Failure to comply with general requirements for informed consent and documentation of informed consent may result in suspension of a study.A. TRUEB. FALSE

Analysis of the Statement

1. Understanding Informed Consent: Informed consent is a fundamental ethical requirement in research involving human participants. It ensures that participants are fully aware of the nature of the research, any potential risks, and their rights before participating.

2. Consequences of Non-compliance: Failure to comply with the general requirements for informed consent can undermine the ethical integrity of a study. Regulatory bodies and institutional review boards (IRBs) enforce these requirements to protect participants.

3. Potential Outcomes of Non-compliance: If a study does not adhere to the informed consent documentation requirements, it can lead to serious consequences, including legal repercussions, loss of funding, and suspension or termination of the study.

Conclusion

Given the above understanding, the statement "Failure to comply with general requirements for informed consent and documentation of informed consent may result in suspension of a study" is A. TRUE. Compliance with informed consent is crucial for the ethical conduct of research and non-compliance can indeed lead to significant repercussions, including study suspension.