cas: initiative 2002-2003 click to read full-size An Examination of the Interaction Between Human Subject Protection Regulations and Research Beyond the Biomedical Sphere. CAS Resident Associate C.K. Gunsalus (Law, LAS, Legal Counsel) When a faculty member writes about students and the teaching process, when is that an "interaction" with human subjects that is or should be covered by federal research regulations? Is it appropriate or a good use of resources for a central institutional review board to govern the questions to be asked and how records are kept and used by faculty and graduate students conducting oral history interviews? Why, under federal policy, is it the case that a journalist working for a newspaper can interview and publish articles and books about sensitive issues, subject only to professional ethical guidance and legal consequences, but a journalism professor must seek prior approval from those outside journalism for the same activities? Nationally, these questions, and others like them in anthropology, sociology, english, law, education and other humanistic disciplines are causing increasing controversy. While we have several decades of close analysis starting from first ethical principles to provide guidance to researchers and regulators in biomedical and behavioral research, there is no such body of work in the humanistic disciplines. Yet the regulations--and from the first have been intended to--apply to "all" research in universities. In an environment of heightened sensitivity to ethical issues involving human subjects rooted in recent well-publicized deaths from experimental genetic therapies to the controversy over stem cell research and cloning, some local reviewing bodies have become hyper-cautious. With prominent reminders of the costs to universities when problems develop, institutional officials and review board members are making new and ever-more stringent interpretations of existing regulations out of an excess of care. Questions about academic freedom and prior restraint that generally do not arise in biomedical or behavioral research assume a larger dimension and take on some urgency when an IRB tells a journalism or english professor what he or she may or may not write. CAS Resident Associate C.K. Gunsalus has organized a two-day conference with participants from UIUC and other academic institutions, as well as representatives from various professional organizations (including AHA, OHRP, NSF, AAU). Participants will address the lines between research and scholarship in the humanistic disciplines, much the way that medicine has worked to define the difference between theraputic treatment and research. What scholarly activities constitute "research" on human subjects that should be subject to advance review and approval? When an activity falls within the regulatory scope, what should the review process be and who should be involved? What disciplinary guidelines exist or need to be developed to guide these developments? Human Subject Protection Conference set for April 11-12, 2003, Law Auditorium Sponsored by the Center for Advanced Study, College of Law, College of Liberal Arts and Sciences, and the Vice Chancellor for Research More information about the conference is available on the Law website. Improving the System for Protecting Human Subjects: Counteracting IRB "Mission Creep" (2005). The Illinois White Paper.