Who’s Minding The Kids? IRB’s & Pediatric Research
2 CommentsBy Ed Silverman // September 26th, 2008 // 1:32 pm
Members of institutional review boards (IRBs) that review protocols involving children may not have adequate understanding of pediatric research regulations, according to a pilot study published in IRB: Ethics & Human Research by The Hastings Center, a nonpartisan, nonprofit bioethics research institute.
The center evaluated 71 eligible IRB members, and 41 responded to five multiple choice questions. Most respondents considered themselves “well prepared” or “very well prepared” to perform common IRB tasks. However, the median knowledge score was one correct answer.
Some other interesting revelations: 13, or 32 percent, replied that they did not have prior training in review of pediatric protocols. And 20, or 49 percent, responded that they did not have professional experience in child health or development.
The Hastings Center concludes that the data suggest the need for comprehensive evaluation of IRB member knowledge and for education regarding pediatric research review. You can look at the questions and answers here.
andres heuberger
Good post!
We found some of the same concerns in Europe as well. Ulrich Granzer discussed some of the issues in a recent audio conference on the pediatric rule in Europe (http://www.fxconferences.com/Industry-Update-The-EU-Paediatric-Rule-P203.aspx). Judging by the level of interest that the event drew, this is a hot - and confusing - topic.
Dan A.
Institutional Review Boards, like the Contract Research Organizations (CROs), are for profit corporations and the two same companies often work together on clinical trial projects.
CROs are a 20 billion dollar a year market now, so this is concerning to some who believe that the trials are void of proper monitoring.
If anyone is interested, going on to http://www.fda.gov and searching these issues will reveal only ‘guidance’ proposals for IRBs, CROs, and investigators that are speculative at best. Sponsors are rarely mentioned in these documents.