V.!The!Institutional!Review!Board!at!Duke!University!
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1.*What*is*an*Institutional*Review*Board*(IRB)*in*general?*
The# IRB# is# a# campusQwide# committee# charged# with# the# review# of# human# participants# research.##
The# main# task# of# the# IRB# is# to# ensure# that# the# rights# and# welfare# of# human# participants# are#
adequately#protected.4##The#IRB#serves#as#an#unbiased#external#body#to#help#researchers#consider#
ethical# issues# within# their# human# participants# research# whatever# that# research# may# be#
(observation,#surveys,#focus#groups#etc.),#as#long#as#it#involves#obtaining#information#directly#from#
people.#
#
2.*Why*were*IRBs*created?*
Throughout#the#1900s#there#were#a#series#of#historical#events#that#prompted#the#creation#of#the#
research#regulations#leading#to#the#formation#of#IRBs#on#campuses#and#other#institutional#bodies.##
These#events#included#the#following:5#
- December# 9,# 1946# –# August# 20,# 1947:# Trial# of# 23# leading# Nazi# physicians# and#
administrators#for#their#willing#participation#in#crimes#against#humanity.#A#major#result#of#
the#trial,#whose#outcome#was#16#guilty#verdicts#and#7#executions,#was#the#Nuremburg#Code,#
a#landmark#document#on#medical#ethics.#
- 1950s# through# 1970s:# Studies# of# the# hepatitis# virus# at# the# Willowbrook# State# School,# an#
institution#for#severely#mentally#retarded#children.##A#research#team#led#by#Saul#Krugman#
of#New#York#University#systematically#infected#healthy,#newly#arrived#children#with#strains#
of#the#hepatitis#virus.#
- 1960# –# 1963:# Experiment# carried# out# to# study# obedience# and# the# influence# of# authority#
following#World#War#II.##In#this#study#by#Stanley#Milgram,#a#social#psychologist,#participants#
believed# they# were# delivering# high# voltage# and# even# potentially# lethal# electric# shocks# to#
fellow# participants.# # Many# participants# experienced# severe# psychological# distress# both#
during#and#following#the#study.#
- July# 1972:# Associated# Press# story# leads# to# public# condemnation# and# review# and#
termination#of#the#Tuskegee#Study.##The#Public#Health#Service#initiated#the#study#in#1932#to#
study#the#natural#history#of#syphilis#using#a#population#of#600#African#American#men,#399#
with#syphilis#and#201#who#did#not#have#the#disease.#Infected#men#did#not#receive#treatment#
for#their#illness,#even#after#penicillin#had#been#determined#to#be#an#effective#cure,#and#the#
study#continued#for#40#years.#
#
In# all# of# the# above# historical# events,# the# research# carried# out# shares# the# same# characteristic# –# a#
lack#of#informed#consent.##Due#to#the#concern#raised#by#studies#including#some#of#the#above,#1973#
congressional# hearings# were# held# on# the# quality# of# health# care# and# human# experimentation.# # In#
1974# the# National# Research# Act# was# passed# and# the# National# Commission# for# the# Protection# of#
Human# Subjects# of# Biomedical# and# Behavioral# Research# created.# # In# 1979# the# National#
########################################################
4#Source:#Top'Ten'Investigator'Responsibilities'When'Conducting'Human'Subjects'Research,#a#PowerPoint#
compiled#by#the#Office#for#Human#Research#Protections#(OHRP),#US#Department#of#Health#and#Human#
Services.##
5#Please#contact#the#Student#Affairs#Office#of#Assessment#&#Professional#Development#if#you#are#interested#
in#learning#more#about#any#of#these#events,#references#for#the#information#provided,#or#more#about#the#
history#of#IRBs#in#general.#
#
11#
Commission# for# the# Protection# of# Human# Subjects# of# Biomedical# and# Behavioral# Research#
published# the# Belmont# Report# that# contained# three# principles,# Respect' for' Persons,# Beneficence#
(protecting# people# from# harm# by# maximizing# possible# benefits# and# minimizing# risk),# and# Justice#
