NJ Dept. of Health
Decision Tree for eIRB Submission
Revised: 01/12/2016
Is this research defined as:
A systematic investigation which includes research
development, testing and evaluation, designed to contribute
to generalizable knowledge, i.e., publication, presentation, or
achievement of a degree
NOTE: Rowan University IRB will make the determination
whether a proposed study is human subjects’ research or not.
The Principal Investigator IS STILL REQUIRED to submit an
eIRB application requesting a Non-Human subjects review.
No
Yes
No
Are you using data /
information about a living
individual?
Yes
No
Is there an interaction or an intervention with a living person related to
this research; OR is the information individually identifiable and is the
information private (is the information collected where the subject can
reasonably expect that a recording is not taking place and the
information was provided for a purpose where there is not an
expectation that the information will be made public or used in the
conduct of research)? If using confidential information or a link exists
between different data sets for this research, then please follow the
arrow marked ‘Yes’
Yes
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2
Human Subjects Review
Non-Human Subjects Review
1
2
1
Principal Investigator requests a Guest
Account in eIRB
Principal Investigator, Coordinators,
Co-Investigators, and Study Staff
request a Guest Account in eIRB.
Personnel receive notification of
eIRB account in approx. 24 hours
Principal Investigator and/or
Co-Investigator creates eIRB
application. Completes and
uploads all applicable
information listed in eIRB
Application Requirements
and completes eIRB
application
All Co-Investigators listed in
the eIRB application need to
Accept Participation.
Principal Investigator receives notification of
eIRB account in approx. 24 hours
Principal Investigator downloads and completes
Rowan University Protocol, Investigator
Financial and Other Personal Interest Form and
a survey or description of what will be obtained
in the course of the work. For example, if a
survey will be used, then that should be
provided in the eIRB application.
Principal Investigator logs into eIRB, creates eIRB
application, uploads the applicable documentation,
and completes the eIRB application. NOTE: PI
needs to select the following when completing the
eIRB application. On page 1.5 Review Type, the
PI selects Non-Human.
Principal Investigator submits study in eIRB. If errors
are noted when submitting, then specific eIRB pages
noted in error message need to be corrected. If no
errors occur, then the study is submitted for
Department Review and Approval.
NJ Dept. of Health
Rowan University eIRB Process
eIRB Application Requirements:
1) Investigator Financial and Other
Personal Interest Form
2) Protocol Template
3) Consent Forms
4) Research Materials – Data
Collection Sheet, survey, interview
or other instruments; screening
instruments
5) Advertisements, letters
6) Detailed data that will be obtained
from NJDOH via Data Use
Agreement (can be listed in the
protocol)
7) Investigators CV’s and resumes
8) Any other document(s)/materials
pertinent to the proposed research
study
9) Agreement for the Ethical Conduct
of Human Subjects Research
(formerly NJDOH OC-41)
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2
3
Human Subjects Review
NJ Dept. of Health (NJDOH)
Rowan University eIRB Process
RU IRB Administration reviews eIRB
application.
RU IRB determines Non-Human
Subjects and issues Non-Human
Subjects Determination Letter to PI
RU IRB Administration reviews study
and identifies any changes required.
Investigator needs to upload data
request in eIRB or detail the NJDOH
data that will be used in the study in the
protocol.
Principal Investigator logs into eIRB,
makes changes requested, responds to
change requests, and submits changes
back to RU IRB for review
Non-Human Subjects Review
Email the data request to
NJDOH
With DUA
RU IRB completes review and
makes a final determination.
Issues Approval with
Conditions Letter.
Without DUA
RU IRB completes review
and makes a final
determination. Issues
Approval Letter.
Principal Investigator obtains fully
executed NJDOH Data Use Agreement,
logs into eIRB, and clicks on Submit
Stipulations Document, uploads the fully
executed Data Use Agreement in the
section titled: ”Supporting Information”,
and then clicks on the OK button to send
the eIRB application back to the IRBA.
RU IRB completes the review
and ensures stipulation is
met. Issues Approval Letter.
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