-
The 10-page human subjects consent form proposed for the Dryvax vaccination study of children, ages 2 to 5, has a number of flaws, according to the IRBs and experts who have reviewed the study proposal and consent form.
-
In an interview with IRB Advisor, Greg Koski talks about the initiatives launched and the success realized during his time as director of the Office for Human Research Protections.
-
Recently updated guidelines for human subjects biomedical research highlight the international research communitys concerns that studies conducted in poor nations may give too little attention to the health and well-being of participants who have few options and fewer medical resources.
-
The proposal for the study, A Multicenter, Randomized Dose Response Study of the Safety, Clinical and Immune Responses of DryVax Vaccine Administered to Children 2 to 5 Years of Age, provides the following details.
-
The continuing publicity surrounding both ever increasing public financial support for clinical research and claims of improper human research activities has led to calls for additional oversight of the clinical research enterprise.
-
The Council for International Organizations of Medical Sciences (CIOMS) published in October 2002 its revised and updated International Ethical Guidelines for Biomedical Research Involving Human Subjects. Here is a brief look at the new and revised guidelines.
-
A new federal advisory panel that will provide ethical guidance for researchers engaged in studies involving human subjects has been charged by the Bush administration to consider human embryos to be human subjects, deserving of the same protections currently afforded fetuses, children, and adults.
-
A list of all IRB Advisor articles published in 2002, organized by topic.
-
As IRBs focus more on efficiency and streamlining, the chief concern involves maintaining the necessary elements while discarding or simplifying everything else. This delicate balance is especially true for streamlining informed consent documents.
-
When it comes to training community partners on human research protection ethics, IRBs would do well to create educational content that best suits the needs of those partners, an IRB chair suggests.
