Dissecting the Declaration of Helsinki
The Declaration of Helsinki is one of the world’s most vital research ethics related to medical research. It was developed with the aim of providing effective and ethical principles to steer physicians and medical research experts in the research involving human subjects. Before World II, an internationally accepted statement to govern scientific research on human subjects was absent. As a result, unacceptable studies were conducted. For example, in 1947, unethical research known as ‘Doctor Trial’ was carried out on 23 individuals who faced accusations of committing crimes against humanity. The study had horrific consequences, such as the loss of life and the paralysis of some of the participants.
The Declaration of Helsinki was adopted in 1964 and encompasses a set of principles such as that of a physician being required to act in the patient’s best interest when providing medical care. According to the document, a physician is tasked with promoting and safeguarding the medical research participants’ health, rights, and well-being. Additionally, the document outlines that only people with the required scientific education, training, and knowledge can undertake scientific research (World Medical Association, 2018). It also outlines that medical research should be conducted effectively to minimize possible harm to the environment and that physicians should engage human subjects in the research study only upon educating them on the purpose and effects of the research.
In medical practice and research, risks, burden, and benefits are part of the intervention used. There is a need to balance these critical issues in the practice or research to safeguard the health, well-being, and rights of the human subjects. In the considerations of balancing these issues, it is important that risks to human subjects are minimized. As such, physicians should use procedures that are consent with sound study design and do not expose the subjects to potential risks. Besides, risks to the subject should be reasonable in relation to the anticipated benefits. The human subjects should be effectively educated on the risks and benefits of the study allowing them to know what they should expect upon the completion of the study (World Medical Association, 2018). Additionally, equitability in the selection of subjects is a fundamental aspect and the research must be on a specific problem that affects a given population to benefit the population in the long run when it comes to helping addressing the problem (World Medical Association, 2018). In the research, data collected should be closely monitored to ensure the safety of the subjects, protect their privacy, and to ensure confidentiality of data.
Informed consent is whereby by a physician reveals crucial information to a research participant regarding a study’s intent or purpose to a participant to allow him or her to make a voluntary choice on whether to take part in the research or not. Primarily, the goal of informed consent is that a patient has an opportunity to actively participate in his or her health care decisions (Hall, Prochazka, & Fink, 2012). As such, the physician is obliged to disclose often the nature of the proposed treatment or procedure, relevant risks, and burdens associated with the proposed procedures, as well as any other options, and the attendant risks of those alternatives.
The Declaration of Helsinki ensures the safety and well-being of patients and the participants of medical studies. Before undertaking a study, it is imperative for a researcher to issue the participants with the details of the study and only involve them with their consent. Physicians should ensure that the risks are reasonable in relation to potential benefits whenever undertaking scientific research on human subjects alongside promoting and safeguarding the health, well-being, and rights of the subjects involved in the research process.
Hall, D. E., Prochazka, A. V., & Fink, A. S. (2012). Informed consent for clinical treatment. Cmaj, 184(5), 533-540. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3307558/
World Medical Association. (2018, July 09). WMA – The World Medical Association-WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. Retrieved from https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/