Ethics of Clinical Trials

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This article discusses the ethical guidelines that have been put in place to protect the interests of patients and the integrity of science in clinical trials. It covers topics such as informed consent, subject welfare, data safety, and more.
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Ethics of Clinical Trials
Clinical research is usually directed at developing generalized knowledge on the
improvement of medicine. Participants in scientific research make this knowledge possible. It is
not possible to find out whether new drugs or treatments are safe or effective without having
them tested on patient volunteers. However, by examining drugs and medications on human
subjects, they are exposed to some risk. The risk of harming some patients for the benefit of
future patients gives these studies the potential to take advantage of vulnerable or desperate
patients. As such, there are specific ethical guidelines which have been put in place to take care
of the interests of such patients and protect the integrity of science.
These ethical guidelines were established in response to some harmful practices in the
past; the most notorious of which was an experiment carried out on African American men in
Tuskegee, Alabama (Miranda and Sanchez 232). Perhaps the inception of these principles was
the Nuremberg Code of 1947 which was formulated as a result of patient rights violations in the
Second World War. There are some other codes of ethics which have been designed since that
guide ethical clinical research. Typically, there are general principles which guide the conduct of
ethical research.
While the emphasis in clinical research is usually on monitoring subject welfare, there are
many other aspects which should be considered to ensure that the ethics of clinical trials are
adhered to. Ethical conduct in a clinical trial is a continuous process that does not begin and end
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with the obtainment of a signature on the informed consent form (Rabinstein et al. 798). There
are fundamental monitoring responsibilities that protect the welfare of the subjects in the trials as
well as other parties involved in the clinical trial. This protection is the responsibility of
authorities such as ethics review committees, investigators and other research staff.
Participation and Informed Consent
One of the critical challenges with clinical trials is that patients who bear the risk and
burden of participating in a clinical trial are not the same patients who stand to gain from the
results. Participation in such studies poses a higher health risk compared to standard clinical care
because there may be unexpected effects of the new treatment (Faden et al. 766). History is
replete with episodes in which trial participants disproportionately bore the burden of research
participation. In some instances, patients were lured with the promise of a cure to a debilitating
condition while in others, the fact that they were participating in a trial was deliberately
concealed.
In the modern ethical conception, any research or study that involves human subjects
must be pre-emptively accepted by the participants by way of informed consent. Informed
consent has become a mainstay in both the treatment and research of clinical conditions. For any
research to be ethical, the subjects should be able to make independent and well-informed
decisions about whether or not they want to participate in the study. They must be adequately
informed of the purpose, methods, risks, benefits, and alternatives to the research (Villamañán et
al. 191). Additionally, they must be in a position to understand the information available to them
and how that information relates to their clinical situation. Finally, the decisions made by these
subjects should be voluntary and free from coercion or incentives. There are some instances in
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which informed consent from an individual is not required such as an adult with diminished
mental capacity due to Alzheimer's or head trauma (McKinney Jr 494). Researchers also need to
ensure that participation is consistent with the values and interests of such a subject. This entails
the empowerment of a proxy who can make decisions for the participant.
Social and Clinical Value of Trials
It is a widely accepted fact that in any clinical trial, the potential harms to research
participants should be proportional to the anticipated benefits. These benefits include direct
benefits to the subject as well as societal benefits (Shah et al. 1308). It is this social value that
justifies the involvement of human participants. The results of a clinical trial typically have a
significant benefit for the society as well as patients with a given illness. These results should
have both a social and clinical value to justify asking subjects to accept the risk of harm that
accompanies the study. Regarding clinical benefit, the research questions in the trial should be
targeted at contributing to a scientific understanding of health as well as improving the various
ways in which certain disease conditions in humans are managed. Societal benefits include the
gaining of useful knowledge through both positive and negative results from the study.
Social value refers to the nature and extent of improvement that an intervention is likely
to have on the quality of life of human beings. The magnitude of the social value is usually used
in justifying the exposure of research participants to conditions or agents that pose a significant
risk to their well-being (Pearce et al. 394). Research ethics committees should first determine
whether the intervention to be tested in a clinical trial has an anticipated social value. The
anticipated social benefits should then be weighed together with the possible clinical and direct
benefits to a subject against the risks to which the participants will be exposed. The research
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question is a research study should have a significant value to the society and direct benefits to
the subjects. This will form the basis for justifying a trial.
