Question

What are the most important moral considerations when using human subjects for clinical research?

Why is it difficult to justify the use of a placebo control in a trial in which a "standard-of-care" therapy already exists? Why is a placebo control easier to justify in trials in which there is no established "standard-of-care" therapy? Should those participating in a clinical trial be notified of the possibility that they may be given a placebo?

Answer 1

THE MOST IMPORTANT MORAL CONSIDERATIONS WHEN USING HUMAN SUJECTS FOR CLINICAL RESEARCH :

The process of informed consent is required to inform the subject of rights, risks and benefits when participating in a clinical trial. Informed consent is an essential element for conducting an ethical research that involves human subjects.

The basic ethical principles to protect human subjects basically: beneficence, justice and respect for individuals. The process of informed consent is crucial in achieving these principles.

further protect human subjects, the informed consent process involves the verbal discussion with the possible subject along with the paper document. The Principal Investigator is accountable to explain the informed consent and determine that the subject has understood the information clearly and given their voluntary approval for participating in a particular trial.

The modern informed consent is considering the difficulty of determining what is an acceptable and sufficient level of information that make the consent to be valid. Generally, consent can be valid when it includes the understanding of voluntary participation, purpose of the research, risk and benefit ratio and the procedures that may be required throughout the study. It is difficult to establish the adequate level of information at each level of these stages.

USE OF PLACEBO CONTROL IN A TRAIL OF THERAPY ALREADY EXISTS :

A placebo is a treatment that looks like a regular treatment but is made with inactive ingredients that have no real effect on patient health. Placebos are used in some types of clinical trials to help make sure results are accurate.

placebos used in clinical trials helps to decide whether or not individual want to participate and enroll in a particular clinical trails.

SHOULD THOSE PARTICIPATING IN CLINICAL TRIAL BE NOTIFIED OF POSSIBITY THAT THEY MAY BE GIVEN AS PLACIBO : Yes, they will always be notified of this possibility during the informed consent process before joining a trial.This will cover any potential risks associated with the control group treatment and what percent of patients are placed in a group that doesn't receive the study treatment.

In most of the cases where a placebo is involved, the participant won't know if they are taking one, and it is often the case that the medical team won't know either. This is because knowing what treatment participants are taking can affect the results of a clinical trial.

For participants, knowing they’re getting a placebo can cause them to not report all the health problems that come up while those who know they're on the treatment do. This can make the treatment look like it has worse side effects than it does. If people don't know if they’re getting the treatment being studied or a different one, it makes the results more likely to be valid.