Local-IRB Review of National Practice-Based Research Network (PBRN) Studies: Helpful or Redundant?

 Stacia Finch, MA ¹, Shari Barkin, MD ², Eric Slora, PhD ¹, Richard Wasserman, MD ^1,3, Niramol Dhepyasuwan, MEd ¹ and Robert Sege, MD ⁴. ¹ PROS, Dept of Prac & Rsch; Ctr for Child Hlth Rsch, AAP, Elk Grove Village, IL; ² Peds, Wake Forest Univ School of Med, Winston Salem, NC; ³ Univ of Vermont, Burlington, VT and ⁴ Peds, Floating Hsp for Children, Boston, MA.

 

Background: PBRNs conduct multi-site studies. Because of federal rules, many require local-IRB approval. Several studies have scrutinized the process of obtaining approval of multi-center studies, but none have examined the impact on practices involved in PBRN studies.

 

Objective: To describe the process and contributions of local-IRB review for 2 Pediatric Research in Office Settings (PROS) studies.

 

Design/Methods: In 2002, PROS began 2 large studies concerning sensitive topics. Child Abuse Recognition Experience Study (CARES) is an observational study of physician decision-making, while Safety Check (SC) is a violence prevention intervention trial. In addition to the AAPs and investigators IRBs, practices with their own IRBs (e.g., academic center-affiliated) also obtained local-IRB approval. Practices were queried about IRB rules at PROS enrollment and study recruitment. Data included local IRB presence, level of PROS aid (info packet vs. active application help (est. 15 hrs/app)), IRB process (e.g., submit obtain approval time, changes made), and study participation.

 

Results: An estimated 1/5 of PROS practices require local-IRB approval.

 

Table 1: Practices Agreeing to Participate in CARES SC By Presence of Local IRB:

	Local IRB	No local IRB
CARES	27/55 (49%)	154/365 (42%)
SC	41/68 (60%)	158/347 (46%)

Of the 68 practices requiring local-IRB approval, 14 dropped out of study (CARES=1; SC=13) and 15 are pending approval (CARES=4; SC=11). All others (N=39) received local approval.

 

Table 2: IRB Process for Local Approval:

	# recd local approval	# needed active application help	# reqd changes	Median days to submit & obtain approval (intraquartile range 25%, 75%)
CARES (N=27)	22 (81%)	9	8	81 (48, 284)
SC (N=41)	17 (41%)	12	11	119 (75, 180)

Changes (N=19) included mostly contact name additions and local-IRB approval stamps. Of the 39 approved, 90% began data collection.

 

Conclusions: Local-IRB review resulted in substantial effort by practices and PROS staff to navigate the process, with approval being universally granted without substantive protocol changes. These results suggest that the national human protections system should consider the unique nature of PBRNs when considering future reforms.