Regulation on the use of human subjects for research
It is important to regulate the inclusion of human subjects for research because historical accounts have shown that individuals were involved in research studies without their knowledge. It is thus now of utmost importance that any human subject who participants in a research study has given his informed consent. The term informed consent technically pertains to the authorization of a person to participate in a research study, as supported by his knowledge and understanding of what will be performed. An informed consent thus involves an explanation by the researcher of the entire scenario of the study, including the goals of the investigation and the exact procedures that will be performed on the study participant (Harnett and Neuman, 2009). It is critical that the potential participant decides on whether he does agree to submit himself to the investigation. In addition, the informed consent of a study participant is also associated with the knowledge of the risks of the study. The study participant also has the right to opt out of the investigation at any moment he desires to do so (Kho et al., 2009).
One of the historical incidents associated with the use of human subjects in research is the Nuremberg trials of 1947 (Annas and Grodin, 1992). In this investigation, physicians performed different forms of testing of camp prisoners such as determining which microbes are lethal, as well as what temperature can induce death in a human being. The Nuremberg trials thus resulted in massive deaths of camp prisoners, as the physicians continued on with different settings of bacterial and viral inoculations and exposures of other individuals to different temperatures for various durations. Since then, the Nuremberg Code was created, which requires that each human subject expresses his consent before he is allowed to participate in a research study. The Nuremberg Code also describes the rules with regards to the extent of testing that will be allowed on human subjects.
Annas, G. J., and Grodin, M. (1992). The Nazi doctors and the Nuremberg Code. New York: Oxford University Press.
Harnett, J.D. and Neuman, R. (2009). Research ethics for clinical researchers. Methods in Molecular Biology, 473, 285-97.
Kho, M.E., Duffett, M., Willison, D.J., Cook, D.J. and Brouwers, M.C. (2009). Written informed consent and selection bias in observational studies using medical records: Systematic review. BMJ, 12, 338-342.