Class assignments or exercises involving human participants may or may not require Institutional Review Board (IRB) or Exempt Review Committee (ERC) review depending on whether they meet the Federal definition of “research,” which is defined as “a systematic investigation designed to develop or contribute to generalizable knowledge,” Code of Federal Regulations: 45 CFR 46 .
Independent Studies, Theses, Dissertations, and Honors Projects
According to the federal definition, all students completing theses (undergraduate honors or graduate), independent studies, or doctoral dissertations must apply through the IRB or ERC. Such research requires a Marywood University faculty sponsor.
Classroom Assignments, Educational Inquiry, and Practice
Research activities that are designed as part of a course requirement and involve human participants may not require IRB or ERC review and approval. Eligible assignments or learning exercises are those that do not involve a systematic investigation designed to contribute to generalizable knowledge. Such activities may engage students in interaction with individuals in order to teach research methods or to help students comprehend topics covered by the course. In most instances, such activities are not intended to create new knowledge or to lead to scholarly publication or presentation.
Classroom activities may not require IRB or ERC review if all of the following conditions are true:
Responsibility of the Course Instructor
The course instructor is responsible for informing students of the ethical considerations of human subject research. Procedures for course assignments should include proper instruction regarding: informed consent, appropriate recruitment of subjects, minimizing risk to subjects, and protecting confidentiality. Completion of the online training courses (CITI) is not required for student projects that do not require IRB/ERC review. As an alternative, the IRB and ERC administrators are available to speak to classes about human subject’s protections and/or ethical research practices.
It is important to note that IRB approval cannot be provided retroactively. If a classroom assignment produces interesting results, the data MAY NOT be used nor may the results be disseminated if IRB/ERC approval was not obtained prior to the implementation of the study. If a student believes that data collected may be useful for research purposes, then IRB or ERC approval must be sought at the outset, before any research activity has begun.
In making a determination of whether or not a class research project requires IRB/ERC review, the instructor is encouraged to contact the Director of Research Compliance, 570-340-6031 to discuss any questionable cases.
Office of Research and Sponsored Programs | Keith J. O'Neill Center for Healthy Families, Room 214 | (570) 340-6088 | firstname.lastname@example.org