(fairness# in# how# benefits# and# risks# are# distributed# across# sample).# # The# Belmont# Report# among#
others#laid#a#strong#foundation#for#federal#regulations#indicating#IRB#requirements#such#as#the#US#
Department#of#Health#&#Human#Services’#Code#of#Federal#Regulations,#Title#45#(Public#Welfare),#
Part# 46# (Protection# of# Human# Subjects)6#and# indeed# for# the# Duke# University# Principles# and#
Procedures#Regarding#Research#on#Human#Subjects#(Campus)7.8#
#
3.*How*is*the*IRB*organized*at*Duke*University?*
As#is#the#case#at#many#universities#affiliated#with#a#hospital,#Duke#University#has#two#distinct#IRB#
offices.##One#IRB,#the#Duke#University#Health#System#(DUHS)#IRB,#is#made#up#of#nine#boards#and#
reviews#all#medical#research#projects#and#some#nonQmedical#human#participants#research#that#fit#
the#following#definitions:#research#with#human#participants#sponsored#by#DUHS;#involving#as#key#
personnel#any#employee#or#agent#of#DUHS,#including#students,#residents#or#fellows;#utilizing#any#
DUHS# property# or# facility;# or# utilizing# any# DUHS# nonQpublic# information.# # All# other# nonQmedical#
research# projects# are# reviewed# by# the# IRB# for# the# Protection# of# Human# Subjects# in# NonQmedical#
Research# coordinated# by# the# Office# of# Human# Subjects# Protection,# an# office# within# the# Office# of#
Research# Support.# # For# most# Student# Affairs# research# what# would# need# to# be# submitted# for# IRB#
approval,# it# is# the# latter# IRB# that# would# be# applied# to# through# the# Office# of# Human# Subjects#
Protection.9#
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4.*How*do*I*know*if*I*need*to*seek*IRB*approval?*
For#any#research#to#be#conducted#with#Duke#students,#undergraduate#or#graduate#where#there#is#
interaction#for#the#purpose#of#collecting#information#and#participants#have#given#some#identifying#
information,#the#Office#of#Assessment#&#Professional#Development#would#recommend#seeking#IRB#
approval.#Research#for#which#IRB#approval#is#not#necessary#include#the#following10:#
- Analysis#of#deQidentified#data,#where#the#information#you#collected#or#were#given#contains#
no#identifiers#whatsoever.#
- Information# obtained# that# does# not# give# any# information# about# a# specific# person# (e.g.#
obtaining#factual#statistics#from#an#expert#in#a#certain#field).#
- Classroom#research,#where#research#methods#such#as#interviewing#may#be#practiced.#
- Information#collected#solely#for#the#purpose#of#evaluating#or#improving#a#program.#
#
5.*What*types*of*IRB*reviews*are*there?*
There#are#three#types#of#IRB#review:#exempt,#expedited,#and#full.##Examples#of#a#type#of#research#
within#each#subset#are#given#below11.#
a.# Exempt# from# Review# (exempt# from# regulations# such# as# annual# review;# shortest# IRB# review#
time):# e.g.# a# basic# survey# with# information# obtained# and# recorded# in# such# a# manner# that# no#
identifiers#are#linked#to#the#responses#and#participants#cannot#be#identified.#
########################################################
6#See#http://ors.duke.edu/researcher/federalQregulations#for#more#information.#
7#See#http://ors.duke.edu/researcher/dukeQtheQpolicyQtheQacademicQcouncil#for#more#information.#
8#Interesting#note:#IRBs#are#required#at#all#institutions#conducting#research#involving#human#subjects#who#
receiving#research#money#from#any#federal#funding#agency#according#to#US#Department#of#Health#&#Human#
Services’#Code#of#Federal#Regulations,#Title#45,#Part#46.122.#
9#Source:#Duke#Faculty#Handbook#5.1.2.3.#
10#See#http://ors.duke.edu/researcher/definingQresearchQwithQhumanQsubjects#for#more#information.#
11#See#http://ors.duke.edu/researcher/newQprotocols#for#more#information.#
