Human Subject Protection Regulations and Research Outside the Biomedical Sphere
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 can a journalist working for a newspaper interview and publish articles and books about sensitive issues, subject only to professional ethical guidance and legal consequences, while a journalism professor must seek prior approval from those outside journalism for the same activities? Is it good public policy to base the regulation of activities involving humans on where the research is performed, rather than on the nature of harm that might result?
Nationally, these questions, and others like them in anthropology, sociology, English, psychology, 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 apply--and from the first have been intended to--to “all” research in universities receiving federal funds.
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 stemming from an excess of care. This conference is intended to examine, from first ethical principles, research outside the biomedical sphere, and to formulate recommendations for improved approaches to their regulations and oversight.
Position papers (below) will form the basis of the April 11-12 working conference. Specifically, the conference will engage a set of structured conversations to address the lines between research and scholarship in the humanistic disciplines, much the way that medicine has worked to define the difference between therapeutic 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?
Goals of the conference are to publish a White Paper and/or a volume of position papers, and then to host a national conference, most likely in 2004, based upon the positions and publication(s). Our goal is for these conferences to contribute to shaping policy in this area.
Background
• C.K.
Gunsalus, College of Law, University of Illinois
Sample Guidelines for Non-Biomedical Research
• Oral
History
What is Research? What is an Experiment;
What is an Experiment that is Research?
• Greg Miller,
Psychology Department, University of Illinois at Urbana-Champaign
• Linda
Shopes, Pennsylvania Historical & Museum Commission
• Leon Dash, Journalism Department, University of Illinois at Urbana-Champaign
• David Wright, English Department, University of Illinois at Urbana-Champaign
What is Harm?
• Matthew
Finkin, College of Law, University of Illinois
• David Smith, Poynter Center, Indiana University
• Peter Finn, Psychology Department, Indiana University
How to Define, Assess and Balance Concepts of Risk
• Richard Campbell,
University of Illinois at Chicago
• Michael Pratt, Business Administration, University of Illinois at Urbana-Champaign
• Patricia
Marshall, School of Medicine, Case Western Reserve University
What Turns a Person into a Human Subject? How do We
Find, and Then Draw, the Lines?
• Bob
Steele, Poynter Institute, St. Petersburg, Florida
• David Boeyink, Poynter Center, Indiana University
Cross Cutting/Emerging Issues
• Cary Nelson,
English Department, University of Illinois at Urbana-Champaign
• Norm Denzin,
Institute for Communications Research, University of Illinois at Urbana-Champaign
• Felice Levine, AERA
• Ann Gellis, School of Law, Indiana University
• Lizanne DeStefano, College of Education, University of Illinois at Urbana-Champaign
