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Write a paper on the ethical topic of Human Subjects Research (HSR) and Clinical Trials with the following criteria:
With an argument for its importance of to the future and advancement of medicine a counter-argument for the risks and ethics associated with bringing products to market too soon without proper HSR or FDA approval channels
Apply a moral theory to your argument conclude with support of HSR and Clinical Trials (not against)

"The Bleeding Edge" documentary that was recently released on Netflix is an excellent source that explores this topic.

Definition of Human Subjects Research

With respect to the United States Department of Health and Human Services, the process of deducting data by a research, via a living individual, through the processes of interpersonal interaction or identification and analysis of individualized information, is what constitutes a ‘human research subject’ (Largent, 2016). The conductance of experimental or observational analysis, with the purpose of research fulfillment, implies, what is known as, ‘clinical trials (Piantadosi, 2017). With the enhancement of dynamic improvements in technology and science, the need for utilization of human subjects in obtaining clinical and medical information, has becoming a concerning issue in today’s world which allocates profuse emphasis on humanity (Barber, 2018). However, clinical trials outlined with the involvement of human subjects research, proves to be beneficial in the assurance of safety and provision of certified products and service, and therefore, this essay presents an argument supporting in favor of the promising potential and importance of its utilization, for the greater benefit of society in the near future.

As outlined by Grady, in the book, ‘Principles and Practices of Clinical Research’ (2017), the field of Human Subjects Research, has been existent for a considerable period of time, highlighted with the establishment of the ‘Nuremberg Code’ by the Allied Forces, during the ongoing incidents of the Second World War, and ironically, upon the backdrop of the unethical treatment of the Jews by the Nazis (Grady, 2017).

With respect to the Nuremberg Code, the subject of Human Subjects Research and their utilization in clinical trials, are required to be outlined by a ‘social benefit’, where the provision of results obtained by the human study, should yield enhanced benefits to the society, which is otherwise difficult to procure by alternative means (Jalal et al., 2018). With due credibility to this principle, human subjects research proves to be highly advantageous, due to its generation of information regarding the practical utilization, viability of particular treatments and medical products. For instance, with regards to studies related to food and nutrition, the requirement of human subjects is of utmost importance, in order to generate useful data regarding the application of dietetics and lifestyle modifications in our daily lives (Williams et al., 2015). Human research subjects are also required for studying the implementation of various public health policies and practices, and further assessing consumer demands and interests, which are prior requirements, outlined for the development of novel products, services or policies. With respect to the aforementioned, it can be argued, that the usage of human subjects for research should be prioritized with respect to the requirement of observation and analysis of customer opinion, which is imperative for market improvement of industries pertaining to the release of novel facilities targeting, of course, the greater population (Brownson et al., 2017).

Significance of Human Subjects Research

Furthermore, the release of novel drugs and medical therapies in the field of pharmacology requires extensive research, in which the involvement of human subjects for the research, is considered imperative. In addition, to further enhance their credibility and safety, the Food and Drug Administration imposes certifications and requires, a total of four phases of drug testing and research, in order to comply to its requirements.

With respect to pharmacological testing, various phases of clinical trials are conducted, which involve extensive observation of the implication of novel drug ingestions on a selected group of participants (Bobo et al., 2016). Such clinical trials involving human subjects, not only yield credible and safe results for their release and application in the retail market, as well as consumer shelves, but also lead to the provision of legalized products, certified for consumption, as approved by the Food and Drug Administration.  This is in due consideration of the fact, that medications and drugs undergoing market entry, require clinical trials conducted at least till the third phase, in order to gain approval and certification by the Food and Drug Administration, prior to its release in to the market (Seife, 2015). With respect to this, the need for clinical trials with the participation of human subjects in research, is of utmost importance, with consideration of its provision of beneficial products of the society.

