Study Design Using the Four Principles of Biomedical Ethics

As I’ve written before, there are a plethora of ethical dilemmas that researchers face. These include, but are certainly not limited to, various forms of less-than-honest data presentation, taking credit for other people’s work, failing to disclose conflicts of interest, conducting unethical research on animals, and conducting unethical research on people. Accordingly, there are a litany of established ethical principles that guide research in various fields. Among these are the four principles of biomedical ethics, originally proposed by Beauchamp and Childress in 1979 and since then widely adopted as standard. These principles are: autonomy, beneficence, non-maleficence, and justice. In this article, I will be discussing how these four principles should be incorporated into research study design.

Let’s begin by defining each of these four terms. Autonomy refers to the right of each person to have the ultimate say over what is or is not done to them (i.e., no overruling their preferences “for their own good”). Beneficence means maximizing benefits for patients/subjects. Non-maleficence means minimizing harm as far as possible. Justice could be taken to be synonymous with fairness. No favoritism or bias must be shown to any person, or any class of person, for any reason. Rather, every patient/subject should be treated according to his or her needs, with the only extenuating factor being the wellbeing and needs of other individuals.

 When applying this framework to research involving human subjects, it’s important that studies be designed and implemented with these principles in mind. To this end, all study subjects must give informed consent, i.e., be told honestly what the risks and potential benefits of the study are, and be freely allowed to either go ahead and participate or withdraw at any time. 

One issue that can complicate this is that of coercion or undue pressure to enroll or stay in the study. To provide just one example, some studies often try to incentivize enrollment by offering monetary compensation to participants. While this may seem entirely benign (hey, who doesn’t like getting paid for it?), it can run the risk of unfairly pressuring subjects who are financially underprivileged, for whom the decision to participate may be made not out of choice but economic necessity (let’s set aside the fact that we live in a society where there are so many people who are that hard up that this is a necessary and salient consideration, or else we’ll be here all day). 

Informed consent also runs into the issue of honestly apprising subjects of the nature of the study. Normally, subjects should be told what the study is about and exactly what they’re being tested on. However, there are often situations, particularly in psychological or sociological studies — in which participants need to be kept in the dark about the true nature of the study or even actively misled so that the researchers can properly measure the variables they wish to observe. For example, a study about what people choose to do when they think no one is looking doesn’t really work if participants know they’re being monitored. Striking a balance between keeping participants sufficiently informed while also not compromising the study can be a delicate tightrope to walk, and it’s for this reason that panels of multiple people with multiple perspectives (i.e., IRBs [link my article]) exist to review and either approve or reject the design of such studies.

When designing studies, it’s vital that the risk of harm be minimized for study subjects while maximizing the benefits that they receive — no pouring chemicals into people’s eyes to see if you can change their color. If surgery has to be administered, subjects should be anesthetized to minimize pain. If study subjects become ill or distressed, they should receive prompt and appropriate medical attention, with their health and well-being prioritized over the study’s results.

Also vital to the rights of study subjects is their confidentiality and privacy. Patient/subject confidentiality is, in itself, an incredibly broad subtopic within the field of biomedical ethics, and is covered under the US Health Insurance Portability and Accountability Act (HIPAA) and the EU’s General Data Protection Regulation. Any identifying information gathered about patients or research subjects needs to be securely guarded in compliance with these relevant guidelines, which, broadly, prohibit disclosure of such information to anyone other than those to whom the subject expressly gives permission. When working with human subjects, such discretion is paramount, as people’s lives can be severely and deleteriously impacted by improperly revealing even seemingly mundane aspects of their participation to the wrong individuals.

 One final aspect worthy of consideration is making sure that all subjects are treated fairly and equitably. This can be confounded by biases harbored by the researchers; either wittingly or unwillingly. There may, for example, be disparities in the treatment of male vs. female subjects, subjects of different races, different languages, or overweight vs. normally weighted individuals. As such, researchers should be trained to help make them aware of some of the more common biases and allow them to mitigate them.

 All of the above is only a cursory and introductory overview of the kind of ethical considerations that need to be taken when designing a study. This doesn’t even touch upon the ethics of working with animals in research, which, while involving some of the same principles, is a topic deserving of its own lengthy discussion. As I’ve mentioned before [link to my article on ethics in grad school], conducting research ethically is not simply a matter of following rules in some book. It is an active, conscious, and subjective process that every researcher, from the earliest neophyte to the most seasoned scholar, must navigate. While such considerations can sometimes feel like legalistic minutia, it’s important to keep in mind what they are intended to serve as a safeguard against. Some of the greatest atrocities in human history have been committed when the well-being of people has been dismissed in the name of scientific progress. It’s vital that we remember that, as researchers, our duty is to humanity, and that duty cannot be served while disregarding its subject.