Consent for audio-video recording of informed consent process in rural South India

Chauhan, Ramesh Chand; Purty, Anil J; Singh, Neelima

doi:10.4103/2229-3485.159941

Cited by 13 publications

(9 citation statements)

References 5 publications

(4 reference statements)

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“…AV recording of informed consent discussions : acceptability of and support for AV recordings varied (a third of lay participants refused in a hypothetical study and nearly all agreed in a real vaccine trial 72 83 ; a third to two-thirds of investigators were in support. 79 89 133 Concerns included the increase in time/resources required to carry out AV recordings and the lack of adequate guidance and support.…”

Section: Resultsmentioning

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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Section: Resultsmentioning

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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“…The Quintet Recruitment Intervention recommends recording conversations between recruiters and potential participants to learn more about the recruitment conversation and how that conversation could be improved [22]. However, it should be noted that requests to record these conversations have sometimes been rejected by a substantial minority of potential trial participants [23].…”

Section: Discussionmentioning

confidence: 99%

Reducing research waste by promoting informed responses to invitations to participate in clinical trials

Gillies

Chalmers

Glasziou

et al. 2019

Trials

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Poor recruitment to, and retention in, clinical trials is a source of research waste that could be reduced by more informed choices about participation. Barriers to effective recruitment and retention can be wide-ranging but relevance of the questions being addressed by trials and the outcomes that they are assessing are key for potential participants. Decisions about trial participation should be informed by general and trial-specific information and by considering broader assessments of ‘informedness’ and how they impact on both recruitment and retention. We suggest that more informed decisions about trial participation should encourage personally appropriate decisions, increase recruitment and retention, and reduce research waste and increase its value.

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“…A study among rural community regarding their willingness to be recorded during the consent process found that more than one-third of the participants refused to be videotaped due to lack of interest in AV recording or feeling shy in front of the camera. [ 4 ] The rule was further amended in 2015, where it was clarified that AV recording was mandatory only for vulnerable participants in NCE trials. Further, only audio recording needs to be maintained of the informed consent process in case of anti-HIV or antileprosy drug trials.…”

Section: Methodsmentioning

confidence: 99%

”The invisible”: Participant's experiences in clinical trials

Nadimpally

Bhagianadh

2017

Perspect Clin Res

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Background:The paper discussing the perspectives of clinical trial participants about the various aspects of CTs is based on the primary research conducted by Sama in 2012-13.Methodology:In-depth interviews were conducted with 36 CT participants from the states of New Delhi, Gujarat, Maharashtra and Andhra Pradesh. In addition to CT participants, other key informants including investigators, representatives of Contract Research Organizations (CROs), sponsor, Ethics Committee (EC) members etc. were also interviewed to develop a comprehensive understanding of the functioning of the CT sector.Findings and Discussion:The paper describes the perspectives of participants on the relevant aspects of recruitment into CTs, reasons for participation in CTs, informed consent, adverse events and compensation. The role played by the push and pull factors in recruitment, the information asymmetry, the power imbalance between the health-care provider and seeker, the role of sociocultural factors, etc., are explored in the paper. Combined with the insights from other stakeholders, the study gives an understanding about the chasm between regulations and realities in the Indian CT sector. Further, the paper briefly explores the recent changes and amendments in the laws governing the CT sector that is aimed at improving the conduct of CTs and uphold the rights of participants.Conclusion:Participants are the most important stakeholders in a CT setting. It is imperative that their voices are heard and their rights upheld for the ethical conduct of CTs.

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Consent for audio-video recording of informed consent process in rural South India

Cited by 13 publications

References 5 publications

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

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

Reducing research waste by promoting informed responses to invitations to participate in clinical trials

”The invisible”: Participant's experiences in clinical trials

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