What one major factor is reviewed by the Institutional Review Board (IRB)?

Prepare for the RAPS Regulatory Affairs Certification – Drugs (RAC‑Drugs) Test. Study with flashcards and multiple choice questions, each question has hints and explanations. Get ready for your certification!

The major factor that the Institutional Review Board (IRB) reviews is the ethical standards in research involving human subjects. The primary responsibility of an IRB is to ensure the protection of the rights, welfare, and safety of participants in clinical trials. This involves evaluating research proposals for compliance with ethical guidelines, such as informed consent, risk-benefit assessment, and the fair treatment of subjects.

The IRB's focus is on ensuring that studies are conducted ethically and that participants are not subjected to undue risks. They assess whether adequate measures are in place to protect participants and whether the research design respects the principles of ethical research, such as respect for persons, beneficence, and justice. This is crucial in maintaining public trust in clinical research and ensuring that studies are conducted with integrity and respect for human participants.

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