From the Guidelines
The correct answer is A. Before the research study can begin. According to Good Clinical Practice (GCP) guidelines, a research protocol must receive approval from a designated Institutional Review Board (IRB) or Ethics Committee before any study activities can commence, as emphasized in a recent statement by the European Association of Cardiovascular Imaging (EACVI) of the ESC 1. This requirement is a fundamental ethical safeguard designed to protect the rights, safety, and well-being of human research participants. The IRB review process ensures that the proposed research meets ethical standards, that risks to participants are minimized, and that the potential benefits justify any risks involved. Key aspects of this process include:
- Ensuring that appropriate measures are taken to protect the rights, health, and well-being of patients participating in the research
- Conforming to the Declaration of Helsinki
- Following good clinical practice (GCP) as the ‘international ethical, scientific and practical standard to which all clinical research is conducted’ Starting research before obtaining IRB approval would constitute a serious violation of GCP principles and could potentially put participants at risk, compromise the validity of the research, and lead to regulatory consequences for investigators and sponsors. This requirement applies to all aspects of the study, including recruitment, screening, and any other study-related procedures, highlighting the importance of IRB approval as a preliminary step in the research process, as outlined in the European Heart Journal 1.
From the Research
Research Protocol Approval
The research protocol must be approved by a designated Institutional Review Board at a specific time. The correct option is:
- A. Before the research study can begin. This is because, as stated in the study 2, the importance and process of ethical approval is crucial in designing a quantitative research study.
Justification
The study 2 emphasizes the importance of ethical approval in the research process, implying that it should be obtained before the study begins. Although the other studies 3, 4, 5, and 6 do not directly address the timing of Institutional Review Board approval, the general principle of obtaining ethical approval before starting a research study is a fundamental aspect of research ethics.
Options Analysis
- B. After the first participant is randomized: This option is incorrect because ethical approval is necessary before any participants are involved in the study.
- C. By the time the last participant has completed the last follow-up visit: This option is also incorrect because ethical approval is required before the study starts, not after it is completed.
- D. There is no designated time for approval: This option is incorrect because there is a designated time for approval, which is before the research study can begin.