understanding the irb process
DESCRIPTION
Understanding the IRB Process. Dr. Cheryl Peters, Evaluation Specialist [email protected]. Is it research?. Does our Extension project require IRB review? 3 Questions. Is it research?. - PowerPoint PPT PresentationTRANSCRIPT
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Does our Extension project require IRB review?
3 Questions
IS IT RESEARCH?
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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?
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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 #1
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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 #2
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Does the research involve intervention or interaction
with the individuals?
If yes, an IRB application is warranted.
IS IT RESEARCH? QUESTION #3
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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).
3 QUESTIONS = 3 YES
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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.
EXEMPT, BECAUSE….
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Most Extension program evaluation is approved by the IRB under the exempt category & can waive collecting a signed informed consent document.
WAIVED CONSENT
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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/
INFORMED CONSENT
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Exempt is still a type of IRB approval.Expedited and Full Board, VERY RARE.
IRB website: humanresearch.msu.edu
Form descriptions
Reference documents/ Forms
TYPES OF IRB APPROVAL
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Updated March 2012• 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
PI STATUS
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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/requiredtraining.html
REQUIRED IRB TRAINING
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Investigator LoginFaculty/Staff need Z-PID
ONLINE IRB APPLICATIONS ONLY
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TitleReview category
ResourcesResearch sites
Project description and procedures (200 words)
WHAT YOU WILL NEED READY
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Subject population characteristicsSubject risks
Subject privacy/confidentialityConflict of interest
TimelineConsent document (possibly)
Survey instrument (or questions)
WHAT YOU WILL NEED READY
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Program Evaluation vs. Research.Intend to Publish Externally.Have your project stabilized and well-described before seeking application.Sometimes a call or email will help flesh out the “three questions”.Sometimes funders “want” IRB.
LAST THOUGHTS