Sean
Philpott,PhD, Associate Professor with The Bioethics Program along with Elisa
Gordon of Northwestern University published a paper on Humanitarian Use
Devices: (Gordon EJ,
Philpott S. 2008. The Convergence of Research and Clinical Practice:
Institutional Review Board Review of Humanitarian Use Device Applications.
Journal of Empirical Research on Human Research Ethics 3(4): 81-98).
ELISA J. GORDON
Northwestern University
SEAN PHILPOTT
Global Campaign for Microbicides, PATH
ABSTRACT: WE SURVEYED IRB CHAIRS IN
THE United States to
ascertain whether their IRBs have clarity regarding their FDA-mandated role in
reviewing humanitarian use device (HUD) applications, which are neither
research devices nor fully tested treatments. Of 2,588 Chairs, 469 (18%)
completed the survey, almost half of whom (44%) reported review of a HUD
application within the previous five years. Findings suggest that many IRB Chairs
are confused about what HUDs are, how to review HUD applications, and why IRBs
should review them. We recommend that the FDA clarify their policies so that
Chairs can provide the guidance necessary for IRBs to more effectively and
consistently review HUD applications, and thereby better protect HUD-treated
patients.
KEY WORDS: Institutional Review Boards, humanitarian
use device, Food and Drug Administration, methodology, survey, ethical review
To read the article click on the PDF Link above, right
