Research Ethics from an IRB Perspective - Presented by Dr. Heidi Sato & Dr. Stefan Hanson Understanding the IRB requirements before initiating a research study may be a challenging task. Learn about research ethics from an IRB perspective. In this webinar you will learn: · What is an IRB and its purpose? · What requires IRB review and approval? · What are the different types of IRB review? · What is the process for submitting an IRB application? · What criteria must be met for IRB approval? · What are possible outcomes of an IRB review? About CORE: The Culture of Research and Education (C.O.R.E.) webinar series is spearheaded by Dr. Bernice B. Rumala, CORE Chair & Program Director of the Ph.D. in Health Sciences program in collaboration with leaders and faculty across all academic programs. This innovative and wide-ranging series is designed to provide continuing education, skills-building techniques, and tools for academic and professional development. These sessions will provide a unique chance to build your professional development toolkit through presentations, discussions, and workshops with Trident’s world-class faculty. For further information about CORE or to present, you may contact Dr. Bernice B. Rumala at Bernice.rumala@trident.edu

1.
C.O.R.E
Webinar
Series:
Ethics
from
an
IRB
Perspec;ve
Culture
of
Research
and
Educa;on
(CORE)
1
Dr.
Heidi
Sato
Chair
-­‐
Ins3tu3onal
Review
Board
Director
of
Ins3tu3onal
Research
Dr.
Stefan
Hanson
Program
Director,
B.S.B.A.,
B.S.H.R.M.,
and
B.S.L
Ins3tu3onal
Review
Board
Member
.

2. 1. What
is
an
IRB
and
its
purpose?
2. What
requires
IRB
review
and
approval?
3. What
are
the
different
types
of
IRB
review?
4. What
is
the
process
for
submiKng
an
IRB
applica;on?
5. What
criteria
must
be
met
for
IRB
approval?
6. What
are
the
possible
outcomes
of
an
IRB
review?
2

3. Which
of
the
following
agenda
items
is
the
most
important
that
you
would
like
to
have
covered
in
this
webinar?
Select
from
the
following:
A)
What
is
an
IRB
and
its
purpose?
B)
What
requires
IRB
review
and
approval?
C)
What
are
the
different
types
of
IRB
review?
D)
What
is
the
process
for
submiMng
an
IRB
applica3on?
E)
What
criteria
must
be
met
for
IRB
approval?
3

4. True
or
False?
As
long
as
a
researcher
does
not
obtain
the
data
directly
from
human
subjects,
then
the
study
would
always
be
considered
as
research
that
does
not
involve
human
subjects
4

5. ¡ Ins3tu3onal
Review
Board
(IRB)
§ A
review
commiSee
established
to
ensure
that
the
rights
and
welfare
of
human
research
subjects
are
protected
§ IRB
ensures
adherence
to
▪ Federal,
state
and
local
regula3ons
▪ Established
ethical
principles
(the
Belmont
Report):
▪ Respect
for
Persons
▪ Beneficence
▪ Jus3ce
5

6. ¡ IRB
Membership
¡ Federal
regula3ons
require
that
an
IRB
have
at
least
five
members
with
professional
exper3se
and
competence
and
of
diverse
backgrounds
¡ The
Trident
IRB
§ Director
of
Ins3tu3onal
Research
(Chair)
§ Ins3tu3onal
Research
Analyst
(Permanent
Member)
§ Four
representa3ve
faculty
members
(with
at
least
one
faculty
member
mee3ng
defini3on
of
a
scien3st
member)
§ One
non-­‐scien3st
staff
member
§ At
least
one
community
member,
not
affiliated
with
Trident
§ Chief
Compliance
Officer
(Ex-­‐officio
member)
6

7. ¡ Research
with
Human
Subjects
requires
IRB
review
and
approval.
¡ “Research”
means
a
systema3c
inves3ga3on,
including
research
development,
tes3ng,
and
evalua3on,
designed
to
develop
or
contribute
to
generalizable
knowledge”
¡ And
where
7

8. ¡ Human
Subject”
means
a
living
individual
about
whom
a
researcher
(whether
professional
or
student)
conduc3ng
research
obtains
the
following:
§ Data
through
interven3on
or
interac3on
with
the
individual
§ Iden3fiable
private
informa3on
8

9. ¡ If
a
project
meets
the
defini3on
of
Research
with
Human
Subjects
then
it
is
subject
to
IRB
review
¡ The
next
step-­‐
§ What
type
of
review?
9

10. ¡ The
Categories
of
IRB
Review
are:
¡ Exempt
¡ Expedited
Review
¡ Full/Convened
IRB
Review
10

11. ¡ Exempt
Research
¡ An
IRB
can
determine
that
some
Research
with
Human
Subjects
is
Exempt
(45
CFR
46.101)
when
the
research
involves:
§ Educa3onal
SeMngs
§ Tests,
surveys,
observa3onal
research
§ Exis3ng
data
11

12. ¡ Expedited
Review
¡ Research
with
Human
Subjects
that
poses
no
more
than
minimal
risk
to
subjects
is
eligible
for
expedited
review
¡
Minimal
risk:
“The
probability
and
magnitude
of
harm
or
discomfort
an3cipated
in
the
research
are
not
greater
in
and
of
themselves
from
those
ordinarily
encountered
in
daily
life
or
during
the
performance
of
rou3ne
physical
or
psychological
examina3ons
or
tests”
45
CFR
46.
102
(i)
12

13. ¡ Full/Convened
IRB
Review
¡ All
members
of
the
IRB
meet
and
review
proposals
that
expose
subjects
to
more
than
minimal
risk
¡ Research
involving
protected
groups
are
subject
to
Full/Convened
Review
13

