IRB Advisor 2002-12-01

IRB review of smallpox vaccine study receives national public scrutiny

Once a final decision is made regarding some proposed research involving very young children and an older smallpox vaccine, there could be long-term repercussions for IRBs nationwide.

In a nutshell: Facts about the Dryvax study

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.

Lengthy consent form still needs adjustments

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.

Shift in philosophy was outgoing director’s goal

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.

Spotlight on Compliance: New legislation will change human research oversight

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.

Poor countries may not benefit from research

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.

Here are CIOMS research guidelines in a nutshell

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.

White House wants embryos protected

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.

2002 Index

A list of all IRB Advisor articles published in 2002, organized by topic.

IRB Advisor – December 1, 2002

December 1, 2002