What should an investigator do regarding informed consent?

The responsibility of the investigator regarding informed consent is critical to ensuring that participants are fully aware of the study's purpose, procedures, risks, and benefits. Ensuring that consent is obtained according to relevant regulations means that the investigator must adhere to ethical standards and legal requirements governing human subjects research. This includes providing clear information, answering questions, and confirming that participants voluntarily agree to participate in the study without coercion.

Informed consent is a foundational principle in clinical research designed to protect the rights and welfare of participants. It is not just a formality; it is an ongoing process that begins before enrollment and continues throughout the study. Following the appropriate regulations ensures that the consent process is ethical, respects participants' autonomy, and fosters trust between participants and researchers.

Other options, such as obtaining consent only if time allows or skipping consent during emergency protocols, undermine the principles of informed consent. While there may be specific circumstances outlined in regulations for emergency situations, these would still require a framework to ensure participant protection. Retaining consent forms indefinitely is also not typically required; regulations provide guidelines for how long such documents must be stored, after which they may be destroyed in accordance with institutional policies. Therefore, the emphasis on ensuring informed consent is obtained according to relevant regulations is paramount for