UNDERSTANDING THE
IRB PROCESS
Dr. Cheryl Peters, Evaluation Specialist
cpeters@anr.msu.edu
IS IT RESEARCH?
Does our Extension project require
IRB review?
3 Questions
IS IT RESEARCH?
MSUE IRB differentiates between
program evaluation (with intent to
inform or improve program
implementation), quality assurance
or quality improvement (is the
program implemented as intended
and with fidelity) and research.
IS IT RESEARCH? QUESTION #1
Is the activity a systematic
investigation designed to develop or
contribute to generalizable
knowledge?
If yes, the activity is defined as
research. Next question to consider:
IS IT RESEARCH? QUESTION #1
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Generalizable knowledge?
Contributes to theoretical framework
Primary beneficiaries are other
researchers/filed practitioners
Publications, presentations intended
for professional purpose
Results intended for replication
IS IT RESEARCH? QUESTION #2
Does the research involve obtaining
information about living
individuals?
If yes, the research involves human
subjects. Next question to consider:
IS IT RESEARCH? QUESTION #2
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Living individuals?
A human subject
Data through investigation or
interaction with the individual
Identifiable private information
De-identified data may not require
IRB review
IS IT RESEARCH? QUESTION #3
Does the research involve
intervention or interaction with the
individuals?
If yes, an IRB application is warranted.
3 QUESTIONS = 3 YES
If yes, an IRB application is warranted.
Most Extension program evaluations fall
under the category of exempt because the
evaluation plan involves research conducted
in established or commonly accepted
educational settings, involving normal
education practices (use of surveys,
interviews, observations, or tests).
EXEMPT, BECAUSE….
Presents minimal risk.
Often the consent document would be the
only record linking the subject and the
research.
Note: Keeping your Extension survey
voluntary and confidential can support
the allowance of waived consent.
WAIVED CONSENT
Most Extension program evaluation is
approved by the IRB under the exempt
category & can waive collecting a signed
informed consent document.
INFORMED CONSENT
All Extension program evaluations should
include the elements of voluntary
involvement, confidentiality, and notifying
participants regarding the intent of the
research or evaluation. The consent process
should be informative and empowering.
Templates of consent forms are available on
the MSU IRB website.
http://www.humanresearch.msu.edu/
TYPES OF IRB APPROVAL
Exempt is still a type of IRB approval.
Expedited and Full Board, VERY RARE.
IRB website: humanresearch.msu.edu
Form descriptions
Reference documents/ Forms
PI STATUS
Updated March 2012
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If Masters degree – no longer require
special permission
If do not currently hold a Master’s or
higher-level degree, special permission
still required for PI status before
beginning work on a grant or project
If Ph.D. research, must apply through
Faculty Advisor
REQUIRED IRB TRAINING
Individuals listed on an IRB proposal as PI,
or staff assisting in the collection of data, are
required to have IRB training. The IRB
training is online and has a test. Once you
complete the training, it is good for 2 years.
Instructions and links for the required IRB
training are here:
http://www.humanresearch.msu.edu/require
dtraining.html
ONLINE IRB APPLICATIONS ONLY
Investigator Login
Faculty/Staff need Z-PID
WHAT YOU WILL NEED READY
Title
Review category
Resources
Research sites
Project description and procedures
(200 words)
WHAT YOU WILL NEED READY
Subject population characteristics
Subject risks
Subject privacy/confidentiality
Conflict of interest
Timeline
Consent document (possibly)
Survey instrument (or questions)
LAST THOUGHTS
Program Evaluation vs. Research.
Intend to Publish Externally.
Have your project stabilized and welldescribed before seeking application.
Sometimes a call or email will help
flesh out the “three questions”.
Sometimes funders “want” IRB.
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Understanding the IRB Process