Biomedical Engineering Reference
In-Depth Information
clinical practices for human subjects research on an
annual basis.” Regarding institutional review boards,
see, for instance, Jeffrey Cooper and Pamela Turner
(2006), who state “An institutional review board (IRB)
'shall be suffi ciently qualifi ed through the experience
and expertise of its members . . . to promote respect for
its advice and counsel in safeguarding the rights and
welfare of human subjects.' Meeting this regulatory
requirement requires initial and continuous training”
(p. 313). They are citing 21 CFR 56.107, IRB
Membership.
13. See Michael Breggar (2009).
14. Interpretive issues about observations arise on the
regulatory side as well. Consider the FDA 483 observation
to MedImmune dated 29 March 2007 “on 28 March
2007 [. . .] an operator was observed cleaning his/her
personal prescription glasses in the ISO Class [. . .] area.”
Compare that to FDA warning letter to MedImmune
dated 24 May 2007: “On 28 March 2007, an operator
was observed removing his/her safety glasses, then
removing and cleaning his/her prescription type glasses,
thus allowing for skin to be exposed.” Available from:
www.fda.gov/downloads/AboutFDA/CentersOffices/
ORA/ORAElectronicReadingRoom/UCM056161.pdf
and
www.fda.gov/ICECI/EnforcementActions/Warning
Letters/2007/ucm076398.htm
15. 21 CFR 211.25(a), Personnel qualifi cations.
16. Health Canada (2009), Regulation C.02.006, ∫ 6.1.
17. See Joanne W. Cochran and Joseph D. Nally (2006).
18. “Standard operating procedures (SOPs) are sequences
of steps for workers to follow to complete tasks.” See
Mark Edelman (2003).
19. See Cochran and Nally, op cit., “Minimum requirements
for trainers may include some formal education (e.g.,
