1980 B.G.S., University of Iowa
1984 D.D.S., University of Iowa
1991 Ph.D., University of Iowa
1991-94 Postdoctoral Cancer Research Institute Fellow, Stanford University
Research using humans as subjects requires oversight as mandated by federal regulations. The system is broken and at both ends. On the high risk biomedical end, it can be difficult to get expert reviewers that are not involved in the study. Overworked and overwhelmed reviewers may not have sufficient time to adequately review proposals. Board meetings are often inundated with proposals that allow little time for adequate discussion of potential risks. In contrast, minimal risk research, both biomedical and social, educational and behavioral is frequently subjected to the same degree of explanation/amount of description as research with potentially more risk. An investigator wishing to review medical charts or to conduct an anonymous survey about shoe preference still needs to complete the same application and endure the same process as an investigator who is using a novel compound in humans for the first time. Since the background level of risk, as defined in the regulations, is “daily life” it is difficult to understand how having multiple reviewers look at an application asking to collect de-identified data from medical charts will add protections to human subjects. It is equally difficult to understand how an investigator wishing to post an internet survey about shoe preference will be protecting human subjects by filling out a 10 or more page application.
If one can reduce the burden of application and review by minimal oversight of minimum risk research, one will also help in improving review of more than minimum risk research. Reviewers will have more time to consider individual applications and board meetings will have more time to spend on each proposal. As a part of a national forum to reduce burden on academics the Federal Demonstration Partnership, (FDP) I am the instigator of an electronic smart form, or wizard, to allow investigators to self determine if their research meets the criteria for an exempt determination, as described in the federal regulations. Starting in the fall of 2012, schools participating in the wizard will “dual” review proposals and a comparison of how the board/reviewer versus the wizard makes exempt decisions will be made. Should the demonstration be successful, allowing investigators to use the wizard to determine if their projects are exempt will greatly reduce the burden on investigators, reviewers and IRB staff.
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Sandalon Z, Fusenig NE, McCutcheon J, Taichman LB, Garlick JA. Suicide gene therapy for premalignant disease: a new strategy for the treatment of intraepithelial neoplasia. Gene Ther. 2001 Feb;8(3):232-8.
Tobacco reduces membrane HLA class I that is restored by transfection with TAP1 cDNA. Craig I. Fine, C. David Han, Xuming Sun, Yuexun Liu, and Jane A. McCutcheon J. Immunol. (2002) 169:6012-6019.
J. A. McCutcheon, H. Yee, R. Hayashi, B. Licari, D. Lombardo, P.A. Rosenberg and J. Phelan. Identification of γδT lymphocytes in human periapical lesions Oral Microbiology and Immunology. (2004). 19:106-110.
Post-transcriptional Regulation of Neuronal Nitric Oxide Synthase Expression by Interferon-γ. David A. Chesler, Jane A. McCutcheon, and Carol Shoshkes Reiss J. Interferon and Cytokine Research (2004). 24:141-149.