The Belmont Report was created as an endeavor to summarize the core principles of ethical research identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The need for the report emerged after the signing of the National Research Act in 1974 (“The Belmont report,” 1979). Among the tasks set for the Commission, there was the identification of the basic ethical principles underlying behavioral and biomedical research concerning human subjects. Furthermore, the Commission was expected to establish the guidelines that researchers should follow. The discussions about the elements to be included in the report were held in 1976 at the Smithsonian Institution’s Belmont Conference Center (“The Belmont report,” 1979). The main units contained in the report are the margins between biomedical and behavioral research, the core ethical research principles (respect for persons, beneficence, and justice), and the requirements for the principles’ application, including the selection of research subjects, informed consent, and risk/benefit evaluation.
The need for a code of conduct in research is primarily associated with the protection of human participants’ rights. The first codes of conduct emerged in the mid-1900s (“The Belmont report,” 1979). Organizations adopt such codes to ensure that research is carried out in a responsible and proper manner. Codes of conduct are aimed at eliminating the unethical behavior of researchers (van Wee, 2019). The code of conduct helps to arrange the adherence to human rights and evidence-based practice principles (World Health Organization [WHO], 2017). For instance, the WHO (2017) expects researchers to follow the principles of integrity, accountability, independence and impartiality, respect for persons and communities, and professional commitment. In fact, the existence of and adherence to the codes of conduct in research has become such a significant issue that some scholars argue for the implementation of such codes not only for researchers but also for research funders (van Wee, 2019). That way, any attempts to perform the research in an unethical way will be eliminated, leading to the most objective findings that will be beneficial for society.
The distinction between biomedical and behavioral research and the practice of therapy allows singling out the elements that should be reviewed with the purpose of protecting the human subjects of study. On the one hand, there is no clear line between practice and research since in many instances, both processes happen simultaneously, for instance, when research is conducted to assess a therapeutic approach (“The Belmont report,” 1979). On the other hand, the difficulty to see the difference between practice and research lies in the inaccuracy of definitions of terms.
It is common to attribute the term ‘practice’ to those studies the primary aim of which is the promotion of patients’ well-being with a high success expectation rate. Biomedical and behavioral research focuses on establishing a diagnosis or finding preventive therapy or treatment (“The Belmont report,” 1979). Meanwhile, the term ‘practice’ is used to denote a process of testing some hypothesis and making conclusions, which leads to either developing or enhancing the generalizable knowledge disclosed in principles or theories. Typically, research is characterized by a formal protocol that introduces a purpose and a series of procedures devised to meet that purpose. Research and practice may be done simultaneously when the aim of the study is to assess the therapy’s efficacy (“The Belmont report,” 1979). Irrespective of the type and goal of research or practice, they must adhere to the basic ethical principles of respect for persons, justice, and beneficence to be considered as such that have followed the code of conduct.
References
The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. (1979). Web.
Samuel, G., Chubb, J., & Derrick, G. (2021). Boundaries between research ethics and ethical research use in artificial intelligence health research. Journal of Empirical Research on Human Research Ethics, 16(3), 325-337. Web.
van Wee, B. (2019). The need for a code of conduct for research funders. Science and Engineering Ethics, 25, 1657–1660. Web.
World Health Organization. (2017). Code of conduct for responsible research. Web.