Science ethics as a bureaucratic problem: IRBs, Rules, and Failures of control
â€œInstitutionalized science ethicsâ€\x9D refers to the statutory, professional and institution-based ethical standards that guide and constrain scientists' research work. The primary institution responsible for implementing institutionalized science ethics is the Institutional Review Board. We examine the limitations of IRBs and institutionalized science ethics, using bureaucratic theory and, especially, theory related to the development and enactment of rules. We suggest that due to the very character of rules-based systems, improvements in IRB outcomes are unlikely to be achieved through either more or better rules or even by bureaucratic reform. Instead, we suggest that improvements in human subject protection can best be advanced through increased participation. Ours is not a call for more participation by the general public but participation, via â€œParticipant Review Boardsâ€\x9D of persons who are eligible, by the protocols of the research in question, to serve as subjects. This provides a level of legitimacy and face validity that cannot be obtained by IRB affiliates, even by â€œexternal representatives.â€\x9D In making these points, we review a recent science ethics controversy, the KKI/Johns Hopkins lead paint study. In spite of being approved by IRBs, the study resulted in a civil lawsuit that reached the Maryland Court of Appeals. The case illustrates the limits of institutionalized science ethics and the bureaucracies created for their enactment. The case also underscores the complex and equivocal nature of the ethical guidelines established under the National Research Act. Copyright Springer Science+Business Media, Inc. 2005
If you experience problems downloading a file, check if you have the proper application to view it first. In case of further problems read the IDEAS help page. Note that these files are not on the IDEAS site. Please be patient as the files may be large.
As the access to this document is restricted, you may want to look for a different version under "Related research" (further below) or search for a different version of it.
References listed on IDEAS
Please report citation or reference errors to , or , if you are the registered author of the cited work, log in to your RePEc Author Service profile, click on "citations" and make appropriate adjustments.:
- Howard-Jones, Norman, 1982. "Human experimentation in historical and ethical perspectives," Social Science & Medicine, Elsevier, vol. 16(15), pages 1429-1448, January.
- Patrick G. Scott & Sanjay K. Pandey, 2000. "The influence of red tape on bureaucratic behavior: An experimental simulation," Journal of Policy Analysis and Management, John Wiley & Sons, Ltd., vol. 19(4), pages 615-633.
When requesting a correction, please mention this item's handle: RePEc:kap:policy:v:38:y:2005:i:4:p:269-291. See general information about how to correct material in RePEc.
For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: (Sonal Shukla)or (Rebekah McClure)
If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.
If references are entirely missing, you can add them using this form.
If the full references list an item that is present in RePEc, but the system did not link to it, you can help with this form.
If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your profile, as there may be some citations waiting for confirmation.
Please note that corrections may take a couple of weeks to filter through the various RePEc services.