Class Research Projects with Human Subjects

Class assignments intended to engage students with people and problems outside the classroom do not require Institutional Review Board (IRB) review and approval if they meet all the following criteria:

1. minimal risk;
2. anonymous data collection;
3. voluntary participation;
4. oral or written informed consent;
5. has no vulnerable population (children, prisoners, or pregnant women);
6. and is not intended for publication outside the university.

Class projects that meet all these criteria may proceed under the supervision of the course instructor. The instructor may request a consultation in cases that are unclear if the class project meets the criteria (email IRBCommitteeChair@stmarytx.edu). Class projects that, due to the nature of the subject matter or procedures, do not meet one or more criteria should complete an IRB Application for Proposal Review.

This is a summary of the IRB policies and procedures for class projects; instructors and students should consult the full policy at § 2.08– § 2.16 of the IRB Policies and Procedure Manual.

Minimal risk: The probability of harm or discomfort is no greater than those ordinarily encountered in daily life.  Harm or discomfort may be physical, psychological, or social; other harms may be economic, legal, or moral.

Examples of each type of risk can assist the instructor in guiding student projects:

• physical harm: Will it bruise or draw blood?
• psychological harm: Will this activity evoke distressing memories?
• social harm: Will this information embarrass someone?
• economic harm: Can someone lose money because of this information?
• legal harm: Can someone get arrested because of this information?
• moral harm: Can someone’s reputation be damaged because of this information?

Informed consent: The project should have a brief informed consent, oral or in writing, to include the purpose of the data collection, the duration, the class title and instructor responsible for the assignment, and how to contact the instructor. Providing the instructor’s business card in an interview or contact information on an internet survey is sufficient contact information.

Anonymous: The data collection activity will not collect any form of personally identifiable information, such as signature, name, phone number, email address, government or university issued ID number, or date of birth. Classroom-based surveys should avoid “inadvertent disclosure.” Given St. Mary’s demographics, a classroom survey that includes detailed demographics (more than Hispanic, Anglo, and Other) can easily identify the one or two African-American or Asian subjects in the class. Class projects that utilize existing data should consult the IRB Policy on Class Projects.

Voluntary participation: Participants should be free to decline participation without loss of benefits outside the research activity.  Linking participation in data collection activities with grades, attendance, or an alteration of course assignments may compromise voluntary participation and will require IRB review.  Inducements of a value greater than a cup of coffee will require IRB review.