Evaluation of factors that motivate participants to consent for non-therapeutic trials in India

Doshi, Maulik; Kulkarni, Shrirang Vasant; Ghia, Canna Jagdish; Gogtay, Nithya J; Thatte, Urmila M

doi:10.1136/medethics-2012-100755

Cited by 19 publications

(29 citation statements)

References 18 publications

(28 reference statements)

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“…These findings agree with findings of studies conducted in Brazil and India by Nappo et al (2013) as well as Doshi et al (2013). In situations of poor service delivery, medical care in a research setting is described in favorable terms.…”

Section: Discussionsupporting

confidence: 94%

Motivational Factors for Participation in Biomedical Research

Mfutso-Bengo

Manda-Taylor

Masiye

2014

Journal of Empirical Research on Human Research Ethics

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Obtaining effective informed consent from research participants is a prerequisite to the conduct of an ethically sound research. Yet it is believed that obtaining quality informed consent is generally difficult in settings with low socioeconomic status. This is so because of the alleged undue inducements and therapeutic misconception among participants. However, there is a dearth of data on factors that motivate research participants to take part in research. Hence, this study was aimed at filling this gap in the Malawian context. We conducted 18 focus group discussions with community members in urban and rural communities of Blantyre in Malawi. Most participants reported that they accepted the invitation to participate in research because of better quality treatment during study also known as ancillary care, monetary and material incentives given to participants, and thorough medical diagnosis.

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Section: Discussionsupporting

confidence: 94%

Motivational Factors for Participation in Biomedical Research

Mfutso-Bengo

Manda-Taylor

Masiye

2014

Journal of Empirical Research on Human Research Ethics

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“…In spite of this, only a fifth of the participants said they would allow their child to participate in a trial if there was a monetary benefit. This is contrary to what we found in a study in healthy adults [29] who participated in non-therapeutic clinical trials, where financial reward was the most common motivating factor for their participation.…”

Section: Discussioncontrasting

confidence: 99%

Awareness about and views of parents on the off-label drug use in children

Bang

Mallad

Sridharan

et al. 2014

International Journal of Risk &Amp; Safety in Medicine

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BACKGROUND: Off-label use of drugs is widely prevalent in children mainly due to a limited data generated in children during drug development process. Parents play a critical role in giving consent for their child to participate in clinical trials. Very few studies have assessed the opinion of the parents regarding such use and permitting their child to participate in clinical trials. OBJECTIVE: In view of lack of information about the awareness among parents regarding both off-label drug use in children as well as about allowing their child to participate in clinical research especially from a developing country, this study was conducted. METHODS: Adults accompanying patients in a tertiary care hospital were administered a validated, structured questionnaire following written informed consent. The questionnaire consisted of 18 items broadly divided into 5 themes -parental views on safety and labelled use of drugs in children, awareness of off-label drug use in children, communication from healthcare worker about it, parental views on off-label drug use in children and willingness to allow their child to participate in a clinical trial. Chi-square or Fisher's exact probability test and McNemar's test were used for analysis. RESULTS: Initially, a majority of the participants felt that the drugs used in children in hospital (89.5%) and prescribed by a family physician (80.3%) were either safe or extremely safe while after the concept of off-label drug use is explained, a significant reduction in the proportion (59.3% in hospital and 59.8% by family physician) of parents felt the same. Only 30% parents were aware of off-label drug use in children. Ninety-three percent of the parents wanted to be informed whenever a doctor prescribes a drug in an off-label manner and a similar percentage felt the off-label drug use would increase the side-effects. Seventy three percent parents felt the off-label drug use is illegal and 57% would ask for change to a labelled drug in case of such prescription in their children. A majority of the parents would allow their child to participate in case of a life-threatening condition (59.8%) or in case of a chronic illness (51.3%) but significantly less when their child is healthy. CONCLUSION: The present study has found a low level of awareness regarding the concept of off-label drug use in children amongst the public. Our study also shows that parents expect that the doctor explains the fact to them, although they appear to vest a large amount of trust in the doctor's judgement in doing the best for their sick child. Parents were more willing to allow their child's participation in clinical research if their child was seriously ill than if healthy, indicating the need to educate the society about the need for clinical research so that they could take more informed decisions.

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“…For example participant trust (in the institution, the researcher or the research protection system) has been indicated as an important condition of taking part as opposed to a reason for taking part [30-33]. A recent study in India examining motivation for participation in non-therapeutic clinical trials found that for patients it was the request from the treating physician that was the main motivating factor (88%), while financial reward was the main reason for 65% of the healthy participants who also reported free medical check up/personal health gains as important reasons (43%) [34]. …”

Section: Introductionmentioning

confidence: 99%

Accessing health services through the back door: a qualitative interview study investigating reasons why people participate in health research in Canada

Townsend

Cox

2013

BMC Med Ethics

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BackgroundAlthough there is extensive information about why people participate in clinical trials, studies are largely based on quantitative evidence and typically focus on single conditions. Over the last decade investigations into why people volunteer for health research have become increasingly prominent across diverse research settings, offering variable based explanations of participation patterns driven primarily by recruitment concerns. Therapeutic misconception and altruism have emerged as predominant themes in this literature on motivations to participate in health research. This paper contributes to more recent qualitative approaches to understanding how and why people come to participate in various types of health research. We focus on the experience of participating and the meanings research participation has for people within the context of their lives and their health and illness biographies.MethodsThis is a qualitative exploratory study informed by grounded theory strategies. Thirty-nine participants recruited in British Columbia and Manitoba, Canada, who had taken part in a diverse range of health research studies participated in semi-structured interviews. Participants described their experiences of health research participation including motivations for volunteering. Interviews were recorded, transcribed, and analyzed using constant comparisons. Coding and data management was supported by Nvivo-7.ResultsA predominant theme to emerge was 'participation in health research to access health services.’ Participants described research as ways of accessing: (1) Medications that offered (hope of) relief; (2) better care; (3) technologies for monitoring health or illness. Participants perceived standard medical care to be a “trial and error” process akin to research, which further blurred the boundaries between research and treatment.ConclusionsOur findings have implications for recruitment, informed consent, and the dichotomizing of medical/health procedures as either research or treatment. Those with low health status may be more vulnerable to potential coercion, suggesting the need for a more cautious approach to obtaining consent. Our findings also indicate the need for boundary work in order to better differentiate treatment and research. It is important however to acknowledge a categorical ambiguity; it is not always the case that people are misinformed about the possible benefits of research procedures (i.e., therapeutic misconception); our participants were aware that the primary purpose of research is to gain new knowledge yet they also identified a range of actual health benefits arising from their participation.

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Evaluation of factors that motivate participants to consent for non-therapeutic trials in India

Cited by 19 publications

References 18 publications

Motivational Factors for Participation in Biomedical Research

Motivational Factors for Participation in Biomedical Research

Awareness about and views of parents on the off-label drug use in children

Accessing health services through the back door: a qualitative interview study investigating reasons why people participate in health research in Canada

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