Research Element Perceptions Source Potential Implications/Consequences
Human participation “Human guinea pigs” Allahabad High Court [22]; PARTAKE survey [16] Indians are exploited by foreign and rich industry entities for financial gain [23].
Exploitation of vulnerable populations (illiterate or impoverished) [24] Petition of Supreme Court [25] Clinical trial applications put “on hold” amid revision of the regulatory system [19]
Adverse events Violation of “right to live” under the constitution Allahabad High Court [22] Proposal to prosecute trial-related adverse events under the Indian Penal Code
Unnecessary and exploitative Media [26]; activists; surveys [27]; government compensation committee [28] Adverse events are always due to trial participation and therefore should be compensated for; hold on clinical trials; withdrawal of drugs with favorable benefit/risk ratios [29]
Placebo assignment Violation of the right to effective treatments Government compensation scheme [30] Proposal to compensate study participants for lack of therapeutic effect [30]
Informed consent The process is not “informed” and “consent” cannot be assumed; consequence of paternalistic model of health care [31] National Human Rights Commission [32], media [33,34], activists, PARTAKE survey [16] Addition of audio-visual recording to informed-consent process [35]
Medical knowledge Enhancing public health Surveys [16,27] Large majority endorses research
Human participation Voluntarism Surveys [16,27] Majority interested in participating in research
Altruism Surveys [16,27] Majority endorses altruism as the only valid motivation to participate in research
PARTAKE, Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment.
Table 1: Examples of Public Perception of Clinical Research in India.
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