No ROMP in the Park: The Complex Intersection Between QI and Clinical Research
What triggers IRB review, who obtains consent, or can it be waived?
Somewhere between typical human research and clinical practice, there is gray area assigned the acronym ROMP — “research on medical practices” — that includes activities such as continuous quality improvement, comparative effectiveness research, and electronic medical record review, the authors of a new study explain.1
“The fact that ROMP shares some characteristics with clinical research and some with usual clinical practice leads to uncertainty as to how the regulations should be applied to ROMP,” they report. “In particular, ROMP that uses a randomized approach, wherein patients are randomized to different treatments already utilized in usual clinical care so that outcomes can be compared, shares some characteristics with research to evaluate new treatments, such as an explicit goal of generating generalizable knowledge. But unlike in studies of new treatments, all participants in ROMP receive a commonly accepted treatment.”
In 2014 draft guidance by the Office for Human Research Protections — which has not been finalized — OHRP explains that ROMP is “designed to evaluate treatments or procedures that are medically recognized standards of care. … Reasonably foreseeable risks must be described to prospective subjects when seeking their informed consent.”2 As the guidance has not been formally completed, IRBs and researchers may have different interpretations and opinions of ROMP activities. To assess this, researchers surveyed IRB members of Public Responsibility in Medicine and Research (PRIM&R).
“We found that PRIM&R members with experience as IRB personnel expressed varying views when responding to three key issues: what triggers IRB review; who should obtain consent; and when consent should be waived,” they reported.
The survey netted 537 responses from people who reported they had experience as IRB personnel. In terms of IRB review, 81.8% indicated that randomly assigning patients to use specific treatments should always trigger a full review. “Few respondents indicated that IRB review should always take place when standard clinical pathways are used to determine patients’ treatments,” the researchers found.
When respondents were asked who should obtain consent for ROMP initiatives, 49.2% agreed that it could be done by the patient’s clinician, or an investigator, research nurse, or study coordinator not involved with the patient’s care. Nearly one-third of respondents indicated that all but a patient’s clinician may ethically obtain consent, but 9.5% said that only the patient’s clinician should seek informed consent.
As an example of the different views expressed, the researchers noted that one commented that it would be “nearly impossible for a patient not to experience undue influence” when recruited by their direct caregiver. In contrast, another argued that the treating physician could best assess the patient’s concerns about receiving randomized care.
Nearly two-thirds of respondents agreed that informed consent could be waived if patients were randomized but still received “usual care.” However, 36.6% said informed consent should not be waived for patients who who were going to receive randomized care as part of a ROMP project.
Thus, there are several areas of discord that must be resolved to protect “research participants while simultaneously allowing important quality improvement initiatives to continue,” the researchers concluded.
Lead author Kathryn M. Porter, JD, MPH, of the Seattle Children’s Research Institute, agreed to field a few questions on this complex topic.
IRB Advisor: This is certainly a thorny area, as ROMP quality improvement activities may mimic and even potentially morph into more traditional human research. First, what are the pros and cons of the current situation, which appears to be that IRBs have considerable variation on their approaches to this problem? Is there substantial benefit to be gained in terms of quality improvement and human protections to develop a standardized approach for all IRBs?
Porter: One of the concerns with IRB variability is that it suggests both over- and under-regulation. Over-regulation can stifle scientific and medical progress while under-regulation runs the risk of endangering research participants. Variability also creates complexity for multicenter trials that strive for cross-site consistency, but may end up faced with multiple rules and guidelines from individual IRBs. While considering community interests and values is worthwhile, it’s important to work toward some level of consistency across IRBs as well.
IRB Advisor: The example of informed consent seems particularly tricky, since it appears valid arguments can be made that the treating clinician is the most likely to know the patient risk, but also could have undue influence in the consent decision. How will your research attempt to reconcile this conundrum, or might this be left to the local IRB?
Porter: Unfortunately, our research doesn’t answer this question — yet. The undue influence argument is used a lot, and for good reason. At the same time, our previous research suggests that participants highly value the relationship they have with their doctor and often want their doctor to be the one who talks to them about research opportunities.
We’ve also seen evidence that some participants would rely on their doctor’s opinion when deciding whether to participate in a particular research study, suggesting that sometimes doctor influence isn’t “undue.” So this is definitely an area that is ripe for future research. We want to better understand how and when people make the decision about whether to participate in research, as well as how much influence — undue or otherwise — doctors actually have in that process.
IRB Advisor: What would be the downside of erring on the side of human protections and treating ROMP as de facto human research with its attendant protections, even in comparing drugs already known to be safe and effective among randomized patient groups?
Porter: It’s important to distinguish between activities like quality improvement and activities like ROMP. ROMP should be treated as research, because that’s what it is. But our current regulatory system is designed to give IRBs some flexibility, depending on the level of risk of a particular research study. Because the drugs being compared in ROMP studies have all been determined to be safe and effective, ROMP is a relatively low-risk kind of research. And with low-risk research, IRBs have the ability to streamline the informed consent process in a way that facilitates research and improves participant understanding. Treating ROMP the same as higher-risk research has its downsides — it would require an approach to informed consent that may be more complicated to administer, less likely to be read or understood by participants, and an unnecessary use of limited resources.
- Porter KM, Cho MK, Kraft SA, et al. Research on Medical Practices (ROMP): Attitudes of IRB Personnel about Randomization and Informed Consent. IRB: Ethics & Human Research January-February 2017;39:1: http://bit.ly/2mrzQZn.
- U.S. Department of Health and Human Services. Draft guidance on disclosing reasonably foreseeable risks in research evaluating standards of care. Fed Reg 2014. https://federalregister.gov/a/2014-29915.
Somewhere between typical human research and clinical practice, there is gray area assigned the acronym ROMP — “research on medical practices” — that includes activities such as continuous quality improvement, comparative effectiveness research, and electronic medical record review, the authors of a new study explain.
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