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Clinical Trial
. 2013 Apr;20(4):403-7.
doi: 10.1111/acem.12117.

The use of delayed telephone informed consent for observational emergency medicine research is ethical and effective

Steven R Offerman  1 , Daniel K Nishijima, Dustin W Ballard, Uli K Chetipally, David R Vinson, James F Holmes
Affiliations
Clinical Trial

The use of delayed telephone informed consent for observational emergency medicine research is ethical and effective

Steven R Offerman et al. Acad Emerg Med. 2013 Apr.

Abstract

Objectives: The objective was to describe the rate of successful consent using an altered (deferred telephone) consent process in emergency department (ED) patients.

Methods: This study evaluated the consent process employed during a prospective, multicenter, observational study of outcomes in anticoagulated patients with blunt head trauma. The study was approved by the institutional review boards (IRBs) at all participating centers. Patients were not informed of the study during their enrollment at their index ED visit. Patient names, clinical findings, and contact information were collected at the time of initial ED visits. The patients or their legally designated surrogates were contacted by telephone at least 14 days after ED discharge, given all the elements of informed consent, and then consented for study participation. Study results are presented with simple descriptive statistics.

Results: A total of 506 patients with a mean (±SD) age of 75.8 (±12.2) years including 274 female subjects (54.2%; 95% confidence interval [CI] = 49.7% to 58.6%) were enrolled into the study. Patients or their surrogates were successfully contacted by telephone in 501 of 506 cases (99.0%; 95% CI = 97.7% to 99.7%). Consent was obtained in 500 of 501 cases at time of telephone follow-up (99.8%; 95% CI = 98.9% to 100.0%). Surrogates provided consent in 199 cases (39.7%; 95% CI = 35.4% to 44.2%). Median time from ED visit to phone contact was 21 days (interquartile range [IQR] = 17 to 27 days). The median number of phone attempts for successful contact was 1 (IQR = 1 to 2 attempts).

Conclusions: The authors achieved a very high rate of successful telephone follow-up in this predominantly older ED population. Obtaining consent to participate in a research study using a deferred telephone contact process was effective and well received by both subjects and surrogates. IRBs should consider deferred telephone consent for minimal-risk studies requiring telephone follow-up, as opposed to a consent process requiring written documentation at the time of initial ED visit.

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Figures

Figure 1
Figure 1
Federal Law 45 CFR 46.116(d)
Figure 2
Figure 2
Consent portion of the study telephone script
See this image and copyright information in PMC

Comment in

  • Delayed telephone consent in emergency medicine research.
    Platts-Mills TF, Keil LG. Platts-Mills TF, et al. Acad Emerg Med. 2013 Aug;20(8):855. doi: 10.1111/acem.12183. Epub 2013 Jul 23. Acad Emerg Med. 2013. PMID: 23879772 No abstract available.
  • In reply.
    Offerman SR, Nishijima DK, Holmes JF. Offerman SR, et al. Acad Emerg Med. 2013 Aug;20(8):856. doi: 10.1111/acem.12187. Acad Emerg Med. 2013. PMID: 24033629 No abstract available.

References

    1. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Elkridge, MD: 1979. April 18, 1979. - PubMed
    1. Nishijima DK, Offerman SR, Ballard DW, et al. Immediate and delayed traumatic intracranial hemorrhage in patients with head trauma and preinjury warfarin or clopidogrel use. Ann Emerg Med. 2012;59:460–8. - PMC - PubMed
    1. State of California. Experimental Research Subject’s Bill of Rights. Available at: http://ag.ca.gov/research/pdfs/bill_of_rights.pdf. Accessed Feb 1, 2013.
    1. Holmes JF, Holubkov R, Kuppermann N. Guardian availability in children evaluated in the emergency department for blunt head trauma. Acad Emerg Med. 2009;16:15–20. - PubMed
    1. Dutton RP, Stansbury LG, Hemlock B, Hess JR, Scalea TM. Impediments to obtaining informed consent for clinical research in trauma patients. J Trauma. 2008;64:1106–12. - PubMed

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