Before starting a hospital-based human subjects study, what must be obtained prior to data collection?

Before starting a hospital-based human subjects study, what must be obtained prior to data collection?

• 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)

Before collecting data from hospital patients in a human subjects study, you must obtain IRB approval and informed consent. The IRB reviews the protocol to ensure risks to participants are minimized, safeguards are in place, and privacy and confidentiality will be protected. Informed consent is the process by which participants are informed about the study, including its purpose, procedures, risks, benefits, and their rights, and they voluntarily agree to participate. Data collection cannot begin until both approvals are in place, because conducting research without them would violate ethical standards and regulatory requirements.

Before collecting data from hospital patients in a human subjects study, you must obtain IRB approval and informed consent. The IRB reviews the protocol to ensure risks to participants are minimized, safeguards are in place, and privacy and confidentiality will be protected. Informed consent is the process by which participants are informed about the study, including its purpose, procedures, risks, benefits, and their rights, and they voluntarily agree to participate. Data collection cannot begin until both approvals are in place, because conducting research without them would violate ethical standards and regulatory requirements.