Human research protections: Time for regulatory reform?

Hastings Center Report

Volumn 38, Issue 2, 2008, Pages 19-22

  Maschke, Karen J ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

EID: 42349109048     PISSN: 00930334     EISSN: None     Source Type: Journal    
DOI: 10.1353/hcr.2008.0029     Document Type: Article

References (13)

1. E. Anthes and S. Allen, "U.S. Cancer Researchers Go Abroad for Trials," Boston Globe, December 29, 2007.
2. R.M. Veatch, "Protecting Human Subjects: The Federal Government Steps Back," Hastings Center Report 11, no. 3 (1981): 9-11.
3. E.J. Emanuel, D. Wendler, and C. Grady, "What Makes Clinical Research Ethical?" Journal of the American Medical Association 283 (2000): 2701-2711.
4. R.F. Weir and R.S. Olick, The Stored Tissue Issue: Biomedical Research, Ethics, and Law in the Era of Genomic Medicine (Oxford, U.K.: Oxford University Press, 2004).
5. See M.A. Baily et al., "The Ethics of Using QI Methods to Improve Health Care Quality and Safety," Hastings Center Report Special Report 36, no. 4 (2006): S1-S40.
6. See D. Doezema and M. Hauswald, "Quality Improvement or Research: A Distinction without a Difference?" IRB: Ethics & Human Research 24, no. 4 (2002): 9-12.
7. D.B. Resnik, "Are the New EPA Regulations Concerning Intentional Exposure Studies Involving Children Overprotective?" IRB: Ethics & Human Research 29, no. 5 (2007): 15-18.
8. N. Jacobson, R. Gewurtz, and E. Haydon, "Ethical Review of Interpretive Research: Problems and Solutions," IRB: Ethics & Human Research 29, no. 5 (2007): 1-8.
9. M. Shuchman, "Commercializing Clinical Trials-Risks and Benefits of the CRO Boom," New England Journal of Medicine 357 (2007): 1365-68.
10. D.A. Zarin et al., "Issues in the Registration of Clinical Trials," Journal of the American Medical Association 297 (2007): 2112-20.
11. K. Barnes, "China 'Most Attractive' Offshore Clinical Trial Option," DrugResearcher.com, April 1, 2007; http://www. drugresearcher.com/news/ng.asp?n=72702-a-t-kearney-china-offshoring-clinical- trials.
12. J.F. Flory and E. Emanuel, "Interventions to Improve Research Participants' Understanding in Informed Consent for Research," Journal of the American Medical Association 292 (2004): 1593-1601.
13. C. Coleman, "Rationalizing Risk Assessment in Human Subject Research," Arizona Law Review 46, no. 1 (2004): 1-49.