Carl E. Schneider
- Published in print:
- 2015
- Published Online:
- September 2015
- ISBN:
- 9780262028912
- eISBN:
- 9780262328784
- Item type:
- chapter
- Publisher:
- The MIT Press
- DOI:
- 10.7551/mitpress/9780262028912.003.0005
- Subject:
- Biology, Bioethics
Good decisions come from good law. For government agencies, that means due process: good regulations and good procedures. The IRB regulations address so few issues that IRBs are relegated to ...
More
Good decisions come from good law. For government agencies, that means due process: good regulations and good procedures. The IRB regulations address so few issues that IRBs are relegated to subjectivity. IRBs may and do ignore all the elements of due process. And rules and procedures are empty without accountability, but IRBs are unaccountable. They may work in secret, researchers have no recourse against them, and they are not subject to standard hierarchical supervision. IRBs are trapped in inadequate procedures because adequate ones would crush IRBs already overburdened with tasks they lack the resources to accomplish. So they work without law and without accountability.Less
Good decisions come from good law. For government agencies, that means due process: good regulations and good procedures. The IRB regulations address so few issues that IRBs are relegated to subjectivity. IRBs may and do ignore all the elements of due process. And rules and procedures are empty without accountability, but IRBs are unaccountable. They may work in secret, researchers have no recourse against them, and they are not subject to standard hierarchical supervision. IRBs are trapped in inadequate procedures because adequate ones would crush IRBs already overburdened with tasks they lack the resources to accomplish. So they work without law and without accountability.
- Published in print:
- 2007
- Published Online:
- March 2013
- ISBN:
- 9780226306254
- eISBN:
- 9780226306261
- Item type:
- chapter
- Publisher:
- University of Chicago Press
- DOI:
- 10.7208/chicago/9780226306261.003.0008
- Subject:
- Society and Culture, Ethical Issues and Debates
This chapter discusses changes in the conduct of medical research in the U.S. following the Office for Protection from Research Risks' (OPRR) suspension of some four hundred human trials supported by ...
More
This chapter discusses changes in the conduct of medical research in the U.S. following the Office for Protection from Research Risks' (OPRR) suspension of some four hundred human trials supported by the National Institute of Health at the Veterans Administration (VA) health-care complex in Los Angeles, California, in March 1999. After the VA incident, the OPRR also issued ominous warnings about further punitive steps and required careful documentation of compliance with institutional review board (IRB) regulations for medical research. The OPRR move has affected university research.Less
This chapter discusses changes in the conduct of medical research in the U.S. following the Office for Protection from Research Risks' (OPRR) suspension of some four hundred human trials supported by the National Institute of Health at the Veterans Administration (VA) health-care complex in Los Angeles, California, in March 1999. After the VA incident, the OPRR also issued ominous warnings about further punitive steps and required careful documentation of compliance with institutional review board (IRB) regulations for medical research. The OPRR move has affected university research.
