Bioresearch Monitoring Alert articles from August 2004

Bioresearch Monitoring Alert archives from August 2004

SACHRP accepts recommendations for changes to HIPAA.(HIPAA)(The Secretary's Advisory Committee on Human Research Protections)(Health Insurance Portability and Accountability Act of 1996)
August 1, 2004... WASHINGTON -- The Secretary's Advisory Committee on Human Research Protections (SACHRP) has voted to accept the recommendations of one of its subcommittees to have HHS Secretary Tommy Thompson push for changes to the Health Insurance...

IRBs, investigators offered scenarios on how to handle PHI under HIPAA.(Protected health information)(Independent Research Board)
August 1, 2004... WASHINGTON -- The use and release of potential research subjects' PHI is tightly regulated under HIPAA because of privacy concerns, but the written authorization requirement can be waived if, and only if, the use of the PHI is for review...

Uniform standard for definition of 'minimal risk' for research involving children is advanced.(Pediatric research)(Secretary's Advisory Committee on Human Research Protections)
August 1, 2004... WASHINGTON -- SACHRP agreed to a proposal to adopt a uniform standard of the definition of "minimal risk" for research involving children under Subpart D at a meeting here July 26. This agreement is contingent upon the successful resolution of...

SACHRP subcommittee recommends guidance for prisoner representative criteria.(prisoner research)
August 1, 2004... WASHINGTON -- An SACHRP subcommittee recommended that OHRP provide guidance that enumerates the possible criteria and the levels of information needed for a "prisoner representative" to advise inmates participating in clinical trials. At a...

Sponsor-sparked audit yields CI four-item 483.(clinical investigators)
August 1, 2004... A complaint from a sponsor to the Center for Drugs regarding protocol deviations resulting in an FDA BiMo inspection and four-item 483 for Charles DeBusk, M.D., of New Tazewell, TN. According to the EIR, Edward Maticka of FDA's Nashville...

FDA investigators slap Case Western with 11-item 483.(GLPs)(Food and Drug Administration)
August 1, 2004... Case Western Reserve University, Cleveland, OH, Cincinnati District S.J. Kilker and Karen Kondas of FDA's Cincinnati District hit Case Western Reserve University, Cleveland, OH, with an 11-item 483, for numerous testing facility management...

Warning letters.
August 1, 2004... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued the weeks of July 12 and July 19. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (e.g.,...

NIDPOE letters.
August 1, 2004... The following are Notices of Initiation of Disqualification Proceeding and Opportunity to Explain (NIDPOE) letters. NIDPOEs are available to subscribers from RECORD-RETRIEVE for $7 plus retrieval. 13155W Jacques Caldwell, M.D., Radiant...

IRB Determination Letters.(Brief Article)
August 1, 2004... The following are Compliance Determination Letters for IRBs issued in June and July 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...