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History of human subjects research
The history of human subjects research can be traced back in 1947, when the Nuremberg code was enacted in Germany. Apparently, this code was not a law, but served as the first time when the aspect of seeking informed consent was first mentioned. This code was passed as a way of regulating numerous researches that were being performed unethically in the concentration of camps of Germany. One year later, a declaration of Geneva which was referred as the physician`s oath was made and published by the world Medical Association. Every health physician all over the world was obliged to make this oath once he or she graduates with a medical degree or diploma. Moreover, in 1964, the Helsinki Report was compiled, and it entailed a hybrid of both the principles of the Declaration of Geneva and the Nuremberg Code. This report was compiled by the World Medical Association and was highly regarded as the cornerstone document of human research ethics. This was followed by the signing into law of the National Research Act in 1974, and a National Commission of the protection of human subjects of Biomedical and Behavioral Research, which started its operations in 1981. In 1978, the Belmont Report was compiled and entailed a number of regulations concerning the use of human subject (The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978). This was followed by the enacting of the Common Rule in 1991, which is widely referred as the Belmont report of today, the Federal policy for the Protection of human subjects.
Protecting human subjects in research is a fundamental aspect in a number of ways. For example, it helps in maintaining and enhancing the dignity of human beings. Before the enactment of the law regulating the use of human subjects in research, there were a number of instances where most of the human beings had been misused by researchers, to such an extent that short and long term injuries are inflicted, or to the worst, death of the research participants. A good example is the Tuskegee study that aimed at establishing the prognosis and pathophysiology of syphilis. In addition, protecting human subjects in research helps health practitioners to maintain confidentiality of the health information of the study participants, especially where case and control studies are involved. For example, if patient is suffering from sexually transmitted disease such as HIV and AIDS, it would be unethical for a health researcher to disclose the patient`s health information to unintended characters without the patient`s consent (Grady & Fauci, 2016). Disclosing patient`s information without his or her consent may result to trauma and even discrimination, which may lead to lower levels of esteem, and even death of that patient. In addition, the physician`s oath, which was passed during the Geneva Declaration sensitizes the health practitioners to safeguard the rights of the patients.
The types of research activities that require the involvement of human subjects
There are a number of research activities that calls for the use of human subjects. For example, an activity like classroom exercises which is done solely to fulfil some course or program requirements or training the students concerning the use particular devices or methods. In such a situation, the researcher does not have any available alternative that he or she can use, if he does not want to use human subjects. In addition, research activities that entail gathering the biographies of individuals. For these activities, the research must approach the individual whom he or she intends to learn more about him or her, and there is no way he or she can manage to gather the individual of interest`s information without going to him or her directly, or seeking information from some of the relatives. In any case, the researcher must use human subjects in order to get the relevant data (Fiske & Hauser, 2014). in addition, an activity such as oral histories that are aimed at creating a record of specific historical events also calls for the use of human subjects. Moreover, course of service evaluations also calls for the use of human subjects, unless when these evaluations can be generalized to other individuals.
Strategies to minimize potential risks to research participants
There are numerous risks that human subjects used in a research can be exposed to, including physical harm, loss of confidentiality, social harms, economic harms, legal harms, invasion of privacy and psychological harms. However, the occurrence of these harms can be minimized through number of strategies. For example, the researcher needs to provide complete information concerning the experimental design as well as the scientific reasons for conducting the research. In addition, there is need for the researcher to ensure that he or she selects human subjects a research team that is experienced in conducting research using human subjects. for example, it is illegal for a research to gather data from mentally ill individuals, especially due to not only their inability to provide reliable information, but also do not have a sound mind of making a decision on whether or not to participate in the research (Wolf, Carman & Clark, 2016). Moreover, the research ought to ensure that he or she uses the projected sample size in order to produce useful results. Moreover, there is need to develop exclusive or inclusive criteria in order to ensure that the study would only focus on the desired population of interest. Consecutively, the research should incorporate measures of protecting the confidentiality of data, such as use of passwords, codes and encryption. Subsequently, the research needs to train study participants in order to minimize the occurrence of risks.
Additional protections needed for federally identified vulnerable populations
Additional protections are needed to a group of populations which the federal policy recognize them as vulnerable. Some of these individuals are not limited to those who are economically disadvantaged, minors, internationals, critically ill individuals or those which have disabilities. The federal policy stipulates that this population are deemed to be exploited by the researchers especially due to their economic, social and psychological status. In order to avoid such situations, the federal policy calls for additional protective measures to be applied by any researcher who intends to gather data from any of these populations.
Ethical standards that are applied in research
There are a number of ethical standards that are applied in research. For example, informed consent, which entails the aspect of asking the potential research participant whether he or she is willing to participate in the research should be embraced by the researcher. Precisely, no individual should be coerced to participate in a research that he or she is not willing to participate. In addition, the researcher should adhere to the principle of beneficence, which stipulates that the research being conducted results to more benefits than harm (Hébert et al., 2015). There is also the need for the researcher to respect the autonomy and confidentiality of the participants’ information.
Fiske, S. T., & Hauser, R. M. (2014). Protecting human research participants in the age of big data. Proceedings of the National Academy of Sciences of the United States of America, 111(38),13675–13676. doi:10.1073/pnas.1414626111
Grady, C., & Fauci, A. S. (2016). The role of the virtuous investigator in protecting human research subjects. Perspectives in Biology and Medicine, 59(1), 122–131. doi:10.1353/pbm.2016.0021
Hébert, J. R., Satariano, W. A., Friedman, D. B., Armstead, C. A., Greiner, A., Felder, T. M., Braun, K. L. (2015). Fulfilling ethical responsibility: Moving beyond the minimal standards of protecting human subjects from research harm. Progress in Community Health Partnerships: Research, Education, and Action, 9 Suppl, 41.
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1978). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. Retrieved from http://www.videocast.nih.gov/pdf/ohrp_belmont_report.pdf
Wolf, L. A., Carman, M., & Clark, P. R. (2016). Protecting behavioral health research participants in the ED setting: Issues of consent. Journal of Emergency Nursing, 42(1), 85–86. doi:10.1016/j.jen.2015.10.017
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