Frequently Asked Questions

You might. Many class projects do not meet the federal definition of involving human subjects, and many projects conducted solely for course credit or educational experience do not meet the federal definition of research. However, some class projects are hard to categorize in these terms, for example in senior capstone/design and Enterprise courses.

If you are unsure if a class project will require IRB oversight, contact the HRPP office (irb@mtu.edu) to discuss it.

Whether or not a class project counts as research, please consider common ethical issues that can arise during academic studies. Also, if you feel that a project might pose physical risks, please contact Michigan Tech’s Environmental Health and Safety (EHS) office at ehs@mtu.edu.

You might. Projects conducted solely for internal MTU use frequently do not need review, but you may need to make an IRB submission if a sponsor requires it, or if you plan on using the results to make a contribution to generalizable knowledge. If you are at all unsure, contact the HRPP office (irb@mtu.edu) to talk it over.

Whether or not an assessment project counts as research, you may want to look at HRPP’s page on common ethical issues that can arise during academic studies. Also, if you feel that a project might pose physical risks, you should contact MTU’s Environmental Health and Safety office at ehs@mtu.edu.

Yes. Typically this will involve arranging some kind of “reliance agreement” with the non-MTU institution. You should contact the HRPP office (irb@mtu.edu) as soon as you can, in order to get this process started.

Through the Cayuse eIRB system. See the Protocol Submission (eIRB) page for instructions and resources.

It depends on how complicated the project is, and how much risk it poses to the subjects involved. New Exempt and Expedited studies typically take 2-3 weeks to review, although they can take longer. Full Board approval can be a much slower process, especially if it requires more than one meeting to complete (since convened meetings are only held once a month). Modifications to Exempt and Expedited studies often take only about 1 week to review.

If a student has not used the eIRB system before, they must fill in an application form to be added to the system. Once that has been processed, they can be added as personnel using the Cayuse Study Personnel search function.

If a student needs to be able to edit a submission, they should be added as a Primary Contact or Co-Investigator.

Older Exempt studies from the IRBNet system were not uploaded to Cayuse but they are still accessible to HRPP staff.  They can be added to Cayuse upon request by contacting the HRPP office at irb@mtu.edu.

They are available in Cayuse in the “Letters” tab at the bottom of the relevant submission page. See the “Where to Find Your Documents” guide on the Protocol Submission (eIRB) page for instructions.

Studies that go through Exempt or Expedited review procedures do not have a fixed closure or renewal date. However, every three years an Administrative Check-in must be submitted to the IRB to indicate if they are still in progress.

Full Board Review approval lasts for one year. A Continuing Review submission must be made and approved before the year is up, in order for the study to continue another year. See the “Creating a Renewal” guide on the Protocol Submission (eIRB) page for instructions.

Yes. A modification submission must be approved before even minor changes are made to a protocol. This applies to Exempt as well as Expedited and Full Board studies, and it includes changes in funding and personnel. A modification should also be submitted if there is a change in the conflict of interest status of any personnel.

Researchers should keep track of any incidents involving human research subjects. Some must be promptly reported via a Cayuse “Incident” submission, while others may need to be summarized when approval for a study is being renewed. See the web page on Reporting Incidents for details, and/or contact the HRPP office (irb@mtu.edu) for more details.

Studies are usually selected randomly from all currently active non-Exempt protocols. Some studies may occasionally be selected non-randomly, if the Board thinks their level of risk warrants additional oversight. Studies can also be selected “for cause,” if adverse events or other problems come to light. Researchers can also request that a study of theirs be audited.

To help researchers maintain compliance with MTU and Federal regulations, to help identify and solve any minor problems, and to help prepare for any external inspection/review by sponsors or government agencies. All these goals can be especially important for large studies with multiple personnel.

If a researcher is prepared, and documents are made easily available, an audit meeting is expected to take around 1 hour.

If no problems are identified, or if all problems are minor and solved during the PAM meeting itself, the PI will simply receive a letter saying that the review is complete. If minor issues are identified that cannot be immediately corrected, the PI will receive a letter asking them to correct any problems within a given timeline. If major or ongoing noncompliance issues are identified, the PI will have to submit an appropriate Incident report in Cayuse and follow MTU’s procedures for such problems (see section 15 of MTU’s HRPP/IRB Policies and Procedures document).

Typically within 10 business days.

PIs are strongly recommended to attend PAM meetings, but if that is not possible, they may designate a lead research team member or project manager to attend in their place.