A clinical field study is a medical research involving human volunteers to gain knowledge such as whether a new cure works or its side effects outweigh the benefits. It should be no surprise that clinical field studies for students in Malaysia involves ethical guidelines to ensure that the patients do not be harmed or feel violated privacy wise.
There are two types of clinical studies that you should be aware of as a new student. Clinical trials are the bread and butter of the study, where medical experiments are conducted based on the research plan and protocols. This involves a range of products from drugs to vaccines, procedures or behavioral changes, such as a subject’s diet.
It is never known how harmful the trials can potentially be, so investigators will try to determine the safety and efficacy of the study by measuring certain outcomes of the subjects.
Observational studies are assessments where participants may receive interventions like medical products or as part of their routine, but they are not assigned to specific tests as in a clinical trial. As an example, you may observe different groups of adults to learn about their different lifestyles and outcomes on cardiac health.
Social and clinical values
No research study is without a specific question, and the answers must be valuable or important enough to justify the risks involved in the study. In other words, the same answers must contribute to scientific understanding or improve treatments, prevention or caring for patients with a certain disease. Only if society gains useful knowledge, as in the shared positive and negative results of trials, can the risks be accepted among human subjects.
Scientific validity
If a research is considered unethical, it is because the risks were unnecessarily exposed and resources were wasted, producing useless results. The answer to a research question must be understandable enough that the study is possible to carry out and bear fruit in the end. Earlier, researchers should reconsider the question by thinking whether it is actually answerable or not. They must also consider whether the methods are valid and feasible, the objective clear as day and use acceptable and moral practices.
Fair subject selection
The reason subjects are recruited is because they fit the scientific goal of the study, not due to privilege, vulnerability and other unrelated reasons. People should be chosen in a way that minimizes risk and enhances benefits to society and other people. Subjects that accept the risks involved should enjoy its benefits, and those who do may share some of the burdens and risks. Certain groups and individuals such as children could also be involved as long as there is a good scientific reason or particular susceptibility to risk.
Favorable risk-benefit ratio
Risks are always present no matter the research, and their degrees are always uncertain, even more so in the early stages of research. Risks can range from trivial to serious, and might leave a short or long lasting impact on participants, such as death and depression. Therefore, measures must be taken to minimize the risks as best as possible, while also maximizing the benefits to determine whether it can outweigh the risks among individuals and society.
Independent review
An independent review panel exists to lower the chances of conflicts of interests and ensure that the study is ethically acceptable. Questions they may ask involve the trial’s freedom from bias or whether it is able to utilize protection onto its subjects. The panel will also monitor the ongoing study and its progress.
Informed consent
Is it obviously ethical if the subject clearly does not want to be involved with the trial, yet they were placed into it anyway? Only immoral researchers do, and history proved a lot of such.
Researchers must obtain the consents of participants by first providing them full information about the study, its reason, risks and benefits. The participants must also be understood of this info and how it relates to their own interests or clinical situation, then make a voluntary decision to participate or decline.
There are some exceptions. For example, a child, an unconscious person with head trauma or an Alzheimer’s patient. Ensure that the participation is consistent with the individual’s own values and interests. This is so a proxy decision maker to decide about participation can be utilized based on possible decisions the subject would have made if possible.
Respect for potential and enrolled subjects
Trial subjects are still sentient human beings, and must be treated with respect. You must respect their privacy and their decision to withdraw themselves from the study should they change their mind. You must also keep them informed of any new information and monitor their welfare. If it changes badly enough for them to no longer continue, removal is necessary.
It is also important to inform subjects about what was learned from the research. Most researchers are very good at taking care of subjects, but may be poor at distributing the study results. If they do not tell you, ask.
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