The scope of the IRB is broad. Activities that fit the definition of research with human subjects include
- Research with humans or human tissue
- Surveys of human subjects
- Review of human subjects' records - even if subject is deceased
- Courses in research methods and class assignments that involve research with human subjects
- Pilot studies and feasibility studies (including single subject studies)
- Research using data on human subjects gathered in earlier projects
Not all class assignments or involvement with humans needs to be submitted to IRB for review and approval. For example, observing an infant’s movements during a child development course for the sake of learning about normal motor development would not need to be reviewed by the IRB because it is not research. That is, it is neither an activity that is intended for publication nor an activity that will advance previous work in another area. This does not absolve the instructor from the responsibility for ensuring the safety of the infants involved in the observation.
Generally, it is not the charge of the IRB to comment upon the scientific merit of proposals submitted for review except where the scientific merit of the research, or lack thereof, increases either the risks to the subject (directly or indirectly) or the research burden to be borne by the subject. In such cases, the investigator may be referred to his/her advisor (in the case of a student) or to institutional experts for further guidance.
It is expected that all protocol submissions be reviewed for scientific merit by the advisor (for students) or departmentally (for faculty/staff) prior to submitting to the IRB for review.