*** If you are doing research in the classroom you MUST consider the following. ***
The New Mexico State University IRB’s policy is to review all research conducted by faculty, staff, and students. The IRB must determine if studies meet the Code of Federal Regulations definition of “Research,” which requires a formal IRB application. Many class-assigned projects using humans as subjects do not meet the criteria in the federal definition of research (i.e., “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge”). In some of these cases, classroom projects may not require an IRB application.
To minimize administrative burdens on instructors and students, the IRB offers instructors an alternative to requiring each student to submit an IRB application, provided NONE of the conditions in A below are met and the instructor agrees to fulfill ALL responsibilities in B.
A. An IRB application is required when the study meets one or more of the following conditions:
1. Use of vulnerable populations or minors.
The project(s) cannot involve minors (under 18), prisoners, or persons lacking the capacity to give informed consent or other vulnerable populations as defined by Title 45 CFR, Part 46.
2. Publication or presentation outside of New Mexico State University.
Data obtained from this class project can NEVER be used for public dissemination, thesis/dissertation research, presentation outside of NMSU or to any media outlets.
3. Risk more than “Minimal Risk.”
“Minimal risk” is when “the probability and magnitude of harm or discomfort in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” [45CFR 46.102(i)]
4. Use of deception.
The class project may not include deception of any kind. All subjects must be fully informed of the nature of the project, its risks and benefits, and give voluntary consent to participate.
5. Use of videotaping.
Videotaping is not allowed. Audio taping is allowed, but only if it is erased by the end of the semester.
B. Instructors granted a classroom research project waiver must accept primary responsibility for ensuring the rights and welfare of the human subjects. Instructors must also:
1. Submit an Application to use Human Subjects in Research if the instructor is doing research in the classroom.
If the instructor is either collecting data from the students in their class or will be using data students have collected from other subjects, an appropriate application must be submitted for approval to the IRB. Once data collection has begun, the instructor cannot change their mind and submit an application after the fact. Retroactive IRB approval will not be granted under any circumstance.
2. Train students in the proper conduct of research and the protection of human subjects.
To supplement classroom instruction on research ethics, the IRB requires instructors to have students complete the CITI Program Human Subjects Research online training program: http://www.citiprogram.org/ prior to beginning the classroom research project. Detailed instructions for enrolling in the CITI Program Human Subjects Research course can be found at: http://compliance.research.nmsu.edu/IRBtraining
3. Review Student Class Project Applications and determine if each project qualifies for a waiver.
The IRB does not review these applications. Instructors are responsible for keeping all paperwork associated with the course for a period of three calendar years, in compliance with federal regulations.
4. Review all methods and instruments used in each project.
All written materials presented to human subjects must be at an appropriate reading comprehension level (generally defined as 8th grade) and/or be a certified translation for non-English-speaking participants.
5. Document that students receive official permission to conduct research at organizations or institutions other than New Mexico State University.
This includes letters from a facility official authorized to approve such activities, for example.
6. Instructors are responsible for ensuring students obtain informed consent from all human subject participants.
1. Instructor submits Request for Classroom Research Project Waiver of IRB Application to IRB office for review.
2. IRB reviews, requests clarification (if necessary), and issues approval or denial notice.
3. Students submit Student Classroom Research Project Application to instructor, who reviews for waiver compatibility and retains for three calendar years, in compliance with federal regulations.
Group or individual student class projects that do not meet waiver criteria cannot be conducted until the IRB Application to Use Human Subjects in Research is submitted to and approved by the IRB.