Skip to main content
Markkula Center for Applied Ethics

A Justifiable Framework Concerning Non-Validated Practice

360x225, one-column

360x225, one-column

Alexander Castro ’23

Dmitriy Gutarev/Pixabay 

Alexander Castro is double-majoring in Biology and Public Health Science and is a 2021-22 health care ethics intern at the Markkula Center for Applied Ethics. Views are his own.

Whenever a patient has been admitted to the hospital for an extended period of time or keeps being readmitted, a high sense of urgency, restlessness, and agitation may occur. The patient and their families, the physician, and all of the other health care professionals involved can also experience these challenges when established health care treatment plans do not lead to beneficial outcomes. 

 While it is safe to say that modern healthcare and medicine only keep evolving, the following question must be considered: what can be done when established treatments do not work? The answer to this question is complex. However, one highly discussed option is the use of non-validated treatment options dedicated to patients that no longer benefit from established or validated treatment options. 

The relationship between non-validated treatment options and the term innovation mirrors one another as this can be considered an enhanced definition of innovative practice. Concerning the definition of non-validated practice, here is a breakdown for one's understanding: the first or most recent use of diagnostic, therapeutic, or preventative interventions that introduce a significant shift ('new'); the lack of sufficient proof of safety or efficacy for routine health care ('non-validated); and finally, having the primary goal of benefiting individual patients ('practice'). With that said, many argue whether this type of practice is justified or not, as it brings up a variety of ethical issues in the discussion. 

Depending on the patient's circumstance, non-validated practice should be justified as long as all ethical circumstances pertaining to the patient are being strongly considered through a robust framework centered on the patient's best interest. Sometimes, this type of practice can derive from a self-interest perspective on behalf of the clinical practitioner. In a nutshell, are physicians and all other practitioners implementing a non-validated treatment option intended to truly benefit the patient? Or are these decisions driven by self-interest to, perhaps, discover the next medical breakthrough and win a Nobel Prize? 

The following are issues that must be considered before making such decisions in order for it to be justified. 

In the matter of validated and already-established treatments, there comes a time when they simply will no longer work for a patient. This places the patient in an unfortunate situation. These treatments have some sole purposes: cure disease, limit disease progression, improve or safeguard disease-affected capabilities, or relieve pain. 

When these treatments are no longer effective, providers will sometimes look to a non-validated practice. However, non-validated treatments impose risks to patients. There is a high level of incertitude of the potential benefits and the risks of harm of the non-validated treatment option. This creates ethical concerns consisting of whether it is in the best interest of the patient to perform a non-validated treatment, whether more harm than good will be caused to the patient due to the lack of validity of the treatment, and a question is imposed on the physician's morality in wanting to try this in the first place. In such circumstances, research is what many clinical practitioners look to research to further examine a non-validated practice's validity. However, time may not be an ally to these practitioners as, on many occasions, there is a tight timeframe in how much longer the patient has to live. It's either putting a stop to all of the currently established and already-performed treatments and letting the nature of life take its course or physicians transitioning to the unknown nature of medicine.

Let's use the Declaration of Helsinki to support this discussion further. This declaration was developed in 1964 by the World Medical Association as a "statement of ethical principles for medical research involving human subjects." Yes, this declaration is heavily involved in research, especially clinical studies, but for this discussion, we will stick to non-validated practice when research is not applicable due to a tight timeframe for the patient. 

One of the general principles of this declaration is stated as the following: "In the treatment of a patient, where proven interventions do not exist or have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician's judgment it offers hope of saving life, reestablishing health, or alleviating suffering…" 

Is this principle from the Declaration of Helsinki enough to justify the use of a non-validated practice? Are the indicated criteria truly in the best interest of the patient? Something that stands out from reading this principle is the phrase, “seeking expert advice," which lacks definition and volume. It is unclear as to what the expert advice is referring to as it can easily mean the consideration of an “expert” based on their knowledge and expertise in a specific field or whether this is some sort of conventional agreement on behalf of certain parties which speaks for strong review and careful consideration.

To justify a non-validated practice, a more thorough review must be implemented as the agreement between the physician and the patient is not enough. This can ultimately result in harmful outcomes, even if the physician thinks that they are acting in their patient's best interest. 

Let's refer to a hypothetical situation: A physician has had the same patient for several years, which has resulted in a close interpersonal relationship. The patient is suffering from liver disease, and it has been determined that no existing established treatment will work. The physician is emotional as he does not want his patient–who has become a close friend–to die. This has created a great deal of desperation and eagerness to be innovative to save his patient. The physician then leans on a non-validated treatment option that he has had in mind for quite some time now. He then tells his patient: "Look, there may be another option, but it hasn't been established in medical practice." The patient sees this as an opportunity and gives the physician informed consent. 

It is important to note that even though the patient can give a physician informed consent for non-validated practice, it does not mean that it can be justified that easily due to all of the emotions that both the provider and the physician share. Again, in his heart, the physician may think that he is acting in the best interest of the patient. In reality though, his emotions may blind him from making a proper ethical decision which can cause harmful outcomes, thus resulting in unintended maleficence. External review of the non-validated practice must be implemented due to the preceding situation as it isn't ethical for the physician and patient to make such a significant decision. 

One may consider ethical review boards, which primarily focus on the ethics behind research where human research subjects are included. In this case, ethical review boards would not be the best option for making treatment decisions about individual cases. Instead, the decision should be made within the hospital/clinic, as these decisions would ultimately impact the location where the non-validated practice is taking place. Perhaps the head of the clinic/hospital would be the most applicable to determine whether the proposed non-validated practice is justified or not. 

Senior physicians would also play an essential role in supporting their leadership when diving into such imperative discussions. In addition, appointing a hospital/patient advisory board would also be an excellent way to determine the justification behind non-validated practice due to the involvement of legal and ethical experts and former patients and their families. Just because a treatment is non-validated does not entirely mean there is no theoretical knowledge behind ideas in this type of practice. The power of theory is essential and can be truly beneficial for patients. However, just because a theory is solid and well-thought-out does not mean that a framework must not be used to determine whether a non-validated practice is justified. Informed consent on behalf of the patient is fundamental; however, a careful assessment must be used to ensure that physicians and patients make the best decision possible instead of creating an injustice. 

Jul 5, 2022

Subscribe to Ethics Center Blogs

* indicates required
Subscribe me to the following blogs:

Make a Gift to the Ethics Center

Content provided by the Markkula Center for Applied Ethics is made possible, in part, by generous financial support from our community. With your help, we can continue to develop materials that help people see, understand, and work through ethical problems.