Bioresearch Monitoring Alert articles from April 2004

Bioresearch Monitoring Alert archives from April 2004

SACHRP asks FDA, OHRP to 'step up to the plate' and issue clear guidance on IRB AE reporting responsibilities.(Adverse event reporting)(Secretary's Advisory Committee on Human Research Protections)(United States. Food and Drug Administration)(Office of Human Research Protections)
April 1, 2004... ALEXANDRIA, VA -- The Secretary's Advisory Committee on Human Research Protections (SACHRP) has recommended that FDA and the Office of Human Research Protections (OHRP) issue guidance to help IRBs review internal and external adverse events...

HHS advisory committee recommends privacy rules be revised to stave impact on research.(HIPAA)(United States. Department of Human Health and Services)
April 1, 2004... ALEXANDRIA, VA -- Citing surveys showing a detrimental effect on clinical research, the Secretary's Advisory Committee on Human Research Protections (SACHRP) is likely to recommend that the HIPAA Privacy Rule be revised, specifically to...

Market forces should dictate accreditation, not government, SACHRP advises.(Accreditation)(United States. Office for Human Research Protections. Secretary's Advisory Committee on Human Research Protections)
April 1, 2004... ALEXANDRIA, VA -- While supporting the concept of accrediting IRBs and research institutions, SACHRP March 29 recommended that HHS not devise incentives to achieve a greater saturation of accreditation in the U.S. Currently, only seven...

SACHRP develops guidelines for children in clinical trials.(Pediatric research)(United States. Department of Health and Human Services. Secretary's Advisory Committee on Human Research Protections)
April 1, 2004... ALEXANDRIA, VA -- The HHS Secretary's Advisory Committee on Human Research Protections (SACHRP) developed final recommendations March 29 for the 407 process, which dictates review of research involving children. The committee voted to...

Subpart C on prisoner research should be scrapped, SACHRP told.(United States. Office for Human Research Protections. Secretary's Advisory Committee on Human Research Protections)
April 1, 2004... ALEXANDRIA, VA -- Subpart C should be completely scrapped and rewritten from scratch to get a new set of standards for prisoners, Subpart C subcommittee chairperson Mark Barnes, an attorney with Ropes & Gray, New York, told SACHRP here March...

Researcher sees bias against mentally ill in studies; argues for placebos.(Mentally ill)
April 1, 2004... CLEARWATER, FL -- Subjects with a variety of mental illnesses including depression, schizophrenia and eating disorders present major issues for IRBs, and some argued whether mentally ill patients should be considered vulnerable subjects by FDA....

IRB fails to conduct continuing review, improper expedited review.(IRBs)(Institutional Review Boards)(Lake Charles Memorial Hospital)
April 1, 2004... Lake Charles Memorial Hospital IRB, Lake Charles, LA, New Orleans District Failure to conduct continuing review, improper use of expedited review and failure to establish written standard operating procedures landed Lake Charles Memorial...

Sponsor/PI conducts device study without IDE.(Sponsors/Clinical Investigators)(Gerald Burma)
April 1, 2004... Gerald Burma, M.D., Parma OH, Cincinnati District FDA's Cincinnati District's S.J. Kilker discovered that sponsor/investigator Gerald Burma, M.D., conducted a device study, which employed a procedure on carotid arteries, without an IDE. ...

CI cited for protocol deviation for not recording AE on CRF.(Sponsors/Clinical Investigators)
April 1, 2004... Michael Brown, M.D., Discovery Alliance, Pensacola, FL, Florida District Clinical investigator Michael Brown, M.D., received one-item 483 for protocol deviations for his initial FDA inspection and first clinical trial. FDA investigator...

Schering Plough gets glowing report from FDA.(GLP)(United States. Food and Drug Administration)
April 1, 2004... Schering-Plough Animal Health Corp., Williamsburg, KS, Kansas District Schering Plough's Kansas animal health facility fared very well for its initial GLP inspection. In fact, FDA's Carl Montgomery, the Kansas District investigator who...

Warning letters.(medical research)
April 1, 2004... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued the weeks of March 8, 15, 22 and 29, 2004. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number...

BiMo FOIA log.
April 1, 2004... 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...