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b.# Expedited# Review# (requires# annual# renewal;# preQreview# and# longer# IRB# review# time):# e.g.# a#
basic# survey# where# respondent# identifiers# are# collected# and# recorded# in# a# manner# that#
participants#could#potentially#be#identified,#but#such#identification#poses#no#risk#to#the#participant.##
c.#Full#Review#(requires#annual#review#and#preQreview#and#longest#IRB#review#time):#e.g.#a#survey#
where# respondent# identifiers# are# collected# and# recorded# in# a# manner# that# participants# could#
potentially# be# identified# and# such# identification# would# pose# more# than# minimal# risk# to# the#
participants.#
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6.*What*is*included*in*an*IRB*application?*
In# order# to# receive# approval# for# any# IRB# application,# the# principal# investigator/Student# Affairs#
professional#must#have#current#certification#to#conduct#research#with#human#subjects.##Obtaining#
or# confirming# this# certification# is# the# first# step# of# any# IRB# application.# # Certification12#is# through#
the# Collaborative# Institutional# Training# Initiative# (CITI)# and# consists# of# a# series# of# 12# modules,#
with#11#short#quizzes.##These#quizzes#can#be#taken#over#a#period#of#time#and#retaken#as#needed#–#
once#the#endQresult#is#completion#with#a#passing#score#of#80%.##A#copy#of#the#transcript#can#then#
be#electronically#sent#to#the#IRB#office.#
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The#application#itself#asks#you#to#explain#why#you#are#applying#for#the#specific#type#of#IRB#review#
you#have#requested,#and#to#give#some#information#about#your#proposed#research#project#such#as:#
research#design;#participant#selection;#risks#and#benefits;#protection#of#participant#confidentiality;#
participant#compensation;#informed#consent#protocols;#deception,#if#any;#and#debriefing#protocols.#
#
7.*How*long*does*IRB*approval*take?*
The#length#of#IRB#review#depends#on#the#type#of#IRB#being#applied#for.##Approval#for#exemption#
from# IRB# review# takes# about# five# to# seven# business# days# assuming# the# IRB# workload# is# not#
extremely# heavy.# # Approval# for# an# expedited# application# takes# about# two# to# three# weeks,# and#
approval#for#a#full#review#three#to#six#weeks.##The#time#ranges#given#are#approximate#depending#
on#the#workload#of#the#IRB#at#the#time#the#applications#are#submitted.#
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8.*Where*can*I*receive*more*information*about*and*assistance*with*IRB*matters?*
If#you#have#any#questions#at#all#about#IRB#matters#or#your#research/information#collecting#in#
general,#please#contact#the#Student#Affairs#Office#of#Assessment#&#Research#through#the#following#
project#request#form:#
https://duke.qualtrics.com/SE/?SID=SV_4OBp1ykcdj2tAG0#or#at#the#following#email#address:#
[email protected]#
#
Our#office#is#located#on#the#top#floor#of#the#Bryan#Center#inside#the#Student#Affairs#Office#Suite,#our#
website#can#be#assessed#here:#
http://studentaffairs.duke.edu/ra/assessment#
We#can#also#be#contacted#by#phone:#
o Anna#Li,#PhD#Director#of#Assessment#&#Research:##
(919)#684Q4582#
o C.#Colgate#Taylor,#Assistant#Director#of#Assessment#&#Research:#
(919)#684Q4186#
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########################################################
12#See#http://ors.duke.edu/researcher/initialQcertification#for#more#information.#
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The#Campus#Human#Research#Protections#Program#in#the#Duke’s#Office#of#Research#Support#also#
has#a#comprehensive#website#with#much#information#about#Duke’s#IRB#process#and#program#staff#
who#can#answer#any#Duke#IRB#question.##The#website#can#be#assessed#here:#
http://ors.duke.edu/researchQwithQhumanQsubjects#
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