Transcript Welcome to the presentation “Education and Social/Behavioral Science Institutional Review Board (IRB).” After you review a slide, click anywhere to advance.

Welcome to the presentation “Education and Social/Behavioral Science Institutional Review Board (IRB).”
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Education and Social/Behavioral Science
Institutional Review Board (IRB)
OFFICE OF RESERCH SERVICES
HUMAN SUBJECTS
Lil Larson, IRB Director, presented this information on November 29,2012, and it has been modified into a selfpaced presentation. It was updated to include changes December 2014.
It is part of a series or seminars coordinated by L&S Administration, intended to connect L&S faculty and staff with
topics and information that may be helpful in their positions. More presentations and information about this series
of trainings can be found at https://kb.wisc.edu/ls/page.php?id=25131
For new faculty and staff:
 Human subject research activity taking place
while employed by UW-Madison requires review
by a UW-IRB.
 Ongoing research approved at a previous
institution will likely require review by a UWMadison IRB.
A faculty member who completed research at another institution and is
only writing at UW-Madison may be an exception from this. However, this
exception should be confirmed in writing with the IRB office.
 If a previously approved project will now become
collaborative, the IRB must approve that
collaboration.
For new faculty and staff:
 In addition to the federal regulations, IRBs are
governed by institutional policies, which may
vary.
• For example: Per campus policy, the IRB must make
a determination if a research study is Exempt. This
is not a federal requirement, but UW-Madison (and
most peer institutions) have determined that PIs
cannot determine if their project is Exempt.
• PI should be tenured or tenure-track faculty.
For new faculty and staff:
 For funded research, RSP must be able to verify
human subjects (IRB) approval before funds will
be released.
• Adding a funding source requires a Change
application.
 Meeting dates are important only if a project is
likely to require full committee review.
• Turnaround times
Proposals
that doreceived
not need
a full
full reviews
committee
review
If you
haven’t
a response
in 7-10
daysonceare
Meeting dates are available on the IRB website.
The
committee
conducting
meets
a
considered
on
ainrolling
basis;
afaculty
response
canissue
be expected
please
check
with
us
in case
thereexpertise,
is an
month. A full review is usually only required with
complex
studies
that
need
or in
from
usmost
in(e.g.
7 common
to when
10 days.
Most
protocols
require
some
(the
issue
is that
the protocol
situations where federal guidelines require a full
review
subjects
are prisoners
or persons
additional
time for
this
should
be built into
wasn’t
successfully
submitted
by the
with disabilities). The assigned Staff Reviewer revision,
will
makeso
the
determination
about
thePI!)
appropriate
your timeline.
type of review.
For new faculty and staff:
This includes any students involved in projects; they must all
 Personnel:
be listed on the protocol and show evidence of human subjects
training before they can be engaged in the research.
• Anyone taking part in recruitment, consent, data
collection, or data analysis is considered engaged in
the research and must take human subjects training
and be listed as a study team member.
• For some labs/departments, it is a good idea to list
support staff as a Point of Contact or study team
member; however that means the staff member
must complete human subjects training as well.
Undergraduate
student research
projects can be a grey area, per our
However, in some cases, a student’s research
could be substantial
and built
campus
policies.
If
a
student
research
project is solely for a class
upon for future publishable or presentable research. We rely on faculty to
gradecan
or course
credit
(no
intention
help identify those types of projects so they
go through
IRB
approval
at to publish or to disseminate
beyond
campus),
it likely
not involve IRB approval.
the onset. More information about student
research
policies
can does
be found
on the IRB website.
Register a NetID
In the older system, every person needing access had to
request authorization through our office. Now, the PI (or
someone else registered as part of the team team) can
register a staff or faculty NetID in the ARROW system to
authorize access. Once an individual’s NetID is registered in
ARROW, they may be added to any study team.
 All Registered Users have access to ARROW
 To gain access, ask your PI or other study team member
to register your NetID in the ARROW system
 The Register a NetID activity can be found in any
protocol application workspace
 Add NetID to the ARROW System or use Look Up
provided
Non-UW Personnel
Once the external collaborators receive their NetID, they may
also complete human subjects training online at UW. (All of
your team members must complete training.) If your
collaborator is from another institution they may complete
their human subjects training at their home institution instead.
 Obtain a UW-Madison NetID for all members of the
study team
• Non-UW-Madison personnel
that need to obtain a NetID
should request one through
the web form:
http://www.gradsch.wisc.edu/
arrow/access/request.pl
Non-UW
individuals
engaged
your research
project
mustNetID, a
Since
individuals
are added
to a inprotocol
in ARROW
by their
be listed
protocol
if our
campus isPIs (or other
NetID
must on
be the
requested
forapplication,
any non-UW
collaborator.
serving
as
the
IRB
of
record.
