What are the ethical and safety concerns raised by a group of activists about the ICMR document on Controlled Human Infection Studies

Informed Consent:

Activists argue that the ICMR document does not adequately address the issue of informed consent. They believe that participants may not fully understand the potential risks and implications of participating in controlled human infection studies.

Participant Safety:

Concerns are raised regarding the safety of participants involved in these studies. Activists fear that participants may be exposed to unknown or poorly understood risks, which could lead to harm or long-term health consequences.

Vulnerable Populations:

Activists point out that certain populations, such as children, pregnant women, or individuals with preexisting health conditions, are particularly vulnerable. They express concerns about the inclusion of these groups in controlled human infection studies.

Lack of Regulation:

The activists question the absence of clear regulations or guidelines for conducting controlled human infection studies in India. They argue that without proper oversight, there is a risk of unethical practices or exploitation of participants.

Equitable Distribution:

Some activists argue that the resources and benefits associated with these studies should be distributed equitably to ensure fairness. They express concerns that controlled human infection studies may primarily benefit wealthier individuals or countries.

Long-term Follow-up:

Activists advocate for proper long-term follow-up of participants to monitor any potential adverse effects that may arise after the conclusion of the study. They stress the need for comprehensive post-study protocols and support for participants.