Ethics Of Clinical Trials

Background

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 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.

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.

Ethical Guidelines for Clinical Trials

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 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.

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 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.

Monitoring Responsibilities in Clinical Trials

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 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.

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.

Balancing Risks and Benefits

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 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 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.

Informed Consent and Patient Autonomy

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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