Ethics is defined as the moral principles that a person follows in conducting a certain activity. It is the moral codes that influence an individual’s beliefs, behavior, and choices in life. In other words, ethics is the governing principles or standards of decency that a person adheres to. In today’s society, ethics serve as a guide to the morality and the decency of people towards one another.
Clinical research is bounded by ethics as well. Even before patient recruitment, ethical considerations greatly influence the study design of a trial and its acquisition of informed consent forms (ICFs). Laws, regulations, and protocols have great emphasis on the participants’ safety, rights, and welfare to avoid unjust, inhumane, and borderline illegal experiments being conducted on humans.
Technical skills are required in Clinical Operations management. However, it is also imperative for the clinical project manager to be knowledgeable and articulate in the technicalities of rules concerning ethics in clinical research. Clinical Operations consulting is one way to make sure that there are more benefits than risks for the participants in the given study.
Evolution of Ethics in Clinical Research
When the United States passed the Food and Drug Act in 1938, Modern Regulation began. As medical treatment became more complex and revolutionary, a need for more intricate governance surfaces to protect the welfare of test subjects. But as technical as it can be, the core principle of ethics still remains as simple as the statement, “do no harm.”
In 1947, the Nuremberg Code was imposed. This code of ethics emphasized that only qualified medical personnel are allowed to perform scientific and medical testing. This also requires informed consent to conduct such clinical trials. The goal of this law is to preserve human dignity and prevent human agony.
The World Medical Association published the Declaration of Helsinki in 1964. This regulation imposes that compensation should be given when harm was inflicted on the participants. Also, the benefits that a certain clinical study might discover should also be given to its subjects.
Since then, ethical concerns in delivering Clinical Operations have greatly evolved. According to Vasantha Muthsuwamy, in her published paper “Ethical Issues in Clinical Research” (2013), even though the regulations in running a clinical operation are based on the principles of autonomy, safety, beneficence, and justice, the continuous evolution of such regulations are still being taken into considerations daily. With the advancement of technologies, increase in research activities, and globalization comes more intricacies, complexities, and sophistication of guidelines needed to uphold by the researchers in order to protect the general welfare of the participants.
According to the American Bar Association (ABA), Clinical Operations management must follow a framework in order to protect the dignity and rights of the test subjects. The ABA was able to come up with 7 principles to guide the management of the Clinical Operations regarding ethical concerns in clinical trials.
Social and Clinical Value
There is risk in every experiment. But in order to expose a subject to it, the risk must be first justified. Any discovery or results by the society or the scientific community must be shared and gain a significant amount of importance to allow the public to question the inconveniences and outcomes for the common good.
Is the research question answerable? Are the methods valid and possible? is the objective of the clinical research clear? Does it use proven and widely-accepted principles and practices? These questions must be taken into consideration before wasting any resources on a study that has no greater purpose or value.
Fair Subject Selection
Patient or participant recruitment should be solely based on the scientific goal that the clinical study is trying to achieve. This process should only impose minimal risk and maximum benefit for both the individual and the society. Also, subjects that are exposed to risk should also enjoy the benefits that the Clinical Operations department can offer.
Favorable Risk-Benefit Ratio
As ABA mentioned in the article, “If the benefits outweigh the risks, the research is justified.” There is no certainty as to the risks and benefits that certain testing can provide. However, clinical projects are carried out not to provide health care but to produce beneficial treatment.
To ensure the integrity of the study, an independent body should review its outcome with no vested or conflict of interest to prevent bias. Reviews can eliminate prejudices and bring light to some overlooked aspects of the study. In the US, there are Institutional Review Boards (IRBS) and Ethics committees (rest of world) available to evaluate and monitor clinical research.
Every participant in the study has the right to fully be informed of the objectives, risks, benefits, and processes in the given study. This will help them decide whether to accept the invitation or not in relation to their situations and interests. Participants must join voluntarily with full disclosure of the experiment being done to them.
Respect for Subjects
Autonomy and confidentiality. These qualities should be followed in any given clinical trial that involves participants in the study. Also, participants must be fully aware of their health situation and progress throughout the duration of the study.
Data Safety Monitoring Boards
There are other organizations that help Clinical Operations management and clinical operations managers with their studies when it comes to safety. Henry Silverman, in his article “Ethical Issues During the Conduct of Clinical Trials” (2007), states that DSMBs are fully recognized in the 1960s because of the concern that individuals closely working on such trials may not be fully objective in reviewing data that might be harmful to their own test subjects.
DSMBs' main focus is to maintain safety experience in a trial. They do this by comparing gathered data to determine whether clear harm or benefits are occurring. They also review adverse effects or AEs and serious adverse effects or SAEs. If there is a significant amount of AEs or SAEs in a control group, DSMBs can decide to stop the trial in order to protect the subjects' overall health and welfare.
The definition of right and wrong can slightly vary from one culture to another. However, everyone, especially in the scientific community, can agree that life is precious and important. The purpose of advancement in medicine, technology, and science is for the betterment of humanity’s welfare. So, it is only sensible that safety, dignity, and decency are taken into highest consideration when conducting Clinical Operations.