CHECKLIST FOR NEW IRB PROTOCOLS (do Not Upload With

checklist for new irb protocols: (do not upload with protocol) 1. online nih tutorial on the protection of human subjects in research:

CHECKLIST FOR NEW IRB PROTOCOLS:
(do not upload with protocol)
1. Online NIH tutorial on the protection of human subjects in
research:
*
Have you and all Key Personnel (persons from BSU who will have a
role in the research project, including Faculty Sponsor if PI is a
student) completed the online tutorial on the protection of
research subjects?
*
If not, go to http://phrp.nihtraining.com/users/login.php to
take the tutorial.
*
Are completion certificates for you and all Key Personnel on file
with the IRB?
*
If not, upload with the protocol an electronic copy of each
certificate not on file.
2. Human Subjects Research Application Form:
*
Have you completed the application form for your study? Did you
download the most recent version from the forms library? Did you
answer all of the items?
*
Are all Key Personnel listed on page 2, with descriptions (not
just “co-PI” or “faculty sponsor”) of their responsibilities?
*
For student PIs: have you listed your Faculty Sponsor on page 2 as
Key Personnel? Did you provide your Faculty Sponsor with full
access to your protocol? Has your Faculty Sponsor completed the
“Faculty Sponsor Assurance Statement” on page 2 of the application
form?
*
Please provide a description of his/her responsibilities with
regard to your study. This may include responsibilities such as
assisting with data collection, analyzing data, recruitment,
limited to general oversight, available for questions from the
PI, etc.
*
Have you listed all collaborators from other institutions on page
3 (or as a separate attachment if necessary)?
3. Narrative:
*
Have you developed a narrative to describe your study, written
according to the Narrative Guidelines? Did you download the most
recent version of the Narrative Guidelines from the forms library?
*
Did you explain all discipline-specific terminology in the
narrative?
*
IRB members are chosen for their varied backgrounds and may
not be familiar with the terminology of your specific area.
Please use laypersons terms when possible.
4. Attachments:
*
Did you upload all relevant additional materials, such as any of
the following?
*
Informed consent documents (for expedited and full review
protocols)
*
Parental permission forms (for expedited and full review
protocols, with minors)
*
Introductory letters (for exempt protocols)
*
Surveys or interview questions
*
Recruitment letters or e-mails
*
Recruitment or introductory scripts
*
Flyers or posters
*
Postcards, PowerPoint presentations, photographs, etc. as
appropriate
In order to grant approval or exemption, the IRB must review all that
participants will see or hear as a result of your study. Therefore,
the IRB cannot complete the review of protocols that are missing these
documents if they are pertinent to your study.
*
If you will be conducting research at another organization or
institution, did you obtain (or are seeking) permission or
approval to conduct your research at that location?
*
This may involve obtaining a letter from someone with
the authority to grant you permission to conduct
research at that organization or institution. Please
upload an electronic copy of that letter with your
protocol, or indicate that a letter is being sought in
you are still in the process of obtaining permission.
*
If you will conduct some or all of your research at
another university, college, or hospital (including Ball
Memorial Hospital), have you determined if review by that
institution’s IRB will be required?
*
You should check with their IRB, research compliance,
or sponsored programs office for that institution’s
requirements before beginning any recruitment efforts
at that institution. Please upload an electronic copy
of any approval/exemption letters with your protocol
once you have received them.
*
IRB approval/exemption should be obtained from Ball
State’s IRB before submitting a protocol for review at
the other institution, but it is strongly recommended
that you initiate communication with the other IRB
office earlier in the process.
5. Electronic signatures and submitting the protocol:
*
Did you as the PI electronically sign the protocol (click on
“Sign study” button for directions) before submitting the
study to the IRB?
*
For student PIs: did your Faculty Sponsor for this study
also electronically sign the protocol before submitting the
study to the IRB?
*
Did you ensure all required forms and documents have been
uploaded (and for student PIs, reviewed by the Faculty
Sponsor) before submitting the study?
*
Once the protocol has been submitted, the study will be
locked and you will not be able to make changes without
contacting the administrator ([email protected] or
765-285-5070).
*
Did you submit the study to “Ball State University IRB,
Muncie, IN”?
NOTE: The IRB website lists deadlines and associated meeting dates for
review. Protocols should be submitted electronically through IRBNet (http://www.irbnet.org).
Training materials are available through the IRB website at
http://www.bsu.edu/irb.
If you have any questions, please contact:
Research Compliance Dr. Leonard Kaminsky
Sponsored Programs Office IRB Chairperson
765-285-5070 Human Performance Laboratory
[email protected] 765-285-4044
[email protected]