TABLE 2.

Studies Involving IRB Process.

Author(s)/Year	objectives	Methods	Results	conclusions
Weil, C. et al. 2010 (38)	Examine the range of determina-tions of non-compliance or deficiencies as a result of principally for-cause evaluations	Review of 235 determination letters issued to 146 institutions between August 2002 and August 2007	Most institutions were cited for problems with the initial review process (55%) or with IRB approved consent documents (51%)	This analysis provides information useful for OHRP in developing targeted guidance and educational programs and for institutions in taking proactive measures to be compliant.
McClure et al. 2007 (20)	Determine IRB members' experience when reviewing protocols using the informed consent exception in emergency research	Semi-structured telephone interviews of 10 purposively selected IRB members in 4 different regions of the U.S.	(1)These studies require lengthy review. (2)Community consultation and notification is vague and difficult to implement. (3)Current regulations protect human subjects. (4)Legal counsel is important. (5)IRB members have little training on regulations.	Studies requiring an exception to informed consent in emergency research take longer to review. Community consultation is difficult and time consuming but adequately protects human subjects. Specific training for IRB members would be useful.
Bramstedt et al. 2004 (37)	Explore the ethical issues contained in FDA warning letters issued to IRBs	52 FDA warning letters evaluated for the type of violations cited	Hospital/medical center IRBs received the most letters, fol-lowed by university IRBs and private IRBs. Regulatory violations were: failure to have and follow adequate written procedures about how research review is conducted (50/52); inadequate documentation of IRB activities (47/52); and failure to provide adequate continuing review of approved studies (36/52). 19 letters were issued for consent form issues.	FDA warning letters consistently indicate weaknesses in review and documentation activities of audited IRBs. Overburdened IRBs who passively monitor studies raise concerns about study oversight and optimal protection of research subjects.
Whittle, A. et al. 2004 (36)	Determine how U.S. IRBs imple-ment the federal assent require-ment in pediat-ric research	Telephone survey of 188 U.S. IRB chairs	One half of IRBs have a method (usually age) for determining when a child can assent; the other half rely on investigators' clinical judgment. IRBs use adult regulations to determine what information should be given to children in assent.	IRBs need additional guidance on how to implement the assent re-quirement in pediatric research.
U.S. President's Commission 1983 (39)	Test whether IRBs could be evaluated by expert peer review	Site visits and interviews of 12 IRBs, records review	Wide process variability among IRBs, but generally effective.	Site visits of IRBs by expert peer reviewers are feasible and useful.