One of the most important arguments which add validity to the inclusion of human subjects in clinical trials, is the worldwide availability of legal and certification frameworks for the same (Grady, 2015). One of the earliest legal frameworks, dated from the time of the Second World War, is the Nuremberg Code, implicated by the Allied Forces, which clearly stated the need for provision of useful data with the conductance of human research, in a justified scenario where alternative analytical methods do not comply with the target requirements. The Nuremberg Code also outlines the importance of consent and voluntary participation, as inevitable requirements in the conductance of human research, and that the beneficial social implications of the research, must never degrade the requirement of permission, safety and risk associated with the performance of the process (Cini, 2018). An additional legal policy, gaining global recognition, is the establishment of the Belmont Report, with the National Commission for the United States Health Department, responsible for its formulation in the year 1979.

The report upholds the presence and fulfillment of key objectives in the inclusion of human volunteers in the execution of clinical trials in medicine and otherwise. These primary principles include the importance of granting autonomous respect and identity to the concerned participants along with a provision of voluntary participation (Vitak, Shilton & Ashktorab, 2016). The provision of medical, physiological and psychological benefits to the human subjects with respect to their willingness and presence in the required experiment, and lastly, the prevalence of justice or imparting of knowledge to the voluntary participants, regarding the details, possible shortcomings and advantages provided by the conductance of the study, are also imperative principles outlined in this report (Kim & Miller, 2015). In recent times, the formulation of the Common Rule, by the United States government in the year 1981, is a major legal framework outlining the criteria research institutions have to consider, in order to attain legal permission in the conductance of the human experimentation research. With respect to the criteria defined by the Common Rule, a research institution will not receive permission to conduct a research, consisting of human subjects, by the Institutional Review Boards, without obtaining the required consent and provision of additional beneficial protection policies for the participants (Feeley, 2017). Hence, the conductance of research with human subjects and the required clinical trials, are not only essential for the assurance of public health and safety in the future, but also holds due credibility and safety of the participating human volunteers. This is due to the jurisdiction of an extensive legal framework, required for fulfillment, by the concerned group of researchers or research institutions.

Clinical Trials and the Involvement of Human Research Subjects

However, one of the primary factors aiming to eradicate the usage of human subjects for experimental research is the compliance to ethical considerations and the possible misuse of the same, with respect to past misconducts stated in history. A number of incidents outlining the potential misconduct of ethical considerations with the utilization of human subjects have attracted major historical importance, most importantly: The unethical and inhumane conductance of experiments on the Jewish population by Hitler’s Nazi’s, which ultimately escalated into what the world is familiarized with today, as ‘The Holocaust’. However, as highlighted in the previous sections of this essay, as well as by Garnett (2017), it is evident that such historical incidences of human experimentation, have attracted emphasis due to the absence of consent, where participants were compelled to experience the physiological and psychological repercussions, with due force by hierarchical authorities (Garnett, 2017). Present day clinical trials outlining human research, upholds consent and the liberty of potential participants to undertake the process with willfulness and due awareness of the nature of the nature, as outlined by National Commission for the United States Health Department, in the year 1979, as well the World Health Organization and Council for International Organization of Medical Sciences (World Health Organization & Council for International organization of Medical Sciences, 2016).

Additionally, the risks of releasing novel medical products or services, present far greater consequences, than the conductance of clinical trials with human subjects as part of the research, which will enhance the credibility, viability and safety of the product. One of the most focused and significant incident of medical mishaps, outlining this example, is the negative consequences in the usage of birth control devices in the United States, as well as, on a global platform, which was released without conductance of standard clinical trials. The release and usage of such devices have inflicted global uproar from women worldwide, regarding the prevalence of painful side effects, which finally resulted in the discontinuation of the device (Alcantara, 2016). Hence, with due consideration of the negative implications of release and usage of medical devices, services and medications which never underwent clinical trials, there is an increased importance of the usage of human subjects in clinical research. Furthermore, the individuals undertaking voluntary participation in the conductance of clinical trials, are subject to reception of several beneficial treatment. These include: reception of highly regulated or increased monitoring practices by a medical workforce, which may otherwise be absent in standard treatment procedures, greater accessibility to novel treatments as compared to the general population, and the benefit and recognition earned due to participation in research comprising of principles aiming at the enhanced benefit of an increased population (Bromlet et al., 2015).

