NIH Protecting Human Research Participants Reflective Paper, Free Example

Human subject research is a systematic and scientific examination that can be interventional or observational. It entails the use of human beings as research subjects. Also, it can be medical which involves clinical research or non-medical such as in the social sciences. Illustrations include obtaining bio-specimens from humans for clinical analysis and medical chart review studies. Non-medical research involves surveys which consist of questions to a specific group of people and the procedure usually involves interviews and questionnaires. The essay will examine the protection of human research participants, and what necessitated the need for the formulation of policy and ethical principles involved in the research.

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After the Second World War, a lot of public attention brought about the need for safeguarding human research subjects. It was introduced by the Nazi doctors' cruel tests on people such as injecting them with gasoline and forceful consumption of poisons. The Nuremberg Code of 1947 stipulated fundamental principles such as discretion of the human subject is essential, freedom from compulsion and knowledge of the risk and benefits involved. It also includes risk minimization, use of competent investigators and the liberty for the subject to quit at any time. Other infamous events include the study of untreated Syphilis in black men in Tuskegee and Cold War Human radiation experiments. Human subjects can be exposed to physical risks such as illnesses or diseases as a result of the investigation, psychological risks such as sensory deprivation and mental stress and loss of confidentiality (Fiske & Hauser, 2014).

In the course of the research, there are "vulnerable populations" who are the impoverished people in the community and require special care and protection. Vulnerable populations have a decreased ability to protect themselves from risks and make knowledgeable decisions. They include the elderly, physically and intellectually challenged people and children. Potential benefits may influence them to take part in clinical studies. Ethical review boards are tasked with the mandate of protecting vulnerable groups. In the case of intellectually challenged individuals, patients who are emotionally and behaviorally challenged permit surrogate consents. For children, parents are tasked with deciding on their behalf due to the child's limited cognitive capabilities. Age-appropriate assent forms may also be developed where necessary. For the elderly, an impartial witness who has a full understanding of the process involved approves and then relays the information to the subject. The measures put in place are adequate as they significantly minimize insensibility and prejudice while promoting humane treatment and allowing free will (Connelly, 2014).

The Belmont Report was adopted to resolve ethical problems that arise from the research of human subjects. Three basic ethical principles were identified. They include reverence for people, beneficence, and justice. Respect for persons depicts that they should be handled separately and people with minimized independence should be protected. The level of autonomy of a person such as mentally disabled is also considered. Beneficence involves two general rules. They entail don't harm and maximization of possible benefits and reduction of hazards. Justice constitutes of fairness during procedures and outcomes in the selection of research subjects. Although all principles are equally important, respect for persons carries the most significant weight as individuals should know the procedure they are going to follow including risks, and should not be coerced. Free will is a primary human right, and a violation might result in bodily harm or death. Beneficence comes in second as inhumane treatment can never be justified morally and where there is a substantial risk. Also, it should not be higher than the benefit as this might result in undesirable outcomes. Lastly, fairness should be emphasized when conducting experiments for the greater good of improved healthcare in the society. Human research participants' safety should always be the first consideration in any analysis that undertaken (Mueller & Hook, 2018).

Patients undergo research trials for many reasons such as the hope for improvement of a particular disease and contribution of knowledge that might assist other people in future. Independent review of risks and potential benefits should be an ongoing process during the experiment, and no one should participate once the risks outweigh the benefits. Participants who are harmed in the course of the research should receive medical care and be compensated. Observance of human rights in research trials is crucial as it adheres to the Universal Declaration of Human Rights. The relevant resolutions include the prohibition of slavery and torture, freedom of thought, opinion and expression and access to medical care as a human right (Holloway & Galvin, 2016).

Nonetheless, there are some current contentious issues in human subject protection. They include regulatory burden, adverse events, scientific merit and conflicts of interest. The increase of regulatory burdens on the investigators can become quite tasking as the workload involved is great. Adverse events are a critical issue as it is chiefly the sponsor's role to monitor these events and report to the relevant authority where a drug or device is involved. The problem arises when some events occur and are unclear or unrelated to the study. Conflict of interest occurs where the external review might be required, but the investigators were not personally involved in the research (Schneider, 2015).

The essay has explored in detail the various aspects of human research subjects including the ethical considerations, the risk involved and the rights and protection of the research participants. Human research subject protection is crucial. It is of great importance because most people are ethical and society has established structures to ensure minimum ethical standards in protecting subjects. Subjects will not participate in the research if there is a considerable threat to their safety. Protection of subjects is a combined task for all people involved in the research experiments. Good science with responsible research provides a valid path to achieving the e desirable results.

References

Connelly, L. M. (2014). Ethical considerations in research studies. Medsurg Nursing, 23(1), 54.

Fiske, S. T., & Hauser, R. M. (2014). Protecting human research participants in the age of big data.

Holloway, I., & Galvin, K. (2016). Qualitative research in nursing and healthcare. John Wiley & Sons.

Mueller, P., & Hook, C. (2018). Belmont Report - an overview | ScienceDirect Topics. Retrieved from https://www.sciencedirect.com/topics/medicine-and-dentistry/belmont-report

Schneider, C. (2015). The censor's hand: The misregulation of human-subject research. MIT Press.