On Wednesday and Thursday, March 8–9, the University of Minnesota will host experts from across the nation to lay the groundwork for improving informed consent in research with human participants. The two days of conferences and training sessions are collectively titled “Frontier Issues in Research Ethics.”
Professor Susan Wolf, chair of the University of Minnesota’s Consortium on Law and Values in Health, Environment & the Life Sciences, emphasizes the urgency of this enterprise, “Making consent work is crucial to protecting the people generous enough to participate in research. They have the right to make an informed choice, and the research community across the country continues to face challenges in ensuring the rights of participants as well as progress in biomedical research.”
Conducting research with human participants requires that they understand what they’re agreeing to, but studies show that many people fail to comprehend that they are signing up for research instead of routine clinical care. At the same time, new forms of research—including online and patient-driven research—are challenging old models for obtaining consent.
The March 8 conference, “The Future of Informed Consent in Research and Translational Medicine” brings together leading national experts—researchers, policymakers, scientists, clinicians, bioethicists and lawyers—to evaluate a century of innovation since informed consent was first established as a legal requirement 100 years ago. Speakers will analyze failures of informed consent, consider what informed consent requires in vulnerable populations and address the special challenges posed by research on emerging technologies such as genomics. They will discuss the federal government’s new revisions to its rules governing research with human participants—just released January 19—with its requirements for informed consent and embrace of new provisions on “broad consent.”
On March 9, the University of Minnesota’s Office of the Vice President for Research will offer a second conference titled “The Challenges of Informed Consent in Research with Children, Adolescents & Adults.” This event focuses on the practical challenges posed by seeking informed consent in research involving adults with diminished capacity, children and adolescents and other community members. This morning conference, involving leading national speakers as well as local experts, will launch the University’s first Research Ethics Day, which grows out of a University-wide effort to advance human research protections.
In beginning an annual tradition of devoting a full day to University-wide dialogue and training on research ethics, the University joins other institutions that similarly dedicate time each year to these vital issues, including Rutgers Research Day (Rutgers University), Ethics & Scientific Integrity Day (University of Alberta) and Ethics Awareness Week (University of Illinois). The afternoon of March 9 will be devoted to training and workshops on practical, hands-on issues in research ethics.
“Our faculty planning committee worked to bring together some of the nation’s most distinguished experts on research with human subjects,” said Professor Douglas Yee, Director of the Masonic Cancer Center, which is a co-sponsor of both conferences. “As a cancer researcher and clinician, I know how important informed consent really is in establishing a research partnership. By offering the March 8 national conference back-to- back with the March 9 conference zeroing in on challenges in day-to-day research, we have put together a unique opportunity for faculty, staff, students and trainees, and most importantly our community to examine these issues together. We hope that speakers and audience members will present multiple points of view, creating dialogue including our in-person and webcast audience.”
“Informed consent is the linchpin of ethical research,” said Interim Vice President of Research Allen S. Levine. “Offering both of these conferences on informed consent and launching an annual Research Ethics Day at the University of Minnesota place front and center our commitment to advance research while protecting human research participants.”
The March 8–9 conferences will feature presentations by speakers including:
- Alexander Morgan Capron, LLB, University Professor; Scott H. Bice Chair in Healthcare Law, Policy & Ethics; Professor of Law & Medicine, Keck School of Medicine; Co-Director, Pacific Center for Health Policy & Ethics, University of Southern California – formerly Executive Director of the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research
- Wylie Burke, MD, PhD, Professor, Department of Bioethics & Humanities; Member, Fred Hutchinson Cancer Research Center, University of Washington – past-President of the American Society of Human Genetics
- Sarah Gehlert, PhD, E. Desmond Lee Professor of Racial & Ethnic Diversity, George Warren Brown School of Social Work; Professor, Dept. of Surgery, School of Medicine; Co-Director, Center for Community Health & Partnerships, Institute for Public Health; Director, Center for Community Engaged Research, Institutes for Clinical & Translational Sciences, Washington University in St. Louis – President of the American Academy of Social Work and Social Welfare
- Eric Kodish, MD, Professor of Pediatrics and Bioethics, Lerner College of Medicine, Case Western Reserve University; pediatric hematologist at Cleveland Clinic; former-Director, Center for Ethics, Humanities & Spiritual Care, Cleveland Clinic – Chair of the Bioethics Committee of the Children’s Oncology Group; past-member of the Secretary’s Advisory Committee on Human Research Protections Subcommittee for Research Involving Children
Full agendas for both conferences, speaker biographies, and registration options can be found at:
- March 8: z.umn.edu/humanresearchethics
- March 9: z.umn.edu/researchethicspanel
The March 8 conference is sponsored by the Consortium on Law and Values in Health, Environment & the Life Sciences and the Masonic Cancer Center at the University of Minnesota. It is also supported in part by National Human Genome Research Institute (NHGRI) & National Cancer Institute (NCI), National Institutes of Health (NIH) grant #1-R01-HG008605 (Wolf, Clayton, Lawrenz, Principal Investigators).
The March 9 conference is sponsored by the University of Minnesota’s Consortium on Law and Values in Health, Environment & the Life Sciences; Office of the Vice President for Research; Human Research Protection Program; and Masonic Cancer Center.
The following individuals are available for comment to the media on issues in research ethics:
- Wylie Burke, MD, PhD
- Alexander Capron, LLB
- Allen S. Levine, PhD
- Douglas Yee, MD
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