Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2009 Aug;16(8):763-70.
doi: 10.1111/j.1553-2712.2009.00455.x.

Perceived challenges to obtaining informed consent for a time-sensitive emergency department study of pediatric status epilepticus: results of two focus groups

James M Chamberlain  1 , Kathleen Lillis, Cheryl Vance, Kathleen M Brown, Olubunmi Fawumi, Shari Nichols, Colleen O Davis, Tasmeen Singh, Jill M Baren; Pediatric Emergency Care Applied Research Network
Collaborators, Affiliations

Perceived challenges to obtaining informed consent for a time-sensitive emergency department study of pediatric status epilepticus: results of two focus groups

James M Chamberlain et al. Acad Emerg Med. 2009 Aug.

Abstract

Objectives: The objective was to describe the perspective of research personnel on issues of informed consent in a time-sensitive clinical study under emergency circumstances.

Methods: The authors convened concurrent focus groups of research staff and investigators involved in a pharmacokinetic study of lorazepam for status epilepticus (SE). Moderators led discussion with open-ended questions on selected issues of parental consent, communication and understanding, patient assent, and comparison to other types of studies. Focus group transcripts were analyzed to identify themes and subthemes from the discussions.

Results: Most themes and subthemes were identified in both research staff and investigator focus groups. Focus group discussion points were categorized into three main themes: barriers to and enablers of informed consent, barriers to and enablers of actual enrollment, and overall ethical concerns about the research. Many of the issues identified were unique to emergency research.

Conclusions: From the perspectives of research staff and investigators enrolling patients in a time-sensitive emergency department study, the authors identified several areas of concern that should be addressed when planning future emergency studies.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest: None

Figures

Figure
Figure
Schematic of study patient cohorts.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Biros MH, Lewis RJ, Olson CM, Runge JW, Cummins RO, Fost N. Informed consent in emergency research: consensus statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers. JAMA. 1995;273:1283–1287. - PubMed
    1. Salzman JG, Frascone RJ, Godding BK, Provo TA, Gertner E. Implementing emergency research requiring exception from informed consent, community consultation, and public disclosure. Ann Emerg Med. 2007;50:448–455. - PubMed
    1. Vaslef SN, Cairns CB, Falletta JM. Ethical and regulatory challenges associated with the exception from informed consent requirements for emergency research: from experimental design to institutional review board approval. Arch Surg. 2006;141:1019–1023. - PubMed
    1. Baren JM, Fish SS. Resuscitation research involving vulnerable populations: are additional protections needed for emergency exception from informed consent? Acad Emerg Med. 2005;12:1071–1077. - PubMed
    1. DeIorio NM, McClure KB. Does the emergency exception from informed consent process protect research subjects? Acad Emerg Med. 2005;12:1056–1059. - PubMed

Publication types