What must institutions have in place when administering investigational drugs?

When administering investigational drugs, it is crucial for institutions to have all essential information and safeguards in place. This includes not only obtaining informed consent from patients but also ensuring that there are appropriate protocols to monitor the safety and efficacy of the drug during the trial. Essential information encompasses study protocols, risk assessments, data management plans, and compliance with regulatory guidelines set forth by entities like the FDA.

Safeguards ensure that the rights, safety, and well-being of trial participants are protected. This includes having an Institutional Review Board (IRB) to oversee the ethical aspects of the study and ensuring that staff members are properly trained to administer investigational products safely. Additionally, monitoring systems must be established to detect and report adverse events promptly.

The other options do not encompass the comprehensive framework necessary for conducting clinical trials with investigational drugs. Consent forms, while essential, do not alone fulfill all regulatory and ethical requirements needed in a research setting. Similarly, authorization from the state or training for physicians in isolation does not cover the extensive requirements to properly manage investigational drug administration. Therefore, having all essential information and safeguards is fundamental to the integrity of clinical research and participant safety.