Medical research involving human beings is necessary for elucidation of physiological or pathological process in health and disease, ascertaining the response to particular intervention by individuals whether ill or healthy, and determining the effect of preventive and therapeutic measures in communities. The process of carrying out human experimentation has very strict rules and regulations with regards to whether the new treatment is likely to bring better benefits to the patient. In the recent past, there has been an unprecedented rise in the number of human experimentation programs to cater for the changing circumstances in the medical field such as increased drug resistance. In this essay, I provide an in depth discussion of the pre requisites for carrying out experiments on humans’ Essentiality.
The proposed research must be necessary for the benefit of the people and the advancement of knowledge, the principle of essentiality respects the ethical principle of beneficence (benefits must be proportionate to risks; potential harm : potential good) Informed consent. The research subject should be fully apprised of the proposed research, including the risks and benefit and alternate procedures available. Free (voluntary) informed consent should be obtained before the commencement of the research. The research subject has the right to abstain from the research at any time. The principle of autonomy is observed by informed consent. It protects the individual‘s freedom of choice.
The identity and particulars of the subject and the research data should be kept confidential. These may be disclosed for valid reasons such as legal or scientific (therapy) and with specific consent with the writing of the subject participating in the research. The research protocol shall include mechanisms for compensation through insurance or other appropriate means to cover all risks and provide for remedial action and aftercare. In case of death, the dependents are entitled to material compensation Immediate recompense and rehabilitative measures should be undertaken when needed. Participants may be paid for inconvenience, time away from work and re-imbursement of expenses incurred Payments should not be so large as to induce the subjects to participate against their better judgment Competence, Accountability, Responsibility, and Transparency the research should be conducted only by competent and qualified persons and who are who are aware of and practice ethical research.
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It must be conducted with integrity. In addition, all persons involved, directly or indirectly in the research are responsible and accountable for observing all the ethical principles and guidelines, There should be no conflict of interest. it should be conducted in a fair, honest, impartial and transparent manner. Due care must be exercised at every stage of the research from its inception, design and conduct to the use of results. The research participants should be subjected to minimum risk and should not suffer from irreversible adverse effects. The research proposals must be submitted to a properly constituted scientific committee that may not approve of the proposal, with or without modifications. The scientific committee may review the protocol periodically. Moreover, a properly constituted ethics committee should be formed to look into all ethical aspects of the proposed research and may or may not approve of the research with or without modifications .
This committee may review the research periodically. Research on human beings should be conducted observing the basic ethical principles of beneficence, non-maleficence, justice and autonomy. The results of research (positive or negative) should be available to the public through scientific or other publications. The information given should be accurate. It should not raise false hopes or expectations, Confidentiality must be maintained while publishing/presenting the results. Special groups as Research Subjects Pregnant and nursing women should not be subjects of any clinical trial except when such trials are designed to protect or promote their health and for which non—pregnant or non-nursing women are not suitable. Children should not be involved in research that could be carried out equally well with adults unless the purpose of the research will give relevant information to the health needs of children.
Vulnerable groups with reduced autonomy such as students, employees, service personnel and prisoners may be involved in research only if there is adequate justification. Their vulnerability should not be exploited. Rights and welfare of the mentally ill or mentally retarded should be protected at all times, Persons who are economically 0r socially disadvantaged should not be used to benefit those who are better off than such persons. Conclusively, in order to protect human research participants, this guidelines should be followed to the latter in human experimentation. These guidelines, not only do they ensure that the patients‘ rights are respected, they also ensure that the patients‘ autonomy is respected and that the patient is not exploited or harmed in any way. This is with regards to the ethical principles of beneficence, non—maleficence and justice.
