Although the Code of Federal Regulations has provided guidelines regarding research involving vulnerable participants, persons not traditionally identified may also be considered vulnerable at a given time due to emergent or acute illness, end-of-life needs, or circumstances encountered that challenge capacity to provide informed consent. In this column, the author presents an overview of institutional review board roles, responsibilities, processes, and suggestions regarding assessment of vulnerability and capacity to consent that is responsive to current societal and healthcare needs.
Benoliel, J. Q. (1975). Research related to death and the dying patient. In P. J. Verhonick (Ed.), Nursing research I (pp. 189-227). Boston: Little, Brown.
2.
Casarett, D. J., & Karlawish, J. H. T. (2000). Are special ethical guidelines needed for palliative care research?Journal of Pain and Symptom Management, 20, 130-139.
3.
De Raeve, L. (1994). Ethical issues in palliative care research. Palliative Medicine, 8, 298-305.
4.
Dean, R. A., & McClement, S. E. (2002). Palliative care research: Methodological and ethical challenges. International Journal of Palliative Nursing, 8, 376-380.
5.
Disability and Rehabilitation Research Projects and Centers Program, 34 C. F. R. §350 (n. d.). Retrieved July 3, 2005, from www.ed.gov/policy/fund/reg/humansub/34cfr350.html
6.
Dobratz, M. C. (2003). Issues and dilemmas in conducting research with vulnerable home hospice participants. Journal of Nursing Scholarship, 35, 371-376.
7.
Hirshon, J. M., Krugman, S. D., Witting, M. D., Furuno, J. P., Limcangco, M. R., Perise, A. R., et al. (2002). Variability in institutional review board assessment of minimal risk research. Academic Emergency Medicine, 9, 1417-1420.
8.
Kovacs, P. J. (1998). Hospice research: Challenges, opportunities and rewards. The American Journal of Hospice & Palliative Care, 15, 295-300.
9.
Larson, E., Bratts, T., Zwanziger, J., & Stone, P. (2004). A survey of IRB process in 68 U.S. hospitals. Journal of Nursing Scholarship, 36, 260-264.
10.
McWilliams, N. A., Jones, E. L., & Davies, R. J. (2003). Problematic variation in local institutional review of a multicenter genetic epidemiology study. JAMA, 290, 360-366.
11.
Moser, D. J., Schultz, S. K., Arndt, S., Benjamin, M. L., Fleming, F. W., Brems, C. S., et al. (2002). Capacity to provide informed consent for participation in schizophrenia and HIV research. The American Journal of Psychiatry, 159, 1201-1207.
12.
Oldham, J. M., Haimowitz, S., & Delano, S. J. (1999). Protection of persons with mental disorders from research risk: A response to the report of the National Bioethics Advisory Commission. Archives of General Psychiatry, 56, 688-693.
13.
Penslar. R. L. (1993). Institutional review board guidebook (chap. 6). Retrieved February 17, 2005, from http://www.hhs.gov/ohrp/irb/irb_chapter6.htm
14.
Polit, D. F., & Beck, C. T. (2004). Nursing research: Principles and methods (7th ed.). Philadelphia: Lippincott Williams & Wilkins.
15.
Protection of Human Subjects, 45 C. F. R. §46 (2001).
16.
Raudonis, B. (1992). Ethical considerations in qualitative research with hospice patients. Qualitative Health Research, 2, 238-249.
