The DOI matches its Crossref record; 11 of the 11 references it cites were found in a registry or an index.
The Use of Delayed Telephone Informed Consent for Observational Emergency Medicine Research Is Ethical and Effective
Open accessAbstract
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 (IRB s) 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. IRB s 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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“Another concern pertains to the substantially disproportionate funding favouring commercial research evaluating the efficacy of highcost, patent protected drugs or devices over the undoubtedly necessary, non-commercial, academic resuscitation research on patent-unprotected, low-cost, widely used drugs of potentially uncertain efficacy, such as adrenaline (epinephrine), or antiarrhythmics. 63,318,”
From European Resuscitation Council Guidelines 2021: Ethics of resuscitation and end of life decisions (2021) · cites this paper as [382]
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Nishijima, D. K., Offerman, S. R., Ballard, D. W., Vinson, D. R., Chettipally, U. K., Rauchwerger, A. S., Reed, M., & Holmes, J. F. (2012) · Annals of Emergency Medicine · doi:10.1016/j.annemergmed.2012.04.007 · Cited by 205
Self-citationKohli, E., Ptak, J. A., Smith, R. H., Taylor, E., Talbot, E. A., & Kirldand, K. B. (2009) · Infection Control and Hospital Epidemiology · doi:10.1086/595692 · Cited by 175
Glickman, S. W., Anstrom, K. J., Li, L., Chandra, A. B., Laskowitz, D. T., Woods, C. W., Freeman, D. H., Kraft, M., Beskow, L. M., Weinfurt, K. P., et al. (2008) · Annals of Emergency Medicine · doi:10.1016/j.annemergmed.2007.11.002 · Cited by 84
Principal Investigator Views of the IRB System
Whitney, S. N., Alcser, K. H., Schneider, C. E., McCullough, L. B., McGuire, A. L., & Volk, R. J. (2008) · International Journal of Medical Sciences · doi:10.7150/ijms.5.68 · Cited by 68
Impediments to Obtaining Informed Consent for Clinical Research in Trauma Patients
Dutton, R. P., Stansbury, L. G., Hemlock, B., Hess, J. R., & Scalea, T. M. (2008) · The Journal of Trauma: Injury, Infection, and Critical Care · doi:10.1097/ta.0b013e318165c15c · Cited by 65
The Hawthorne effect in the measurement of adolescent smoking.
Murray, M., Swan, A. V., Kiryluk, S., & Clarke, G. C. (1988) · Journal of Epidemiology & Community Health · doi:10.1136/jech.42.3.304 · Cited by 51
Observed Behaviors of Subjects During Informed Consent for an Emergency Department Study
Baren, J. M., Campbell, C. F., Schears, R. M., Shofer, F. S., Datner, E. M., & Hollander, J. E. (2009) · Annals of Emergency Medicine · doi:10.1016/j.annemergmed.2009.09.023 · Cited by 19
Systematic Bias Introduced by the Informed Consent Process in a Diagnostic Research Study
Mitchell, A. M., & Kline, J. A. (2008) · Academic Emergency Medicine · doi:10.1111/j.1553-2712.2008.00066.x · Cited by 17
Campbell, S., McCarvill, E. M., Magee, K. D., Cajee, I., & Crawford, M. (2008) · Academic Emergency Medicine · doi:10.1111/j.1553-2712.2008.00234.x · Cited by 15
Guardian Availability in Children Evaluated in the Emergency Department for Blunt Head Trauma
Holmes, J. F., Holubkov, R., & Kuppermann, N. (2008) · Academic Emergency Medicine · doi:10.1111/j.1553-2712.2008.00293.x · Cited by 12
Self-citation
Research works printed but not linked: 1
- The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979, 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
Cited by
European Resuscitation Council Guidelines 2021: Ethics of resuscitation and end of life decisions
Mentzelopoulos, S. D., Couper, K., Voorde, P. V. D., Druwé, P., Blom, M., Perkins, G. D., Lulic, I., Djakow, J., Raffay, V., Lilja, G., et al. (2021) · Resuscitation · doi:10.1016/j.resuscitation.2021.02.017 · Cited by 246
Metadata
- Authors
- Offerman, S. R., Nishijima, D. K., Ballard, D. W., Chetipally, U. K., Vinson, D. R., & Holmes, J. F.
- Affiliations
- Kaiser Permanente Northern California (US)
- University of California Davis Medical Center (US)
- Kaiser Permanente Northern California Oakland CA
- Corresponding author
- Holmes, James F.
- Venue
- Academic Emergency Medicine
- Publisher
- Wiley
- Published
- 2013-04
- Volume
- 20
- Issue
- 4
- Pages
- 403-407
- ISSN
- 1069-6563 (ISSN-L)
- 1553-2712
- PMC
- PMC4034372
- OpenAlex
- W2028900175
- Cited by
- 25
- References
- 11
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 1 · 2023: 3 · 2022: 1 · 2021: 3 · 2020: 1 · 2019: 1 · 2018: 2 · 2017: 2 · 2016: 1 · 2015: 3 · 2013: 2
- FWCI
- 2.05
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Academic Emergency Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Center for Research Resources (UL1RR024146)
- National Center for Advancing Translational Sciences (L30 TR000286)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
- Health Sciences › Medicine › Emergency Medicine › Emergency and Acute Care Studies
- Keywords
- anticoagulated patients, blunt head trauma, surrogate consent, research participation rates, telephone follow-up, elderly patients
- MeSH terms
- Aged, Aged, 80 and over, Anticoagulants, Emergency Medicine, Female, Humans, Informed Consent, Male, Prospective Studies, Telephone, Time Factors, Head Injuries, Closed, Patient Selection
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.