Group receives ethics research grant to protect human subjects

The project will tackle ethics issues involving nanomedicine.

by Katie Wieglos

A group of University of Minnesota faculty and top scholars across the nation recently began an unprecedented project that will address ethical concerns in nanomedicine research. The project will focus on devising safeguards to protect human subjects participating in research on nanomedicine products, said Susan Wolf , the projectâÄôs principal investigator and chair of the UniversityâÄôs Consortium on Law and Values in Health, Environment and the Life Sciences. Nanomedicine involves the medical application of microscope technologies built on an atomic scale. The two-year project, which is funded by a nearly $915,000 grant from the National Institutes of Health , aims to develop the first set of comprehensive guidelines for protecting human subjects. The goal is âÄúto figure out what really is needed in the world of research ethics and research protections so that nanomedicine research can go forward safely,âÄù Wolf said. Despite the burgeoning field of research surrounding nanomedicine, many of the risks for those involved âÄî including research subjects, scientists, lab workers and medical personnel âÄî are still not fully understood by scientists. âÄúThis will be the first major national project to try to wrestle that problem to the ground and come up with consensus recommendations,âÄù Wolf said. Efie Kokkoli, a professor of chemical engineering and material science, is involved with the research and design of targeted nanotechnologies for cancer therapeutics, including chemotherapy agents. Nanomedicine is beneficial because of its ability to target cancer tumors, Kokkoli said, but scientists need to be sure the benefits outweigh the risks, since nanoparticles have the potential to invade healthy organs. âÄúYou have to make sure that you are not damaging the rest of the body,âÄù she said. Kokkoli said the guidelines set by the project team will help eliminate some of the problems facing nanotechnology researchers by adding regulations and addressing ethical questions or issues through more oversight. âÄúIt may make life a little bit simpler, because you will have a set of rules that you will have to follow [as a scientist],âÄù she said. The recommendations the project team develops will stem from information currently known and understood about the study of nanotechnology, said Ralph Hall, University law professor and co-investigator. In areas of food and drug law, regulations have been imposed after problems occurred âÄî something the University researchers are trying to avoid. âÄúHere, weâÄôre trying to get ahead of the curve and to determine what regulations are necessary or beneficial before thereâÄôs a problem,âÄù Hall said. Nanoresearch on human subjects is an urgent issue because it canâÄôt be governed and reviewed properly without specific guidelines, Wolf said. âÄúThe current standards donâÄôt really address nanomedicine research and some of the challenges,âÄù she said. âÄúSo thatâÄôs what weâÄôre trying to do.âÄù