Any such research project initiated or conducted by a student and that is not classifiable as a research practicum meets the definition of research. This includes, but is not limited to, theses and dissertations. If a pilot project is designed simply to help the researcher refine data collection instruments and procedures or perfect the project design, it would not be considered research, since it would not contribute to generalizable knowledge. IRB review, therefore, would not be required. However, if the investigator intends to publish the results or otherwise disseminate the findings of the pilot project or to use the results in subsequent research projects, then it would be considered research, and IRB review and approval would be required.
Interaction includes communication or interpersonal contact between investigator and subject.
According to federal regulations, minimal risk means that the probability and magnitude of harm or discomfort anticipated 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. Informed consent is the process by which prospective human subjects, or their legal representatives, are informed of the nature and purpose of the proposed research, including risks, in a manner appropriate to their level of understanding and in non-technical language that they have the right to decline to participate or to withdraw from participation at any time without penalty given adequate time to decide if they want to participate Informed consent is a critical part of the IRB approval process, and it is essential that investigators understand and comply with the regulations. Details are provided in the Informed Consent section of this Guide. Additional requirements for informed consent exist for special populations such as children and prisoners. Investigators should take care to observe all requirements for consent.