What is Clinical Research?
The National Institutes of Health (NIH) defines clinical research as a comprehensive study that tests the safety and efficacy of new treatments and therapies.
Clinical research is not the same as laboratory research. It involves volunteers for clinical trials that help us explore new treatment options. The currently available drugs, devices, tools, diagnostic tests, techniques, and technology have all undergone testing by volunteers. Clinical research trial ethics protects participants from unethical clinical trials.
In this blog piece, we see how ethics enables good research practices and helps safeguard every participant’s rights.
What are the Ethics of a Clinical Trial?
Clinical trial research ethics includes ethical considerations. It involves a set of guidelines that assists researchers in maintaining scientific integrity, upholding human rights, respecting dignity, and collaborating between society and science. Ethical issues in clinical trials in developing countries are common due to a lack of adherence to regulations and proper regulatory bodies.
The government authorities require all procedures to be first approved by IRBs (Institutional Review Boards), which helps prevent the exploitation of the participants.
The Codes of Ethics
The code of ethics allows researchers to adhere to clinical research trial ethics. Some of the most prominent are:
The Belmont Report:
The purpose of The Belmont Report was to identify ethical considerations that should dictate biomedical and behavioral research. It was a result of the National Research Act of 1974.
The Declaration of Helsinki:
The Declaration of Helsinki was put forth by the World Medical Association. Its purpose was to protect the participants enrolled in clinical trials.
The Nuremberg Code:
The Nuremberg Code provides an international standard for clinical research trial ethics. It concentrates on the importance of ethics in clinical research. The unethical clinical trials that followed World War 2 resulted in its formation.
The U.S Common Rule:
The U.S. Common Rule is also known as the Federal policy for protecting human subjects. It outlines ethics in clinical research for the safety of participants in clinical research trial ethics.
What are the 7 Principles of Ethics in Research?
Clinical trials must follow a framework of seven ethical principles to protect the rights of all participants:
Social and Clinical Value:
Every study should answer particular questions. Additionally, the results have to be shared with the medical community so that it follows clinical research trial ethics.
The aim of a study is to answer a valid question.
Some of the questions may be:
- Is the researchers’ question answerable?
- Are the research methods scientifically valid?
- Does this study have a scientific objective?
Fallacious research is unethical and a waste of resources that exposes people and communities to unnecessary risk with no greater purpose.
Selection should be based exclusively on scientific goals. Candidate selection should proceed with little risk and more benefit to individuals. The primary basis for recruiting and enrolling individuals should be the scientific goal.
Favorable Risk-Benefit Ratio:
Uncertainty about the degree of risks and benefits associated with clinical research poses a question about ethics in clinical research. The study adheres to clinical research trial ethics if the benefits outweigh the risks. Research volunteers often receive some health services during clinical trials. Nevertheless, the purpose of clinical research is not to provide these health services.
An independent review panel, which has no personal interest in the study, reviews the proposal. The administrators should be impartial and follow ethics in clinical research. Additionally, the study should protect the participants. Institutional Review Boards (IRBs) evaluate and overlooks clinical research in the United States.
It is part of the clinical research trial ethics to have informed consent from participants. The participant carefully reads and signs the informed consent. Children and mentally disabled people are an exception to this rule.
Respect for Potential and Enrolled Participants:
Researchers should maintain participants’ confidentiality and agree to their wishes to discontinue participation. The importance of participant confidentiality is a part of clinical research trial ethics. Researchers must share new information that arises mid-treatment.
What are the 5 Ethical Considerations in Research?
Clinical research trial ethics guarantees that an individual’s rights are upheld and not violated. When practicing ethics in clinical research, researchers must adhere to ethical considerations. The ethical considerations are as follows:
An informed consent testifies that the participant has agreed to partake in the clinical trial. The participant needs to read everything and understand the risks and benefits associated with the study. Informed consent forms the basis of clinical research trial ethics.
” The researcher usually provides a document that lists the hypothesis. The most important aspect of the consent form is that the researcher has to disclose the potential harm.”
Participant’s rights to withdraw from the research:
The right to withdraw allows the participant to leave the clinical research trial at any point. The right of withdrawal by the participant is an essential part of clinical research trial ethics.
In clinical research trial ethics, confidentiality is when participants’ details are kept undisclosed throughout and after an experiment. The information about the patient’s history and personal habits shall remain private because it protects the participant’s social status. Along with this, it also helps avoid discrimination. Participants in the study are assigned specific numbers rather than names.
Preventing psychological and physical harm:
Clinical research trial ethics protects the participant from harm. Medical staff should be available and ready to deal with potential situations. Furthermore, the researcher should offer counseling sessions during and after clinical trials to ensure the patient’s psychological health remains well.
Debriefing and deception prevention:
In clinical research trials, deception and debriefing are considered serious issues. Deceiving involves misinforming the participant to increase enrollments falsely. Moreover, the participants are debriefed at the end of the trial to prevent issues of deception. This malpractice results in the alteration of results.
Clinical research trial ethics aims to protect participants from unethical clinical trials. Clinical research relies on individuals ready to bear personal risks for the benefit of society. It is crucial to avoid researchers with personal interests who prey on the vulnerable population. Enforcing ethics in clinical research will help achieve active health justice. For this purpose, the clinical research team should be well-trained in good clinical practice (GCP) and HIPAA guidelines.