Institutional Review Board
All research activities involving the use of human subjects must be reviewed and approved by the IRB before data collection can begin.
The Mount Marty College Institutional Review Board (IRB) is to ensure compliance with the Federal Policy for Protection of Human Subjects (45 CFR 46) and observance of college policies regarding the protection of human subjects in all research conducted by faculty, students or staff.
MMC’s IRB is registered with the Office of Human Research Protections (Department of Health and Human Services). Current status of MMC’s IRB and Federalwide Assurance (FWA) can be found by the searching the OHRP Database.
All faculty and staff involved in administering, overseeing, teaching or conducting research involving human participants at MMC are required to complete the “Protecting Human Subject Research” course that is available online through the NIH Office of Extramural Research. Participants will receive a certificate upon successful completion of the modules and quizzes.
Applications are accepted on a rolling basis. Expedited and Exempt applications will be reviewed within 7 business days of the submission date. Applications requiring a Full Board review will be completed within 14 business days.
Exempt Level of Review
"Exempt" means review by one IRB member, and if necessary, in consultation with other members. A research activity may be declared exempt if it is considered low-risk and the only involvement of human subjects will be in the categories outlined in 45 CFR 46.101(b). Briefly described, these categories are:
- Research conducted in established or commonly accepted educational settings, involving normal educational practices.
- Research using anonymous or no-risk tests, surveys, interviews, or observations.
- Most research involving public officials.
- Research involving the collection or study of existing data if it is publically available or if subjects cannot be identified.
- Research examining public benefit or service programs.
- Taste and food quality evaluation and consumer acceptance studies.
Although subject consent is always needed, signed consent forms are typically not recommended if they are the only identifying variable in an otherwise anonymous project. Approval for exempt projects is good for one year, unless the researchers decide to change the protocol.
Most exempt level reviews are completed within one week after being received by the IRB chair.
Expedited Level of Review
Projects not eligible for an exempt review may be eligible for an expedited review. "Expedited" means review by the IRB chair and one or more IRB members.
In general, research may qualify for expedited review if it is judged to involve only minimal risk, does not include intentional deception, does not employ vulnerable populations or topics, and includes appropriate informed consent procedures. For example, the collection of physical data through non-invasive procedures is eligible for an expedited review, including:
- Height and weight
- ECG, MRI, Ultrasound
- Moderate exercise
- Blood or other bodily fluids
The full list of categories of research that may be reviewed as expedited can be found in 45 CFR 46.110.
Most expedited reviews are completed within approximately two weeks after being received by the IRB chair.
Full Board Review
A full board review is required for research that is not eligible for exempt or expedited review. In short, research that is judged to involve more than minimal risk, or involves protected populations such as children, prisoners, or disabled individuals, must undergo a full board review. Individuals intending to conduct research that requires a full board review should allow ample time to complete the review process.
The following categories of research require full IRB approval:
- Projects for which the level of risk is determined by the IRB Chair to be greater than minimal.
- Projects that involve the intentional deception of subjects, such that misleading or untruthful information will be provided to participants.
- Projects that involve sensitive or protected populations (such as children or cognitively disabled individuals).
- Projects that plan to use procedures that are personally intrusive, stressful, or potentially traumatic (stress can be physical, psychological, social, financial, or legal).