Despite the potential for high risks, modern medicine, as in past centuries, is forced to conduct clinical trials in humans. This need seems inevitable but must be closely monitored by formal oversight systems. The Institutional Review Board plays the role of an ethical censor in medicine and pharmaceuticals. The board defines the value and necessity of this or that testing, measuring, and approving the ethical boundaries in which research involving people has the right to be incorporated into practice. Ethical boundaries mean the actual need for research, its observance of moral standards, and the absence of racist bias or discrimination in research.
The ethical principles were last approved in 2013 under the revised Declaration of Helsinki. The Declaration of Helsinki was drawn up after the immoral experiments on people in Nazi Germany. In response to these shocking crimes, global action was taken to prevent similar inhuman practices in the future. The Declaration of Helsinki is updated periodically and not at the expense of additions to the previous settings of the code – the new version makes the previous one completely obsolete and relevant only for the historian. The latest version was adopted in 2013, and it is on it that the Institutional Review Board is guided. These principles, limitations, and guidelines, adopted by this commission, assess the risks and needs of research conducted on a human subject.
The use of people of a particular gender or race in medical research is legally discriminatory. Therefore, it is difficult to assume that such selection from an ethnic point of view is possible in modern medical testing. It is required to find a company in the target audience and the test group of which, in principle, all categories of people fall. Thus, one can say that the modern cultural situation requires the maximum inclusiveness of all groups of the population in medical practice.
However, one should also pay attention to the fact that modern medicine builds certain methodological limitations, taking into account which groups of people should be involved in medical research. A person may undergo clinical testing and participate in biomedical experiments only if it is justifiably necessary. In this case, the risk category is also taken into account – if the danger statistically outweighs the possible positive results, the study in no case can be carried out.
John Hopkins Medical is a research network, institute, and hospital for biomedical research and several healthcare centers. The John Hopkins Project describes itself as a patient-centered organization focused on patient interaction. Based on this ethical principle, focusing on the authority of the patient and the principle of not harming him, it can be concluded that the organization is highly reliable. In the Johns Hopkins policy the organization, susceptible populations are considered as having certain disabilities, physical or mental. At the same time, economically disadvantaged members of society are perceived within the policy of the organization in a similar category of susceptible. The Institutional Review Board methodology is used to define this category. The board also requires inclusiveness as a result of which a multicultural, diverse group of subjects is involved in research if justified.
The university’s policies on women and racial minorities and sub-minorities thus follow the guidelines given by the Review Board and include them equally in biomedical research. Children, on the other hand, are subjects who have not yet reached the age of 18. Therefore, the underage cannot be personally responsible for decisions and take voluntary participation in the study, which is separately stipulated in a special document. If it is necessary to involve a child in biomedical research, the consent of his parent or guardian is required, which fully complies with the IRB regulations. The age, health, and psycho-emotional state of the minor patient can be recorded in order to be further interpreted as a result of the research.
As for children who do not even have a guardian, orphans, and foundlings, if they are required for research, the IRB assigns them a lawyer who observes their condition and the normality of the experiments. The cognitive abilities of children must also be closely monitored by observers to avoid the possibility of direct manipulation of the experience. In the case of mentally disabled patients, they are given proper care while their legal representative is in charge of communicating (John Hopkins Medicine, 2020). The ability of the patient to give meaningful consent is also established by the Review Board, especially in situations where a balanced decision may depend on the patient’s mental state at one time or another.
Thus, the Institutional Review Board is focused on overseeing any patient decisions when it comes to their participation in biomedical research and testing. The policies of different research universities and hospitals can be detailed to varying degrees. However, in general, hospitals use the IRB and the Declaration of Helsinki as the main models for decision-making and the legalization of research. In the context of our time, any wide-ranging medical research must take into account various social, cultural, racial, gender, age, and other groups.
Reference
Organization policy on research involving vulnerable populations. (2020). John Hopkins Medicine. Web.