Good Clinical Practice (GCP) Practice Exam

What does approval from an Institutional Review Board (IRB) signify?

1. Rejection of the proposed clinical study

2. The study has not been reviewed

3. The clinical trial may be conducted at the institution

4. The trial will automatically receive funding

The correct answer is: The clinical trial may be conducted at the institution

Approval from an Institutional Review Board (IRB) signifies that the clinical trial may be conducted at the institution. The primary role of the IRB is to ensure that research involving human subjects is conducted ethically and that participants' rights and welfare are safeguarded. When an IRB reviews a proposed study and grants its approval, it indicates that the study meets established ethical standards and regulatory requirements for conducting research involving human subjects. This approval is a vital step in the research process, allowing the study to move forward with participant recruitment and data collection, provided all other regulatory and administrative requirements are also met. This is distinct from other options, such as the notion of rejection or that the study has not been reviewed, as approval confirms that the study has gone through a thorough evaluation process. Additionally, an IRB's approval does not relate to the funding of the trial, as funding decisions are made separately, often by other organizations or entities based on different criteria.