NR553 Week 3 Discussion, Ethical Principles in Global Research

Ethical Principles in Global Research NAME Chamberlain College of Nursing NR 553: Global Health Policy DATE Using the Chamberlain online library, explore global-health research being conducted in developing countries. Discuss ethical principles (autonomy, nonmaleficence, beneficence, and/or justice) of global health related to a specific global-health research study being conducted in developing countries. Week 3: Ethical Principles in Global Research Ethical and legal issues relating to clinical research especially those involving human subjects have for decades dominated debates among, scientist, lawyers, clinicians as well as policymakers due to the high risks involved. Consequently, many guidelines toward hindering research misconduct have been set out. Some of the most prominent ones are the Hippocratic Oath, the Declaration of Helsinki which was formulated in 1964 and The Belmont Report (Yip, Han, & Sng, 2016). Nonetheless, there have been numerous instances that ethical and legal guidelines have been blatantly overlooked and the participants subjected to harm notably the Tuskegee experiment and the Nuremberg trials. Consequently, it is vital to explore current research in the global arena and more importantly in the vulnerable communities. According to Folayan, Haire, Harrison, Odetoyingbo, Fatusi, and Brown (2015), there are numerous ethical issues in adolescents’ sexual reproductive health research in Nigeria which is essential in identifying health concerns as well as ways combatting HIV/AIDs. One of the major concerns is autonomous decision making as informed consent is a crucial requirement for research participation. Besides, it should be voluntarily obtained and undue of coercion or inducement. However, the adolescents have considerably low legal capacity and are also vulnerable to incompetent decision making. The laws on the age of consent for participation in research are unclear and thus may necessitate parental consent which compromises the privacy and confidentiality of research and subsequently the autonomy. The assurance of privacy and confidentially also bolsters adolescent’s participation in sexual and reproductive health research. However, in instances where the confidentiality is upheld, and a minor is found to be HIV positive, the parents may need to be informed in order to facilitate the minor’s access to Antiretroviral treatments. Further, there are also issues on who provides parental consent, for examples unmarried adolescents heading a household are not allowed to consent despite the increasing number of such families as a result of HIV/AIDS epidemic. Further, the law only recognizes consents from legally accepted guardians thus negating the principle of justice as the selection of study participants excludes some people (Folayan et al. 2015). References Folayan, M. O., Haire, B., Harrison, A., Odetoyingbo, M., Fatusi, O., & Brown, B. (2015). Ethical issues in adolescents' sexual and reproductive health research in Nigeria. Developing world bioethics, 15(3), 191-198 Yip, C., Han, N.-L. R., & Sng, B. L. (2016). Legal and ethical issues in research. Indian Journal of Anesthesia, 60(9), 684–688. PROFESSOR RESPONSE TO POST: Thanks Carole. It is unfortunate that unethical practices continue despite oaths and guidelines. What other prevention, monitoring and resources have worked to prevent these practices among the most vulnerable populations? Dr. Fildes, Every researcher has a responsibility to protect the participants in an investigation. In the United States, policies guiding ethical treatment of humans in research have been influenced by the principle of respect for persons(autonomy), beneficence(nonmaleficence) and justice. The respect for persons(autonomy) extends essentially to deciding whether to participate, free from coercion, in a research study. This principle ensures there are informed consent procedures to provide respect for persons and are the results of the principle of autonomy. There are various circumstances that could bring about a change in vulnerability status of a person including health, financial status or social position. In this perspective, the elderly though not inherently vulnerable often become vulnerable because of aging. In addition to the elderly, children, the institutionalized, and women are recognized to be more susceptible to harm and vulnerable to coercion in research. Determining of comprehension is essential with a vulnerable population in research. Researchers should be moderate in speech and presentation when handling this group. Researchers should eliminate coercion when handling this group through avoiding an authoritative appearance when conducting the research. In addition to that, researchers should avoid contact with the participants in places of work or public areas to avoid violation of privacy of respondents. During the study, participants in this bracket should be given repeated opportunities