Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants

Our colleagues at AAHRPP recently brought to our attention a new World Health Organization publication, “Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants.” This document "has been developed for individuals and organizations involved in health-related research with human participants, including biomedical, behavioural, social science, and epidemiological research...In particular, this document is intended to provide guidance to the research ethics committees (RECs) on which organizations rely to review and oversee the ethical aspects of research, as well as to the researchers who design and carry out health research studies."
http://www.who.int/ethics/publications/en/

Clinical Trials in India: ethical challenges?

The Washington Post and Associated Press on Monday featured an article about ethical challenges in clinical trials being conducted in India. The article reported, "Since India eased guidelines for conducting drug trials in 2005, the number of Indians participating has shot up to 150,000 from close to zero, as international drug companies take advantage of lower costs here. But questions about the consent process have fueled fears that many Indians are entering the trials without knowing the risks." An Indian journal editor quoted in the article said, ""India is emerging as a hub for drug trials, and Indian patients are like guinea pigs...The ethical review panels are bogus...The drug control authority approves almost all the trial applications without rigorous scrutiny. And poor, unsuspecting patients get duped, while doctors and hospitals earn money."http://lists.aamc.org/t/153809/795361/15339/0/

Presidential Commission for the Study of Bioethical Issues: Washington Post editorial

An editorial in Monday's Washington Post reviewed some of the major recommendations of the Presidential Commission for the Study of Bioethical Issues in its new report, ""Moral Science: Protecting Participants in Human Subjects Research."http://tinyurl.com/7y9da2e http://lists.aamc.org/t/153809/795361/15110/0/