Updated on October 11, 2022
Overview – Ethical Issues in Clinical Trials:
Ethical Issues In Clinical Trials – With the advancement in science and technology, research has reached new heights, revealing things that are beneficial to humankind. Research in medicine plays an integral role in developing new drugs, medical devices, and medical strategies. It improves services and treatments by following protocols that ensure no harm or injustice is done to a human or animal.
One of the critical aspects of Research is Ethics. To ensure the success of a Clinical Trial, it is important for the researchers to adhere to ethical principles and follow the code of conduct till the end. To learn more, continue reading as we dive into the depths of Ethical Issues in Clinical Trials and how it affects the results of a Trial.
What is Ethics in Clinical Trials?
Ethical considerations are a set of guidelines that assist researchers in their research designs and practices. Ethics holds importance in any Clinical Trial to maintain scientific integrity, human rights, dignity, and collaboration between society and science. It is crucial to obey ethical principles because any deviation from the guidelines can cause ethical issues in Clinical Trials. This can have a negative impact on the overall results of a Clinical Trial.
Since Clinical Trials require collaborative efforts, ethical standards or principles promote values such as trust, accountability, justice, and mutual respect. In case of ethical lapses, it can profoundly harm human subjects or animals. For instance, if a researcher fabricates the data in a Clinical Trial, this may cause significant harm to the human subject.
Code Of Ethics:
A Code of Ethics helps the researcher to abide by the rules and avert ethical issues in Clinical Trials. A few popular codes of ethics are:
- Nuremberg Code: It concentrates on the human rights of research subjects.
- The Belmont Report: Addresses the ethical issues in Clinical Research and to overcome those issues a set of guidelines is established in this report.
- Declaration of Helsinki: To protect human participants enrolled or participating in Clinical Research.
- The U.S Common Rule: Outlines basic requirements for IRBs, consent forms, and assurance of compliance.
Fundamental Principles of Ethics:
Ethics is an intimate element of Clinical Research. If these principles are not observed, ethical issues in Clinical Trials may emerge that can impact their authenticity. The four fundamental principles of Ethics include:
Beneficence:
It refers to the obligation of a doctor to act for the benefit of their patient and support moral rules to protect and defend the rights of patients, prevent harm and eliminate conditions that may harm them. Beneficence is not only limited to avoiding harm but also to benefiting patients and ensuring their well-being.
Non-Maleficence:
It refers to no harm to the patients. It relates to moral values, that is, do not kill, cause pain, do not incapacitate, do not cause offense, and do not deprive others of a good life. The motive of non-maleficence is to weigh the pros and cons of a treatment or intervention and to choose the best course of action that will be helpful for the patient.
Autonomy:
It refers to the sense of authority of an individual towards their body. The person subjected to any treatment or intervention should have the right to make rational decisions and moral choices. Truth-telling and Confidentiality lie under the umbrella of autonomy. Truth-telling refers to providing patients with authentic details regarding their condition and the potential treatment. The patient has the right to disclosure of diagnosis/prognosis and to forgo the diagnosis/prognosis. Confidentiality is to respect a patient’s decision not to disclose their personal information to anyone, including their families.
Justice:
It refers to the equitable and fair distribution of health care resources as per the defined norms. Justice is to serve people equally and be fair with them in terms of providing quality care during treatment. It also ensures that the exploitation of powerless communities does not persist.
What Are The Ethical Issues In Clinical Trials?
The ethical issues in Clinical Trials majorly entail the protection of the rights, safety, and well-being of the participants. Some of the ethical concerns are:
Agreeing to put others at risk:
The fundamental ethical issue in Clinical Trial is whether exposing a chunk of people to perils and burdens for the well-being of others is acceptable or not.
Cultural differences:
pose a major concern in the conduct of Clinical Trials as they may lead to biases in terms of recruiting and compensating the participants.
Undue influence/exploitation:
Undue influence/exploitation of certain communities because of their socioeconomic status. This deprives them of appropriate attention and care that should be rendered according to the principles of ethics. This can be one of the major ethical issues in Clinical Trials.
Conflict of interest:
Conflict of interest between sponsors and organizations may compromise their professional decision, which might lead to neglecting participants’ welfare and only focusing on making profits. The well-being of participants should be the first and highest priority in any Clinical Trial and no compromise should be made on their integrity.
Risk-benefit assessment:
Risk-benefit assessment has a crucial role in ensuring the safety of participants. It is vital to weigh the benefits against the risks and make a decision that is in favor of the participant. It also emphasizes informing the participants about the risks and benefits of the trial.
Outlook:
Clinical Trials are crucial to medical advancement. Likewise, conducting Clinical Trials following ethical guidelines is the cornerstone to the success of a Trial. Any deviation from the set standards can lead to unfavorable results that may not only affect the authenticity of the team involved and raise questions about their credibility but may also harm the subjects enrolled. However, it is to be noticed that ethical issues in Clinical Trials at times help us in shaping the processes for Clinical Trials in ways that protect patients’ rights along with providing meaningful content to the public.
One way to confound the ethical issues in Clinical trials is by meticulous planning. For this purpose, a team of skilled professionals is needed that is well-trained in the GCP (Good Clinical Practice) and HIPAA guidelines and training focusing on the conduct of Clinical Trials within ethical limitations.
