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Home > ARRA Stories > Professor Susan Wolf: Examining Ethics in Nanomedicine Research
Professor Susan Wolf: Examining Ethics in Nanomedicine Research

By Alison Davis

January 20, 2010

Susan M. Wolf, J.D., Professor of Law, Medicine and Public Policy, University of Minnesota

Photo of Professor Susan M. Wolf

Professor Susan Wolf

The fields of nanotechnology and nanomedicine are dedicated to building and engineering materials at the atomic level, in the range of one to 100 nanometers. To offer some perspective, the period at the end of this sentence is about a million nanometers wide, and an average-sized microbe is about 1,000 nanometers wide. At the nanoscale, materials can exhibit unusual properties, offering exciting possibilities for new diagnostics and treatments. Bioethicist and attorney Susan Wolf is focused on guarding the safety of people who come into contact with nanomaterials.

The Problem: Nanotechnology research is "barreling ahead," says Professor Wolf, and the potential implications are dramatic. The ability to make and control substances at the scale of individual molecules opens up tremendous new opportunities. For example, she says, scientists are developing nanomaterials that "seek and destroy" cancer cells just starting to spread through the body. This technology could be used to find micrometastases, small changes that occur early in the development of cancer. Finding these changes could allow the detection and targeting of affected cells only, leaving nearby, healthy cells intact.

Developing this new technology calls for research with human participants, and laboratories should ensure that those participants are adequately protected. Professor Wolf and her team are concerned about the unknowns surrounding some nanomaterials. Some of the questions include: What about the safety of lab workers who use nanomaterials every day in experiments, and what are the long-term effects of exposure? What are the environmental effects and the destiny of the nano-waste that accumulates?

Finding a Solution: Nanomedicine is an interdisciplinary science that integrates a range of different fields: engineering, chemistry, genomics, physiology, computer sciences and physics. As a result, Professor Wolf explains, nanomaterials can have complex effects, and risk analysis can be tough. Fortunately, federal agencies, such as the Food and Drug Administration, the Environmental Protection Agency, and the Occupational Safety and Health Administration, are beginning to face these issues.

Professor Wolf's Recovery Act project aims to get to the heart of the uncertainty. She and her team, along with a nationwide working group of experts, are taking a three-step approach to tackle the issue. First, they will map the challenges posed by human subjects research in nanomedicine. Second, the researchers will inventory current practices to find out what's being done now to protect human participants in this research. Finally, Professor Wolf and her group will develop and communicate the first set of comprehensive recommendations on the ethics and oversight of nanomedicine research involving participants.

How This Funding Helps: Professor Wolf thinks it's remarkable that no one has "wrestled to the ground" the issues raised by human subjects research involving nanomaterials. She says her group would not be able to do this work without the infusion of funding from the Recovery Act.

"NIH had great foresight to fund this research to protect the health of the American people," says Professor Wolf. "There's a nanotechnology and nanomedicine revolution under way. It's important that we do it right, safeguarding the welfare of those people generous enough to participate in human subjects research involving nanomaterials."

After Two Years … Professor Wolf expects that nanotechnology research will continue at a rapid clip. She notes that the field is a huge economic driver for the nation and one that will help define our global competitiveness.

Over the next two years, Professor Wolf's team will work with nanomedicine researchers, clinicians, attorneys, policy analysts and bioethics experts to build consensus on what guidelines and safeguards are needed in nanomedicine research with human subjects. The group will develop concrete recommendations.

"Nanomedicine is the next big challenge in human subjects research," Professor Wolf says. "Our team is going to get out in front of this challenge — filling a big need — and work to assure safe and ethical development of this important technology."

Recovery Act Investment: The "Nanodiagnostics and Nanotherapeutics: Building Research Ethics and Oversight" study received $433,066 in fiscal 2009 from the National Human Genome Research Institute.

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