Given below are two statements: Statement I: While developing a ‘consent…
2022
Given below are two statements:
Statement I: While developing a ‘consent form’, an explanation of the purpose of the study and the reason for selection of the participants should be explicit.
Statement II: However, there is no need to give a description of any potential risks to the participants.
Choose the correct answer from the options given below:
Answer: C. Statement I is true but Statement II is false — ConceptInformed consent is a process of voluntary decision-making based on adequate, understandable information. A consent form should explain why the study…
- A.
Both Statement I and Statement II are true
- B.
Both Statement I and Statement II are false
- C.
Statement I is true but Statement II is false
- D.
Statement I is false but Statement II is true
Show answer & explanation
Correct answer: C
Concept
Informed consent is a process of voluntary decision-making based on adequate, understandable information.
A consent form should explain why the study is being conducted and why the person is invited, and it should disclose reasonably foreseeable risks so that participation is genuinely informed.
Application
Statement I requires an explicit explanation of the study purpose and the reason for selecting participants. These details give the participant the context needed to understand the invitation, so Statement I is true.
Statement II says that potential risks need not be described. Risk disclosure is a core part of informed consent because a participant must be able to weigh foreseeable harm before agreeing, so Statement II is false.
Contrast
“Both statements are true” accepts the omission of risk information, which would leave the participant unable to assess foreseeable harm.
“Both statements are false” rejects the required explanation of purpose and participant selection.
“Statement I is false but Statement II is true” removes both the contextual explanation and the risk-disclosure duty.
Result
Therefore, Statement I is true but Statement II is false.