Clinical Research Administration and Replacement of Ethical Code - Paper Example

Effective January 22, 2019, Mainhill University Laboratory wrote Gordon Scott the supervisor, showing their interest to replaces their ethical code through their clinical research administration and replacement in their ethical code. The main aim was to have an ethical code that ensures that the human subject is treated in the most ethical manner possible.

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Deciding on the institutional code of ethics

Human subjects are supposed to be treated with the utmost proper care, the institution of Mainhill University is an example an institution that has experience in dealing with the human subject and further experience in ethical code values provided by organizations. There has been a violation of the ethical code in the practice of clinical research. Some time back the Nuremberg code institution had allegations in violating the human subjects, which led to introducti8onof new values in the institution after the Second World War (Code, 1949). The most significant thing to consider in an ethical code consideration is the engagement of physicians themselves to take mandate in the general care of the human subject. According to many people in Mainhill University, Declaration of Helsinki seems to cover many ethical practices to human subjects than the Belmont report Act that is currently mandating values on the subject. The institution proposes to adopt the Declaration of Helsinki from the World Medical Association and replace it with the Belmont Report Act (World Medical Association, 2001).

The Belmont report code consists o vital elements like rules, procedures, and ethical practices that are expected to be practiced in the clinical research (Zucker, 2014). The institution is aware that such a decision causes conflict and ethical malpractices. However, the institution provides a general summary of the ethical practices and principles. The Belmont report also provides readily available federal reports to the scientists, physicians, and members of the clinical institution. The decision seems dangerous since the physician or the medical practitioner can choose to take their own means after gaining direct registration. Contrary to the Belmont report, Declaration of Helsinki provides general principles that majorly deal with medical research, physician engagement, risk-related, and informed consent (World Medical Association, 2001). The human subject should be a matter of voluntary decisions and should apply forces or any means of coercing the subject. As provide by the Belmont report there are three main principles have recorded and maintained by the Belmont institution

Clinical Concepts/Consideration and Reviewing Ethical Code Institution

The institution wishes to access the ethical code institutions practices and values in the two ethical code institutions. The main agenda is to show the need of changing ethical codes and most significantly showing the behavioral research and biomedical research on the human subjects. The following are some of the concept used in the two institutions

Belmont Report Act

General Principles and Applications

Respects for persons is the main ideas provided by the act, it requires two ethical requirements, one is the autonomy, and the other is and protection of the diminished autonomy. Autonomy ethics are the ones that can give autonomy to primary personal objectives while protection of diminished autonomy is the lack of self-determination. The first group's of-of people can decide what they need in clinical experiments and make volunteer decision on informed consent. On the other hand, the other group of people can be coerced by the medical practitioner into an experiment (Zucker, 2014). . The other principle is beneficence that protects from harm it calls for care and kindness; the principle urges people not to harm in order to heal the others. Another role in beneficence is to involve all the considered group's friends, family, and society at large. Justice insists on the decision on what is to be performed.

Declaration of Helsinki and Principle

General principle and Research Requirements

The general's principle in the declaration is mainly aimed at the physicians; they demand that the medical practitioner will act on the patient best interest. The declaration checks on the physician professionalism and studies involving human subjects (World Medical Association, 2001). The primary consideration would be the prevention of disease, therapeutic interventions, and diagnostic. The research must be subject to medical research to heal and protect life and create privacy. Proper documentation and manners to control risk to reduce risks in the human subjects call for participation in the research. The human subject must have informed consent of the experiment. Practitioners are not included in the human subject study. Most activities involve the risks that can occur and requires that requirements to research need to be done. In the Declaration of Helsinki, research ethics committees provide monitors and submit protocols to the research

Ethical Code Institutional Review

The Belmont Report does not guarantee confidentiality and privacy like in the Declaration of Helsinki. There is no record keeping in the Belmonte report where the failures could be recorded in order to mitigate risk in the process later (Zucker, 2014). The declaration also does not include practitioners in the research but in clinical procedures only. The Belmont Report lacks diminished autonomy; hence human subject could be coerced in any time and therefore tarnishes the name of the University or any other organization. On the informed consent, the Belmonte requires the highest degree of respect while in the Declaration of Helsinki it requires that the physician get direct engagement in everything needed for the human subject (World Medical Association, 2001). The medical practitioners must acquire enough knowledge in dealing with the human subjects. The Belmonte Report does not dwell much on research like the Declaration of Helsinki. There are other several requirements needed in Declaration that are not present in Belmonte; one is placebo usability that analysis benefits, and risks.

Final Proposal

According to the ethical code institutions review, the Declaration of Helsinki seems to be better than Belmont. This will reduce the risk and ethnographic issues related to the concept of human subject practices. The University can attain much success when adhering with the Declaration of Helsinki.

References

World Medical Association. (2001). World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Bulletin of the World Health Organization, 79(4), 373.

Zucker, D. (2014). The belmont report. Wiley StatsRef: Statistics Reference Online.

Code, N. (1949). The Nuremberg Code. Trials of war criminals before the Nuremberg military tribunals under Control Council Law, 10, 181-182.