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This week’s news is divided into three sections. First is Regulatory
News, second is General News and third is Journal Articles.
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Regulatory News ()
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Spanish
Web Page, Office for Human Research Protections(OHRP) Web Site, Dec 13, 2005
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The
Office for Human Research Protections has recently launched its new Spanish web page. The Spanish web page includes:
- 45 CFR 46, subparts A, B, C, and D
- Step-by-Step Instructions to Register an IRB
- Instructions for IRB Updates
- Terms of the Federalwide Assurance (FWA)
- Step-by-Step Instructions for an FWA application
- Instructions for FWA Updates
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General News ()
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Researcher
tries to distance himself from cloning work, Seattle Times, Dec 14, 2005
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"Some
of stem-cell researcher Hwang Woo-suk's high-profile human cloning work announced earlier this year may have been "fabricated," a former top collaborator charged as he attempted to distance himself from the groundbreaking research…"
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Fraud
earns researcher time in jail, The Scientist, Dec 13, 2005
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"A
Veterans Administration researcher based in New York was sentenced to almost 6 years in jail after he admitted to doctoring patient test results – an extreme punishment for an extreme crime, experts say…"
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Human
brain cells working in mice, The Seattle Times, Dec 13, 2005
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"By
injecting human embryonic stem cells into the brains of fetal mice inside the womb, scientists in California have created living mice with working human brain cells…Reflecting growing concerns about the ethics of making animal-human hybrids, the National Academy of Sciences earlier this year released voluntary guidelines on chimera research that have been adopted by major research institutes and have been made mandatory in California for state grant recipients…"
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Guidelines
for Human Embryonic Stem Cell Research, Committee on Guidelines for Human Embryonic Stem Cell Research, National Research Council, April 26, 2005 ()
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When
researchers are the guinea pigs. Should scientists be allowed to continue studying themselves?, Boston Globe, Dec 12, 2005
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"…Self-experimentation,
though controversial, is a tradition that dates back centuries… But the ethical issues surrounding such research remain unresolved…"
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Journal:
Bad Vioxx outcomes not disclosed, Boston Globe, Dec 8, 2005
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"Authors
of a study funded by Vioxx maker Merck & Co. failed to disclose in a report published in the New England Journal of Medicine in 2000 that three additional patients in a clinical study suffered heart attacks while using the now-withdrawn painkiller, the journal wrote in an editorial released Thursday…"
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Editorial:
Expression of Concern: Bombardier et al., "Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis," N Engl J Med 2000;343:1520-8, Curfman et al., New England Journal of Medicine, early publication, Dec 8, 2005 ()
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Press
Release: Human Research Protection Award Recipients Announced, Dec 8, 2005
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"Winners
of the 2005 Award for Excellence in Human Research Protection were announced today by Dr. Peter G. Goldschmidt, President and Founder of the Health Improvement Institute…"
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Journal Articles ()
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Behavioral
and Social Issues Among Volunteers in a Preventive HIV Vaccine Trial in Thailand, Jenkins et al., Journal of Acquired Immune Deficiency Syndromes 40, Dec 15, 2005 ()
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Assessing
the Attitudes, Knowledge, and Awareness of HIV Vaccine Research Among Adults in the United States, Allen et al., Journal of Acquired Immune Deficiency Syndromes 40, Dec 15, 2005 ()
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Designing
research in vulnerable populations: lessons from HIV prevention trials that stopped early, Mills et al. British Medical Journal 331: 1403-1406, Dec 10, 2005 ()
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Payment
to healthcare professionals for patient recruitment to trials: a systematic review, Bryant and Powell, British Medical Journal 331: 1377-1378, Dec 10, 2005 ()
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Oocyte
and Somatic Cell Procurement for Stem Cell Research, Kyu Won Jung and Insoo Hyun, American Journal of Bioethics 5, Nov/Dec 2005 ()
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A
Commentary on Oocyte Donation for Stem Cell Research in South Korea, Magnus and Cho, American Journal of Bioethics 5, Nov/Dec 2005 ()
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