Build Emergency Care Research on Strong Regulatory, Financial Foundation
June 1, 2022 2 minutes read
There are some notable gaps in studies of the ethics of emergency care in low- and middle-income countries, according to the authors of a recent analysis.1 Researchers reviewed 17 articles published from 2000-2020. They found no clear guidelines on how to protect vulnerable patients, or on how to design ethical consent processes.
“Within the research environment, there’s been more comfort and growth, if you will, to the ability to do Exemption from Informed Consent (EFIC) research. But it still remains a very challenging issue,” says Jon Mark Hirshon, MD, PhD, MPH, FACEP, FAAEM, FACPM, senior vice chairman of the University of Maryland, Baltimore IRB.
Generally, emergency care research is challenging. IRBs have to determine if study protocols meet criteria for EFIC research. When research is conducted in other countries with different regulatory environments, the task is even harder. “What’s defined as a ‘legally authorized representative’ is going to be different. There may not even be very clear regulations on EFIC,” Hirshon says.
Here, IRBs should ask several key questions: Who is in the study population? How will researchers confirm subject safety and regulatory compliance? What is the consent process? How will the authors engage research participants’ legally authorized representatives? Hirshon and co-authors examined ethical and regulatory challenges of emergency care research in low- and middle-income countries.2 Regulatory variability, risk assessment, involving sick patients in decision-making, and the role of families and legally authorized representatives are among them.
If research is conducted in other countries on individuals who cannot give consent and are living with an acute, life-threatening problem that is time-sensitive, Hirshon says investigators must consider whether the proper regulatory environment exists to move forward. “We may have challenges just doing a clinical trial, even with consent,” he notes. “Part of it is also driven by the funders; the standards for an NIH study may be different from a European Union study.”
A central challenge for both IRBs and researchers in that scenario is to understand the regulatory framework, to ensure that whatever the regulations are in that jurisdiction are met. “If you’re going to do this type of research, you need to have the financial foundation and the regulatory infrastructure to do it. A junior researcher is not going to be able to do this type of research. This is high-risk, high-harm research — or at least with a high-risk population. Whether it’s an industry-sponsored or grant-sponsored project, you have to have the wherewithal to do it,” Hirshon says.
Good communication between study investigators and IRB members is critical. “You need to have a good working relationship to be successful,” Hirshon adds.
REFERENCES
- Hirner S, Saunders C, Stassen W. The ethical considerations for emergency care research in low- and middle-income countries: A scoping review of the published literature. Afr J Emerg Med 2022;12:71-76.
- Millum J, Beecroft B, Hardcastle TC, et al. Emergency care research ethics in low-income and middle-income countries. BMJ Glob Health 2019;4:e001260.
There are some notable gaps in studies of the ethics of emergency care in low- and middle-income countries, according to the authors of a recent analysis.
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