Regulations and Ethics of Clinical Trials
Clinical research is designed to improve human health and increase our understanding of human biology, ultimately leading to significant advances in scientific knowledge. The number of registered clinical trials has increased drastically in recent years, with more than 409 thousand globally registered studies as of March 2022. These studies are crucial for researching and developing novel drugs for treatment purposes.
In response to many past cases where patients were exploited, ethical guidelines and regulatory processes have been developed over the years to ensure that volunteers are protected and that the integrity of science is maintained.
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Why Are Regulations and Codes of Ethics Important in Clinical Research?
Regulatory and ethical principles have been put in place over the years due to unfortunate cases of unethical research that have occurred throughout history. One of the most well-known cases is the Tuskegee Syphilis Study. This unethical trial involved deceptively administering placebos to 400 African American males in Alabama with syphilis. These participants were led to believe that they were receiving treatment when researchers never intended to give any treatment but instead performed the trial to assess the progression of syphilis over time.
Regulatory and Ethical Principles
Several regulatory and ethical principles have been implemented, followed by clinical trials. Firstly, the clinical trial must have a scientifically valid objective where a clear conclusion can be obtained, ensuring that the study has a defined purpose in advancing scientific knowledge. The research methods must also be valid and achievable.
This principle helps to avoid unethical use of valuable resources that could be used elsewhere for scientifically justified studies. Furthermore, a study needs to hold scientific validity as research puts participants at risk, and therefore the study must have a valuable purpose to ethically authorize asking humans to risk their health with unknown outcomes for research.
It is also necessary for researchers to evaluate the potential benefits and risks to patients that may occur as a result of treatment. A full assessment of benefits and risks is necessary, including those that are significant, minor, physiological, physical, and even social. The research will only be ethically justified if the benefits are favorable and outweigh the risks.
Patient selection is also another aspect of clinical studies that must be carefully regulated. Recruiting patients must solely be based on the scientific purpose and goals of the study. Patient selection should avoid bias and must not be influenced by other factors such as the vulnerability or privilege of patients.
Informed consent is another principle that has been put in place. Individuals have the right to decide whether they want to participate in clinical studies. They must be provided with thorough information regarding the objectives, risks, benefits, and methods of the research to make an informed decision. However, exceptions include people who cannot make an informed decision themselves, such as children, people with limited mental capacity, adults with advanced Alzheimer’s, adults unconscious due to head trauma, etc.
For those who provide informed consent to participate in a clinical trial, it is imperative to keep subjects’ personal information confidential. Throughout the clinical study, participants should be informed of the necessary information, such as any adverse events they are experiencing. This may cause patients to no longer wish to participate in the ongoing study, so the researchers should accept their decision.
Moreover, another regulatory principle includes an approval process that all clinical trials must undergo. The clinical trial protocol should be approved by a peer review group such as health care professionals or members of the public who are not involved with the trial. In addition, the protocol should also be assessed and approved by a review committee who are not involved with the trial again, such as the Research Ethics Committee (REC) in the UK or Institutional Review Boards (IRBs) in the US.
To decide whether the trial is safe and ethical, peer review groups and review committees assess numerous aspects of the study protocol. Such as whether the trial has a valid aim that addresses a vital issue within the medical field, if there is a favorable risk-to-benefit ratio, how qualified and experienced the team leads are, if patients have been provided with detailed information sheets, and whether subjects are protected, etc.
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Regulations and ethics remain vital in maintaining the validity and morals of clinical trials. These are imperative to ensure research is conducted in a way that protects patients while simultaneously helping to advance scientific research. There are still many ethical issues within the field of clinical research that need to be addressed.
For instance, there are concerns surrounding stem cell research due to the use of human embryos to harvest stem cells. Moreover, human gene editing research opens the possibility of editing human embryos, another ethical concern that needs to be addressed in the future.
- Guraya S., et al. (2014). Ethics in medical research. Journal of Microscopy and Ultrastructure, 2:121-126.
- Nardini, C., et al. (2014). The ethics of clinical trials. ecancer, 8:387.
- Shafiq, N., Malhotra, S. (2011). Ethics in clinical research: Need for assessing comprehension of informed consent form? Contemporary Clinical Trials, 32: 169-172.
- NIH. (2021). Ethics in clinical research [Online]. Available at: https://clinicalcenter.nih.gov/recruit/ethics.html (Accessed on 5 April 2022)