Study projects that require the use of humans, their data, or biospecimen to complete the study can be placed in one of two main categories, regulated or non-regulated. Each category has different requirements and must be conducted in accordance with all University policies and applicable local, state, and federal regulations.
Regulated Human Research Projects
Regulated projects include both research and human subjects. Both of these are defined in the federal regulations (45 CFR 46 102) and are summarized below:
- Research is a systematic investigation, being developed with the intention of other research professionals building upon the results, AND that apply to larger populations beyond the study group participants or site of data collection.
- Human subjects are defined as a living individual about whom investigators use, study, or analyze information or biospecimen obtained through intervention or interaction with the individual; OR obtains, uses, studies, analyzes or generates identifiable private information or biospecimen.
All projects that meet these definitions require submission to Michigan Tech’s eIRB submission system for official determination of exemption by HRPP staff or MTU-IRB review and approval PRIOR to starting. This applies to funded and non-funded projects.
Some examples of activities involving humans as subjects that typically meet these definitions:
- Independent research studies conducted by graduate students for a thesis or dissertation
- Use of a non-public dataset that contains identifiable human data, often received from a third party source
Non-Regulated Human Research Projects
Non-regulated projects often include a systematic investigation but lack the ability of other research professionals building upon the results or only apply to the project’s study group participants, but they require the use of humans, their data or biospecimen to conduct their project. These projects do not fall under the MTU-IRB’s responsibility to review, approve, or oversee.
However, as a research focused University, even projects that are considered non-regulated require some form of review to protect participants and ensure adherence to basic ethical principles found within The Belmont Report that guide our University.
In accordance with these principles, non-regulated projects must ensure people are provided with: appropriate information about the project and what they are being asked to do, how their information will be used and kept safe, and that they are free to decide if they want to participate. Non-regulated projects may NOT involve risks (physical, social, or psychological) to participants.
The following are examples of activities that might be considered non-regulated projects at Michigan Tech.
- Project conducted for course credit or educational experiences, i.e., Research Methods Courses, Senior Design/Capstone Courses/Enterprise
- Projects designed and conducted for the sole purposes of quality improvement, assessment, or evaluation of the institution, course, or program
Who Can Determine If A Project Is Regulated Human?
There are many factors to consider when determining if a project is regulated. The following are examples of specific types of projects and how determinations can be made.
Due to Michigan Tech internal processes for accepting awards and to ensure compliance transparency of any work involving humans, externally funded projects (regardless of funding source) must be reviewed by an HRPP staff member and have official determination or approval documented in the eIRB submission system.
Course instructors and faculty advisors leading projects being conducted in conjunction with a course at MTU are encouraged to review the Guidance for Course Projects document for more information. Qualified instructors or faculty advisors may be able to self-determine course projects through a form that is provided via a link within the guidance document.
Educational or Institutional Projects
Guidance for these projects are currently being developed and will be accessible here when complete. In the meantime, contact HRPP for assistance.
For either category, regulated or non-regulated, if you are unsure if your project meets the definition of regulated human subject research described above, contact HRPP for assistance by sending an email to firstname.lastname@example.org or calling 906-487-1799.