The Use of Delayed Telephone Informed Consent for Observational Emergency Medicine Research Is Ethical and Effective

Offerman, Steven R.; Nishijima, Daniel K.; Ballard, Dustin; Chetipally, Uli K.; Vinson, David R.; Holmes, James F.

doi:10.1111/acem.12117

Cited by 19 publications

(13 citation statements)

References 11 publications

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“…We found that ED patients do not object to receiving a telephone follow-up survey for an observational study to which they had not previously consented in person. This finding accords with other emergency medicine research on the topic (33)(34)(35).…”

Section: Discussionsupporting

confidence: 92%

Managing Emergency Department Patients with Recent-onset Atrial Fibrillation

Vinson

Hoehn

Graber

et al. 2012

The Journal of Emergency Medicine

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Section: Discussionsupporting

confidence: 92%

Managing Emergency Department Patients with Recent-onset Atrial Fibrillation

Vinson

Hoehn

Graber

et al. 2012

The Journal of Emergency Medicine

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“…We appreciate the work of Offerman and colleagues, 1 which describes the process of enrolling emergency department (ED) patients in a study by identifying them using the ED record and contacting them by telephone after the ED visit to request consent. We agree with the authors' conclusion that delayed telephone consent is generally ethical and efficient, but offer the following observations.…”

mentioning

confidence: 99%

Delayed Telephone Consent in Emergency Medicine Research

Platts‐Mills¹,

Keil

2013

Acad Emerg Med

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We appreciate the work of Offerman and colleagues, 1 which describes the process of enrolling emergency department (ED) patients in a study by identifying them using the ED record and contacting them by telephone after the ED visit to request consent. We agree with the authors' conclusion that delayed telephone consent is generally ethical and efficient, but offer the following observations.The investigators report that of 506 eligible patients identified by emergency providers in the ED, 501 (99.0%) patients or their surrogates were successfully reached by phone using phone numbers in the ED medical records, and 500 (99.8%) consented to the study. These very high rates of reaching and consenting patients are not consistent with our experience or that of others performing ED-based research.A recent large study of medication adherence among ED patients obtained 1-week follow-up for 86% of patients (3,386 of 3,940). 2 In the medication adherence study contact information was obtained via in-person interview, and patients received $10 gift cards for completing follow-ups. Our own experience conducting research on older adults is similar; short-term follow-up can be achieved for 85% to 90% of older patients if one obtains comprehensive contact information in the ED and makes considerable efforts to reach the patient. 3 When we used similar methods to that of Offerman et al. (i.e., making calls to patients using information from the ED record), only approximately 50% of patients or surrogates were contacted. 4 The other prior similar study referenced by Offerman et al. reached 80% of patients (167 of 209) using delayed consent, which was similar to the 81% (180 of 221) reached following ED consent. 5 The much higher rates of contact reported by Offerman et al. may in part be because of sociodemographic differences in the study population or because the study question is essentially a continuation of the patient's clinical care. Regardless of the explanation, a 99% contact rate is unusually high, and future researchers should neither expect to obtain nor be criticized for not obtaining a similar response rate. Further, we think it unlikely that deferred consent is likely to provide consistently higher follow-up rates than ED consent.The other conclusion the authors draw from their study is that this approach is ethical. We agree that in most situations making an unsolicited phone call to request study participation following an ED visit is ethical, but the details matter. Calls to home phones for individuals who have recently visited the ED for complaints related to substance abuse or an early pregnancy may be unwelcome and unethical, even if the study does not contain an intervention.

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“…In a recent multicentre study, Offerman et al (2013) recruited patients at the ED, and none of them were informed about the study during their recruitment. The investigators contacted the patients or their legally designated surrogates through the telephone 2 weeks post-discharge to obtain consent for their study participation after providing all the components of informed consent.…”

Section: Deferred Consentmentioning

confidence: 99%

Research in Emergency and Critical Care Settings: Debates, Obstacles and Solutions

et al. 2015

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Research is an integral part of evidence-based practice in the emergency department and critical care unit that improves patient management. It is important to understand the need and major obstacles for conducting research in emergency settings. Herein, we review the literature for the obligations, ethics and major implications of emergency research and the associated limiting factors influencing research activities in critical care and emergency settings. We reviewed research engines such as PubMed, MEDLINE, and EMBASE for the last two decades using the key words "emergency department", "critical care", "research", "consent", and "ethics" as the search terms. Research within emergency settings is slow or non-existent due to time and financial constraints as well as the lack of a research tradition. There are several barriers to conducting research studies in emergency situations such as who, what, when, and how to obtain patient consent. The emergency environment is highly pressurized, emotional, and overburdened. The time taken for research is a particular risk that could delay the desired immediate interventions. Ethical issues abound, particularly relating to informed consent. Research in emergency settings is still in its infancy. Thus, there is a strong need for extensive research in the emergency setting through community awareness, resource management, ethics, collaborations, capacity building, and the development of a research interest for the improvement of patient care and outcomes. We need to establish a well-structured plan to assess and track the decision-making capacity, consider a multistep enrolment and consent strategy, and develop an integrated approach for recruitment into studies.

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The Use of Delayed Telephone Informed Consent for Observational Emergency Medicine Research Is Ethical and Effective

Cited by 19 publications

References 11 publications

Managing Emergency Department Patients with Recent-onset Atrial Fibrillation

Managing Emergency Department Patients with Recent-onset Atrial Fibrillation

Delayed Telephone Consent in Emergency Medicine Research

Research in Emergency and Critical Care Settings: Debates, Obstacles and Solutions

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