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
Comparative Study
. 2016 Feb 1;122(3):464-9.
doi: 10.1002/cncr.29759. Epub 2015 Oct 27.

Informed consent conversations and documents: A quantitative comparison

Shlomo A Koyfman  1   2 , Chandana A Reddy  1 , Sabahat Hizlan  2 , Angela C Leek  2 , And Eric D Kodish  2 ; Phase I Informed Consent (POIC) Research Team
Affiliations
Comparative Study

Informed consent conversations and documents: A quantitative comparison

Shlomo A Koyfman et al. Cancer. .

Abstract

Background: Informed consent for clinical research includes 2 components: informed consent documents (ICDs) and informed consent conversations (ICCs). Readability software has been used to help simplify the language of the ICD, but to the authors' knowledge is rarely used to assess the language used during the ICC, which may influence the quality of informed consent. The current analysis was performed to determine whether length and reading levels of transcribed ICCs are lower than their corresponding ICDs for selected clinical trials, and to assess whether investigator experience affected the use of simpler language and comprehensiveness.

Methods: The current study was a prospective study in which ICCs were audiorecorded at 6 institutions when families were offered participation in pediatric phase I oncology trials. Word count, Flesch-Kincaid Grade Level (FKGL), and Flesch Reading Ease score (FRES) of the ICCs were compared with corresponding ICDs, including the frequency with which investigators addressed 8 prespecified critical consent elements during the ICC.

Results: Sixty-nine unique physician/protocol pairs were identified. Overall, ICCs contained fewer words (4677 vs 6364 words; P = .0016) and had a lower FKGL (6 vs 9.7; P ≤ .0001) and a higher FRES (77.8 vs 56.7; P<.0001) compared with their respective ICDs, but were more likely to omit critical consent elements, such as voluntariness (55%) and dose-limiting toxicities (26%). Years of investigator experience was not correlated with reliably covering critical elements or decreased linguistic complexity.

Conclusions: Clinicians use more understandable language during ICCs than the corresponding ICD, but appear to less reliably cover elements critical to fully informed consent. Efforts focused at providing communication training for clinician-investigators should be made to optimize the synergy between the ICD and the ICC.

Keywords: clinical trials; consent documents; ethics; informed consent; oncology; pediatric; phase I.

PubMed Disclaimer

Conflict of interest statement

Conflicts of Interest: None

Figures

Figure 1
Figure 1
Flesch Kincaid Grade Level of Informed Consent Conversation by Number of Years Clinician in Practice (N=58)
See this image and copyright information in PMC

Comment in

References

    1. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? Jama. 2000;283:2701–11. - PubMed
    1. Flory J, Emanuel E. Interventions to improve research participants’ understanding in informed consent for research: a systematic review. Jama. 2004;292:1593–601. - PubMed
    1. Hoffner B, Bauer-Wu S, Hitchcock-Bryan S, Powell M, Wolanski A, Joffe S. “Entering a Clinical Trial: Is it Right for You?”: a randomized study of The Clinical Trials Video and its impact on the informed consent process. Cancer. 2012;118:1877–83. - PMC - PubMed
    1. Grossman SA, Piantadosi S, Covahey C. Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families? J Clin Oncol. 1994;12:2211–5. - PubMed
    1. Jefford M, Moore R. Improvement of informed consent and the quality of consent documents. Lancet Oncol. 2008;9:485–93. - PubMed

Publication types

LinkOut - more resources