Safeguards for Patient Volunteers
An area of concern for many patients who are considering treatment in a clinical trial is “being treated like a Guinea pig.” Historical events can certainly reinforce that perception, but they have also fueled the push for comprehensive safeguards in clinical trials. The central tenet of all clinical investigative trials is that the patient remains in control of all decision-making throughout trial participation. The Institutional Review Board (IRB), sometimes known as the Ethical Review Board, is the premier safeguard for research study participants. Any organization that is conducting a study must have an IRB. An IRB can be composed of researchers, health professionals, clergy members, bioethicists, community members, lawyers, and anyone with expertise in the topic of study. Its board members monitor a study from the beginning to the end. They enforce three ethical principles – beneficence, justice, and respect for persons – to ensure the safety and wellbeing of participants. The principle of beneficence requires that the treatment being tested does not harm the participant, and if possible, benefits them as well. Justice promotes equality in the processes of recruitment and treatment distribution. Respect for persons safeguards a participant’s autonomy
Autonomy – a patient’s right to make their own health care decisions if they are capable. The patient’s doctor is not allowed to decide for them.. The application of this principle can be seen through the participant’s right to informed consent, to agree to participate, as well as the decision to leave a trial.