An audit of consent refusals in clinical research at a tertiary care center in India

Thaker, SJ; Figer, Brinal H; Nj, Gogtay; Thatte, U M

doi:10.4103/0022-3859.166515

Cited by 12 publications

(9 citation statements)

References 23 publications

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“…which assessed the reasons for consent refusal in CR had identified “concerns about the risk” as one among the several factors influencing the decision to participate. [ 13 ]…”

Section: Discussionmentioning

confidence: 99%

A survey of knowledge and variables influencing perceptions about clinical research

Figer

Lamture

Gandhi

et al. 2021

Perspectives in Clinical Research

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Purpose: Clinical research in India has been besieged by controversies. While studies have addressed other stakeholders, few have addressed the patient. The present study was conducted to assess the extent of awareness and understanding about the nature and conduct of CR among people of Mumbai. Methods: Institutional Ethics Committee approval was taken (EC/OA-12/15) and written informed consent was obtained. Adults who were residents of Mumbai were enrolled. A prevalidated and published 48-item questionnaire based on six themes, namely awareness and participation, voluntariness and autonomy, compensation, confidentiality, safety, and involvement in CR were administered. Perception based on themes and association of variables such as age, gender, socioeconomic class, and education on this perception was assessed. Descriptive statistics along with Chi-square test/Chi-square test for trend and crude odds ratio (cOR) were assessed. Results: Of the 453 participants approached, 400 (age 32 [18–96]) consented. Only 210/400 (52.5%) were aware of CR and 194/400 (48.5%) said they needed permission for participation. Only 226/400 (56.5%) were aware of their rights and 111/400 (27.75%) felt that clinical trial participants received compensation. The socioeconomic class influenced awareness of CR ( P < 0.00001; r 2 = 0.495) as did the age ( P < 0.0001; r 2 = 0.82). Men were less likely to need permission to participate relative to women (cOR [95% confidence interval (CI)] 2.47 [1.6, 3.6] [ P < 0.00001]). Those who had heard of CR were twice more willing to participate (cOR [95% CI] 1.72 (1.2, 2.6); P = 0.008). Conclusions: There is a greater need to improve awareness, especially about safety, compensation, and confidentiality in CR.

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“…which assessed the reasons for consent refusal in CR had identified “concerns about the risk” as one among the several factors influencing the decision to participate. [ 13 ]…”

Section: Discussionmentioning

confidence: 99%

A survey of knowledge and variables influencing perceptions about clinical research

Figer

Lamture

Gandhi

et al. 2021

Perspectives in Clinical Research

View full text Add to dashboard Cite

show abstract

“…The lack of a comprehensive and informative ICF might have negative implications on the quality of research and might potentially threaten subjects safety. For instance, subjects who are not clear about the research to be conducted might initially refuse to participate, withdraw during enrollment, or may be exposed to harm 17. It has been reported that inadequate education and training of researchers responsible for obtaining the informed consent may result in poor communication of research objectives, risks, and benefits 18.…”

Section: Discussionmentioning

confidence: 99%

<p>The quality of consent form structure in biomedical research: a study from Jordan and Sudan</p>

Ibrahim¹,

Alshogran²,

Khabour³

et al. 2019

JMDH

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Background Informed consent is one of the primary standards of ethical clinical research. This study assessed the quality of the informed consent forms (ICF) utilized in medical research conducted in Sudan and Jordan. Subjects and methods A total of 435 studies that were performed at health sciences schools in Jordan and Sudan were initially screened for the presence of ICF. Of these, 189 studies were reviewed for the major components of ICF using a standard checklist. Results The majority of the reviewed ICFs did not achieve the full standards of the universal guidelines for the informed consent structure. The following elements were described in >50% of consent forms reviewed from both countries: study title, objectives, research investigators, description of study procedure, and confidentiality. Other essential elements such as duration of the subject’s participation, risks/benefits, compensation, voluntary participation, and contact information were poorly described. Conclusion The major elements of ICFs were not adequately described in medical research studies from Jordan and Sudan. Improved understanding of major elements of ICF among researchers in the examined countries is necessary. Clear and informative consent template can be very valuable in this perspective.

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“…[ 2 ] The second was an analysis of consent declines in ten studies conducted at a tertiary referral centre and thus disparate. [ 14 ]…”

Section: Methodsmentioning

confidence: 99%

A literature review of consent declines and consent withdrawals in randomized controlled trials conducted during the COVID-19 pandemic

Gogtay¹,

Sheth²,

Maurya³

et al. 2021

Journal of Postgraduate Medicine

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Objectives: We evaluated the extent of consent declines and consent withdrawals during the COVID-19 pandemic as seen in published randomized controlled trials (RCTs) and compared it with non-COVID-19 RCTs published at the same time and two historical controls. Methods: PubMed/Medline only was searched using key-word “COVID-19” and “RCTs” separately, and filtered for COVID-19 RCTs and non-COVID-19 RCTs respectively, published during a nine-month period (1 Feb - 1 Nov 2020). Exclusions were study protocols, observational studies, interim analysis of RCT data and RCTs with missing data. Primary outcome measures were the proportion of consent declines and consent withdrawals as percentage of total participants screened and randomized respectively in COVID-19 RCTs. We compared consent declines and consent withdrawals of COVID-19 RCTs with non-COVID-19 RCTs and two earlier studies on the same topic that served as historical controls (non-pandemic setting). Results: The search yielded a total of 111 COVID-19 RCTs and 49 non-COVID-19 RCTs. Of these, 39 (35.13%) COVID-19 RCTs and 11 (22.45%) non-COVID-19 RCTs were finally analysed. A total of 770/17759 (4.3%) consent declines and 100/7607 (1.31%) consent withdrawals were seen in 39 COVID-19 RCTs. A significant difference was observed in consent declines between COVID-19 vs non-COVID-19 RCTs [4.3% vs 11.9%, p < 0.0001] and between COVID-19 RCTs vs two historical controls [(4.3% vs 8.6%, p < 0.0001) and (4.3% vs 21.1%, p < 0.0001), respectively]. Conclusion: RCTs conducted during the COVID-19 pandemic appear to have significantly lower consent declines relative to non-COVID-19 RCTs during pandemic and RCTs conducted in non-pandemic settings.

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An audit of consent refusals in clinical research at a tertiary care center in India

Cited by 12 publications

References 23 publications

A survey of knowledge and variables influencing perceptions about clinical research

A survey of knowledge and variables influencing perceptions about clinical research

<p>The quality of consent form structure in biomedical research: a study from Jordan and Sudan</p>

A literature review of consent declines and consent withdrawals in randomized controlled trials conducted during the COVID-19 pandemic

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