to affirm consent or withdrawal. According to Shivayogi, to assure the safety of patients during research studies comprehensive safety monitoring plans with Data Safety Monitoring Committee (DSMC) supervision and Observational Study Monitoring Boards are crucial in early and late trial phases (2013). The principal role of the DSMC is to review study data for subject safety, study conduct, and progress, and provide formal recommendations regarding study continuation, modification, and termination (U.S. Department of Health & Human Services, 2011). The principal role of the OSMB is to monitor regularly the data from the observational study, review and assess the performance of its operations, and make recommendations with respect to issues related to participant safety, confidentiality, and informed consent, including notification of and referral for abnormal findings (U.S. Department of Health & Human Services, 2011). Protection of rights, well-being, safety with measurements of risk-benefit scales, privacy and confidentiality of vulnerable subjects and ascertaining safeguards are prerogatives of institutional review boards (IRB) (U.S. Department of Health & Human Services, 2018). “IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure the protection of the rights and welfare of human subjects of research” (U.S. Department of Health & Human Services, 2018). The IRB performs periodic reviews throughout the trial’s duration and may take place at least once a year and include the entire trial, not just changes. Misconduct in research damages the scientific enterprise and undermines the trust of research participants. Thus, recognizing and responding to the ethical dimension of research is a fundamental part of the research governance process. It is imperative that responsible research is utilized in order to provide the authentic groundwork to heighten best practices in the medical management of vulnerable populations. Reference Shivayogi, P. (2013). Vulnerable population and methods for their safeguard. Perspectives in Clinical Research, 4(1), 53–57. U.S. Department of Health & Human Services. (2018). Institutional Review Boards Frequently Asked Questions - Information Sheet. Retrieved May 15, 2018, from U.S. Department of Health & Human Services. (2011). Data and safety monitoring FAQ's. Retrieved May 15, 2018, from PEER RESPONSE TO POST: I agree that consent must be voluntarily obtained with no undue coercion or inducement. Barnes and Wallace (2017) reported that many clinical trials are now conducted outside of the United States. The 20 largest pharmaceutical companies conduct over one third of their trials outside of the United States because of the possibility of significant savings, shorter trial times and lower costs per participant. They also state that it is easier to recruit human subjects in foreign countries than the United States. This gives me great cause for worry as greed still seems to be a huge motivator for many companies. If clinical trials are conducted outside of the United States, both foreign and US laws must be followed by the corporations conducting the trials. References Barnes, M., & Wallace, N. (2017). Laws and ethics affecting clinical trials in Africa. Journal of Health Care Law and Policy. 248-274. RESPONSE TO PEER: Leslie, The 1979 report, of the President’s Commission for the Study of Ethical Programs in Medicine and Biomedical and Behavioral Research, or “Belmont Report”, laid out much of the ethical principles for the Federal Policy for the Protection of Human Subjects or the “Common Rule” (U.S. Department of Health & Human Services, 2016). The primary purpose of the Belmont Report is to protect subjects and participants in clinical trials or research studies. Human subjects’ considerations are essential to the design and implementation of research projects. The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research supported by the U.S. Department of Health and Human Services (HHS) (U.S. Department of Health & Human Services, 2016). The OHRP International Program ensures that human subjects outside of the United States who participate in research projects conducted or funded by HHS receive an equal level of protection as research participants inside the United States (U.S. Department of Health & Human Services, 2016). THE OHRP International Program has over 1,000 laws, regulations, and guidelines to protect human subjects in 130 countries and other international organizations. Preferably, research conducted outside the U.S. should be treated as if they are conducted within borders. International research poses unique and complex ethical challenges. Prior before the research begins the investigators should obtain IRB approval; demonstrate cultural understanding and sensitivity; and understand the research ethics guidelines of the host country. Reference U.S. Department of Health & Human Services. (2016). Federal policy for the protection of human subjects ('Common Rule'). Retrieved from