All Bookmarks

HHS announces proposal to improve rules protecting human research subjects

Changes under consideration would ensure the highest standards of protections for human subjects involved in research, while enhancing effectiveness of oversight

The U.S. Department of Health and Human Services announced today that the federal government is contemplating various ways of enhancing the regulations overseeing research on human subjects. Before making changes to the regulations – which have been in place since 1991and are often referred to as the Common Rule – the government is seeking the public’s input on an array of issues related to the ethics, safety, and oversight of human research. The changes under consideration can be found in an Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, published in the July 25 Federal Register. The proposed changes are designed to strengthen protections for human research subjects.

Saved once (save to my bookmarks)
Bookmarked by Dina Bogecho on 1 Aug 2011
0 points

Useless Studies, Real Harm: Neurontin study more marketing than science: report

Useless Studies, Real Harm
By CARL ELLIOTT

LAST month, the Archives of Internal Medicine published a scathing reassessment of a 12-year-old research study of Neurontin, a seizure drug made by Pfizer. The study, which had included more than 2,700 subjects and was carried out by Parke-Davis (now part of Pfizer), was notable for how poorly it was conducted. The investigators were inexperienced and untrained, and the design of the study was so flawed it generated few if any useful conclusions. Even more alarming, 11 patients in the study died and 73 more experienced “serious adverse events.” Yet there have been few headlines, no demands for sanctions or apologies, no national bioethics commissions pledging to investigate. Why not?

Saved once (save to my bookmarks)
Bookmarked by Dina Bogecho on 1 Aug 2011
0 points

Equity, social determinants and public health programmes

Equity, social determinants and public health programmes

Edited by Erik Blas and Anand Sivasankara Kurup 2010, 300 pages
ISBN 978 92 4 156397 0
World Health Organization 2010

Available online PDF [300p] at: http://bit.ly/cv95bR

“…This book is a collection of analyses of the social determinants of health that impact on specific health conditions. Stemming from the recommendations of the Commission on Social Determinants of Health, promising interventions to improve health equity are presented for the areas of: alcohol-related disorders, cardiovascular diseases, child health and nutrition, diabetes, food safety, maternal health, mental health, neglected tropical diseases, oral health, pregnancy outcomes, tobacco and health, tuberculosis, and violence and injuries.

The book was commissioned by the Department of Ethics, Equity, Trade and Human Rights as part of the work undertaken by the Priority Public Health Conditions Knowledge Network of the Commission on Social Determinants of Health, in collaboration with 16 of the major public health programmes of WHO. In addition to this, through collaboration with the Special Programme of Research, Development and Research Training in Human Reproduction, the Special Programme for Research and Training in Tropical Diseases, and the Alliance for Health Policy and Systems Research, 13 case studies were commissioned to examine the implementation challenges in addressing social determinants of health in low-and middle-income settings….”

To know more about the work of WHO on social determinants of health, please visit: www.who.int/social_determinants/en

Saved once (save to my bookmarks)
Bookmarked by Dina Bogecho on 21 Jul 2011
0 points

Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials Jill A. Fisher

New book that may be of interest to the bioethics community.

Saved once (save to my bookmarks)
Bookmarked by Dina Bogecho on 4 Jul 2011
0 points

Panel on Research Ethics Launches the TCPS 2 Tutorial

The Interagency Advisory Panel on Research Ethics is pleased to announce the launch of a new, online tutorial, TCPS 2: Course on Research Ethics (CORE). CORE was designed to support the Canadian research community’s implementation of the 2nd edition of the Tri-council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2).

Saved once (save to my bookmarks)
Bookmarked by Dina Bogecho on 21 Jun 2011
0 points