14. Which
of
the
following
would
be
considered
exempt?
A)
Any
study
that
involves
only
exis3ng
data
B)
A
primary
researcher
surveys
children
in
a
school
seMng
C)
An
anonymous
survey
conducted
on
a
healthy
adult
popula3on
regarding
a
previous
medical
condi3on
D)
Any
study
that
involves
minimal
risk
E)
Studies
in
which
par3cipants
provide
informed
consent
14

15. True
or
False?
Exempt
studies
do
not
need
to
be
reviewed
by
the
IRB.
15

16. ¡ Step
1:
Complete
online
IRB
training
hSps://phrp.nihtraining.com
¡ Step
2:
Obtain
approval
from
PhD
Director
on
disserta3on
proposal
(for
PhD
students)
¡ Step
3:
Complete
pre-­‐IRB
review
(star3ng
in
Oct)
¡ Step
4:
Obtain
permission
from
study
site
¡ Step
5:
Submit
IRB
applica3on
in
TLC
¡ Step
6:
Send
an
email
to
IRB@trident.edu
¡ Step
7:
Make
requested
revisions
¡ Step
8:
Receive
results
of
IRB
review
16

17. Required
for
all
Studies:
[
]
Cer3ficate
of
comple3on
of
online
training
[
]
Completed
IRB
applica3on
[
]
Approved
research
protocol/methodology
[
]
All
data
instruments
[
]
Permission
to
administer
study
Required
for
Studies
Involving
Data
Collec;on:
[
]
Informed
Consent
Form
[
]
All
documents
used
to
recruit
par3cipants
_____
*Addi3onal
requirements
may
be
required
for
certain
types
of
studies

18. 1. The
risks
to
subjects
are
minimized.
2. The
risks
are
reasonable
in
rela3on
to
benefits.
3. The
selec3on
of
subjects
is
equitable.
4. Informed
consent
will
be
sought.
5. Informed
consent
will
be
documented.
6. Safety
of
subjects
will
be
ensured.
7. Privacy
of
subjects
will
be
protected
and
confiden3ality
of
data
maintained.
8.
Safeguards
against
undue
influence
or
coercion
Source:
Code
of
Federal
Regula3ons
(45
CFR
Part
46.111)
18

19. 1. Exempt
2. Approved
3. Modifica3ons
or
addi3onal
documents
required
4. Deferred
un3l
full
IRB
CommiSee
review
5. Disapproved
19

20. Which
of
the
following
is
an
example
of
minimizing
risks
to
subjects?
A) Not
collec3ng
personal
iden3fiers
from
subjects
when
sensi3ve
data
is
being
collected
B) Having
a
teacher
present
when
a
researcher
is
interviewing
children
C) Both
A
and
B
D) Neither
A
nor
B
20

21. Which
of
the
following
does
not
apply
for
informed
consent?
A) Subject
or
legal
representa3ve
must
give
consent
B) Language
must
be
8th
grade
level
C) Coercion
must
be
avoided
or
minimized
D) It
must
disclose
purpose,
benefits,
risks,
procedures,
benefits,
risks,
and
how
confiden3ality
will
be
maintained,
E) None
of
the
above
21

22. ¡ Primary
purpose
of
IRB:
to
protect
the
rights
and
welfare
of
human
subjects
¡ Federal
regula3ons
require
IRB
review
for
all
research
involving
human
subjects
¡ Three
different
types
of
IRB
review:
exempt,
expedited,
and
full
review
22

23. ¡ Key
documents
required
documents
for
all
studies:
1)
cer3ficate
of
comple3on
of
online
IRB
training,
2)
completed
IRB
applica3on,
3)
approved
research
methodology,
4)
all
data
instruments,
5)
permission
to
administer
study
¡ Key
criteria
that
must
be
met
for
IRB
approval:
1)
Clear
documenta3on
on
how
risks
to
subjects
are
minimized,
2)
Informed
consent
that
includes
required
items
(if
ac3ve
data
collec3on)
23

24. Visit
hSps://www.trident.edu/webinars/core/
24

25. 25

26. 26

27. ASen3on
Faculty,
Students,
Alumni
and
Guest
Speakers
in
Business,
Health
Sciences,
and
Educa3on:
¡ Have
you
wanted
to
present
your
ongoing
scholarly
and
professional
work
to
a
general
audience?
¡ CORE
Grand
Rounds
provides
a
plaporm
for
professional
development
and
increased
engagement
to
receive
construc3ve
feedback
from
peers
and
scholars-­‐in-­‐training.
¡ Email
Dr.
Bernice
B.
Rumala
at
Bernice.Rumala@Trident.edu
to
sign
up

28. ¡ To
receive
more
informa3on
about
C.O.R.E.
please
visit
the
C.O.R.E.
webpage
at:
www.trident.edu/webinars/core
¡ For
further
informa3on
about
Trident’s
doctoral
programs
in
educa3onal
leadership,
business
and
health
sciences
please
visit
:
hSps://
www.trident.edu/degrees/doctoral/
¡ Do
you
have
any
comments
for
C.O.R.E.,
you
may
email
Dr.
Bernice
B.
Rumala,
C.O.R.E.
Chair,
at:
bernice.rumala@trident.edu
28

29. Contact
Ins3tu3onal
Review
Board
¡ Email:
IRB@trident.edu
¡ Phone:
Ø Dr.
Heidi
Sato,
Chair
(x2189)
Ø Ms.
Yan
Ma,
IRB
Member
(x2617)
¡ IRB
website:
hSps://www.trident.edu/students-­‐and-­‐alumni/
ins3tu3onal-­‐review-­‐board/
29