This
includes
collaborators
team members) can then add the individual to their ARROW protocol
submitted
byfrom
their other
NetID,universities,
just as theyunless
would they
with have
any other
UW personnel.
protocols to the IRB at their home institution. Everyone
included
in the
research project
must
covered
bydays;
one so when
The
extra step
of requesting
a NetID
maybe
take
several
approval.
youIRB
have
external collaborators, it’s important to plan ahead.
The Special Considerations & Procedures area of the protocol should be attended to closely. If
proposers do not check the boxes that relate to their study or interview questions, they will
not be prompted for additional required information. This can hold up the review process.
Special Considerations & Procedures
 Use of new media (Facebook, Twitter, blogs, etc.)
• May require review by the Full IRB
• Provide Privacy Statement/Terms of Use and explain how research is in
compliance with site’s policies
 Sensors or monitors applied to subjects
•
When a research project includes social media
(for reasons other than recruitment postings),
Include description in the Research Design & Procedures
section
the proposer must provide assurance their
research falls within the site’s privacy policies.
Because the area of social media is changing so
rapidly, research involving it will likely require a
Explain how samples will be collected, stored, full
and
IRBprotected
review. If you’d like to know whether a
project will require full review, please work with
the assigned Staff Reviewer after submission.
 DNA
•
 Not Applicable
• Very few projects should select this option
Special Considerations & Procedures
 Research activities occurring in an educational setting
• Research activities taking place in schools, classrooms, etc.
• Site permission will be needed (likely from district or principal)
 Review of records/data/images
• Includes reviewing databases, registries, existing data, etc.
If researchers are using
any existing data, they
must provide
information about it,
including what data
points they will be
using, if a data use
agreement in place, and
how the researcher got
access to that data.
 Watching or listening to materials that subjects might consider
offensive, threatening, or degrading (e.g., pictures, videos)
• Ensure the consent form adequately prepares participants for
participation
 Community-based research
• Includes any sites where additional permission may be required
(community centers, businesses, etc.)
Special Considerations & Procedures
 Creation of audio or video recordings or photographs
• Explain how recordings/photos will be used and stored
 Collection and/or use of biological specimens for research
purposes
• ED/SBS IRB can only review non-invasive measures and/or one
venipuncture
 Deception
• Provide debriefing
• May require Full review
 Interviews, focus groups, surveys, questionnaires, assessments
• Most ED/SBS researchers will include this option
Most common errors:
An example inconsistency is when a protocol outlines five
potential risks, but the consent form only includes two. All
provided documents should be consistent with the protocol.
 Inconsistencies
• Protocol description says something different than consent
forms or instruments
• Risks
• Identifying risk does not mean the study cannot be
approved—only that steps to mitigate risk are included.
• Most
research
not anonymous
Identifying
no risks is oftenis
anconfidential–
error. A breach of confidentiality
is often a potential risk. Most risks will be
minimal, and will not affect approval of the study; but the IRB office will want to see how researchers plan on
mitigating those minimal
risks –
(such
as how data
will be protectedand
to minimize
a breach ofshould
confidentiality).
• Academic
jargon
study
description
abstract
be
Another common
error is misidentifying
research
as anonymous. If the study
includes interviews, collects
names, email addresses, or even if a web survey collects IP addresses, the study is not truly anonymous.
written
in layman’s terms, not copied and pasted from a
The review is not affected if there are direct or indirect identifiers, but the IRB office will look to see how
that identifying
information will be protected.
grant
application.
Finally, keep in mind that the reviewers will likely not have a
background in your particular research area. Explain your
project in layman’s terms to ensure readers understand what
your project is.
… and finally
 Remember to SUBMIT!
The
A protocol
ARROW cannot
system be
willsubmitted
indicate the
if it’s
protocol
missingwas
required
successfully
submitted.
information.
Nevertheless
The most common
we run into
missing
situations
components
where are:
proposers thought they submitted the protocol when they did
not
(1)actually
Missingdo
answers
so. Double-check
to requiredthe
questions.
history area
You to
can
ensure
run a it
has been
validation
submitted,
of theand
protocol
checkbefore
in withsubmitting;
our office ifityou
willhave
not received
show you
a response
any required
to your
questions
protocol
missing
withinan7 answer.
to days of
submission.
(2) Missing human subjects training of a team member.
The activity area shows individuals included on the
protocol that indicates the team members and whether
they have completed the training. All individuals must
have their training indicated here before the protocol
can be submitted.
If an attempt is made to submit an incomplete protocol,
the submission will be blocked, and an error message will
appears with the reason.
Questions?
Contact the IRB Office:
http://www.irb.wisc.edu/
(608) 263-2320
3rd Floor (west) Lathrop Hall