IRB Advisor articles from November 2008

IRB Advisor archives from November 2008

Bad seed? Critics say drug study more marketing than medicine.
November 1, 2008... Bad seed? Critics say drug study more marketing than medicine Merck says research was legitimate science Many in IRB circles have worried about the potential existence of "seeding" trials, which are defined as clinical trials that seek...

Kill it before it grows: IRBs and seeding trials.
November 1, 2008... Kill it before it grows: IRBs and seeding trials Hard to detect, but watch for red flags IRBs striving to ensure they're not inadvertently approving a seeding trial have a tough job ahead of them. Because of the nature of the...

Pain enrollees cite complex reasons.
November 1, 2008... Pain enrollees cite complex reasons Patients do own risk-benefit calculation People participating in pain research report having complex combinations of reasons for enrolling -- part altruism, part seeking new treatments, part simply...

New SACHRP chair looks to the future.
November 1, 2008... New SACHRP chair looks to the future Q&A focuses on harmonization & IC Barbara Bierer, MD, professor of medicine at Harvard Medical School, and the senior vice president for research and the director of faculty development and...

Two Questions for Marjorie Speers of AAHRPP.
November 1, 2008... Two Questions for Marjorie Speers of AAHRPP IRB accreditation rules explained IRB Advisor: Dr. Marjorie Speers, would you please explain how AAHRPP accreditation requirements work with regard to institutions that are seeking...

High 'Hope": Private institute overcomes IRB obstacles.
November 1, 2008... High 'Hope": Private institute overcomes IRB obstacles Accreditation process took about two years Accreditation for an academic research institution is a time-consuming and difficult process for the research office and the...

Real time: Web-based data system for CTs.
November 1, 2008... Real time: Web-based data system for CTs Recruitment was on time; results were quick A new web-based data management system serving clinical research has improved data collection and accuracy through an ongoing data collection and...

CE/CME objectives/questions.
November 1, 2008... 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...