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Scholar Results 1 - 10 of about 97 citing Burman: Breaking the camel's back: multicenter clinical trials and local institutional review boards. (0.12 sec) 

Problematic variation in local institutional review of a multicenter genetic epidemiology study

- psu.edu [PDF] 
R McWilliams, J Hoover-Fong, A Hamosh, S … - Jama, 2003 - Am Med Assoc
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Cited by 91 - Related articles - BL Direct - All 9 versions

[CITATION] Improving protection for research subjects


R Steinbrook - The New England journal of medicine, 2002 - nejm.highwire.org
Clinical research in the United States is under scrutiny for many reasons. These
include the deaths of subjects; problems with the review and monitoring of
research at leading medical centers, such as those at Duke University and ...
Cited by 86 - Related articles - BL Direct - All 5 versions

A central institutional review board for multi-institutional trials


MC Christian, JL Goldberg, J Killen, JS … - New England Journal of Medicine, 2002 - content.nejm.org
We believe that the effectiveness of IRBs has been undermined by many factors
that are, in part, the consequence of a system that has failed to adapt to major
changes that have occurred in the research environment since the IRB system ...
Cited by 79 - Related articles - BL Direct - All 5 versions

Monitoring and ensuring safety during clinical research


MA Morse, RM Califf, J Sugarman - JAMA, 2001 - Am Med Assoc
Increased numbers of clinical trials, many of which are large, multicenter, and
sometimes international, and the marked shift of funding for clinical trials to
industry have made apparent the inadequacy of mechanisms for protecting ...
Cited by 65 - Related articles - All 4 versions

Randomized, controlled trial of an easy-to-read informed consent statement for clinical trial …

- ascopubs.org
CA Coyne, R Xu, P Raich, K Plomer, M Dignan … - Journal of Clinical Oncology, 2003 - jco.ascopubs.org
Purpose: Studies have documented that the majority of consent documents for
medical diagnosis and treatment are written at a reading level above that of the
majority of the US population. This study hypothesized that use of an ...
Cited by 53 - Related articles - BL Direct - All 7 versions

[BOOK] Ethical conduct of clinical research involving children


MJ Field, RE Behrman, 2004 - books.google.com
THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001 NOTICE:
The project that is the subject of this report was approved by the Govern- ing
Board of the National Research Council, whose members are drawn from the ...
Cited by 43 - Related articles - All 4 versions

When does quality improvement count as research? Human subject protection and theories …

- bmj.com
J Lynn - British Medical Journal, 2004 - qshc.bmj.com
The publication of insights from a quality improvement project recently
precipitated a ruling by the lead federal regulatory agency that regulations
providing protection for human subjects of research should apply. The ...
Cited by 42 - Related articles - BL Direct - All 10 versions

The effects of local review on informed consent documents from a multicenter clinical trials …


W Burman, P Breese, S Weis, N Bock, J … - Controlled clinical trials, 2003 - Elsevier
There is increasing controversy about the appropriate role of the local
institutional review board in the review of multicenter clinical studies. We
evaluated the effects of the local review process at 25 study sites on the ...
Cited by 39 - Related articles - All 7 versions

Impact of institutional review board practice variation on observational health services …


LA Green, JC Lowery, CP Kowalski, L … - Health services research, 2006 - pubmedcentral.nih.gov
Address correspondence to Lee A. Green, MD, MPH, Associate Professor, Department
of Family Medicine, University of Michigan, 1018 Fuller, Campus 0708, Ann
Arbor,MI 48109. Julie C. Lowery, Ph.D., MHSA, is Associate Director of ...
Cited by 30 - Related articles - BL Direct - All 6 versions

In defense of the Hopkins lead abatement studies


LF Ross - JL Med. & Ethics, 2002 - heinonlinebackup.com
We hold that in Maryland, a parent, appropriate relative, or other applicable
surrogate, cannot con- sent to the participation of a child or other person
under legal disability in nontherapeutic research or studies in which there ...
Cited by 27 - Related articles - BL Direct - All 5 versions


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