Human Subjects in Research or Other Projects
Effective January 19, 2018 there will be changes to the Federal Policy for the Protection of Human Subjects (aka - the "Common Rule"). Read about these changes on the VPR newsblog.
Institutional Review Board (IRB)
FWA 00005174 (expires 6-26-19). All research or other projects involving the participation of human subjects must be submitted for review by the Institutional Review Board for the Protection of Human Subjects (IRB). This is done by submitting an application to the IRB.
At the first stage of the approval process, applications for research or other projects considered to be exempt will be waived from further review. Nonexempt applications will receive either an expedited or full board review. All research or other projects must be exempted or approved by the IRB before it can be conducted.
The Institutional Review Board is guided by the ethical principles found in the report of the National Commission for the Protection of the Human Subjects of Biomedical and Behavioral Research (entitled “Ethical Principles and Guidelines for the Protection of Human Subjects in Research”) and the Code of Federal Regulations. You should also review the Standards for Privacy of Individually Identifiable Health Information.
When reviewing a proposal, the board considers:
- The risks to the subjects
- The anticipated benefits
- The importance of the knowledge that may result
- The informed consent process to be employed
Investigators are responsible for conducting the research or other project as described in the approved or exempted application and for submitting a revision to the application describing any departures from the original before revisions are implemented. Research may be subject to intramural inspection or audit.
Through its program, the IRB ensures that all research or other projects associated
with Michigan Tech complies with all relevant government rules and regulations.
All research studies involving human participants conducted by Michigan Tech faculty,
staff, or students as part of his or her university responsibilities are subject to IRB review and must be submitted via IRBNet.org. Feel free to contact our office if you have any questions on what you should submit.
Some studies (such as those listed below) that involve human subjects ARE NOT considered research but should be submitted for evaluation purposes. Please either submit an exemption request via irbnet.org or contact us at firstname.lastname@example.org for assistance.
- Michigan Tech president, dean/chair, teacher, and student evaluations;
- Program evaluation research to benefit Michigan Tech and/or programs carried out by Michigan Tech administrative officials;
- Projects designed to enhance or improve curricula offerings;
- Projects designed to enhance or improve customer satisfaction;
- Benefits or Human Resource surveys and evaluations;
- Michigan Tech employee performance evaluations;
- State of Michigan mandated program evaluations;
- Marketing research that is designed to market the institution as a product;
- Classroom projects (which do not extend beyond the classroom).
- Are a general requirement of a course,
- Have the sole purpose of developing the student’s research skills, and
- Will be overseen by a faculty member
Some other studies that ARE considered research and ARE subject to IRB review. Examples of these types of studies are mentioned below and you are required to submit complete applications when human subjects are:
- Intended to satisfy the academic requirements for independent study, dissertation, or master’s thesis;
- Intended or expected to result in publication, presentation outside the classroom, or public dissemination in some other form;
- Part of a larger research project that has current Michigan Tech IRB approval; or
- Conducted outside the classroom and/or department research participant pool if they
- Minors (i.e., persons under the age of 18),
- A targeted population of adults whose ability to freely give informed consent may be compromised (i.e., person who are socio-economically, educationally, or linguistically disadvantaged, cognitively impaired, elderly, terminally ill, or incarcerated),
- Pregnant women and/or fetuses,
- A topic of sensitive or personal nature, the examination or reporting of which may place the research participant at more than minimal risk, or
- Any type of activity that places research subjects at more than minimal risk.
- Part of a larger research project that has current approval of a registered IRB at another institution, provided that, if research participants are to be recruited at Michigan Tech, and the Michigan Tech IRB has given permission for such on-campus recruitment.