ORSP provides administrative support to the Institution-
al Review Board (IRB) under 45CFR §46. Pam Moser,
Associate Director for Human Research Protection,
maintains IRB records; facilitates communication be-
tween the IRB and researchers; coordinates meetings;
updates and maintains the university’s IRB policies and
website; monitors training for researchers and other key
personnel; provides continuing education for IRB mem-
bers; and keeps the university’s Federalwide Assurance
and IRB Registration current. She is assisted by Jeanie
Baird, Human Research Protection Specialist.
In 2015-2016, the IRB reviewed 136 new applications
(124 expedited review and 12 exempt). An additional 190
amendments, 162 continuing reviews, and 18 safety
events (14 protocol deviations and 2 unanticipated prob-
lems) were processed. The highest recorded number of
active applications (330) was achieved in June. All cate-
gory totals exceed last year’s numbers with the exceptions
of full board (decreased from 3 to 0) and exempt level
reviews (no change). A marked increase in reported cases
of investigator noncompliance, protocol deviations and
unanticipated problems reflects more vigilant oversight
and investigators’ increased awareness of reporting re-
FY 15-16 was the first full year of post-approval moni-
toring (PM), a necessary component of a comprehensive
human research protection program. Our goals for PM
are to ensure the safety of human research subjects, pro-
vide education to researchers and identify areas for im-
provement in research practices. Two studies were select-
ed based on federal funding and greater than minimal
risk level, i.e., not “for cause”.
Group outreach efforts targeted Education graduate stu-
dents as well as undergraduate URECA Scholars/Fellows
and Political Science, Counseling and First Year Seminar
classes. Our office facilitated collaborative research by
executing IRB Authorization Agreements, developing an
administrative procedure for establishing cross-campus
eIRB accounts with Wake Forest School of Medicine and
approving recruitment of WFU personnel by non-
affiliated investigators. Training and support for eIRB,
the electronic submission and review system, continued
for individual users across campus.
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