What must a researcher obtain in the Human Subject Model?

In the context of conducting research involving human subjects, obtaining informed consent is a fundamental ethical requirement that ensures participants are fully aware of the nature of the study, including its purposes, procedures, potential risks, and benefits before agreeing to participate. This process respects the autonomy of the participants, allowing them to make an informed choice about their involvement in the research.

Informed consent typically involves providing potential participants with clear and comprehensive information, followed by an opportunity for them to ask questions. It confirms that individuals voluntarily agree to participate without coercion. This ethical guideline is central to protecting human subjects and is crucial in maintaining the integrity of the research process.

While institutional approval, legal exemptions, and data protection clearances may also be necessary under certain circumstances, they are not as universally fundamental to the ethical treatment of human subjects as informed consent. Informed consent directly addresses the rights and welfare of the participants, making it a primary requirement in research involving human subjects.