Before participation in a research project involving human subjects in the hospital, the NPD must obtain or ensure:

Before participation in a research project involving human subjects in the hospital, the NPD must obtain or ensure:

• A. IRB approval and informed consent but can start collecting patient information while waiting
• B. IRB approval and informed consent and must not collect data until it is obtained
• C. No approval
• D. Governing board approval

Answer: (B)

At the heart of this item is protecting participants in any research involving people. Before participants can be involved, there must be ethical oversight by an Institutional Review Board (IRB) to review the study’s risks, benefits, and safeguards. In addition, participants must give informed consent, meaning they are informed about what the study involves, potential risks and benefits, and their rights, and they voluntarily agree to participate. Data collection cannot start until both IRB approval is secured and informed consent is obtained. This ensures that participants are adequately informed and that their rights and welfare are protected from the very first moment of involvement. Merely having approval from a governing board does not address the ethical protections for individuals, and starting data collection before consent is obtained would violate autonomy and regulatory standards. While there are rare scenarios where an IRB may waive consent, those are specific exceptions; the standard expectation is clear IRB approval plus informed consent before collecting any data.

At the heart of this item is protecting participants in any research involving people. Before participants can be involved, there must be ethical oversight by an Institutional Review Board (IRB) to review the study’s risks, benefits, and safeguards. In addition, participants must give informed consent, meaning they are informed about what the study involves, potential risks and benefits, and their rights, and they voluntarily agree to participate.

Data collection cannot start until both IRB approval is secured and informed consent is obtained. This ensures that participants are adequately informed and that their rights and welfare are protected from the very first moment of involvement. Merely having approval from a governing board does not address the ethical protections for individuals, and starting data collection before consent is obtained would violate autonomy and regulatory standards. While there are rare scenarios where an IRB may waive consent, those are specific exceptions; the standard expectation is clear IRB approval plus informed consent before collecting any data.