The Nanny state meets the inner lawyer: Overregulating while underprotecting human participants in research

Ethics and Behavior

Volumn 14, Issue 4, 2004, Pages 369-382

  Gunsalus, C K ^a  

^a UNIVERSITY OF ILLINOIS AT URBANA CHAMPAIGN   (United States)

Author keywords

Human interaction; Oral history; Overregulating research; Post hoc complaint system; Underprotecting human participants

Indexed keywords

EID: 12944268788     PISSN: 10508422     EISSN: None     Source Type: Journal    
DOI: 10.1207/s15327019eb1404_7     Document Type: Review

References (23)

1. Borror, K. C. (2002). Memo to Ming T. Tsuang and Lester Grinspoon. Retrieved November 18, 2004, from http://www.hhs.gov/ohrp/detrm_letrs/YR02/jul02g.pdf
2. Brabin, P. J., & Berah, E. F. (1995). Dredging up past trauma: Harmful or helpful? Psychiatry, Psychology and Law, 2, 165-171.
3. Burman, W. J., Reeves, R. R., Cohn, D. L., & Schooley, R. T. (2001). Breaking the camel's back: Multi-center trials and local institutional review boards. Annals of Internal Medicine, 134, 152-157.
4. Carome, M. A. (2003). Letter to Linda Shopes and Donald A. Ritchie. Retrieved November 18, 2004, from http://www.historians.org/press/IRBLetter.pdf
5. Committee on National Statistics, Board on Behaviorial, Cognitive, and Sensory Sciences and Education. (2003). Protecting participants and facilitating social and behavioral sciences research. Washington, DC: National Academies Press.
6. Dyregrov, K., Dyregrov, A., & Raundalen, M. (2000). Journal of Traumatic Stress, 12, 413-426.
7. Federal Policy for the Protection of Human Subjects. 45 C.F.R. § 46 (2001). Retrieved November 9, 2004. from http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
8. Fendrich, M. (2004, July). Suggested OHRP advisories to IRBs and survey research review. Paper presented at the Secretary's Advisory Committee on Human Research Protections Social and Behavioral Research Issues Panel. Retrieved August 12, 2004, from www.hhs.gov/ohrp/sachrp/mtgings/mtg07-04/present.htm
9. Getz, K. (2004, June). PowerPoint presentation at the Drug Information Association annual meeting, Washington, DC.
10. Gunsalus, C. K. (1998. September). An examination of the issues in unifying and expanding federal oversight of human subjects in research. Commissioned Paper for the National Bioethics Advisory Commission. Bethesday, MD: National Bioethics Advisory Commission.
11. Illinois White Paper, (in press). Human subjects protection outside the biomedical arena (Tech. Rep. No. 9). Urbana: University of Illinois Press.
12. Levine, R. J. (2001). Institutional review boards: A crisis in confidence. Annals of Internal Medicine, 134, 161-163.
13. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report: Ethical principles and guidelines for the protection of human subjects (Federal Register Document No. 79-12065). Washington, DC: U.S. Government Printing Office.
14. Nelson, C., & Watt, S. (2004). Office hours: Activism and change in the academy. New York: Routledge.
15. Newman, E., Walker, E. A., & Gefland, A. (1999). Assessing the ethical costs and benefits of trauma-focused research. General Hospital Psychiatry, 1, 187-196.
16. Office of Inspector General, Department of Health and Human Services. (1998). Institutional review boards: A time far reform (OEI Publication No. 01-97-00193). Washington, DC: U.S. Government Printing Office.
17. Protecting Human Beings: Institutional Review Boards and Social Science Research. (2001. May-June). Academe.
18. Ruzek, J. I., & Zatzick, D. F. (2000). Ethical considerations in research participation among acutely injured trauma survivors: An empirical investigation. General Hospital Psychiatry, 22, 27-36.
19. Sieber, J. E. (2003. October). An open-syste ms model for evaluating institutional review boards that oversee social and behavioral research. Paper presented at FOCUS: Forum for Institutional Review Boards (IRBs)/Research Ethics Boards (REBs) in Canada and the United States; Montreal. Quebec, Canada.
20. Sieber, J. E. (2004/this issue). Empirical research on research ethics. Ethics & Behavior, 14, 297-304.
21. Sieber, J. E., Planner, S., & Rubin, P. (2002). How (not) to regulate social and behavioral research. Professional Ethics Report, 15, 1-4.
22. Social Sciences and Humanities Research Ethics Special Working Committee to the Interagency Advisory Panel on Research Ethics. (2004). Giving voice to the spectrum. Retrieved August 12, 2004, from http://www.pre.ethics.gc.ca/english/workgroups/sshwc/SSHWCRptMay2004.cfm
23. Walker, E. A., Newman, E., Koss, M., & Bernstein, D. (1997). Does the study of victimization revictimize the victims? General Hospital Psychiatry, 19, 403-410.