Legal Frameworks for Human Subjects Research

Hence, it can be rightly concluded, that the need of the hour is the implementation and execution of extensive clinical research trials, involving the participation of human subjects. Risks and shortcoming are inevitable in the conductance of any and every scientific analytical research, and despite the possible risks associated with the performance of a research including humans as subjects, its benefits clearly hold greater weight, in comparison to its negative consequences (Barber, 2018). Moreover, when citing examples of historical incidents outlining the possible consequences, one must consider the absence of voluntary participation and consent prevalent at the respective time, which is extensively fulfilled by the global participation in formulation and execution, of a highly accountable and active legal framework, ensuring the presence of the same (Grady, 2017). In addition, highlighting the key medical incidents affecting the female population in the United States and worldwide, as previously mentioned in this essay, there is an utmost importance in the conductance of research studies and clinical trials, with the utilization of human subjects (Alcantara, 2017). Such research, which will ultimately yield beneficial results in the provision of goods, services and applicatory information, to be further utilized in enhancement of medical and public health businesses, ultimately ensuring long term consumer safety and satisfaction on a global platform.

References:

Alcantara, I. L., Rezai, S., Kirby, C., Chadee, A., Henderson, C. E., & Elmadjian, M. (2016). Case Report Essure Surgical Removal and Subsequent Resolution of Chronic Pelvic Pain: A Case Report and Review of the Literature.

Barber, B. (2018). Research on human subjects: Problems of social control in medical experimentation. Routledge.

Bobo, D., Robinson, K. J., Islam, J., Thurecht, K. J., & Corrie, S. R. (2016). Nanoparticle-based medicines: a review of FDA-approved materials and clinical trials to date. Pharmaceutical research, 33(10), 2373-2387.

Bromley, E., Mikesell, L., Jones, F., & Khodyakov, D. (2015). From subject to participant: Ethics and the evolving role of community in health research. American Journal of Public Health, 105(5), 900-908.

Brownson, R. C., Baker, E. A., Deshpande, A. D., & Gillespie, K. N. (2017). Evidence-based public health. Oxford university press.

Cini, E. (2018). Informed Consent in Clinical Studies. Malta Medical Journal, 30(1), 22-25.

Feeley, M. (2017). Legality, social research, and the challenge of institutional review boards. In Crime, Law and Society (pp. 55-74). Routledge.

Garnett, R. W. (2017). Why Informed Consent? Human Experimentation and the Ethics of Autonomy. The Catholic Lawyer, 36(4), 5.

Grady, C. (2015). Enduring and emerging challenges of informed consent. New England Journal of Medicine, 372(9), 855-862.

Grady, C. (2017). Ethical principles in clinical research. In Principles and Practice of Clinical Research (Fourth Edition)(pp. 19-31).

Jalal, S., Imran, M., Mashood, A., & Younis, M. (2018). Awareness about Knowledge, Attitude and Practice of Medical Ethics pertaining to Patient Care, among Male and Female Physicians Working in a Public Sector Hospital of Karachi, Pakistan-A Cross-Sectional Survey. European Journal of Environment and Public Health, 2(1), 04.

Kim, S. Y., & Miller, F. G. (2015). Informed consent for pragmatic trials: the integrated consent Model.

Largent, E. A. (2016). Recently proposed changes to legal and ethical guidelines governing human subjects research. Journal of Law and the Biosciences, 3(1), 206.

Piantadosi, S. (2017). Clinical trials: a methodologic perspective. John Wiley & Sons.

Seife, C. (2015). Research misconduct identified by the US Food and Drug Administration: out of sight, out of mind, out of the peer-reviewed literature. JAMA internal medicine, 175(4), 567-577.

Vitak, J., Shilton, K., & Ashktorab, Z. (2016, February). Beyond the Belmont principles: Ethical challenges, practices, and beliefs in the online data research community. In Proceedings of the 19th ACM Conference on Computer-Supported Cooperative Work & Social Computing (pp. 941-953). ACM.

Williams, E. P., Mesidor, M., Winters, K., Dubbert, P. M., & Wyatt, S. B. (2015). Overweight and obesity: prevalence, consequences, and causes of a growing public health problem. Current obesity reports, 4(3), 363-370.

World Health Organization, & Council for International Organizations of Medical Sciences. (2016). International ethical guidelines for health-related research involving humans. Geneva: Council for International Organizations of Medical Sciences.

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