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M-05: Public Knowledge and Perception of Clinical Research in Mumbai
Ashnik Bakulesh Chauhan
Seth GS Medical College & KEM Hospital India
Of all the stakeholders in clinical research [CR], the patient is the most important. His point of view about CR has been the subject of very few studies in developing countries. This study was envisaged to assess the extent of awareness and understanding about CR amongst lay people of Mumbai.
A cross sectional study with probability sampling was conducted. A validated, 48-item questionnaire with nine themes [after consent] was administered. Descriptive and inferential statistics [measures of association, logistic regression for between group analysis] were used to describe the data.
Of the 453 participants approached, 400 [88%] aged 32 (18-96) years consented. There were 233 [58.2%] males and 167 [41.8%] females. Two hundred and sixty two [65.5%] were from upper middle class and 264 [66%] were at least high school educated. Themes explored were awareness, willingness to participate, autonomy, adequacy of information given, confidentiality, safety, voluntariness, payment for participation and public engagement. Impact of age, education, socioeconomic class [SEC] and gender on the themes was analyzed.
Two hundred and ten [52.5%] had heard about CR while 238 [59.5%] were willing to participate. Nearly, half [196, 48.5%] needed permission to participate. Two hundred and forty three[60.8%] believed that participants get adequate information. Most [324, 81%] felt that confidentiality is vital. A majority [359, 89.7%] said that participation was voluntary. Just 14 [3.5%] mentioned coercion. Three quarters [310, 77.5%] endorsed public engagement.
A few associations were seen 1) Awareness with willingness - those who were aware of CR were approximately twice more willing to participate (crude OR 1.725 95% CI [1.15, 2.57]) relative to those who were not aware of CR. 2) Autonomy and willingness - Those who had autonomy were twice as likely to participate relative to those who did not (crude OR 2.4 95% CI [1.58, 3.57]). 3) Gender and autonomy - Women twice more likely to need permission to participate relative to men (crude OR 2.5 95% CI [1.61, 3.64]).
SEC impacted awareness, willingness, autonomy and understanding of confidentiality [p <0.05]. Age impacted awareness [reduction with rising age], willingness [reluctance to participate with rising age], adequacy of information [Older people relative to younger felt adequate information was given], confidentiality [Older age less concerned with confidentiality]. With rise in education, willingness rose, and need for permission as also belief of disclosure of adequate information dropped.
A little over half of participants surveyed were aware about CR. Age, gender, socioeconomic class and education were identified as the key variables that impacted perception and willingness to participate in CR. Women were seen to have less autonomy relative to men for participation. Knowledge of and awareness about CR directly impacts the informed consent process. Given that only half the participants studied were aware of CR, investigators have a greater responsibility to ensure adequacy of the informed consent process, an ethical imperative. Given that three quarters endorse public engagement in CR, true collaboration can be achieved in countries like India, with greater health – related education of the lay public and empower them to make truly informed decisions.