1NURSING Unethical research involves violation of bioethics while conducting research and leading to harm for participants, researchers and clinical practice. One such example is the research done related to HIV transmission in Nigeria in the period from 2004 to 2005. The unethical aspect of the trial was that after participation in the Tenofovir trial, five Cameroon women became infected. The unethical aspects that lead to the event were that participants in the trial were not informed about the risk associated with the experience. In addition, language gap between volunteers and participants were not addressed leading to miscommunication of information related to benefits and risks associated with the trial (Peterson & Folayan, 2019).. For researchers involved in evaluating the efficacy and safety of interventions in human subject, one of the fundamental obligation for them is do no harm to participants. This involves taking the step to protect confidentiality and maintain informed consent obligation while recruiting participants in the study. While taking informed consent, it is critical to ensure that participants understood the information and arrived at decision to participation without any coercion (Hlongwa, 2016). However, no such step was taken in the Tenofovir trial resulting in harm for the participants. The Belmont report is concerned with protection of subjects and participants in clinical trials and this report mentions about three ethical principles to protect rights of human subjects which include beneficence, justice and respect for participants (Miracle, 2016). The first requirement is to ensure that no harm is done to participants. However, in case of Tenofovir trial, five women became HIV-infected leading to cancellation of the trial. Hence, apart from affect on research participants, the trial had impact on the researchers too as the research was cancelled. The researcher was held accountable for the harm resulting in cancellation. Other possible implications of such unethical research include initiation of legal action against the harm caused (Paul & Brookes, 2015).
2NURSING Unethical research as seen for the Cameroon trial results in practice changes too. For example, in the case of contemporary practice, the unethical research resulted in establishment of broad committee to address issues in HIV research and ensuring access to at least two years of post trial tenofavir access to participants of the trial. In addition, the present change that has been seen is the establishment of ethical principles particularly for HIV research. This involve the need to address issue of fairness, honest and respect for fellow human beings. Special emphasis has been paid particularly to reduce risk for vulnerable population group. This involves focusing on six categories of vulnerability such as economic social, medical, cognitive, institutional and deferential.In addition, as unethical research creates a black hole in medical research, non- publication of such results has become a norm. The Declaration of the Helsinki proposal also proposedthe use of placeboincontrolledtrialasthiswill demonstrateefficacyof the intervention and result in no additional risk to harm (Hlongwa, 2016). Therefore, maintaining ethics during trial with human subject is critical to avoid legal issues and prevent non-publication of research.
3NURSING References: Hlongwa, P. (2016). Current ethical issues in HIV/AIDS research and HIV/AIDS care.Oral diseases,22, 61-65. Miracle, V. A. (2016). The Belmont report: The triple crown of research ethics.Dimensions of Critical Care Nursing,35(4), 223-228. Paul, C., & Brookes, B. (2015). The rationalization of unethical research: revisionist accounts of the Tuskegee syphilis study and the New Zealand “unfortunate experiment”.American journal of public health,105(10), e12-e19. Peterson, K., & Folayan, M. O. (2019). Ethics and HIV prevention research: An analysis of the early tenofovir PrEP trial in Nigeria.Bioethics,33(1), 35-42.