Consent Informed in Clinical Trials – Medical Ethics Example

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"Consent Informed in Clinical Trials" is an excellent example of a paper on medical ethics. A clinical trial is a procedure where treatment of a new drug or new medical procedure is being tried and experimented on the effects. Consent is the agreement to participate in the clinical trial in the discussion. Informed consent is being told about the procedure of the clinical trial and every step of the trial as well as what is expected is told before-hand to the participant before an agreement can be reached. A document indicating one has agreed to participate in the trial is signed by the participant and this seals the deal on informed trial.

The document is proof that the agreement was not made under duress and permission to participate in the discussion was given by the participant (Friedman, Furberg and DeMets, 2010). In order to get the informed consent however, there are procedures that need to be followed as will be explained in detail below. The first step is to being informed what the clinical trial is all about including what is so far known or unknown about the drug or procedure being tried.

This is followed by an explanation of what is expected of the participant including details such as how long one will take, or the trial will last, whether there are any breaks, what food or drink to take and what not to take, what exactly will be done during the trial. Information about the expected benefits of engaging in the trial should also be provided at this stage (Mulay, 2001). The benefits may include money being paid to participate; the chance to be a participant in future clinical trials or even gifts that will be provided. The participant also has certain rights before the consent can be signed.

These include the right to ask questions and be answered as truthfully as possible about the trial, right to be informed about the available options including an option to refuse to participate or discontinue with the clinical trial at any point. It is also right to medical treatment in case of complications arising from the trial as well as to have the copy of the signed consent form (Tanya, et al, 2014). Even though there will be debriefing after the clinical trial is over (which is a mandatory procedure), participants need to, first of all, understand the potential risk factors and problems that may occur following the administration of the drug in trial.

This, therefore, means that before signing any document to give consent, the participant needs to be sure they want to go through with the procedure despite the risks and problems (Getz and Borfitz, 2002). The other thing to consider is the wording of the document before signing.

Many participants just sign the document without actually going through it word for word or having gone through it and not understood. In as much as one has a right to medical treatment following complications from the trial, not all clinicians provide this right and the medical treatment may only be offered for a short term period and hence any long term complications may not render the clinician liable and most of this is mentioned in the document (Joffe, et al, 2001). Conclusion If the participant understands the clinical trial procedure and the risks and benefits, then they can decide to sign the document giving informed consent or not.

References

Friedman, L., Furberg, C. and DeMets, D. (2010). Fundamentals of Clinical Trials. New York: Springer.

Getz, K. and Borfitz, D. (2002). Informed consent: a guide to the risks and benefits of volunteering for clinical trials. Michigan: CenterWatch.

Joffe, S. et al. (2001). “Quality of Informed Consent: a New Measure of Understanding among Research Subjects.” Journal of National Cancer Institute, vol. 93(2), pp. 139-147.

Mulay, M. (2001). A Step-by-step Guide to Clinical Trials. New Jersey: Jones & Bartlett Learning.

Tanya, M. et al. (January, 2014). “Ethical Principles of Informed Consent: Exploring Nurses’ Dual Role of Care Provider and Researcher.” The Journal of Continuing Education in Nursing, vol. 45(1), pp. 35-42.

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