Improving Participant Comprehension in the Informed Consent Process

Cohn, Elizabeth; Larson, Elaine

doi:10.1111/j.1547-5069.2007.00180.x

Cited by 99 publications

(76 citation statements)

References 37 publications

(42 reference statements)

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“…Our findings revealed an average comprehension score of 58, indicating that some participants gave their consent without fully understanding the study protocol and risks. Similarly, in a systematic review, Cohen and Larson 12 suggested that despite increasing regulatory scrutiny, deficiencies still exist in participants' comprehension of the research in which they participate. In our study, we found a strong correlation between educational levels and subjects' average comprehension score.…”

Section: Discussionmentioning

confidence: 99%

The Informed Consent Process in Genetic Family Studies

Panoyan

Lee

Arar

et al. 2008

Life Sci Soc Policy

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The informed consent process provides protection by ensuring that potential research subjects understand the goals of the research project they are being asked to voluntarily partake in as well as the risks associated with the study. We examined subjects' comprehension and ability to identify issues explicitly raised during the consent process that was conducted as part of their participation in a genetic family study (GFS). We employed cross-sectional design by providing a short, selfadministrative questionnaire to 246 participants recruited from families enrolled in the Extended Family Investigation of Nephropathy and Diabetes (EFIND) study conducted at the University of Texas Health Science Center. Participants responded to the questionnaire directly after their enrollment in the EFIND study. The questionnaire consisted of multiple-choice questions and focused on the understanding of the purposes, procedures, and risks associated with their participation in the EFIND study. These questions were formulated to reflect basic information presented to subjects through the consent process. Responses to questions were expressed as percentages, placing equal weight on each response. Participants were Mexican-American, 62.3% female and averaged 35.2 ±12.7 years old (range: 18-76). Our findings showed that the average comprehension score was 58. About 30% of the participants did not know the name of the study, and 70% did not identify all elements related to the study procedures. The most striking finding was the lack of understanding concerning the social risks associated with participation in EFIND. While 35.1% of participants identified all potential physical risks, only 1.3% could identify all of the social risks. Our findings showed that participants comprehension score was significantly associated with their level of education and income. We conclude that using the informed consent process to communicate research social risks to subjects participating in GFS has some limitations. Future research directed at improving risk communications to subjects of low socioeconomic levels participating in genetic research is justified.

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Section: Discussionmentioning

confidence: 99%

The Informed Consent Process in Genetic Family Studies

Panoyan

Lee

Arar

et al. 2008

Life Sci Soc Policy

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“…Bu sürecin mekanizmaları genellikle hemşirenin onam formu üzerinde hastanın imzasını almasını gerektirse de, hemşire-nin birincil önceliği otonom karar verme süreci için gerekli olan tüm ölçütlerin karşılanmasını sağ-lamaktır. 5,22,23 Hemşirelerin aydınlatılmış onam süreçlerinde yaşadığı diğer bir sorun ise hastalara doktoru tarafından aydınlatılmış onam formu imzalatılırken hemşirelerin tanık olarak bulunması ve formu imzalamalarıdır. Hemşirelerin tanık olarak formu imzalaması birtakım sorumluluğu da beraberinde getirmektedir.…”

Section: Gönüllü Onam Olmalıdırunclassified

“…10) Herhangi bir sağlık hizmeti sunarken hasta ile birlikte tartışarak, işlemlerin kaydedilmesi gerekmektedir. 6,20,22 Sullivan'a göre hemşirenin imzası; hastanın onamı isteyerek verdiğine, imzayı zamanında attı-ğına, hastanın imza atacak yeterlilikte olduğuna ve hastanın imzasının gerçek olduğuna dair beyanı-dır. 24 Tedavinin hastaya açıklandığı zamana tanık olmayan hemşireler, hastanın işlemi anlayıp anlamadığı, hekim ile görüşülmesi gereken herhangi bir sorun olup olmadığı ve hastanın baskı altında olup olmadığı konusunda bilgi edinmelidirler.…”

Section: Gönüllü Onam Olmalıdırunclassified

The Nurse's Role and Responsibilities in Informed Consent: Review

Akyüz¹,

Karadağ²,

Bulut³

2016

Turkiye Klinikleri J Nurs Sci

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“…Any successful consent process should at a minimum include various communication modes and is likely to require one-to-one interaction with someone knowledgeable about the study." 52 Others have also noted instances where, even when a consent process met regulatory requirements, "it was inappropriate for most patients." 53 Fundamental issues include literacy rates in the United States of half the population at the 8th-grade level.…”

Section: Do We Achieve Informed Consent?mentioning

confidence: 99%