Medical law and ethics: compensation in clinical trials: practice question

A Forensic Medicine question in the style of the NEET PG paper. Answer it first, then read why the right option is right and why each of the others is wrong.

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Forensic Medicine · Medical law and ethics: compensation in clinical trials

Sample item

A participant in a registered clinical trial develops a serious adverse event that is judged to be related to the trial drug. What is his entitlement under the New Drugs and Clinical Trials Rules, 2019?

Original practice item, not a recalled exam question. Nothing here is recorded.

The answer and the reasoning

B. Free medical care and financial compensation from the sponsor, whether or not there was negligence

Under the New Drugs and Clinical Trials Rules, 2019, a participant who suffers injury related to the trial is entitled to free medical management for as long as needed, and compensation is payable by the sponsor for trial-related injury or death, whatever the question of fault. A signed consent does not waive this right. The ethics committee reviews the cases.

Option by option

  • A. No compensation, since he signed an informed consent form

    Informed consent does not remove the right to compensation.

  • B. Free medical care and financial compensation from the sponsor, whether or not there was negligence (correct)

    Correct. Trial-related injury attracts care and compensation from the sponsor, irrespective of fault.

  • C. Compensation only if he proves that the investigator was negligent

    Proof of negligence is not required for trial-related injury.

  • D. Compensation from the ethics committee's own funds

    The sponsor pays; the ethics committee does not fund compensation.

Source note: Original NextPrep sample item — pending expert review. This item is original practice material awaiting independent expert review, so confirm important facts in a standard textbook.

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Questions about this Forensic Medicine question

What is the answer to this Forensic Medicine question?

The best answer is B, Free medical care and financial compensation from the sponsor, whether or not there was negligence. Under the New Drugs and Clinical Trials Rules, 2019, a participant who suffers injury related to the trial is entitled to free medical management for as long as needed, and compensation is payable by the sponsor for trial-related injury or death, whatever the question of fault.

Why is "No compensation, since he signed an informed consent form" not the answer?

Informed consent does not remove the right to compensation.

Why is "Compensation only if he proves that the investigator was negligent" not the answer?

Proof of negligence is not required for trial-related injury.

Why is "Compensation from the ethics committee's own funds" not the answer?

The sponsor pays; the ethics committee does not fund compensation.

What concept does this question test?

It tests Medical law and ethics: compensation in clinical trials in Forensic Medicine. A signed consent does not waive this right. The ethics committee reviews the cases.

How hard is this question?

We tag it as an application question: it asks you to use a fact on a patient or a finding. The tag is our own editorial judgement, not an official difficulty rating, so read the reason for every option, not only the answer.

How should I study Medical law and ethics: compensation in clinical trials?

Learn postmortem changes with their timelines, and toxicology as poison, sign, test and antidote. Then use the flashcards and the other Forensic Medicine questions on this site to test what stuck.

Is this a real NEET PG question?

No. It is an original practice item (editorial status: sample, version 1). NextPrep does not publish recalled or leaked questions, and independent faculty review of this item has not been completed yet, so confirm important facts in a standard textbook.