The right to healthy living and its protection as a fundamental human right is enshrined in the main international human rights standards and most countries’ national legislation. At the same time, the development of new drugs is associated with the need to test their properties, and at a particular stage of this process, people themselves become the objects of medical research. In this regard, special attention should be paid to the issues of legal regulation of clinical research of medical products and providing participants in clinical trials with guaranteed protection of their rights. This paper aims to analyze the process of ensuring human subjects’ protection, its history, importance, standards, fulfillment strategies, and necessary additional protections.
The history of research with human subjects dates back to the horrifying events of the Second World War. The Nuremberg Code was issued due to the trials on the nazis’ war crimes, and later, the World Medical Association (WMA) began to provide legal regulation of biomedical research (Robinson Bailey, 2018). In particular, such WMA acts as the Geneva Declaration of 1948, and the 1964 Helsinki Declaration established the basic principles of humanity about patients, based on which all professional activities in the field of medicine should be found. In the United States, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was created after the mistreatment of the syphilis patients in the PHS Tuskegee Study. The Commission established the Belmont Report, which became the main document regulating human subjects’ protection in the country’s current healthcare system (Miracle, 2016). The human subjects protection regulation is necessary to ensure the medical safety of the research participants and respect for their fundamental human rights. Moreover, these regulations will become even more strict with time, as medical research is under governmental control.
The word research in itself means “a systematic investigation including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (Office for Human Research Protections, 2018). The systematic investigation requires the involvement of the human subjects to collect their biospecimens or biological information. Thus, such information can be collected with the following two research types – interventions and interactions (National Institute of Dental and Craniofacial Research, 2018). Interventions may be physical – like measuring brain function and behavioral – collecting data from educational programs or psychological theories, as, for example, encouraging smokers to quit the habit and observe the positive and adverse health outcomes. As for the interactions, they include communication between the researchers and the subjects of their study, as well as the interpersonal contact between the two. It implies communications in person, on paper, or in an online format, participant observation, and personal interviews.
One of the most crucial issues the researchers face is the attempt to minimize risks for the human subjects that may be reflected in privacy invasion, confidentiality breaches, and risks associated with study procedures. The strategies that help eliminate these risks include providing thorough information about the research procedure; keeping the anonymity of the subjects by removing direct identifiers from the database, as well as encrypting the data, and using complex secure passwords, which will be least invasive for the research participants (Artal & Rubenfeld, 2017). Moreover, the study procedures risks can be minimized by hiring experienced personnel, implementing the latest technology, and conducting standardized procedures. In addition, additional federal regulations are required for the vulnerable groups of subjects such as pregnant women, fetuses, children, and prisoners. The risk minimization strategies will include implementing standard-of-care procedures to ensure the elimination of harm and the negative consequences of the physical and psychological invasion.
As it was mentioned before, the Belmont Report primarily regulates the process of human subjects protection in the United States. It is based on the three fundamental standards of respect for persons, justice, and beneficence (Robinson Bailey, 2018). The principle of respect guarantees the voluntariness of the person’s participation in the research, as well as the fulfillment of the informed consent process and protecting the subjects’ privacy. It means that the researchers must provide the potential participants with all the necessary information about the process and make sure that they made the conscious independent decision to become a part of the conducted study. The standard of justice implies an equal distribution of benefits and burdens of the participants’ research process. Thus, the research must be designed in a way that the subjects are not selected based on the convenience of access and conduct. Finally, the beneficence standard advocates for maximizing the benefits for the research’s positive outcome and minimizing the harm for the subjects. Accordingly, the examination must be carried out on the principle of not harm.
To conclude, the unprecedented crimes of the nazis conducting clinical experiments on living human beings, as well as the brutal Tuskegee Study of the US Public Health Service, roughly initiated the development of the first basic ethical principles of human subjects research. It made an immense contribution to the world’s healthcare system in the sense it now strives to put the person’s safety and well-being first. Considering different types of study activities, the researchers develop effective strategies for eliminating the risks for human subjects, putting an even stronger emphasis on the safety of the vulnerable groups. Thus, according to the ethical standards of medical research, if these criteria are followed strictly, they will bring fruitful results without consequences for the participants.