The Role of the IRB Review Process for CME Writers and Medical Education
Does the IRB review process help or hinder CME projects?
I think about the business of Institutional Review Board (IRB) approval a lot, especially its role in human research protection. It’s something CME content creators have to think about since in-practice qualitative research often needs IRB review. Sometimes that means using an academic review center's IRB process or, when there is no academic partner involved, outsourcing the process to an IRB service provider, such as Western IRB.
There is an ongoing debate about whether IRB is strictly necessary for CME projects or quality improvement (QI) in healthcare, like needs assessments or outcomes research. Some of the arguments against the IRB review process for CME include:
IRB is time-consuming, expensive, and places undue burden on the research process; this is especially true for research activities involving human subjects.
QI or continuing education in the health professions (CHCP) projects do not really involve human subject research as defined by the Department of Health and Human Services since these are typically local studies and not generalizable; and
IRB panel members don't really want to waste their time on reviewing QI or CHCP studies since these are not really 'proper' research.
I'm uncomfortable with these views, and here’s why.
IRB Review Provides Oversight for CHCP Research
If you are asking providers questions about their clinical practice (whether via surveys or interviews) for QI or CHCP research — even in a local context — you are doing human subjects research. This also applies to interviewing/surveying patients, either preceding or following education programs. Although most QI/CHCP projects involve little substantive risk to participants, per the Common Rule (45 Code of Federal Regulations 46), it is up to the IRB, rather than the researchers, to determine the potential for this risk.
The Institutional Review Board Process Is Required for Publication
Many journals that consider QI or CEHP manuscripts for publication increasingly require documentation of ethical approval via a formal IRB process.
The IRB Review Process Is Often a Condition for Funding
Supporters of QI/CHCP research recognize the journal requirement for IRB and increasingly want assurance that the organizations and consultants they hire to conduct QI/CEHP research are not only competent in their research methodologies but also ethical in their approach.
In particular, they want to know that such research is trustworthy and that QI/CEHP researchers have reflected on the ethical issues related to their research or evaluation, including the need for verbal or written informed consent and the potential for risk in the research relationship. Going through the IRB process is currently one of the few ways for funders to receive such assurance.
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Institutional Review Boards and the Bureaucratization of Research
IRB has expanded its reach beyond human research in the last couple of decades, as many critics have recognized and written about (most notably, Zeke Emanuel). Although the Common Rule was modified in 2016 to make certain kinds of research exempt from IRB review, or at least eligible for an expedited review, the process remains frustrating.
CEHP/QI research typically sits within this expedited category as a form of social, educational, or behavioral research, yet for many the approval process remains too slow, not least because questions from board members about the research are often irrelevant and delay the research itself. T
his irrelevance is, first, because the genesis of IRB is in biomedical research, and, second, because IRB panels are typically not comprised of people who have social science expertise, especially in qualitative methodologies. In fact, according to at least one national survey, IRB panels often lack diversity, with members that are often predominantly white, well-educated, and male.
Thus, the IRB process is an admittedly imperfect way to oversee CHCP and CME projects. But for the moment, it is one of the few ways to ensure the ethical treatment of potential participants in CEHP research. The expedited process needs further modification to ensure that those reviewing this kind of research have expertise in its unique parameters.
What Are Your Views on the IRB Review Process in CME?
Let me know your views on IRB. Do you find the review process to have merit for CHCP research, see it as a hindrance, or something in between? Connect with me on LinkedIn and share your thoughts.
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