Nursing Research and Ethics: A Study of the Tenofovir Trial Case

This essay examines unethical research practices in nursing, focusing on the Tenofovir trial in Nigeria (2004-2005) where women became HIV-infected after participating in the trial. The unethical aspects included a lack of informed consent, failure to address language barriers, and inadequate communication of risks. The essay references the Belmont Report's principles of beneficence, justice, and respect, highlighting how the trial violated these principles. The implications of such unethical research include trial cancellation, researcher accountability, potential legal action, and changes in practice, such as the establishment of committees to address issues in HIV research and ethical principles focused on fairness, honesty, and respect, particularly for vulnerable populations. The essay concludes by emphasizing the importance of maintaining ethics in human subject trials to avoid legal issues and research suppression, referencing the Declaration of Helsinki's proposal for placebo use in controlled trials.

Running head: NURSING
Nursing
Name of the student:
Name of the University:
Author’s note

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
proposed the use of placebo in controlled trial as this will demonstrate efficacy of 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.