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Clinical research plays a critical role in health care and helps scientists to develop new treatments. What’s more, clinical research disclosed the potential side effects of new drugs. During the clinical research process, researchers are required not only to maintain scientific rigor but also to adhere to ethical standards. Ethics are emphasized in clinical research because they can ensure the integrity of the research results and protect the safety of patients who volunteer to participate in the trials. The proposed clinical trials should be approved to ensure that the trials are ethical and that the rights of participants will be protected. Ethical conduct in clinical trials focuses on pre-study protocol review and subject welfare.
Fig.1 Ethical aspects of drug development (Arányi, 2016)
Ethics, in a broad sense, is based on standards of right and wrong and prescribes what human beings should do, usually according to rights, duties, interests to society, fairness, or specific virtues. In clinical research, ethics is about norms, values, right and wrong, good and bad, and what ought and ought not to be done in the context of clinical research. Currently, clinical ethics has developed a practical discipline that helps health professionals in identifying, analyzing, and resolving ethical issues that arise in clinical practice.
Clinical research is valuable to society because it aims to develop generalizable knowledge to improve health. The path to finding out if a new drug or treatment is safe or effective is to test it on patient volunteers. Research subjects are the means to securing such knowledge. Their safety, dignity, and autonomy must therefore be respected. Experience has shown that unregulated practices can lead to unhealthy consequences in drug development. In the 1960s, for example, thalidomide was given to pregnant women complaining of morning sickness. However, babies born to mothers who take the pill are born with birth defects. The ethical guidelines are designed to protect patient volunteers while maintaining the integrity of science. Appropriate compensation and treatment should be provided in the event of injury to the subject.
A code of ethics is a guide of principles designed to help clinical researchers conduct trials honestly and with integrity. Clinical researchers should be trained and qualified personnel with the requisite scientific and ethical bent of mind. Physicians have an ethical obligation to benefit the patient, to respect the values and preferences of the patient, and to avoid or minimize harm. In addition, some core principles also guide the work of clinical researchers. Before starting the clinical trials, all volunteers should be informed of what the trial involves and potential risks. Clinical researchers need to keep fair and free of prejudice to choose clinical trial participants. Ensure testing is rigorous and in full compliance with prescribed clinical protocols. The fundamental principles of ethics are beneficence, nonmaleficence, autonomy, informed consent, truth-telling, confidentiality, and justice.
In clinical research, the ethical issues primarily involve the protection of the safety, rights, and well-being of the research participants. All national and international guidelines emphasize guaranteeing the rights and safety of research participants. The fundamental ethical question raised by clinical research is whether and when it is acceptable to impose risks and burdens on some people for the benefit of others. Compensation for participation in research and harm associated with research is the main focus of the current debate. Under the principle of justice, participation in research should be accessible to everyone, regardless of socioeconomic status, and there is no exploitation of any vulnerable group because of their socioeconomic, ethnic, or cultural status. The continuous capacity-building exercises in clinical ethics will go a long way in ensuring public confidence about the safety and well-being of the research participants.
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