Enrolling subjects by exception from consent versus proxy consent in trauma care research.
Study Objective: For clinical research, the consent process plays a critical role in protecting human subjects. In emergency research, proxy consent can impose substantial delays or even render a study infeasible if the intervention involves a highly time-sensitive treatment. The objective of this s...
| Published in: | Annals of Emergency Medicine Vol. 51; no. 4; pp. 355 - 361 |
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| Main Authors: | , , , , , , , , , |
| Format: | research tables/charts Journal Article |
| Published: |
Elsevier B.V.
Apr2008
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=105744725&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 105744725 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 01960644 1WN jtl: Annals of Emergency Medicine issn: 01960644 maglogo: N pubinfo: dt: Apr2008 vid: 51 iid: 4 pid: 467 pub: Elsevier B.V. place: New York, New York artinfo: ui: 105744725 105744725 NLM17933428 2009893066 10.1016/j.annemergmed.2007.08.021 NLM17933428 105744725 ppf: 355 ppct: 6 formats: tig: atl: Enrolling subjects by exception from consent versus proxy consent in trauma care research. aug: au: Wright DW Clark PL Pentz RD Hertzberg V Kellermann AL Wright, David W Clark, Pamela L Pentz, Rebecca D Hertzberg, Vicki Kellermann, Arthur L affil: Department of Emergency Medicine, School of Medicine, Emory University School of Medicine, Atlanta, GA 30303, USA sug: subj: Consent (Research) Research Subject Recruitment Methods Brain Injuries Diagnosis Brain Injuries Therapy Descriptive Statistics Emergency Patients Funding Source Outcomes (Health Care) Progesterone Therapeutic Use Research Subject Retention Methods Treatment Duration Human ab: Study Objective: For clinical research, the consent process plays a critical role in protecting human subjects. In emergency research, proxy consent can impose substantial delays or even render a study infeasible if the intervention involves a highly time-sensitive treatment. The objective of this study is to compare the time required to enroll brain-injured trauma patients in a study with proxy consent versus exception from consent.Methods: We analyzed data from a clinical trial (Progesterone for Traumatic brain injury-Experimental Clinical Treatment-ProTECT) of a promising treatment for acute brain injury that used proxy consent for subject enrollment. Performance metrics using proxy consent (actual study) were compared to assumptions of what would have happened if the study had been conducted with exception from consent (hypothetical study). The total number and monthly rate of enrollees, mean time from injury to initiation of the study treatment, and number of subjects receiving unwanted treatment for any span of time were compared.Results: During the 30-month enrollment period, the actual study accrued 100 consenting subjects (3.3 per month) compared with 122 subjects (4.1 per month) for the hypothetical study. Mean time from injury to initiation of experimental treatment in the actual study was 379.2 standard deviation 118.0 minutes, approximately 6.3 hours, compared with 122 minutes in the hypothetical study.Conclusion: Exception from consent can reduce mean time from injury to initiation of study treatment of trauma patients by 4 hours or more. For a time-critical trauma care intervention, this difference may justify elaborate efforts to comply with the Final Rule. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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