Medical law and ethics: consent documentation in 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: consent documentation in trials

Sample item

Under the New Drugs and Clinical Trials Rules 2019, how must the informed consent process of each trial participant be recorded in addition to the signed form?

ABy a photograph of the participant with the investigatorBBy audio-video recording, preserved by the investigatorCBy notarisation before a magistrateDBy counter-signature of the ethics committee chair

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

The answer and the reasoning

B. By audio-video recording, preserved by the investigator

The rules require the process of informed consent to be recorded by audio-video means and preserved with the trial records, in addition to the written consent form. The ethics committee reviews the process but does not countersign each form.

Option by option

A. By a photograph of the participant with the investigator
A photograph does not record the content of the consent process.
B. By audio-video recording, preserved by the investigator (correct)
Correct. Audio-video recording of the consent process is mandatory.
C. By notarisation before a magistrate
Notarisation before a magistrate is not required.
D. By counter-signature of the ethics committee chair
The ethics committee chair does not countersign each participant's form.

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.

Questions about this Forensic Medicine question

What is the answer to this Forensic Medicine question?

The best answer is B, By audio-video recording, preserved by the investigator. The rules require the process of informed consent to be recorded by audio-video means and preserved with the trial records, in addition to the written consent form.

Why is "By a photograph of the participant with the investigator" not the answer?

A photograph does not record the content of the consent process.

Why is "By notarisation before a magistrate" not the answer?

Notarisation before a magistrate is not required.

Why is "By counter-signature of the ethics committee chair" not the answer?

The ethics committee chair does not countersign each participant's form.

What concept does this question test?

It tests Medical law and ethics: consent documentation in trials in Forensic Medicine. The ethics committee reviews the process but does not countersign each form.

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: consent documentation in 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.