What is meant by "ethical review" in the context of clinical research?

Prepare for the MedTech Laws and Ethics Test. Enhance your knowledge with multiple choice questions, detailed explanations, and interactive flashcards. Ace your exam with confidence!

In the context of clinical research, "ethical review" refers to the process of evaluating the ethical implications of a study proposal. This review typically focuses on ensuring the protection of research participants, assessing issues such as informed consent, risk-benefit analysis, and the overall moral considerations surrounding the study. It is crucial that any clinical research adheres to ethical standards to maintain public trust, safeguard participant welfare, and comply with regulatory requirements.

An ethical review is conducted by an Institutional Review Board (IRB) or a similar ethics committee, which critically examines the study's aims, methodology, potential risks, and the provisions in place to mitigate those risks. This process is pivotal in identifying any ethical concerns before the research begins, allowing for modifications to be made if necessary.

In contrast to assessing financial costs or marketing viability, which are operational aspects of research, and reviewing scientific accuracy, which pertains more to the research’s validity and reliability, ethical review is primarily concerned with the moral and ethical responsibilities of researchers towards their participants and society. Thus, option B captures the essence of ethical review effectively.

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