Bioresearch Monitoring Alert articles from March 2002

Bioresearch Monitoring Alert archives from March 2002

OHRP director outlines three-pronged approach to better IRB compliance.(United States Department of Health and Human Services, Office for Human Research Protections)(Institutional Review Board)
March 1, 2002... "I would like to see our office get to the point where our compliance division is out of business," Greg Koski, M.D., Ph.D, director of the HHS Office for Human Research Protections (OHRP) said in a recent interview. "We don't want a culture...

'Best practice' approach seen as effective way to ensure protections overseas.(Brief Article)
March 1, 2002... A growing concern about U.S. patients becoming more savvy to how new drugs and devices are studied is leading more and more sponsors to do overseas studies, thus posing ethical dilemmas about patient protection. Addressing a Center for...

IRBs take on new role in pediatric trials; adult standards don't always work.(Institutional Review Board)(Brief Article)
March 1, 2002... PHILADELPHIA - With the emergence of clinical trials in pediatrics, the clinical trial rulebook must be rewritten to accommodate the particular medical and emotional needs of children and their parents as well as the specific ethical dilemmas...

'Assent' becomes as important as 'consent' when dealing with children.(Brief Article)
March 1, 2002... PHILADELPHIA - A common refrain among pediatric experts is that children are not "little adults." Children need not only their own medicines, but also their own clinical trials, with project methods and protocol which are tailored to their...

Should incentives be offered in trials with children?(Brief Article)
March 1, 2002... PHILADELPHIA - While the problems of incentives offered to researchers for their involvement in clinical trials are oft-discussed, less attention has been paid to the incentives offered to participants in pediatric clinical trials and the...

FDA visit sparks IDE withdrawal, SciOptic president 'loses it' during audit.(United States Food and Drug Administration)(SciOptic International)
March 1, 2002... SciOptic International, Ossining, NY, New York District SciOptic International's guest book was signed by FDA inspectors Thomas Hansen and L. Glenn Massimilla of the New York District Office, who visited the firm March 21-27, 2001. The...

White Eagle falters in first inspection, soars in second.(White Eagle Laboratories)(Brief Article)
March 1, 2002... White Eagle Laboratories, Doylestown, PA, Philadelphia District White Eagle Laboratories played host to FDA on back-to-back non-clinical GLP visits. While the first visit ended in a three-item 483 and a letter of entry from EPA, the...

Failure to include data in final report nets company 483.(Brief Article)
March 1, 2002... Cedra Corporation, Austin, TX, Dallas District Contract lab Cedra Corp. landed a four-item 483 after an inspection revealed that certain data did not make it from the lab to the final report. Pharmacologist Martin Ya, Ph.D. and Joel...

Principal investigator acknowledges Center's troubled past, moves to greener pastures.(Research Associates of Central Florida)(Brief Article)
March 1, 2002... Rakesh Prashad, M.D., Research Associates of Central Florida, Ocala, FL, Florida District An unannounced audit of Rakesh Prashad, M.D, netted the principal investigator (PI) a 13-item 483. The form noted lapses in areas including...

Inspection update: Response from Debra Breneman, University Dermatology Consultants.(Brief Article)
March 1, 2002... In a follow-up to the analysis of the inspection of Debra L. Brenneman, M.D., (See February issue, page 9), a representative of University Dermatology Consultants provided a copy of Brenneman's written response to FDA. The letter, dated...

BiMo FOIA Log.
March 1, 2002... This is a list of FOIA requests for copies of 483s and EIRs for inspections of CROs, testing labs, sponsor/monitors, IRBs and clinical investigators, which were filed with FDA under the Freedom of Information Act (FOIA). This list does not...

IRB Determination Letters.
March 1, 2002... The following are Compliance Determination Letters for IRBs issued in February by the HHS Office for Human Research Protections (OHRP). Each letter is $7 plus retrieval. Copies of documents related to these letters also are available by...