IRB Advisor articles from May 2006

IRB Advisor archives from May 2006

Clinical trial problems in England raise ethical questions in US.
May 1, 2006... Clinical trial problems in England raise ethical questions in US Could IRBs require more information from protocols? Three weeks after a phase I clinical trial ended terribly wrong, four of the six London, England, volunteers remained...

Research is changing IRB views about PTSD studies.
May 1, 2006... Research is changing IRB views about PTSD studies Risks of harm may be less than previously believed In the past, IRBs considering protocols that sought to survey or interview trauma victims had to essentially follow their gut when...

Consent, confidentiality key in PTSD research.
May 1, 2006... Consent, confidentiality key in PTSD research Spell out what will be asked, and who will see it While recent studies have shown that interviews with trauma victims may not cause serious harm, and in fact can be beneficial, there still...

Spotlight On Compliance: The FDA launches guidance initiative.
May 1, 2006... The FDA launches guidance initiative J. Mark Waxman, JD Partner Foley & Lardner Boston Mr. Waxman reports no financial relationships with companies related to the content in this CE/CME activity. To keep IRBs...

Liaison efforts can improve compliance.
May 1, 2006... Liaison efforts can improve compliance Survey director worked at IRB Compliance in research oversight has become a more prevalent concept in recent years, and this has led IRBs and research institutions to search for new ways to...

Guest Column: Different disciplines, similar challenges.
May 1, 2006... Guest Column Different disciplines, similar challenges Biomedical vs. social science Marjorie Speers, PhD Executive Director Association for the Accreditation of Human Research Protection Programs Dr. Speers...

CE/CME objectives/questions.
May 1, 2006... CE/CME objectives The CE/CME objectives for IRB Advisor are to help physicians and nurses be able to: *establish clinical trial programs using accepted ethical principles for human subject protection; *apply the mandated...