Policies and Procedures

Research must receive IRB approval before starting any activity that fits the HRPP definition of Human Subjects Research (HSR). The HRPP definition is taken from Federal regulation 45CF46, which requires that an activity counts as research, and that it involves human subjects. Research is here defined as 

“a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (45CFR46.102(l)). A human subject is defined as "a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens." (45CFR46.102(e)(1), emphasis added).”

This HSR definition covers most research involving questionnaires, interviews, observations and  measurements of living individuals. However, it does not always apply to class projects, assessments/evaluations, oral histories, or the analysis of data that has already been collected  and stripped of identifying information. If you have any questions about whether or not an  activity meets this definition, please contact the IRB Administration at irb@mtu.edu or 906-487-1799.

Exempt Reviews

Exempt projects are those which are judged to involve zero to minimal risks, and little or no intervention in people's daily lives. They are reviewed on a rolling basis. Studies approved at this level are exempt from further IRB oversight, so long as they do not change. They do not require team members to submit a yearly renewal. Once Exempt Review studies are completed, researchers must submit a study closure report or send an email notification to HRPP at irb@mtu.edu.

Expedited Reviews

Expedited Review projects are those which are determined to pose no more than minimal risks to subjects, but which involve interventions or information-gathering procedures that must be handled carefully to ensure safety and/or confidentiality. They are reviewed on a rolling basis. Most studies approved at the Expedited Review level do not require the submission of a yearly renewal report to the IRB. PIs of Expedited Review studies must however promptly submit an incident report to HRPP if there are any unanticipated problems that increase the risks faced by subjects. Once they are completed, Expedited Review studies must be officially closed by submitting a final report through the eIRB system or by sending an email notification to irb@mtu.edu.

Full Board Reviews

Full Board Review projects are those which pose more than minimal risk to subjects. They can only be approved at a convened meeting of the IRB. These meetings take place roughly once per month during the school year. Full Board Review projects take longer to process than Exempt or Expedited studies. They should therefore be submitted well in advance, ideally with an aim to completing the pre-review process before the relevant meeting's submission deadline.

Studies approved at the Full Board Review level require continuing oversight by HRPP staff, at least until they reach the stage of pure data analysis or clinical follow-up. Research team members must submit renewal reports through the eIRB system at least once a year. PIs must also promptly submit an incident report to HRPP if there are any unanticipated problems that increase the risks faced by subjects. When completed, Full Board Review studies must be officially closed with a final report through the eIRB system.

Note: Please visit Protocol Submission (eIRB) for instructions on how to submit incident reports, study closures, and renewals.

Changes made to previously-reviewed studies, such as adding research personnel, modifying recruitment, or altering study procedures, must be approved by the IRB in advance unless the safety of subjects is immediately at risk.

Modifications are made through the eIRB system. Modifications are pre-reviewed by HRPP staff and evaluated on whether they can be Expedited or require Full Board Review. See the “Creating a Modification” guide on the Protocol Submission (eIRB) for instructions on how to submit a modification.

Payments to research subjects are meant to compensate them for time and effort, not entice them into doing something they really don’t want to do. It is important therefore to think about how much might be too much to offer for participation.

It is also important to make it clear exactly what people must do in order to receive full compensation. If people who drop out of a study before its completion are to be paid less, this “pro-rating” must be made clear in the informed consent document.

Payments to research subjects must also be done in an accountable way. MTU’s regulations require that researchers keep a log of payment dates and amounts for reporting to Financial Services and Operations. If a study is not anonymous, this log must also include the subjects’ names, or code identifiers linked to a list of names kept separately.

Finally, payments to research subjects are a form of income, so they must be made in accordance with tax laws. MTU addresses this by requiring tax reporting documents from all subjects paid more than $100 and all subjects who are not U.S. residents for tax purposes. This means that it is not possible for subjects in these categories to remain entirely anonymous. 

Further details can be found in MTU’s official research subject compensation procedures document, which includes information that must be included in informed consent documents/scripts. 

You can download relevant tax reporting documents and instructions here:

• W-9 form (for citizens and residents for tax purposes) 
• W-8BEN form (for subjects who are not U.S. residents for tax purposes)

These are described in our HRPP Standard Operating Procedures.  This document includes, but is not limited to:

• IRB Roles and Responsibilities, Membership Policy, Approval/Authority
• Conflict of Interest Information
• Procedures for Submissions
• Reviews for Exempt, Expedited, and Full Board
• Incident Reporting
• Recruitment and Informed Consent
• Changes/Modifications/Continuing Review/Closure in Research Projects
• Suspension/Termination of Research
• Vulnerable Subjects in Research
• Principal Investigator Responsibilities