Bioresearch Monitoring Alert articles from December 2002

Bioresearch Monitoring Alert archives from December 2002

Conducting research, maintaining patient protections during crises weighs on HHS. (Human subject protection).(Health and Human Services)
December 1, 2002... SAN DIEGO -- Whether an emergency serves as the impetus or impediment to research, times of crisis and natural disaster require special measures for those who conduct studies and the people responsible for monitoring their adherence to...

Joint FDA, OHRP registration rule seen in '03; more inspections seen. (IRBs).(Office of Human Research Protections)
December 1, 2002... SAN DIEGO -- FDA and the Office of Human Research Protections (OHRP) might issue an IRB registration rule proposal in 2003, plus new IRB Information Sheets, along with revised standards for inspecting clinical investigators, a top FDA official...

Koski sums up key issues facing OHRP. (OHRP Management).(Greg Koski, Office of Human Research Protection)
December 1, 2002... SAN DIEGO -- In an address to PRIM&R's conference here Nov. 18, just a week before he departed as OHRP director, Greg Koski, M.D., reviewed the agency's progress during his tenure. "We have been living in interesting times," he noted, "but...

Officials debate IRB involvement in social sciences. (IRBs).(Institutional Review Board)
December 1, 2002... SAN DIEGO -- Should social science research be handled separately from its bio-medical counterpart in IRB evaluations? Addressing a PRIM&R conference in San Diego this November, Philip Zimbardo contended that different levels of regulatory...

Experts debate IRB problem, offer solutions.(Institutional Review Board)
December 1, 2002... SAN DIEGO -- Have IRBs gotten too clubby? Should governmental agencies have the authority to impose fines? Have industry professionals lost sight of the human factor amid the regulatory framework? These were among questions raised at the...

Ex-OHRP official sees forms, documents, training as major causes of IRB breakdowns; sponsors at risk. (Informed consent).(Office of Human Research Protections, Tom Pugilisi)
December 1, 2002... PHILADELPHIA -- Poor record-keeping, badly written consent forms and lack of training were cited by a former Office of Human Research Protections (OHRP) official as leading reasons many IRBs and clinical investigators are not protecting...

Many deviations from protocol lead to hefty six-item 483. (Clinical investigators).
December 1, 2002... Akinyele Aluko, M. D., Mid Carolina Cardiology, Charlotte, NC, Atlanta District Numerous deviations from study protocol as well as informed consent misrepresentation racked up a six-item 483 for clinical investigator, Akinyele Aluko, M.D.,...

Experienced PI emerges clean from FDA audit. (Clinical investigators).(principal investigator Victor Biton)
December 1, 2002... Victor Biton, M.D., Arkansas Epilepsy Program, Little Rock, AR, Dallas District Experience has served Victor Biton, M.D., well, having conducted many clinical trials and FDA inspections and emerging squeaky clean following this six-day...

Significant deviations trigger five-item 483; consent form cited. (Clinical investigators).
December 1, 2002... Douglas Fraker, M.D., Division of Surgical Oncology, University of Pennsylvania Health System, Philadelphia, PA, Philadelphia District Significant deviations, including a consent form with apparent different signatures, brought FDA's Mike...

Baylor PI gets clean bill from FDA, even in EIR. (Clinical investigators).(principal investigator)
December 1, 2002... Adaani Frost, M.D., Baylor College of Medicine, Houston TX, Dallas District No 483 was issued to principal investigator, Adaani Frost, M.D., for his initial FDA inspection, conducted by FDA inspector Patrick Stone of the Dallas District....

FDA inspector reaches to come up with item to discuss. (Clinical investigators).
December 1, 2002... Frank Hampel, Jr., M.D., Central Texas Health Research, New Braunfels, TX, Dallas District. The Good Clinical Practice Branch, Division of Scientific Investigations in the Center for Drugs requested this clinical investigator/data audit...

Principal investigator only peripherally involved in study, if at all. (Clinical investigators/SMOs).
December 1, 2002... Paul Holoye, M.D., Oncology Consultants, Inc., Houston, TX, Dallas District There was no evidence to suggest that principal investigator William West, M.D., personally conducted or supervised the study at Oncology Consultants, Inc., for...

BiMo FOIA log.(Freedom Of Information Act)
December 1, 2002... This is a list of FOIA requests for copies of 483s and EIRs for inspections of CROs, testing labs, IRBs and clinical investigators, filed with FDA under the Freedom of Information Act (FOIA). This list does not imply that a 483 or EIR has been...

NIDPOE letters.(Notice of Initiation of Disqualification Proceedings and Opportunity to Explain)(Brief Article)
December 1, 2002... The following "Notice of Initiation of Disqualification Proceedings and Opportunity to Explain" (NIDPCE) letter was issued by the CDER Office of Medical Policy to the clinical investigator regarding his concoct of clinical studies. This and...

Warning letters.(Brief Article)
December 1, 2002... The following are FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs, which were released in November 2002. Each letter is $7 plus retrieval. Please order by RECORD RETRIEVE Number (i.e., 12069W)....

IRB Determination letters.(Institutional Review Board)(Brief Article)
December 1, 2002... The following are Compliance Determination letters for IRBs issued in October by the Department of Health and Human Services Office for Human Research Protections (OHRP). Each letter is $7 plus retrieval. Copies of documents related to these...