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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

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irb committee why it exists
IRB Committee – why it exists
  • 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:
  • respectfor persons
  • beneficence
  • justice
  • US Federal Code & State regulations
  • Michigan Tech Policies and Procedures
michigan tech irb
Michigan Tech IRB

Office of Research Integrity and Compliance, Lakeshore Center, downtown Houghton

http://www.mtu.edu/research/administration/integrity-compliance/review-boards/human-subjects/

a variety of scholarly work
A variety of scholarly work…

Does my work require IRB approval?

2 questions to ask yourself

1 does my project involve human subjects
#1. Does my project involve “human subjects”?
  • 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

2 is my project considered research
#2. Is my project considered “research”?
  • 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?
now the bad news
Now the bad news…
  • 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!
how to apply for irb approval
How to apply for IRB Approval:
  • 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.
irb timeline
IRB Timeline:
  • 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.
required training that awful thing you have heard about
“Required Training”: that awful thing you have heard about!
  • 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

slide13

CITI Page 3: Provide Member Information, can select Basic Human Subjects – Social & Behavioral Focus

slide14

CITI Page 4: Learner Course – Students Conducting no more than Minimal Risk Research, Have not completed Basic Course

slide15

CITI Page 5: If you previously registered for the wrong course, change your “learner group” here:

what s new
What’s new?:
  • 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.