WHAT ARE THE ETHICAL ISSUES SURROUNDING HUMAN SUBJECT CLINICAL TRIALS

Clinical research is essential in determining the effectiveness of health care systems, human subjects in
clinical trials have come a long way with histories of success and scandals that often times mold people’s
perspectives on ethics in human subject clinical research. Adherence to good clinical practice is
extremely critical in ensuring the safety of the human subject and the legitimacy of the clinical research.
Positive outcomes of clinical trials depend heavily on the ability of the researchers to respect ethical
responsibilities and fulfill the related duties toward the human subjects who are direct participants in
the clinical trials. During the past five years there have been various major debates on ethics
surrounding human subject clinical research. A lack of ethical responsibility will not only cause failure of
the clinical trial, but also have serious consequences and outcomes such as subject health problems. It is
almost crucial at this point to place a spotlight on the ethics surrounding human subject clinical trials.

The primary concern regarding ethical issues is informed consent. Researchers tend use deceptive ways
to assure the participants that a cure is possible. But in this contemporary convention, the consent of
participants is protocol, whereby participants have to voluntarily express as a proficient subject and be
adequately informed as well. For example, the basic way getting informed consent is by incorporating
the purpose, risks and benefits of the study beforehand in the initial procedure. Despite these
components, the conviction of informed consent still casts a doubt because it is strenuous in
highlighting which information is sufficient enough to be considered valid. Participants may fall under
therapeutic misconception if they misunderstood the aim behind the research due to lack of
understanding regarding the concept of medical trials or not given enough closure. All in all revelation,
comprehension, competency and voluntariness are the principal objectives when receiving consent.

Another main ethical issue surrounding human subject clinical trials is confidentiality which is the act of
safeguarding one’s personal information. Most doctors set research outcomes as their nucleus of
attention rather than the subject’s welfare and this has unfortunately led to the participant’s privacy
being invaded. An example of privacy invasion is the Humphrie’s study “Impersonal Sex in public places”
whereby he observed sexual activities done by homosexuals in public men’s rooms. The disclosure of
one’s personal information to be shared with the public for their own good has led to subjects
experiencing psychological traumas, embarrassment and loss of dignity. Researchers need to be extra
careful while conducting their studies in order for their findings to be ethical and useful for the society.

Beneficence and nonmaleficence are also chief factors to be considered when conducting human
subject clinical trials. The basic principle of beneficence is balancing the benefits of human subject
clinical trials against risks and costs involved, on the other hand nonmaleficence can be defined as
avoiding causation of harm. In most human subject clinical trials a certain degree of harm is inevitable,
in these instances it is extremely important to note that the harm that could be caused should not be
disproportionate to the benefits of the research. Conflicts particularly occur when what in the doctor’s
view is in their best interest does not align to the patient’s request, sometimes in these cases medical
staff have to convince subjects to undesired treatment to prevent development in the future even if the
treatment may be uncomfortable or even painful.
The criticism and uncertainty of human subject clinical trials should be encouraged rather than
suppressed as it both educates and raises awareness on the various ethics surrounding human subject
clinical trials. A popular misconception among society is to solely hand over their trust to medical staff
when undergoing treatment and this behaviour has resulted in various tragic results. Ethics surrounding
human subject clinical trials is an issue with very little public awareness amongst society. As much as
clinical trials may not seem like a very relatable topic it is safe to be informed of the ethics surrounding
it. Newsjacking, hosting educational events and the traditional brochures are some methods to raise
awareness on human subject clinical trial guidelines. Clinical trials have increased in the context of
complexity and it has become a challenge to evaluate clinical research progresses, as research questions
become more sophisticated. Research context as a whole has grown to an increasing level of interplay
among diverse actors. The ethical discourse has to keep abreast of these changes, in order to provide an
adequate guidance for medical research in the future.