From Institutional Review Blog:
Alice Dreger reviews Laura Stark’s Behind Closed Doors for the Journal of American History:
Contrary to the self-aggrandizing story bioethicists like to tell about how IRBs arose out of concern for human subjects of research, Stark shows that, when you dig into this history, it is lawyers all the way down . . . She argues that IRB work was decentralized not to make it more ethical, but to protect the NIH from lawsuits. Stark convincingly concludes that IRBs today do not primarily enact ethical principles; they manage procedures.”
[Dreger, Alice. “Behind Closed Doors: IRBs and the Making of Ethical Research.” Journal of American History 99, no. 4 (March 2013): 1328–1328. doi:10.1093/jahist/jas666.]
“Faden et al. Question Research-Treatment Distinction
Writing in a special report of the Hastings Center Report, a team of prominent ethicists and researchers “argue that conceptual, moral, and empirical problems surround the received view that we can and should draw sharp distinctions between clinical research and clinical practice.” Yet they decline to detail the implications of any regulatory change for IRB review of medical research, much less research in the social sciences and humanities.”
[Kass, Nancy E., Ruth R. Faden, Steven N. Goodman, Peter Pronovost, Sean Tunis, and Tom L. Beauchamp. “The Research-Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight.” Hastings Center Report 43, no. s1 (2013): S4–S15. doi:10.1002/hast.133. h/t Yashar Saghai]
The Belmont Report covers this,”innovative treatment” in clinical practise is’nt covered by IRBs. There is a blurred line b/t clinical practise/research.