Voluntary informed consent and good clinical practice for clinical research in South Africa: Ethical and legal perspectives

Britz, Retha; Roux-Kemp, Andra Le

doi:10.7196/samj.5498

Cited by 9 publications

(11 citation statements)

References 4 publications

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“…Participatory decision-making is when potential research participants reach a decision regarding research participation in consultation with others (e.g. family members or community leaders; Britz and Le Roux-Kemp, 2012). It is ultimately, however, still up to the potential research participant to make the final voluntary decision (Britz and Le Roux-Kemp, 2012).…”

Section: Discussionmentioning

confidence: 99%

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Voluntariness of consent to HIV clinical research: A conceptual and empirical pilot study

Mamotte

Wassenaar

2016

J Health Psychol

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Obtaining voluntary informed consent for research participation is an ethical imperative, yet there appears to be little consensus regarding what constitutes a voluntary consent decision. An instrument to assess influences on participants' consent decision and perceived voluntariness was developed and piloted in two South African HIV clinical trials. The pilot study found high levels of perceived voluntariness. The feeling of having no choice but to participate was significantly associated with lower perceived voluntariness. Overall the data suggest that it is possible to obtain voluntary and valid consent for research participants in ethically complex HIV clinical trials in a developing country context.

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Section: Discussionmentioning

confidence: 99%

“…family members or community leaders; Britz and Le Roux-Kemp, 2012). It is ultimately, however, still up to the potential research participant to make the final voluntary decision (Britz and Le Roux-Kemp, 2012).…”

Section: Discussionmentioning

confidence: 99%

Voluntariness of consent to HIV clinical research: A conceptual and empirical pilot study

Mamotte

Wassenaar

2016

J Health Psychol

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“…Britz and Le Roux-Kemp [22] emphasised that pain, psychological factors or socioeconomic factors may influence the process of getting IC from a participant. The decision-making capacity of women in labour or during the postpartum period may thus be compromised: stress, pain and anxiety may influence the decision-making process.…”

Section: Discussionmentioning

confidence: 99%

Informed consent in clinical trials

Kovane

Nikoderm

Khondowe

2022

S Afr J Bioethics Law

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Background. Informed consent (IC) is not only a regulatory but also an ethical requirement to participate in any clinical trial. It is essential to determine that research participants understand what they consent to. Studies that evaluate participants’ understanding of IC conclude that recall and understanding of IC is often low, and researchers recommend that interactive multimedia interventions should be implemented to optimise understanding. Objectives. To assess participants’ understanding of IC of the research trial that they agreed to participate in.Methods. A descriptive survey design, within a quantitative research approach, was used to conduct the study at two government hospitals in the Eastern Cape Province. A semi-structured, self-administered questionnaire was used to collect information from 170 participants in research studies. Descriptive statistics were used to analyse the results.Results. Participants were recruited from among women who enrolled in any of the three studies that were ongoing at the two sites during the recruitment period. The study participants had a mean age of 25.9 years. Nearly one-third (30%) could not recall the purpose of the original trial that they consented to. The concept of randomisation was not understood by any of the participants.Conclusion. Regardless of extensive efforts to ensure that participants understood their participation, this study unveiled poor recall of essential information on IC. It is proposed that IC should be short and only address essential components such as purpose, procedure, possible risks or benefits, alternative options if not participating and explaining the concept of voluntary participation.

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“…Researchers, therefore, need to ensure, in line with the Declaration of Helsinki, the comprehension of information they give to potential participants. [5] The process of informed consent is confronted by several challenges which include, but are not limited to: a conducive environment, presence of pain/distress, [6] poverty, education, [7,8] health literacy, [9] presence of investigation intervention only in the context of the trial, [10,11] insistence on signatures rather than oral agreement, [12] use of voluminous and complex consent forms owing to the need to ensure legality, [13,14] language barriers and foreign accents of researchers. [9] These challenges assume a larger dimension in resourcelimited settings where populations have limited literacy.…”

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confidence: 99%

Piloting a tool for informed consent comprehension in a cardiovascular clinical trial in South Africa: An IMPI-2 pilot trial substudy (ICC Study)

et al. 2023

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Background. Informed consent is a key requirement in research. However, the comprehension of information presented is rarelyevaluated prior to or during the research. Ensuring that participants understand the key issues in trials is important, not just forethical reasons, but also because it can help set patient expectations. We evaluated the feasibility of using the University of California Brief Assessment of Capacity to Consent (UBACC) questionnaire to guide informed consent comprehension in the pilot study for the second Investigation of the Management of Pericarditis in Africa (IMPI-2) trial. IMPI-2 is a randomised control trial (RCT) on the use of alteplase-facilitated pericardial drainage, compared with routine care among patients with large pericardial effusion. We used an abbreviated version of the UBACC to evaluate participant comprehension of key elements of the consent documentation and to guide discussions.Method. Comprehension was assessed using a 10-item UBACC at baseline, 6 weeks, 3 months and 6 months follow-up to reiterate the information about the trial. Each response was scored from 0 to 3 and the sum at each visit was recorded to represent comprehension. A UBACC score ≥25 was considered adequate comprehension. Bivariate logistic regression was performed to evaluate comprehension over time. A multivariate analysis was conducted to identify predictors of UBACC score.Results. The Informed Consent Comprehension (ICC) Study included 71 participants with a median age of 42 years; 45% were females and 49% had at least a secondary level of education. Level of comprehension improved with time; the odds of passing the evaluation at baseline compared with 6 months was higher (odds ratio (OR) 1.39, 95% confidence interval (CI) 1.17 - 1.65, p<0.001). Not using interpreters and having a secondary level of education were associated with higher comprehension. Despite knowing that they were participating in research, many participants still did not accept that the trial drug may have no effect.Conclusion. It is feasible to use the UBACC questionnaire for informed consent comprehension evaluation in RCTs. Repeated learning during follow-up improves comprehension over time, while a low level of education and use of interpreters reduces comprehension.

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Voluntary informed consent and good clinical practice for clinical research in South Africa: Ethical and legal perspectives

Cited by 9 publications

References 4 publications

Voluntariness of consent to HIV clinical research: A conceptual and empirical pilot study

Voluntariness of consent to HIV clinical research: A conceptual and empirical pilot study

Informed consent in clinical trials

Piloting a tool for informed consent comprehension in a cardiovascular clinical trial in South Africa: An IMPI-2 pilot trial substudy (ICC Study)

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