Improving Protection for Human Research Subjects: Better Oversight, Not Just More Oversight

REFERENCES

• Agre , P. and Rapkin , B. 2003 . Improving informed consent: A comparison of four consent tools . IRB , 25 : 1 – 7 .
   PubMedGoogle Scholar
• Agre , P. , Campbell , F. A. Goldman , B. D. 2003 . Improving informed consent: The medium is not the message . IRB , : S11 – S19 .
   Google Scholar
• Burman , W. J. , Reves , R. R. , Cohn , D. L. and Schooley , R. T. 2001 . Breaking the camel's back: Multicenter clinical trials and local institutional review boards . Annals of Internal Medicine , 134 : 152 – 157 .
   PubMed Web of Science ®Google Scholar
• Burman , W. , Breese , P. , Weis , S. , Bock , N. , Bernardo , J. and Vernon , J. A. 2003 . The effects of local review on informed consent documents from a multicenter clinical trials consortium . Controlled Clinical Trials , 24 : 245 – 255 .
   PubMedGoogle Scholar
• Flory , J. and Emanuel , E. 2004 . Interventions to improve research participants' understanding in informed consent for research: A systematic review . Journal of the American Medical Association , 292 : 1593 – 1601 .
   PubMed Web of Science ®Google Scholar
• Emanuel , E. J. and Grady , C. 2007 . Four paradigms of clinical research and research oversight . Cambridge Quarterly of Healthcare Ethics , 16 : 82 – 96 .
   PubMed Web of Science ®Google Scholar
• Emanuel , E. J. , Wood , A. Fleischman , A. 2004 . Oversight of human participants research: Identifying problems to evaluate reform proposals . Annals of Internal Medicine , 141 : 282 – 291 .
   PubMed Web of Science ®Google Scholar
• Jefford , M. and Moore , R. 2008 . Improvement of informed consent and the quality of consent documents . Lancet Oncology , 9 : 485 – 493 .
   PubMed Web of Science ®Google Scholar
• Larson , E. , Bratts , T. , Zwanziger , J. and Stone , P. 2004 . A survey of IRB process in 68 U.S. hospitals . International Journal of Nursing Education Scholarship , 36 : 260 – 264 .
   Google Scholar
• McWilliams , R. , Hoover-Fong , J. , Hamosh , A. , Beck , S. , Beaty , T. and Cutting , G G. 2003 . Problematic variation in local institutional review of a multicenter genetic epidemiology study . Journal of the American Medical Association , 290 : 360 – 366 .
   Web of Science ®Google Scholar
• Office of the Inspector General, Department of Health and Human Services . 1998 . Institutional review boards-a time for reform , Washington, DC : DHHS .
   Google Scholar
• Office of the Inspector General, Department of Health and Human Services . 2000 . Protecting human research subjects—status of recommendations , Washington, DC : DHHS .
   Google Scholar
• Shamoo , A. E. and Schwartz , J. 2008 . Universal and uniform protections of human subjects in research . American Journal of Bioethics , 8 ( 11 ) : 3 – 5 .
   PubMed Web of Science ®Google Scholar
• Silverman , H. , Hull , S. C. and Sugarman , J J. 2001 . Variability among institutional review boards' decisions within the context of a multicenter trial . Critical Care Medicine , 29 : 235 – 241 .
   PubMed Web of Science ®Google Scholar