Cases in Bioethics: Health Research Ethics in Southeast Asia
Keywords

informed consent, retrospective consent, emergency medicine, asthma, waiver, emergency medicine

Obtaining informed consent for treatment and research in an emergency department can be challenging. Sometimes consent requirements are waived for clinical treatment because it is needed urgently to save a patient’s life.1 In the context of interventional clinical research conducted in the emergency department, uncertainty about the potential benefits and harms associated with a study intervention may suggest a need for a different approach.

Measuring peak expiratory flow rate (PEFR) is a standard bedside test to measure severity of respiratory symptoms and treatment response. It takes seconds to minutes to perform. During airway obstruction from an acute asthma attack, a life-threatening condition, emergency physicians will measure PEFR, usually before and after delivery of inhaled medications.

Interested in potential ways to improve the delivery of inhaled medications for treating asthma,2 a researcher sought to conduct a study to explore the correlation between peak inspiratory flow rate (PIFR) with severity of asthma in patients presenting to the emergency department. Use of PIFR in the emergency department for this purpose is not standard of care in the country where the research is proposed. PIFR is typically measured in nonurgent care settings. The researcher is interested in using PIFR instead of PEFR because it may provide a better indication of the effectiveness of drug delivery to guide identification of the optimal type of inhaled medications. Eligible study participants include individuals between 18 and 60 years of age with underlying, previously diagnosed mild to moderate asthma who are able to understand and follow the process for measuring PIFR. Since PIFR is not a standard of care locally, informed consent was considered necessary by a research ethics committee reviewing the protocol.

Similar to measuring PEFR, taking PIFR takes seconds to minutes; however, explaining the process adds time.3 Furthermore, the process of enrolling individuals and obtaining informed consent for research can take additional time, potentially delaying treatment up to 30 minutes or more.

Questions

  1. From an ethics perspective, what justification is needed to conduct a clinical research study in an emergency department context? Does the proposed study seem to meet those justificatory conditions?

  2. Should researchers involved in the above study be required to obtain prospective informed consent from patients for the study? Why or why not?

  3. Might “retrospective consent” be appropriate in this case? Why or why not?

  4. What steps could be taken by the research team to minimize the chance that participants will be harmed during the study?

References

Foex, B A. “The Problem of Informed Consent in Emergency Medicine Research.” Emergency Medicine Journal 18, no. 3 (May 1, 2001): 198–204. https://doi.org/10.1136/emj.18.3.198.
Gelinas, Luke, Alan Wertheimer, and Franklin G. Miller. “When and Why Is Research without Consent Permissible?” Hastings Center Report 46, no. 2 (February 19, 2016): 35–43. https://doi.org/10.1002/hast.548.
Haughney, John, Amanda J. Lee, Eddie McKnight, Inna Pertsovskaya, Michelle O’Driscoll, and Omar S. Usmani. “Peak Inspiratory Flow Measured at Different Inhaler Resistances in Patients with Asthma.” The Journal of Allergy and Clinical Immunology: In Practice 9, no. 2 (February 2021): 890–96. https://doi.org/10.1016/j.jaip.2020.09.026.
Holmes, Martin S, Jansen N. Seheult, Colm Geraghty, Shona D’Arcy, Ultan O'Brien, Gloria Crispino O'Connell, Richard W Costello, and Richard B. Reilly. “A Method of Estimating Inspiratory Flow Rate and Volume from an Inhaler Using Acoustic Measurements.” Physiological Measurement 34, no. 8 (July 26, 2013): 903–14. https://doi.org/10.1088/0967-3334/34/8/903.
Lecouturier, Jan, Helen Rodgers, Gary A. Ford, Tim Rapley, Lynne Stobbart, Stephen J. Louw, and Madeleine J. Murtagh. “Clinical Research without Consent in Adults in the Emergency Setting: A Review of Patient and Public Views.” BMC Medical Ethics 9, no. 1 (April 29, 2008). https://doi.org/10.1186/1472-6939-9-9.
Picton, Aled, Kerry Woolfall, Mark D. Lyttle, and Stuart Hartshorn. “Research without Prior Consent in Paediatric Emergency and Critical Care Medicine.” Paediatrics and Child Health 30, no. 2 (February 2020): 74–78. https://doi.org/10.1016/j.paed.2019.11.008.
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