Use of Placebo and Deception
Randomized controlled trials involve the use of placebos to establish the efficacy of a
given therapy. The personal expectations about treatment by both patients and investigators may
play a critical role in how a trial progresses. As such, in testing a new intervention, subjects in
the control group should receive a placebo. Placebos are typically indistinguishable from the
experimental treatment except the fact that they lack the active principle in it. The issue of
deception arises since patients enter a trial with the expectation that they are going to get a
specific drug to cure or treat a medical condition (Cheah et al. 19). In a trial, patients on a
placebo must be convinced that they are receiving the active treatment, even though that is not
the case, for the clinical trial to work. This fact makes it contentious whether controlled trials are
inherently deceptive towards patients. Initially, patients are informed that they will not be told
whether or not they will be put on the actual experimental treatment.
Aside from deception, the use a placebo may pose harm to the patient as opposed to
receiving the actual treatment. For some diseases, not receiving active treatment may expose the
patients to higher levels of pain, aggravate their conditions and even increase their risk of death
(Blease et al. 17). In such cases, the use of placebos is unethical since the patients are put at risk
for the benefit of other parties. As such, the study design of trial should be such that the same
population of subjects is used to study both the response to the active treatment as well as the
placebo. The use of placebo must involve a delicate balance between the stringency of the
scientific rationale for it as well as the possibility of harming the subjects in the trail. According
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to the Declaration of Helsinki, its use is only acceptable in cases where no proven treatment
exists, and there are sound methodological rationales for its use (World Medical Association 14).
Additionally, the use of placebo should not subject any of the participants to severe or
irreversible harm.
Subject Welfare
In clinical research, there is an apparent discrepancy between the trial participants and
future patients as well as the society at large. This gap arises from the fact that trial participants
are exposed to severe risks while the others are intended beneficiaries of the results from the
trial. As such, ethical guidelines need to protect the trial subjects from bearing all the risks and
burdens of research (Tsan et al. 224). These guidelines prioritize the interests and welfare of the
participants above all other interests. However, the strict enforcement of such guidelines has
worked to the detriment of research in developed countries. It has encouraged the outsourcing of
the conduct of trials to countries where subject protection standards are much lower. Besides,
both these countries and study participants often find themselves in a state of vulnerability owing
to the might of large pharmaceutical companies that run the trials.
Secondly, there are concerns that the stringent application of the protection guidelines
may contradict the free choices of the participants. For instance, a patient with a severe medical
condition may be willing to take higher risks for the sake of a perceived more significant benefit.
This is usually the case with patients who have terminal conditions (Grady 20). Such patients
may be willing to taking more chances with innovative and promising treatment. Alternatively,
charitable patients may take such risks for the sake of benefiting other patients in the future.
Patient protection guidelines take these decisions away from the patients and place them solely
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on the hands of research ethics committees. Currently, ethical guidelines put a lot of emphasis
on the protection of participants as opposed to their autonomy. Therefore, there is a need for a
delicate balance between the two aspects for the trials to be successful.
Data Safety
Data safety is a crucial premise of any sound scientific research. Ethical guidelines
indicate that any data used or acquired in a trial should be secured and protected from third
parties. This led to the establishment of data safety monitoring boards (DSMBs). The
independent monitoring of data is essential to determining the safety of subjects in a trial (Zenati,
Marco and Henderson 398). Researchers involved in the design and conduct of a trial may not be
entirely objective in reviewing the data for concerns with the welfare of the subjects. As such,
DSMBs with experts in the condition under study, statisticians and community representatives
are used for interim independent review. These boards are used owing to the increasing number
of trials associated with high mortality or morbidity rates, concerns over the inaccuracy and bias
in results as well as the lack of objectivity in researchers.
Interim analyses of trial data are conducted in a bid to reassess the scientific validity of
the trial concerning what is clinically useful and what is ethical. The data collected in a clinical
trial is also continuously monitored to ensure that the rights and overall well-being of trial
participants are safeguarded (Debono et al. 281). The data safety monitoring boards are used to
reduce the risk of a significant adverse health outcome for the participants and to monitor the
safety of a trial on the long-term. Besides, the data collected in a test should be secured in a
manner that protects the privacy of the subjects, and that does not compromise their dignity.
