Office of Research Integrity and ComplianceMarch 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

http://www.mtu.edu/research/administration/integrity-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:

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

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

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

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 emails from a study

package which will become a permanent record.