All personnel engaged in an Human Subject Research (HSR) project must complete required training prior to conducting research. Personnel includes anyone assisting in a research project who will be interacting or intervening with participants or their private identifiable data/specimens collected for research purposes. This includes Michigan Tech faculty, staff, undergrad or graduate students, and any external investigators/collaborators.
CITI Program training is Michigan Tech’s primary tool for training and documentation. Please visit the CITI Program website to register. Choose Michigan Technological University as your affiliation and continue the online instructions. The following list of CITI modules are required for the respective areas (note a minimum score of 80% is required to pass).
Human Subjects Training Requirements
The Biomedical Research course is required for researchers and staff involved primarily in biomedical research with human subjects. This is research that could involve risks associated with potential physical harms such as exercise, exposure to minor pain and discomfort, or side effects from pharmaceuticals. Researchers taking this course do not have to take the Social & Behavioral Research course, but note that additional courses in Biosafety may be required when working with biological materials. Please visit the Biosafety Training website for more information.
The Social/Behavioral Research course is required for researchers and staff involved primarily in social and behavioral research with human subjects. Social-behavioral research applies the behavioral and social sciences to the study of humans. Its methods include, but are not limited to: interviews, focus groups, surveys, observations, and ethnography.
Please contact irb@mtu.edu if research involves prospective clinical trials. Required training for clinical trial research could include the following courses:
- Social & Behavioral Research Best Practices for Clinical Research
- Clinical Research Coordinator (CRC) Foundations
- Clinical Research Coordinator (CRC) Advanced
The Research with Biomedical Data or Laboratory Specimens Only course is required for researchers and staff who have no direct contact with human subjects but are using human subject data (including human biospecimens).
IRB members are required to complete either the Biomedical Research or Social/Behavioral Research course and the IRB Member course. An additional course is required for the IRB Chair.
In addition to specific IRB training, other safety training may be required depending on your specific department requirements and the presence of chemical/biosafety/hazardous materials within a laboratory or field site.
Webinar Videos
IRB submissions are significantly different from grant proposals or academic papers. They have to focus mainly on the practical details of how participants will be found, recruited and consented, and exactly what people will have to do as part of the project.
In this ~30 minute video, Mike Reay talks about what the IRB is looking for in a submission, and how to minimize the number of changes required before a project is approved.
Informed consent is at the heart of the ethical treatment of research participants. People need to know exactly what they are getting into, and they have to be free to choose.
In this ~30 minute presentation, Mike Reay talks about treating consent as an ongoing process, providing the necessary information, making sure language is understandable, and addressing situations where people cannot consent for themselves. He also discusses when various consent requirements can be ‘waived.’
Video: Handling Informed Consent
If you are joining a human subjects research team run by someone from outside Michigan Tech, or if you want outsiders to collaborate with you on one of your own projects, you will probably have to contact more than one Institutional Review Board to get approval. This is often referred to as setting up a “single IRB / sIRB” or “IRB of record,” and while it usually goes without a hitch, it is always worth figuring out sooner rather than later.
In this 30-minute covers the various options available, including how to set up “reliance agreements” like an IAA (IRB Authorization Agreement) or IIA (Individual Investigator Agreement).
Video: Getting IRB Approval For Projects With Non-MTU Team-Members