Determining whether a study is Quality Improvement (QI) or Research is important because QI studies do not require IRB review and Research studies do. This determination is formally made through the PME Education Scholarship Study Review. It cannot be made by the study proposal writer.
The Harvard Longwood Campus (HLC) Institutional Review Board (IRB) has put together an IRB Decision Tool to assist investigators in determining if their activities are research, if their research involves human subjects, and/or if they need to submit an IRB application. This decision tool should only be used by investigators who will act on behalf of a HLC School (HSPH, HMS, or HSDM) while conducting research activities. HarvardKey log in is required to use the tool. The IRB Decision Tool can be found here: DECISION TOOL
In most cases, the PME Review can discern whether a study falls into the QI or Research category. If the PME Review is unsure whether or not a study falls into the category of research, the HMS IRB will provide guidance on this question. An HHS decision chart outlines the details of determining whether a project would be considered human subjects research.
Quality Improvement:
QI studies, perhaps more familiar to clinicians in patient safety and quality approaches such as Plan-Do-Study-Act (PDSA), also apply to the continuous quality improvement of medical courses, clerkships, and curricula. Work that aims to assess and improve a specific course, program, or rotation is likely to fall into this category. Theoretical models may be employed to inform the study, but these are not always needed, and more exploratory, hypothesis-generating approaches are often prevalent. Studies with a QI approach can be published, but investigators should provide journals with a QI exemption letter from the PME Education Scholarship Review validating that the study was determined to be “not human subjects research.” Although human subjects, such as students, may be actively participating in the study, the study would not be considered “research.”
Information on publishing QI studies:
While it is always advisable to check with a specific journal editor or review articles in your targeted journal to ensure that they publish QI studies, in general, studies that have a “not human subjects research” determination can be published. In place of the usual description of IRB approval, you can simply provide journals with a QI exemption letter from the PME Education Scholarship Review Committee validating that the study was determined to be “not human subjects research.”
Research:
The US Department of Health and Human Services Office for Human Research Protections (OHRP) provides guidelines and regulations for research involving interaction with and/or data related to human subjects—in this case, medical students. The OHRP definition of research is as follows: “Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” “Generalizable knowledge” is a key consideration in determining whether or not a study is considered research; that is, can the results be generalized to a larger population (of schools or students), or do the results primarily pertain to HMS? Studies that are designed to test theories or build knowledge in the field are likely to be considered research. Examples would include research on motivation, depression and burnout, or cognitive load.
IRB reviews fall into one of four categories:
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A determination of not human subjects research form (sometimes just called a “determination form,” which is a brief form used to determine if IRB review is needed or not from your hospital)
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Exempt review, which would receive an initial review but not require annual continuing review forms
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Expedited review (often required when there are data being collected that allow one to know the identity of specific students)
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Full board review, which is required when studies pose greater than minimal risk to subjects (this last category is rare in education research)
For more information see, refer to a description of criteria for each of these categories.
