Ethical Considerations in Clinical Trials: A Case Study Analysis

This case study analyzes ethical obligations in clinical trials, focusing on informed consent, post-trial care, and the balance of risks and benefits. The assignment addresses two main scenarios: the duty of researchers to disclose facts, consequences, and risks to subjects, and the provision of post-clinical care. It examines ethical dilemmas, such as higher infection rates in vaccine trials, and the responsibilities of researchers to provide post-trial treatment. The second case study explores differing perceptions of risks and benefits, the role of the Institutional Review Board, and the consequences of participant misinterpretations. The author provides detailed responses to questions about ethical responsibilities and the need to maintain patient safety. The assignment emphasizes the importance of clear communication, informed consent, and the right of participants to withdraw from trials, reinforcing the principles of non-malfeasance and patient well-being. The case study references relevant regulations and guidelines such as the Declaration of Helsinki, the European Convention on human rights in biomedicine, and the U.S Food and Drug Administration.

Non-clinical and Clinical Evaluation of Pharmaceutical Technologies1
NON-CLINICAL AND CLINICAL EVALUATION OF PHARMACEUTICAL
TECHNOLOGIES
By
Name of the Author:
Name of the class:
Professor:
Name of School:
City and Place where located:
Date:

Non-clinical and Clinical Evaluation of Pharmaceutical Technologies2
Case study 1: Ethical Obligations in Clinical trials
Question one
Yes, the clinical researchers have an obligation to disclose the facts, consequences
and risks of the research to the subjects before the process begins. Clinical trials are research
carried out in the medical field with human beings as the subjects and they are intended to
examine the effects of new treatments and tests on human beings. These studies are
conducted to introduce new drugs that will be used to manage, diagnose and treat diseases
affecting humans. Each clinical trial has its specific subjects that will be involved, the
intervention being tested and risks and benefits to be incurred from the study.
The researcher is required by the law to provide all the facts of the study to the
participants so they can make an informed decision on their involvement in the trials.
Through this information, the subject gets an opportunity to decide whether to participate or
withdraw from the trials There are several U.S and Eu regulations that govern how clinical
trials should be conducted (Van Norman, 2016). Clinical trials are conducted by qualified
personnel and they usually follow a particular protocol of the research plan.
According to the Declaration of Helsinki and the European Convention on human
rights in biomedicine, the participants have a right to make an informed consent base on the
information about the process provided by the researchers (Borysowski, Ehni and Górski,
2017). Based on the European Patients Forum the subject has a right to participate and
withdraw from the process at any given time. The information provided by the researcher
should be clear, comprehensive and comprehendible by the subject. The informed consent
process is undertaken under conditions that will not lead to any influence or compulsion.
In this case study, the researchers should tell the subjects of the higher infection rates
that were realized among the subjects who received the vaccines. Based on the U.S Food and

Non-clinical and Clinical Evaluation of Pharmaceutical Technologies3
Drug Administration, the informed consent should consistently update the subject on the
progress of the clinical trials in case any situation arises. Therefore, the subjects who had
higher HIV infection rates should be informed in accordance with the agreed informed
consent. The European Patients forum further states that subject involvement in the whole
process is very crucial and all the relevant information during the trials should be provided to
the subject clearly and comprehensively.
Question two
Yes, the researchers have a duty to provide post clinical care to all the subjects if the
need arises (Cohen, 2018). Clinical trials are essential processes as they provide new medical
knowledge that is crucial in diagnosing, treating and preventing diseases affecting human
beings. These trials should follow the set standard of the Good Clinical Practice according to
the International Conference of Harmonization guidelines. This will ensure that the rights and
safety of the participants are protected throughout the clinical trial procedures.
Human beings are volunteers in clinical trials and some laws protect the subjects
from violation According to the Declaration of Helsinki, article 22 the researcher must
provide a clear protocol for the post-trial care. Article 34 further indicates that clinical
researchers have a responsibility to issue medical care after the clinical trial procedure to the
participants who will have been deemed worthy for the intervention (Singh, Daar and Singer,
2010). Besides, the International AIDS Society states that post medical care should be
provided to all the participants who agreed to take part in the study as a compensation for the
risks and dangerous process they underwent during the trials. This information should be
availed during the informed consent process.
Furthermore, the Nuffield Council of Bioethics requires the researchers to set up a
protocol for post-trial care before the process begins failure of this should be justified by the

Non-clinical and Clinical Evaluation of Pharmaceutical Technologies4
committee in the research ethics (Bryant, 2013). In this case study, the subjects who
administered with the experimental vaccine had a higher rate of infection as compared to the
ones who were given the placebo vaccine. Therefore, according to this regulation given the
researchers have a responsibility to issue post-trial treatment to all the subjects who
contracted HIV including the ones who received the placebo vaccine. Post-trial care is
therefore important in ensuring that the principle of non-malfeasance in medicine is not
disputed and the rights and wellbeing of the subjects are a priority (De La Torre, Nikoloski
and Mossialos, 2018).
.
Case study 2: Differing perceptions of risks and benefits
Question one
Clinical trials are carried out to examine and evaluate the effects of new treatments on
human beings. These trials are closely regulated by various authorities which seek to protect
the rights and safety of the human volunteers. In the U.S the Institutional review board has to
grant its permission for the clinical trials to begin (SILBERMAN and KAHN, 2011). This
body is in charge of determining if the risks and benefits associated with the study are in line
with the acceptable ethics and would safeguard the rights of the subjects. Once the risks have
been termed as reasonable the board gives directions to proceed with the trial.
Participants in clinical trials can have direct benefits in trials where the processes and
intervention applied are designed to offer prospect benefits (Developing integrated platforms
for learning and practice: PPCR Journal experience, 2015). For example, the subjects can get
new treatments that are not available outside the clinical trial setting. This treatment may
have more efficacy and reduced side effects as compared to the one that is currently
available. It is also frequent and close monitoring care provided by qualified personnel.

