31 Aug 2022

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Ethical Principles and Guidelines for the Protection of Human Subjects

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Academic level: High School

Paper type: Essay (Any Type)

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Creation of an IRB board is needed at the local university to determine that research projects meet at least one of the federal exempt categories criteria ( Bromley et al., 2015) . Some of the categories criteria that are used for the determination that the project is exempt include the respect for persons, benefice, justice, informed consent, risk assessment, and selection of subjects ( Sims, 2010) . The purpose of creating an IRB is to protect the rights and welfare of the human subjects while carrying out research ( Department of Health, 2014) . The IRB at the local university will have the authority to approve and to give requirements for modifications in securing approval or disapproval of research. The group review will serve an important role in protecting the rights and welfare of human participants in research as stated in the FDA regulations. 

IRB is a way of ensuring that appropriate steps are taken to protect the rights and welfare of human participants as subjects in research, especially regarding the special populations. Firstly, the board is tasked with creating the boundaries between biomedical or behavioral research and the accepted and routine practice of medicine ( Department of Health, 2014) . It will then rake up the role assessment task-benefit criteria while determining the appropriateness of research that involves human subjects ( Sims, 2010) . The board is also tasked with the determination of the nature and definition of informed consent in various settings of research at the university. 

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On end, it will give the appropriate guidelines for selecting human subjects for participation in the biomedical and behavioral research ( Bromley et al., 2015) . The implementation of the IRB body will also protect the welfare of human research subjects who are recruited to take part in research activities conducted under the auspices of the institution with which it is affiliated in the sense that it will aid in the determination of the basic principles relating to research especially that which involves human subjects. 

References 

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. 

Department of Health, E. (2014). The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research.  The Journal of the American College of Dentists 81 (3), 4. 

Sims, J. M. (2010). A brief review of the Belmont report.  Dimensions of critical care nursing 29 (4), 173-174. 

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StudyBounty. (2023, September 15). Ethical Principles and Guidelines for the Protection of Human Subjects.
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