Life Sciences)
Co-Investigators: Prof. Jeffrey Kahn (Center for Bioethics) and Prof. Susan Wolf (Consortium on Law and Values in Health, Environment & the Life Sciences)
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.

Project outcomes include:

  • a public conference on "Proposals for the Responsible Use of Racial and Ethnic Categories in Biomedical Research: Where Do We Go From Here?" held on April 18, 2005, and
  • a symposium entitled "The Responsible Use of Racial and Ethnic Categories in Biomedical Research: Where Do We Go from Here?" published in the Journal of Law, Medicine & Ethics, Fall 2006.

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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 (Center for Bioethics)
Co-Investigators: Prof. Susan Wolf (Consortium on Law and Values in Health, Environment & the Life Sciences) and Dr. Dianne Bartels (Center for Bioethics)
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:

  • a symposium entitled "Genetic Testing and Disability Insurance" in the Journal of Law, Medicine & Ethics, Summer 2007, and
  • a public conference on "Genetic Testing and the Future of Disability Insurance: Ethics, Law & Policy" held on March 14, 2003.

  

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Selected grant proposals aided by the Consortium 
 

Future Tense—a multi-media project to educate Americans about choices posed by emerging technologies
Grant proposal to: Nathan Cummings Foundation
Year: 2012
PIs: Prof. Gary Marchant (Arizona State University)

From the Lab to the Clinic: ELS Issues in Cancer Stem Cell Research
Grant proposal to: Cancer Stem Cell Consortium (CSCC)
Year: 2010
PI: Prof. Tim Caulfield (University of Alberta)

Human Geneticists' Practices Preferences and Beliefs about Biobanks and Large Cohort Studies
Grant proposal to: National Human Genome Research Institute (NHGRI)
Year: 2009
PI: Prof. David Kaufman (Johns Hopkins University) 

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