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Navigating the IRB process

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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Navigating the IRB process

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  1. Office of Research Integrity and Compliance March 2011 Navigating the IRB process

  2. 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

  3. 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/

  4. A variety of scholarly work… Does my work require IRB approval? 2 questions to ask yourself

  5. #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

  6. #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?

  7. 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!

  8. 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.

  9. 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.

  10. “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

  11. CITI Page 1: https://www.citiprogram.org/default.asp

  12. CITI Page 2: Provide Institution, username, password, name, email

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

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

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

  16. CITI Page 6: Change Learner Group: “Students Conducting no more than minimal risk research”

  17. 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.

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