Subject Selection and Risk-Benefit Ratio
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In a clinical trial, the participants are often as important as the intervention itself. The
primary basis for recruitment of subjects should be the scientific objectives of the study. The
study participants should be selected in a manner that minimizes risks and enhances the social
and clinical value of the trial (Piantadosi 102). Additionally, those who may benefit should share
some of the risks and burdens of the clinical trial. Besides, the study should have a favorable
risk-to-benefit ratio to be ethically acceptable. The societal and clinical benefits of the clinical
trial should far outweigh the risks it poses for it to be viable.
Conclusion
In summary, any clinical research that involves human subjects has to adhere to the
highest standards of ethics. Ethical guidelines have been developed over the years owing to the
infamous experiments conducted on humans in the name of science in the past. Currently,
researchers and scientists have to comply with ethical requirements while trying to achieve their
scientific goals. There is an increased emphasis on the protection of subject welfare, informed
consent, data safety as well as patient privacy. Above all, the trials should have a social and
clinical value that far outweighs the risks posed by the experimental treatments to be beneficial.
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Works Cited
Blease, Charlotte, Felicity Bishop, and Ted J. Kaptchuk. "Informed consent and clinical trials:
where is the placebo effect?." Bmj 356 (2017).
Califf, Robert M., and Jeremy Sugarman. "Exploring the ethical and regulatory issues in
pragmatic clinical trials." Clinical Trials 12.5 (2015): 436-441.
Cheah, Phaik Yeong, et al. "The ethics of using placebo in randomised controlled trials: a case
study of a Plasmodium vivax antirelapse trial." BMC medical ethics 19.1 (2018): 19.
Debono, Victoria Borg, et al. "Survey of professional views on sharing interim results by the
Data Safety Monitoring Board (DSMB): what to share, with whom and why." Trials
19.1 (2018): 281.
Faden, Ruth R., Tom L. Beauchamp, and Nancy E. Kass. "Informed consent, comparative
effectiveness, and learning health care." N Engl J Med 370.8 (2014): 766-768.
General Assembly of the World Medical Association. "World Medical Association Declaration
of Helsinki: ethical principles for medical research involving human subjects." The
Journal of the American College of Dentists 81.3 (2014): 14.
Grady, Christine. "Ethical principles in clinical research." Principles and Practice of Clinical
Research (Fourth Edition). 2017. 19-31.
McKinney Jr, Ross E., et al. "Use of altered informed consent in pragmatic clinical research."
Clinical Trials 12.5 (2015): 494-502.
Miranda Jr, Daniel, and David Jesse Sanchez. "The Tuskegee experiment: an introduction in
ethics for pre-healthcare professional students." Journal of microbiology & biology
education 15.2 (2014): 232.
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Pearce, Warren, Sujatha Raman, and Andrew Turner. "Randomised trials in context: practical
problems and social aspects of evidence-based medicine and policy." Trials 16.1 (2015):
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Piantadosi, Steven. Clinical trials: a methodologic perspective. John Wiley & Sons, 2017.
Rabinstein, Alejandro A., Waleed Brinjikji, and David F. Kallmes. "Equipoise in Clinical Trials:
Angst and Progress." Circulation research 119.7 (2016): 798-800.
Shah, S. K., et al. "Response—Evaluating human trials: FDA's role." Science 360.6395 (2018):
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Tsan, Min-Fu, and Linda W. Tsan. "Assessing the quality of human research protection
programs to improve protection of human subjects participating in clinical trials."
Clinical Trials 12.3 (2015): 224-231.
Villamañán, Elena, et al. "Bridging the gap between researchers and patients: The role of the
Institutional Review Boards in the informed consent process." JAHR 8.16 (2017): 191-
208.
Zenati, Marco A., and William G. Henderson. "Data Safety Monitoring Board: Composition and
Role." Clinical Trials Design in Operative and Non Operative Invasive Procedures.
Springer, Cham, 2017. 329-334.
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