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Add up the number of citations of noncompliance related to IRB issues that the Office of Human Research Protections (OHRP) at the Department of Health and Human Services in Rockville, MD, handed out between October 1998 and June 2002 and the numbers are pretty staggering. Of the 1,120 citations given to 155 institutions, 1,014 of them say something about IRB noncompliance and deficiencies.
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The regulations regarding the use of prisoners in research have not changed since 1978, but the research communitys awareness and perception of these have changed. As a result its a good idea for IRBs to update policies regarding such research.
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IRBs and institutions might take away two important thoughts from the NIHs recent experience: First, it doesnt take more than the appearance of a conflict to harm ones reputation. Secondly, some of the measures NIH has taken in response might guide institutions in their own conflict of interest (COI) policy-making.
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The bivalent HPV vaccine was efficacious in prevention of incident and persistent cervical infections with HPV-16 and HPV-18, and associated cytological abnormalities and lesions. Vaccination against such infections could substantially reduce incidence of cervical cancer.
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Cantor and Baum, lawyers from the Yale University School of Medicine, have written an op-ed piece in the New England Journal of Medicine focusing on the central role of pharmacists in providing emergency contraception.
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GEMINI Trial; CAMELOT Trial; INVEST Trial; The Dangers of Vitamin E; FDA Actions.
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Raloxifene treatment of postmenopausal women with osteoporosis is associated with a lower incidence of estrogen receptor-positive invasive breast cancer.
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This study demonstrates that a sequential screening program that provides patients with first-trimester results and offers the option for early invasive testing or additional serum screening in the second trimester can detect 98% of trisomy 21-affected pregnancies. However, such an approach will result in 17% of patients being considered at risk and, hence, potentially having an invasive test.
