Should consent forms used in clinical trials be translated into the local dialects? A survey among past participants in rural Ghana

Baiden, Frank; Akazili, James; Chatio, Samuel; Achana, Fabian Sebastian; Oduro, Abraham; Ravinetto, Raffaella; Hodgson, Abraham

doi:10.1177/1740774515609290

Cited by 5 publications

(4 citation statements)

References 21 publications

(28 reference statements)

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“…In this study, Morrow and colleagues showed that most participants in South Africa perceive medical research to be similar to medical care, and may not understand the study purpose and therefore caregivers believed that their infants would be protected from HIV if they joined the research project. Similar findings were reported by Moodley et al [48]In Ghana, Baiden et al [49], Malawi, Bentley [59] South Africa, Ndebele et al [41], and Moodley et al [60] reported that most clinical trials with complex study procedures or consent forms tended to evaluate the understanding or recall of specific scientific and technical trial terms including randomisation, placebo. In Ghana, O [57] reported varied comprehension levels of disclosed information among participants and variability was also observed among younger and older participants.…”

Section: Ic Assessment Toolssupporting

confidence: 80%

“…This led to two interrelated issues with the language in IC forms; the words or terms used by local communities and the translation of them into local languages to make them more accessible. The studies reviewed reported misunderstandings and miscommunication, especially when investigators and participants speak different languages, when IC documents have to be translated, or when scientific research and the notion of IC are unfamiliar to study participants [33,37,40,42,[49][50][51][52][53].…”

Section: The Language Used and The Translation Of Icmentioning

confidence: 99%

“…To address limitations inherent in translations, Boga and colleagues in Kenya [23], went beyond translations and targeted the broader socio-cultural context by codeveloping a dictionary of language with communities to incorporate the socio-cultural nuances and issues that might be missed during the translation. Interestingly, only one study by Baiden and colleagues [49]argued against the appropriateness of translating approved English version ICF into the local language, and instead proposed the development of contextualized informed procedures based on the values and aspirations of the participants in different contexts. In fact, Burgess et al argued that translating IC documents into unfamiliar local dialects could ironically enhance the vulnerability of the participants [50].…”

Section: The Language Used and The Translation Of Icmentioning

confidence: 99%

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Beyond translations, perspectives for researchers to consider to enhance comprehension during consent processes for health research in sub-saharan Africa: a scoping review

et al. 2023

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Background Literature on issues relating to comprehension during the process of obtaining informed consent (IC) has largely focused on the challenges potential participants can face in understanding the IC documents, and the strategies used to enhance comprehension of those documents. In this review, we set out to describe the factors that have an impact on comprehension and the strategies used to enhance the IC process in sub-Saharan African countries. Methods From November 2021 to January 2022, we conducted a literature search using a PRISMA tool. We searched electronic databases (PubMed, EMBASE, EBSCOHOST) to identify relevant peer reviewed studies. We then reviewed the references of these articles to find additional literature that might have been missed through the initial search. We were particularly interested in full text articles in English that focused on the IC process in SSA published between 2006 and 2020. We included systematic reviews, and studies from Western and Asian countries that included data about SSA. We excluded articles that focused on medical interventions and studies that did not require IC. Results Out of the 50 studies included most were multi-country (n = 13) followed by single country studies in South Africa (n = 12); Kenya, Tanzania, Uganda (n = 5) each; Gambia, Ghana and Nigeria (n = 2)each ; and one each for Botswana, Malawi, Mali, Mozambique. We identified three areas of focus: (1) socio-cultural factors affecting IC; (2) gaps in the ethical and legal frameworks guiding the IC process; and (3) strategies used to improve participants’ understanding of IC. Conclusion Our review showed wide recognition that the process of achieving IC in SSA is inherently challenging, and there are limitations in the strategies aimed at improving comprehension in IC. We suggest that there is a need for greater flexibility and negotiation with communities to ensure that the approach to IC is suited to the diverse socio-cultural contexts. We propose moving beyond the literal translations and technical language to understanding IC comprehension from the participants’ perspectives and the researchers’ views, while examining contextual factors that impact the IC process.

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Section: Ic Assessment Toolssupporting

confidence: 80%

Section: The Language Used and The Translation Of Icmentioning

confidence: 99%

Section: The Language Used and The Translation Of Icmentioning

confidence: 99%

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Beyond translations, perspectives for researchers to consider to enhance comprehension during consent processes for health research in sub-saharan Africa: a scoping review

et al. 2023

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“…However, informed consent in the local language should be provided for a better understanding of the research and participation. [ 19 ] In that case, the consent form in the local language may be provided as an additional attachment with a clear description that the consent is available in the local language in the attached portable document format file. However, the major limitation of the informed consent process in an online survey is that the researchers do not have any idea how much the participant understands the consent form.…”

Section: Discussionmentioning

confidence: 99%

A cross-sectional audit of informed consent of online survey: Characteristics and adherence to prevalent guidelines

Mondal¹,

Mondal²,

Soni³

2023

Perspectives in Clinical Research

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Background: Research on human participants requires formal approval from a competent ethics committee. During the recruitment of the research participants, obtaining informed consent is a prerequisite. The online survey method is used by many researchers as it can collect the data from a diverse population in a short time. Aim: This study aimed to observe the characteristics and adherence to prevalent guidelines (set by the Indian Council of Medical Research [ICMR]) of informed consent coupled with online surveys. Methods: We collected the informed consent text from online survey links obtained from a network of colleagues who got a request to participate in a survey. Data were collected from July 2020 to June 2022. The text was anonymized for further analysis. The word count, sentences, and Flesch reading ease score were calculated. The adherence to ICMR guidelines where checked by two authors individually and a consensus was reached to prepare the final result. Results: A total of 44 online surveys in English were audited and among them, 10 did not have informed consent. The informed consent in 34 surveys had a median of 6 sentences and 84 words. The median reading ease score was 45.7 (college level). The majority of the consent states the purpose of the research (91.18%), the voluntary nature of the participation (85.29%), and mentioned that it is research (64.71%). However, the rest of the components are ignored by the majority of the survey consent form. Conclusion: Informed consent form with online surveys lacks adherence to the components suggested by ICMR. Hence, the forms should be made carefully by the researchers so that the vigor of informed consent is maintained in the online surveys.

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Case Reports and Consent for Publishing in Rheumatology Journals

Pineda

Sandoval

2018

J Clin Rheumatol

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Case reports have a long-standing tradition in the current rheumatology literature. We aimed to present the main points of view regarding the importance, meaning, and barriers of consent for publishing under the comprehensive protection of patients' rights within this genre. We encourage Latin American editors and authors of rheumatology journals to adopt the best ethical practices in the field, avoiding security and legal liabilities from a regional perspective.

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Should consent forms used in clinical trials be translated into the local dialects? A survey among past participants in rural Ghana

Cited by 5 publications

References 21 publications

Beyond translations, perspectives for researchers to consider to enhance comprehension during consent processes for health research in sub-saharan Africa: a scoping review

Beyond translations, perspectives for researchers to consider to enhance comprehension during consent processes for health research in sub-saharan Africa: a scoping review

A cross-sectional audit of informed consent of online survey: Characteristics and adherence to prevalent guidelines

Case Reports and Consent for Publishing in Rheumatology Journals

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