INTRODUCTION: In these times of rapid discovery, it is vital to remember five bioethical foundations undergirding all beneficial medical research. These foundations (summarized by the acronym BNAIJ) are beneficence, nonmaleficence, autonomy, informed consent/assent, and justice. Others have written more detailed explanations of these foundations. However, this primer is presented as a quick review for medical science liaisons (MSLs), key opinion leaders (KOLs), primary care providers (PCPs), clinical research coordinators (CRCs), clinical research associates (CRAs), pharmaceutical companies, medical institutions, and community leaders. The purpose of this primer is to optimize the evaluation and communication of not only today’s medical marvels and dilemmas but also tomorrow’s clinical wonders and challenges.
BENEFICENCE: Beneficence is ensuring that clinical research practices and projects always promote the well-being and best interests of those involved. While it includes following the time-honored Hippocratic Oath, it goes beyond that noble goal. In addition to ensuring that the practices and research do not harm patients and research subjects, it makes objectively verifiable benefits that outweigh any risks a concrete, non-negotiable goal. Thus, clinical research and practices must be based upon experimentally evaluated, objective scientific research, not upon opinions or philosophical trends. Such research and practices must also be supervised and conducted so well that the integrity of principal investigators, supporting institutions, and individual studies is never compromised.
NON-MALEFICENCE: Nonmaleficence is the coequal other side of the bioethical “coin” whose first side is beneficence. Thus, non-maleficence avoids harming patients and research subjects, or at least severely minimizes such harms, during the pursuit of objective, experimentally tested benefits. While ensuring non-maleficence is sometimes more easily said than done, preserving it is still a non-negotiable goal. When research and practice are properly balanced and executed, avoiding or minimizing such harms naturally arises from beneficence.
AUTONOMY: Autonomy is the respect and protection of individual patients’ or research subjects’ inherent rights to determine the course of their therapy or research participation. Respecting and preserving such autonomy are only possible when the patients/subjects are as well-informed as possible regarding procedures, benefits, and risks. Keeping patients and subjects sufficiently informed requires not only educating and updating them regarding potential benefits and risks throughout their treatment and participation but also respecting all their decisions during the full course of therapy and treatment. Typically, discussions of autonomy include active consideration of informed consent issues. Ensuring patient/subject autonomy is particularly difficult when dealing with members of vulnerable populations such as minors, the elderly, incarcerated individuals, persons with disabilities, and other groups.
INFORMED CONSENT / ASSENT: Informed consent, or at least informed assent, is traditionally considered to be the bioethical foundation of autonomy. While these foundations are closely related, it is useful to give special consideration to informed consent and informed assent here as a separate, but intertwined, foundation of bioethics. This is because situations may become ethically murky when therapies & research are applied to vulnerable populations. It can be difficult to assess the ability of minor children, pre-adolescents, or late adolescents to fully understand the risks and benefits of more hazardous procedures. Likewise, it is sometimes tricky to balance the needs and desires of those individuals with the wishes and obligations of their parents or other guardians assigned to protect them. Therefore, additional caution with riskier treatments offering more uncertain outcomes is especially warranted. Children under the age of majority are especially vulnerable and have difficulty predicting or understanding the long-term consequences of certain treatments. For this reason, the term informed assent is sometimes used when discussing the more limited power of children to make informed decisions and extend greater protection to those children. Thus, special efforts must be made during study subject recruitment and implementation to ensure that both the minors and their guardians are properly informed. A similar need for caution exists when considering treatments and therapies for incarcerated individuals, the very elderly, cognitively impaired people, and other vulnerable populations.
JUSTICE: Justice is the fifth and final bioethical foundation discussed here. It rightfully requires the fair, beneficial distribution of healthcare benefits, resources, knowledge, and access to all members of a population. Thus, everyone in a population, without regard to membership in various demographics, should be given fair, scientifically objective access to various therapies while assuring simultaneous compliance with the other four bioethical pillars described above. This includes not only giving appropriate access to necessary, experimentally verified therapies, but also ensuring that incentives removing obstacles to research participation do not become tools for pressuring or coercing vulnerable populations into such participation.
CONCLUSIONS: Adhering to the five bioethical foundations (BNAIJ) of medical research and therapy summarized above will allow a society to maximize the benefits and minimize the risks of various therapies and research projects. Thus, MSLs, KOLs, PCPs, CRCs, CRAs, pharmaceutical companies, medical institutions, and community leaders should do their best to incorporate these foundations into all aspects of medical research and care both now and in the future.
About the author:
Dallas V. Mullins II, MSc, MAT
This article was written by Mr. Dallas V. Mullins II, M.Sc., M.A.T. Mr. Mullins most recently completed a 3-year stint as a Biology Instructional Coordinator for Northeast State Community College (NeSCC) in Blountville, Tennessee. In that crucial role, he not only prepared all Anatomy & Physiology labs, General Biology labs, and Microbiology labs for their primary campus but also taught courses in Majors Biology, Biology for Nonmajors, Anatomy & Physiology, Microbiology, Physical Sciences, and other science courses for NeSCC. Furthermore, Mr. Mullins taught courses in Anatomy & Physiology, Infectious Diseases, and Microbiology for nursing students at American National University (ANU) and General Biology courses for Virginia Highlands Community College (VHCC).
Mr. Mullins’ work for all three institutions involved teaching not only on-site, in-person courses but also hybrid and exclusively online Biology courses using various LMS and instructional platforms. Finally, his extensive scientific employment experiences include many years as a science educator at both the high school and college level, document review work for a clinical research organization (CRO), a research internship in the bioanalytic product development lab of a pharmaceutical company, and quality-control work for both the pharmaceutical and general chemical industries. Over the years, his scientific interests coalesced into a passion for effective clinical communication and the optimization of ethics in the healthcare industry. He appreciates the opportunity to present his insights to the MSL Journal and its readership and welcomes greater collaboration between himself and the MSL industry.
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