Undergraduate students at Harvard are encouraged to become deeply involved in the research life of the University. There is a vast array of opportunities for students at all experience levels to participate in academic inquiry, from research assistantships to independent projects. Frequently, these research projects involve interactions with and/or identifiable data about human beings as participants. While some undergraduate research activities that involve human participants require approval by the Institutional Review Board (IRB; the federally mandated committee that reviews human subjects research protocols) many others do not.
Prior to this initiative, the IRB provided oversight for these projects whether or not the activity met the requirements for IRB review according to the federal regulations. This applied both to projects assigned by the instructor of a course as part of the curriculum (i.e., Course Projects), and to projects undertaken independently for thesis or other reasons. While the previous process provided a mechanism to ensure that the proposed project includes appropriate precautions for protecting human participants, what was lacking was a comprehensive platform to create better prepared undergraduate researchers.
New Training Program for Undergraduates
The Undergraduate Research Training Program (URTP), through a partnership with the office of Undergraduate Education (OUE), the Office of Undergraduate Research and Fellowships (URAF), the Office of the Vice Provost of Research (OVPR), and the Committee on the Use of Human Subjects (CUHS), is a comprehensive platform to create better prepared undergraduate researchers. The URTP is comprised of in-person training sessions offered several times throughout the academic calendar, a student-focused curriculum, and an online decision form that will assist students in determining whether their project requires IRB review.
- URTP Decision Form: An online form administered through Qualtrics that guides the student through the various regulatory and institutional requirements. Definitions and examples are provided with each question. A decision about whether the student needs IRB review is provided. Each form is also reviewed by an IRB regulatory expert to ensure that the form was completed accurately and the correct decision was provided.
- URTP Student Guide / Curriculum: The guide is designed to help student investigators understand their ethical obligations as a researcher, the federal regulations governing human subjects research, and the University’s policies and procedures associated with the conduct of such research whether IRB review is required or not.
- In-Person Training Sessions: Held at various dates throughout the academic year, the in-person training sessions are an alternative to the standard online CITI training. The sessions have been developed with students in mind: they are 90 minutes in length, interactive, and developed with enthusiasm and energy.
- URTP Advisory Group: An Advisory Group to not only develop the training program, but to also monitor the progress, quality of material, and long term goals of the program. Members from the following University areas are represented: CUHS, OUE, URAF, OVPR, and representatives from the various concentrations of Harvard College.
But What About Course Projects?
Class projects and research methods classes may involve data collection activities for training purposes that do not require IRB review and oversight because the intent is to teach methods, not to contribute to generalizable knowledge. It is no longer necessary for the Course Instructor to submit an IRB application when the purpose of the class is for educational purposes only.
However, when the primary focus and initial intent of the class activities are designed to collect data to be used by students beyond the classroom, for example for scholarly publication or use for future research, it is the responsibility of the faculty advisor to assist students in determining whether obtaining IRB approval or exemption is required and if so, that this is done prior to the initiation of a human subjects research project.
Please feel free to contact the CUHS office at firstname.lastname@example.org or 617-496-2847.