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If the activity is to be used to teach or practice a method but the results are not going to be “published” or "presented" to the public (including conferences) it does not require IRB review.

Example: Students are asked to administer a questionnaire at a mall (age, gender, ethnicity, work schedule, time they like to shop) for a class project, data will be analyzed by the class, data will be destroyed after the assignment, and the activity is used to teach students how to do this type of research.

• Does not need review by the IRB although it does: a) involve humans, b) the individual could be possibly identified, but c) questions are not private, i.e. ones they would avoid disclosing in public.
• However, if the mall management wants to see the data to make a decision about mall hours, this project would need submission to the IRB.
• Or, if a student wanted to use the data for a research project to be done at a later date – needs IRB review.
• Or, if a student(s) and faculty plan to present the data at a conference or submit for publication - needs IRB review.
• All dissertations, master's theses, honor's theses, and undergraduate theses that may be presented at a professional venue or published and involve human subjects require IRB approval.

If you're unsure whether your research project requires IRB approval, please refer to this reference document or contact irb@msmu.edu.

Yes. The Mount Saint Mary's University Human Subjects Committee requests that you complete an IRB application with the approval of your faculty advisor. Even if the study involves normal classroom strategies, you are required to submit the application in order for the committee to make the decision that the research is qualifies as exempt: the researcher may not make the decision.

The researcher may not use passive consent in school settings (participant or parents agree to participate by not returning an informed consent form).

Conducting observations with minors must undergo submission of a research protocol to the IRB, even if risk is minimal.

D. Note for nursing: may qualify for expedited/exempt from full review but must still submit to IRB as the workplace does not qualify as a typical educational setting.

Category I - Exempt research (Limited human subjects committee review required)

This does not mean the project is exempt from review. It means that a member of the HSC (not the researcher) has determined the study involves minimal risk, involves benign behavioral interventions from adult subjects (refer to Application and Guidelines for more details), conducted in established or commonly accepted educational settings, involving normal practices, or utilizes secondary research for which consent is not required. Projects that meet the criteria for exempt review include the following:

1. Projects involving collection of data using opinion surveys, questionnaires or interviews (e.g., opinion surveys, marketing surveys, exit interviews) for which response is voluntary and completely anonymous. When data gathered concerns issues of personal sensitivity (e.g., drug use, criminal behavior, sexual behavior, or employability, financial standing, or reputation) careful attention is needed to assure complete anonymity with no linkable, individually identifiable data.
2. Projects limited to activities involving normal educational practices in commonly accepted educational settings (e.g., in-class demonstration studies, laboratory exercises, and studies of curriculum or teaching strategies).
3. Usually, any study, which requires that subjects be removed from their normal classroom situation for testing, and or involves minor children, is not exempt.
4. Projects limited to the observation of public behavior for which anonymity of subjects is maintained.
5. Projects limited to the examination and analysis of existing data or specimens so long as these are publicly available and individual subjects will not be identified in any report of the research.
6. Review will be conducted by one member of the HSC.

Category II - Research activities subject to expedited review

The project does not meet the criteria for Category I and involves no more than minimal risk to the subject. Minimal risk is defined as "the risks of harm, anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests" (Code of Federal Regulations). Projects that require expedited review include the following:

1. Most laboratory investigations of cognition, perception, social behavior, and personality.
2. Any long-term investigation of the same individuals where identifying information (including coding schemes) must be maintained with the subject's data.
3. Studies that require the examination of existing data or specimens that are not publicly available.
4. Studies involving the collection of voice or video recordings.
5. Studies of healthy individuals involved in moderate exercise.
6. Review will be conducted by two members of the HSC.

Category III - Research activities subject to full review

The project does not meet the criteria for Category I and Category II. Projects that require full review include the following:

1. Projects that do not meet the criteria for Category II because subjects will be exposed to more than minimal risk (e.g., use of invasive techniques or unusual therapeutic techniques such as hypnosis).
2. Projects requiring the use of deception.
3. Projects requiring the use of subjects from populations in need of special protection (e.g., prisoners, individuals with disabilities, victims of abuse, pregnant women, and children).
4. Review will be conducted by quorum of the HSC (majority).

Please address all questions to the Human Subjects Committee at irb@msmu.edu.