navigating the irb process
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Office of Research Integrity and Compliance March 2011. Navigating the IRB process. IRB Committee – why it exists. Responsible for protecting the rights and welfare of human research subjects, Michigan Tech researchers, and the University - PowerPoint PPT PresentationTRANSCRIPT
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Office of Research Integrity and ComplianceMarch 2011
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Responsible for protecting the rights and welfare of human research subjects, Michigan Tech researchers, and the University
Human research subject basic ethical principles, The Belmont Report:
(1) respect for persons(2) beneficence
(3) justice US Federal Code & State regulations Michigan Tech Policies and Procedures
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Office of Research Integrity and Compliance, Lakeshore Center, downtown Houghton
http://www.mtu.edu/research/administration/integrity-compliance/review-boards/human-subjects/
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Does my work require IRB approval?2 questions to ask yourself
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Intervention – physical methods of collecting data from subjects, or manipulation of environment performed for research purposes
Interaction: project involves communication or interpersonal contact between investigator and subject (survey, interview, internet contact,…)
Identifiable Information – ID of subject is/can be readily identifiable
If “YES” to any of above, move to question #2
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Are you using a systematic approach and predetermined methods for studying a specific topic, answering a specific question, testing a hypothesis, or developing a theory?
Is the activity designed to contribute to generalizable knowledge beyond a specific individual or unit?
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Researchers can not determine that their “project” is not human subjects research, the IRB must determine “exempt” status!
So, if your work “might be” human subjects research, play it safe and submit an application for approval!
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Generally 3 things to submit: Application coversheet,
Consent / assent document, project summary & methods
Templates, instructions, forms, examples are provided on our website on the right side of the page in the resources boxes under titles such as applications / other forms.
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Initial determination of “exempt” is handled administratively, generally < 1 week turn around
If original determination deemed “expedited”, sent for designated member review, approximately 1 to < 2 weeks
If “full board”, application deadline posted on web site is two weeks prior to IRB meeting date, and determination is dependent upon meeting quorum, modifications required, etc.
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Yes, Michigan Tech is required to train researchers
CITI Training Information regarding training can be
found on our website in the resources box on the right or at the following link:
http://www.mtu.edu/research/administration/integrity-compliance/review-boards/human-subjects/citi-training.html
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CITI Page 1: https://www.citiprogram.org/default.asp
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CITI Page 2: Provide Institution, username, password, name, email
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CITI Page 3: Provide Member Information, can select Basic Human Subjects – Social & Behavioral
Focus
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CITI Page 4: Learner Course – Students Conducting no more than Minimal Risk Research,
Have not completed Basic Course
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CITI Page 5: If you previously registered for the wrong course, change your
“learner group” here:
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Coming soon: Introducing the IRBNet software tool
IRBNet registration and training sessions
How will this help me? Researchers can have their NEW projects in one
easy location for access. Each study will contain it’s own documents which
can be shared with other research team members. You can send and receive emails from a study
package which will become a permanent record.