Another look at the informed consent process: The document and the conversation

Wall, Louisa; Pentz, Rebecca D.

doi:10.1002/cncr.29760

Cited by 4 publications

(5 citation statements)

References 16 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Finally, it is worth reiterating that consent should be viewed as ‘a series of conversations’, 10 with the revised form proposed as a method of providing a more complete record of these conversations.…”

Section: Discussionmentioning

confidence: 99%

“…Few authors have examined this area, although some have included the consent conversation as an adjunct to research focused on the form itself, 9 while others have examined the respective roles of the form and the conversation with a view to improving the consent process. 10 In the UK, the advice given to healthcare professionals is that '(f)or significant procedures, it is essential for health professionals to document clearly both a patient's agreement to the intervention and the discussions which led up to that agreement'. 11 The consent form in veterinary medicine Much of the information surrounding the use of consent forms in veterinary practice is gleaned from professional ethical guidance.…”

Section: The Consent Form In Human Healthcarementioning

confidence: 99%

“…However, it is the form's role as a record of the consent conversation that is perhaps under‐researched. Few authors have examined this area, although some have included the consent conversation as an adjunct to research focused on the form itself,9 while others have examined the respective roles of the form and the conversation with a view to improving the consent process 10…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Role of the consent form in UK veterinary practice

Gray

2020

Veterinary Record

View full text Add to dashboard Cite

BackgroundInformed consent from the client is required before veterinary professionals may administer treatment or perform surgery on an animal patient, except in an emergency. This study investigates the potential role(s) of the consent form in the consent process in the UK.MethodsThematic analysis was carried out on the text contained in 39 blank consent forms sourced from veterinary practices in the UK. Analysis was conducted at the levels of topical survey and thematic summary.ResultsConsent forms were used to authorise procedures, to define proposed treatment, to offer or recommend additional procedures, to convey the risks of treatment and to document the client’s financial obligations. None of the forms analysed provided sufficient space to document the accompanying conversation. Notable omissions from the submitted forms included options for treatment and benefits of treatment.ConclusionsThe consent form acts as a record of the procedure to be performed, the associated costs and the status of the person giving consent. However, from this analysis, it often fails to record the detail of the consent discussion, an essential part of the consent process. A proposal for an improved version of a veterinary consent form is provided.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: The Consent Form In Human Healthcarementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Role of the consent form in UK veterinary practice

Gray

2020

Veterinary Record

View full text Add to dashboard Cite

show abstract

“…Regulatory requirements state that consent materials should present concise, understandable study information to ensure that potential participants truly understand all aspects of the study and make an informed and autonomous decision (Larson et al, 2015; Office for Human Research Protections, 2009). Participants who do not speak English or have limited English proficiency face additional barriers that require researchers to implement extended time for discussion while completing the consent process (Koyfman et al, 2016; Wall & Pentz, 2016). The CBPR partnership engaged Marshallese community stakeholders in the development of informed consent materials related to the use of participants' health data for biomedical research.…”

Section: Introductionmentioning

confidence: 99%

Multicomponent Informed Consent with Marshallese Participants

Purvis

Ayers

Bogulski

et al. 2021

Journal of Empirical Research on Human Research Ethics

View full text Add to dashboard Cite

Pacific Islanders are the second fastest-growing population in the United States; however, Pacific Islanders, and Marshallese specifically, are underrepresented in health research. A community-based participatory research (CBPR) approach was used to engage Marshallese stakeholders and build an academic-community research collaborative to conduct health disparities research. Our CBPR partnership pilot tested a multicomponent consent process that provides participants the option to control the use of their data. Consent forms used concise plain language to describe study information, including participant requirements, risks, and personal health information protections, and were available in both English and Marshallese. This study demonstrates that when provided a multicomponent consent, the vast majority of consenting study participants (89.6%) agreed to all additional options, and only five (10.4%) provided consent for some but not all options. Our description of the development and implementation of a multicomponent consent using a CBPR approach adds a specific example of community engagement and may be informative for other indigenous populations.

show abstract

“…This requires that researchers have informed consent conversations with participants while reviewing consent document to ensure informed consent from participants. 46,47 The challenges of understanding the consent process are most acute for those who do not speak English or have limited English proficiency, which includes recent immigrants, migrants, and refugees. 48 Consequently, Institutional Review Boards (IRBs) caution investigators to consider "the ethical/legal implications of subjects who do not understand English."…”

Section: Introductionmentioning

confidence: 99%

Facilitators, barriers, and recommendations related to the informed consent of Marshallese in a randomized control trial

et al. 2020

View full text Add to dashboard Cite

Background The Pacific Islander population is the second fasting growing population in the United States and Arkansas is home to the largest Marshallese population in the continental US. The Marshallese community have significant health disparities with high prevalence of diabetes, heart disease, and obesity compared to the general US population. Using a community-based participatory research approach, researchers and Marshallese community stakeholders identified diabetes as the top health issue for research. Methods From 2014 to 2018, a randomized control trial was conducted comparing standard diabetes management education with a culturally adapted family model of standard diabetes management education delivered in participants’ homes by Marshallese community health workers and certified diabetes educators. Interviews were held with Marshallese participants to document their experiences with and perceptions of the informed consent process for this randomized control trial. Results Participants provided feedback on the process of enrolling in the study, describing barriers and facilitators to giving informed consent from their perspective, and offering recommendations for improving the informed consent process. Conclusion Findings suggest that informed consent with underserved communities, including immigrant and migrant populations who do not speak English or have limited English proficiency, is possible, and that using a community-based participatory research approach can help facilitate the informed consent process.

show abstract

Another look at the informed consent process: The document and the conversation

Abstract: text pagesThere was no specific funding for this editorial and the authors have no conflicts to report.Precis: Koyfman et al report an innovative research strategy analyzing the simplicity of both the consent document and conversation. We offer modifications to their two recommendations.

Cited by 4 publications

References 16 publications

Role of the consent form in UK veterinary practice

Role of the consent form in UK veterinary practice

Multicomponent Informed Consent with Marshallese Participants

Facilitators, barriers, and recommendations related to the informed consent of Marshallese in a randomized control trial

Contact Info

Product

Resources

About