What is the key role of an investigator in a clinical study?

The key role of an investigator in a clinical study is obtaining informed consent from subjects. This process is fundamental to the ethical conduct of clinical research. Informed consent ensures that participants are fully aware of the study's purpose, procedures, potential risks, and benefits before deciding to participate. It emphasizes the importance of voluntary participation and the right of subjects to make informed choices regarding their involvement in a study.

Informed consent is critical in safeguarding the rights and welfare of participants, as it promotes transparency and empowers individuals to understand what they are agreeing to. The investigator is responsible for ensuring that the informed consent process is conducted ethically and in accordance with regulatory requirements and guidelines, such as those outlined in Good Clinical Practice (GCP).

While compliance with drug marketing regulations, recruiting participants, and handling financial matters are important aspects of a clinical study, they do not reflect the investigator's paramount responsibility in protecting participant rights and ensuring ethical standards in research. The focus on informed consent underscores the investigator's role as a primary advocate for the well-being of study participants.