Univerrsity of Denverr Institutional R
Review Board ((IRB) Appe
endix E: D
DETERMINA
ATION OF HUMAN SSUBJECT RESEARCH This form iss used to help rresearchers de
etermine if a prroject requiress IRB review. Itt also providess documentatio
on that the IRB will use to review the project de
escription and issue a determ
mination. Please allow
w up to five (5)) business dayss for review and response. Email comp
pleted form to IRBAdmin@d
du.edu Project Tiitle Section A
A Contact Infformation Name (last name, first nam
me) CCredentials:
ermination on
nly if you thinkk that your pro
oject Submiit this form to the DU IRB for a formal dete
NOT require IR
RB review. does N
No Yes Is it Research w
with Human Subj
bjects as Defined by the Federal Regulaation? Is DU Engaged in the Is the Ressearch Regulated
d No No Research?
R
by the FDA? Yes Yes IRB REVIEW REQUIRED Submit this Determinattion Fo
orm to the IRB IR
RB REVIEW R
REQUIRED Section B Summary o
of Activities B.1 Provide a brief description of your project. Includ
de a descriptioon of what any participants w
will be asked to
o do and a description of the data acccessed and/orr collected. nned ws, focus groups, surveys, queestionnaires, etc., provide a ccopy of all plan
B.2 If yourr study will invvolve interview
‐15 B/Office of Reseaarch Compliance
e DU IRB
Determ
mination of Hum
man Subject Rese
earch Form, v.1, dated 5‐13 Univerrsity of Denverr Institutional R
Review Board ((IRB) questions o
or sample questions if they haave been developed. List all attachments:
ect publicly available, (e.g. b log, aggregate data, etc.)? B.3 Are all of the data ussed in this proje
Yes No Section C: Is this Projject Human Subjects Re
esearch as D
Defined by Feederal Regu
ulations? Research is defined in the Code of Federral Regulationss, 45 CFR 46.1002(d), as a systtematic investigation designeed to develop or ccontribute to ggeneralizable kknowledge The Belmon
nt Report state
es “. . . the term
m “research” designates an a ctivity designeed to test a hyp
pothesis or formal protocol thaat sets forth an
n objective and
d a set of proce
edures to reachh that objectivve.” Research ge
enerally does n
not include ope
erational activiities such as rooutine outbreak investigation
nal and diseasee monitoring and studies for internal man
nagement purp
poses such as pprogram evaluaation, quality aassurance, quaality improvement, fiscal or pro
ogram audits, marketing stud
dies or contraccted for servicees. Generalizab
ble knowledge
e is information
n where the inttended use of the research findings can bee applied to populations or situations beyond that study. Note th
hat publishing the results of aa project doess not automaticcally meet the definition of generalizable
e knowledge. u have a speciffic research que
estion or hypo
othesis?
C.1 Do you
C.2 Is yourr primary inten
nt to generate knowledge thaat can be applieed broadly to tthe group/condition under study?
Human subject is defin
ned in the Cod
de of Federall Regulations,, 45 CFR 46.1102(f)(1 or 2),, as a living individual about whom
m an investigaator obtains d
data through
h intervention
n or interactio
on or identifiiable private infformation. The specimen(s)/data/information mustt be collected ffrom or be aboout live subjectts. Research o
on cadavers, au
utopsy specimens o
or specimens/information fro
om subjects no
ow deceased iss not human su
ubjects researcch. C.3 Does this project invo
olve interventiion or interaction with a livinng individual orr group of indivviduals? (e.g. nal testing) confidential surveys, interrviews, medicaal or education
‐15 B/Office of Reseaarch Compliance
e DU IRB
Determ
mination of Hum
man Subject Rese
earch Form, v.1, dated 5‐13 Univerrsity of Denverr Institutional R
Review Board ((IRB) C.4 Does this project invo
olve access to identifiable prrivate data or sspecimens from
m living individ
duals? C.5 Was th
he original dataa collection forr the current project? C.6 Does this project con
nsist exclusivelyy of interviewing or surveyinng subjects abo
out his/her area of expertise,, with a olicies, practice
e, and/or proce
edures (e.g. the
e collected datta does not foccus on personaal opinion or prrivate focus on po
information
n)? C.7 Is the p
project meant to record the sstories, knowle
edge or experi ences of indiviiduals? Oral hisstories typicallly do not intend to an
nswer a researrch question orr hypothesis. Section D
D: Determining if DU is EEngaged in R
Research DU is usuallly considered e
engaged in research if any off the following are true:
 DU
U is the primaryy awardee on tthe grant or co
ontract  DU
U is the only sitte  DU
U employees, sstudents, or agents are obtain
ning consent/aassent  DU
U employees, sstudents, or agents are interaacting or intervvening with hu
uman subjects. Exaamples include
e online surveyys, interviews, participant obbservations, invvasive/non‐invvasive study pro
ocedures, man
nipulating the ssubject’s enviro
onment for ressearch purposes, or  DU
U employees, sstudents, or agents are obtain
ning or receivinng identifiablee, private inform
mation or biolo
ogical sam
mples Does condu
ucting this project cause DU tto be engaged in research? YYes No
If a protocol (research narrative)) exists for th
his project i t must be su
ubmitted for review. Su
ubmit this reque
est along wiith any supp
plemental do
ocuments th
hat may aid in review off your projeect to the Unive
ersity of Den
nver IRB at: IRBAdmin@
@du.edu ‐15 B/Office of Reseaarch Compliance
e DU IRB
Determ
mination of Hum
man Subject Rese
earch Form, v.1, dated 5‐13