Audiovisual recording of the consenting process in clinical research: Experiences from a tertiary referral center

Shetty, Parvan; Maurya, Miteshkumar; Figer, Brinal H; Thatte, Urmila M; Gogtay, Nithya J

doi:10.4103/picr.picr_172_17

Cited by 7 publications

(4 citation statements)

References 3 publications

(4 reference statements)

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“…For example, in India, audiovisual documentation of obtaining informed consent is now required for most clinical trials if participants are low literate. This introduced significant new logistical challenges and costs related to obtaining and archiving recordings, and it may also pose a barrier to potential research subjects who may distrust or refuse to be recorded 19…”

Section: Resultsmentioning

confidence: 99%

Cultural considerations for informed consent in paediatric research in low/middle-income countries: a scoping review

Colom¹,

Rohloff

2018

bmjpo

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IntroductionConducting research with children in low/middle-income countries (LMIC) requires consideration of socioeconomic inequalities and cultural and linguistic differences. Our objective was to survey the literature on informed consent in paediatric LMIC research, assessing for practical guidance for culturally and linguistically appropriate procedures.MethodsWe conducted a scoping review on informed consent in paediatric LMIC research searching the PubMed, Web of Science and PsycINFO databases. Eligible articles were published in English, from any date range, of any study design or format.ResultsThe search identified 2027 references, of which 50 were included in the analysis following full-text review. Reviewed guidelines emphasised individual, informed and voluntary consent from parents and caregivers. Reviewed articles provided detailed practical guidance on adapting these guiding principles to LMIC settings, including considerations for community engagement, verbal or other alternative consent procedures for low-literacy settings or less commonly spoken languages and guarding against therapeutic misconception by caregivers. There was uncertainty, however, on how to best protect individual autonomy, especially when influenced by gender dynamics, leadership hierarchies or the social status of researchers themselves. There was, furthermore, limited research discussing the special case of research involving adolescents or of procedures for documenting assent by participating children.ConclusionsA scoping review of paediatric research in LMICs revealed substantial guidance on several features of culturally appropriate informed consent. However, additional research and guidance is needed, especially in the areas of gender imbalances, research with adolescents and children’s own assent to participate in research.

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Section: Resultsmentioning

confidence: 99%

Cultural considerations for informed consent in paediatric research in low/middle-income countries: a scoping review

Colom¹,

Rohloff

2018

bmjpo

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“…Given the breaches of good practice reported in the past and the routine AV recording of the informed consent interaction, it is notable that only one study 83 was conducted using this resource. It is unclear if the challenges in undertaking, storing and retrieving AV recordings 150 151 has a role in their underutilisation for research purposes or if this is due to regulatory restrictions. Opening the black box of the informed consent process in future qualitative research can help optimise comprehension of participants, communication of complex trial-related terminology in local languages and identify aspects of the doctor-patient interaction that contribute towards therapeutic misconception.…”

Section: Discussionmentioning

confidence: 99%

What empirical research has been undertaken on the ethics of clinical research in India? A systematic scoping review and narrative synthesis

et al. 2021

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IntroductionThe post-2005 rise in clinical trials and clinical research conducted in India was accompanied by frequent reports of unethical practices, leading to a series of regulatory changes. We conducted a systematic scoping review to obtain an overview of empirical research pertaining to the ethics of clinical trials/research in India.MethodsOur search strategy combined terms related to ethics/bioethics, informed consent, clinical trials/research and India, across nine databases, up to November 2019. Peer-reviewed research exploring ethical aspects of clinical trials/research in India with any stakeholder groups was included. We developed an evidence map, undertook a narrative synthesis and identified research gaps. A consultation exercise with stakeholders in India helped contextualise the review and identify additional research priorities.ResultsTitles/Abstracts of 9699 articles were screened, full text of 282 obtained and 80 were included. Research on the ethics of clinical trials/research covered a wide range of topics, often conducted with little to no funding. Studies predominantly examined what lay (patients/public) and professional participants (eg, healthcare staff/students/faculty) know about topics such as research ethics or understand from the information given to obtain their consent for research participation. Easily accessible groups, namely ethics committee members and healthcare students were frequently researched. Research gaps included developing a better understanding of the recruitment-informed consent process, including the doctor-patient interaction, in multiple contexts and exploring issues of equity and justice in clinical trials/research.ConclusionThe review demonstrates that while a wide range of topics have been studied in India, the focus is largely on assessing knowledge levels across different population groups. This is a useful starting point, but fundamental questions remain unanswered about informed consent processes and broader issues of inequity that pervade the clinical trials/research landscape. A priority-setting exercise and appropriate funding mechanisms to support researchers in India would help improve the clinical trials/research ecosystem.

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“…On 31 st July 2015, the original notification was modified, making AV recording mandatory only in cases of vulnerable populations and with research on new clinical entities. [ 24 ] Important elements of the AV recording are:…”

Section: Current Regulationmentioning

confidence: 99%

Informed Consent in Biomedical Research

Chatterjee¹,

Das

2021

Indian Dermatology Online Journal

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Medical science is evolving constantly and this evolution cannot happen without biomedical research involving human participant. Owing to a tumultuous history, importance of ethical research cannot be over emphasized in today's world and the concept of informed consent becomes the guardian of ethics, not only to improve the bonding between the participant and researcher aiding a wholehearted involvement but also ensuring safety for the participants from research related injury/loss. Subject information sheet (SIF) and Informed consent form (ICF) are the fundamental elements of informed consent document. Process of obtaining them from illiterate and vulnerable populations involves the legally authorized representative (LAR) and impartial witness. Audiovisual recording becomes important in case of clinical trials. Process of obtaining informed consent becomes challenging for vulnerable populations as well as during pandemic situations. A comprehensive informed consent is essential for a credible and ethical research.

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Audiovisual recording of the consenting process in clinical research: Experiences from a tertiary referral center

Cited by 7 publications

References 3 publications

Cultural considerations for informed consent in paediatric research in low/middle-income countries: a scoping review

Cultural considerations for informed consent in paediatric research in low/middle-income countries: a scoping review

What empirical research has been undertaken on the ethics of clinical research in India? A systematic scoping review and narrative synthesis

Informed Consent in Biomedical Research

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