* Age: Children and elderly adults are often considered to be vulnerable subjects because they may not have the capacity to fully understand the risks and benefits of participating in a clinical trial.
* Mental illness: Individuals with mental illness may also be considered to be vulnerable subjects because they may not be able to make sound decisions about their participation in a clinical trial.
* Physical illness: Individuals with serious or debilitating physical illnesses may be vulnerable to coercion or undue influence to participate in a clinical trial.
* Social or economic disadvantage: Individuals who are socially or economically disadvantaged may also be vulnerable to coercion or undue influence to participate in a clinical trial.
Vulnerable subjects require special protection to ensure that their rights and welfare are not compromised. This protection may include:
* Additional informed consent procedures: Vulnerable subjects may be required to undergo additional informed consent procedures to ensure that they fully understand the risks and benefits of participating in a clinical trial.
* Independent review: An independent review board may be required to review the risks and benefits of a clinical trial involving vulnerable subjects.
* Monitoring: Vulnerable subjects may be monitored more closely during the clinical trial to ensure that they are not experiencing any adverse effects.
By taking these steps, we can help to protect the rights and welfare of vulnerable subjects in clinical trials.