Research Element |
Perceptions |
Source |
Potential Implications/Consequences |
|
Negative |
|
|
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] |
|
Positive |
|
|
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 |