Currents in Contemporary Ethics

[...]in testimony before the Committee on Government Reform and Oversight, Deputy Inspector General George Grob acknowledged that "IRBs feel pressure to accommodate these sponsors who are looking for quick turnaround of their research and for whom time is money. 42 A heavy workload, including b...

Full description

Saved in:
Bibliographic Details
Published in:The Journal of law, medicine & ethics medicine & ethics, 2001-06, Vol.29 (2), p.220-228
Main Authors: Anderlik, Mary R., Elster, Nanette
Format: Article
Language:English
Subjects:
Accountability
Care and treatment
Clinical trials
Ethics
Genetic disorders
Litigation
Management
Researchers
Review boards
Citations: Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:[...]in testimony before the Committee on Government Reform and Oversight, Deputy Inspector General George Grob acknowledged that "IRBs feel pressure to accommodate these sponsors who are looking for quick turnaround of their research and for whom time is money. 42 A heavy workload, including both initial reviews and continuing reviews (performed at least annually), has made it nearly impossible for even the most committed and informed IRB to discharge its responsibilities under the current federal regulations. According to one professional at an institution with a suspended Multiple Project Assurance, "[a] prolonged delay in new research would cost the hospital millions of dollars in federal and private grant money and inflict immeasurable harm on its prestige. [...]when asked to explain why individual IRB members were named as defendants, attorney Alan Milstein of Sherman, Silverstein, Kohl, Rose & Podolsky, the New Jersey law firm involved in all three lawsuits, told a reporter, "[f]ederal regulatory agents made specific reference to the inadequate job of supervision that the IRB did."ss Government reports highlighting the current deficiencies in the review process and specific investigations documenting areas of non-compliance provide fodder for plaintiffs' attorneys, which they can use to support charges against particular review boards. According to the Seattle Times, the OPRR failed to interview IRB members, study investigators, Hutch officials, subjects, subjects' families, or outside experts.
ISSN:1073-1105
1748-720X
DOI:10.1111/j.1748-720X.2001.tb00342.x