Office of Research Integrity and Compliance March 2011

 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

Office of Research Integrity and Compliance, Lakeshore Center, downtown Houghton ntegrity-compliance/review-boards/human- subjects/

Does my work require IRB approval? 2 questions to ask yourself

 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

 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?

 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!

 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.

 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.

 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: ity-compliance/review-boards/human- subjects/citi-training.html

CITI Page 1:

CITI Page 2: Provide Institution, username, password, name,

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

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

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

 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 s from a study package which will become a permanent record.