Non-clinical and Clinical Evaluation of Pharmaceutical Technologies5
Clinical trials are conducted by highly qualified personnel such as top-notch researchers and
doctors therefore the patient has the best care in case any negative side effects arise.
Additionally, clinical trials enable the subjects to play an active role in the development of
the healthcare system. The subjects involved in the clinical trials feel that they have control in
their lives as they can gain a greater understanding of their diseases and conditions. These
trials are also beneficial to subjects with rare conditions which are hard to treat or manage.
Potentially some of the interventions and procedures used in clinical trials can pose
several risks to the participants (Naci et al., 2019). For example, in random trials, the
treatments are assigns randomly and the subjects have no say in the treatment being
administered to them. Much worse in random blinded trials neither the subject nor the doctor
knows about the treatments the subjects are getting. However, if need be, the information is
then provided. The treatment may also pose severe side effects to the subjects in the trials and
it may not work for some of the subjects thereby proving to be less effective than the
currently available treatment (Imbens, 2018). Furthermore, the participants are regularly and
closely monitored, they undergo a lot of tests which would not have been the case if they
didn’t participate in the trials. They, therefore, end up spending most of their time in hospitals
for a checkup.
Question two
No. If the participants have misinterpreted risk and benefits of the study, I will
discontinue the clinical trials process. According to the Institutional Review Board, the
information that is provided to the participants should be clear and concise. This will ensure
that the subjects make an informed decision on whether or not they will participate or
withdraw from the studies. The informed consent is not final, subjects are at liberty to leave
the trial at any point.

Non-clinical and Clinical Evaluation of Pharmaceutical Technologies6
Therefore, if I decide to continue with the study I will go against the law and put the
safety and wellbeing of the participants at risk.
Question Three
If I continue with the trials despite the misinterpretation of the information by the
participants, then I will have to make then necessary changes to ensure they are fully
informed on the benefits and risks of the study (Thorlund, Haggstrom, Park and Mills, 2018).
For example, I will reissue the criteria for subject participation and withdrawal from the
study. This will include providing facts about risks and benefits to be incurred from the study.
The participants will then make an informed consent based on the facts I give them. The trials
will then proceed after obtaining the informed consent from the participants. The Institutional
Review Board will then reevaluate the informed consent of the subjects, risks and benefits of
the clinical trials before approving the research to continue. All the participants are required
by the law to make informed decisions on whether to participate or withdraw from the trial
based on the information given by the researcher. The informed consent is not final, subjects
are at liberty to leave the trial at any point.

Non-clinical and Clinical Evaluation of Pharmaceutical Technologies7
References
Borysowski, J., Ehni, H. and Górski, A., 2017. Ethics review in compassionate
use. BMC Medicine, 15(1).
Bryant, J., 2013. Ethics, Equity, and Human Rights Dimensions in Strengthening
Public Health in Developing Countries. World Health & Population, 3(1).
Cohen, T., 2018. Expendable Commodities. International Journal of Applied
Philosophy, 32(2), pp.219-229.
De La Torre, A., Nikoloski, Z. and Mossialos, E., 2018. Equity of access to maternal
health interventions in Brazil and Colombia: a retrospective study. International
Journal for Equity in Health, 17(1).
Principles and Practice of Clinical Research Journal, 2015. Developing integrated
platforms for learning and practice: PPCR Journal experience. 1(1), pp.1-1.
Imbens, G., 2018. Understanding and misunderstanding randomized controlled trials:
A commentary on Deaton and Cartwright. Social Science & Medicine, 210, pp.50-52.
Naci, H., Davis, C., Savović, J., Higgins, J., Sterne, J., Gyawali, B., Romo-Sandoval,
X., Handley, N. and Booth, C., 2019. Design characteristics, risk of bias, and
reporting of randomised controlled trials supporting approvals of cancer drugs by
European Medicines Agency, 2014-16: cross sectional analysis. BMJ, p.l5221.
SILBERMAN, G. and KAHN, K., 2011. Burdens on Research Imposed by
Institutional Review Boards: The State of the Evidence and Its Implications for
Regulatory Reform. Milbank Quarterly, 89(4), pp.599-627.
Singh, J., Daar, A. and Singer, P., 2010. Shared Principlesfor Infant and Young Child
Nutrition in the Developing World. BMC Public Health, 10(1).

Non-clinical and Clinical Evaluation of Pharmaceutical Technologies8
Thorlund, K., Haggstrom, J., Park, J. and Mills, E., 2018. Key design considerations
for adaptive clinical trials: a primer for clinicians. BMJ, p.k698.
Van Norman, G., 2016. Drugs and Devices. JACC: Basic to Translational Science,
1(5), pp.399-412.