What is necessary when conducting research that involves human participants?

When conducting research that involves human participants, compliance with regulations set forth by the Food and Drug Administration (FDA) and the Department of Health and Human Services (DHHS) is crucial. These regulations are designed to ensure that the rights, welfare, and safety of participants are protected throughout the research process. This includes adhering to ethical standards, obtaining informed consent, and ensuring appropriate oversight of the research activities.

These regulations also mandate Institutional Review Board (IRB) approval for studies involving human subjects to ensure that the research design is ethical and that risks are minimized. Additionally, adhering to these guidelines helps maintain the integrity of the research data and fosters public trust in the research findings.

In contrast, while the marketing department's approval, obtaining customer feedback, or conducting a financial assessment may be relevant to certain projects, they are not fundamental requirements when it comes to the ethical conduct of research involving human participants. Focusing on regulatory compliance is essential for safeguarding participant welfare and the overall credibility of the research outcomes.