Drug Trials and the Ethics of Medical Researchers
By: Cohen, Placitella & Roth @ Mar 08, 2016
When it comes to the legal requirements for drug trials, can society rely on the ethics of medical researchers? Or are there limits when we consider the treating physician as a researcher? That question was posed by an article in the Temple Journal of Science, Technology & Environmental Law. In short, medical research conducted by a physician actually may hinder a subject’s (or patient’s) ability to give informed consent, which is a serious concern in drug trials. Indeed, if a patient does not actually give the level of consent required by law and later sustains injuries as a result of the drug trial, the physician may be liable for those injuries. As the article contends, “current federal regulation and judicial remedies are inadequate to protect research subjects.”
Rise in Pharmaceutical Research and the Need for Drug Trial Subjects
Why is there a need to focus on the issue of informed consent now? As the article notes, pharmaceutical company research has been on the rise for the last couple of decades. And when drug companies conduct a lot of research, they need a lot of subjects for drug trials. To be sure, back in 1980, pharmaceutical companies funded about $1.5 billion in research, including drug trials. By the year 2000, however, that number had skyrocketed to about $22.4 billion. The amount spent on human research has continued to expand at seemingly exponential rates, as the figure from 2000 grew to more than $49.3 billion on human research in 2004.
When these human trials take place, can we count on patients to give informed consent when the researcher is their physician? To better understand the logistics and potential dangers of drug trials, it is important to understand what happens during a clinic trial.
Learning More About Clinical Trials
What is a clinical trial, and how does a subject give consent? According to a fact sheet from the National Institutes of Health (NIH), clinical trials are “research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans.” The research methods must abide by specific scientific standards, and they must have informed consent from anyone who is going to be a subject of the study.
In general, the NIH explains that clinical drug trials usually result in one of the following outcomes:
- Proof that the drug improves patient outcomes;
- Evidence that the drug does not offer any benefits to patients; or
- Proof that the drug causes an unexpected harm to the patient.
The latter category is the one that is particularly concerning. When a subject suffers an injury during a drug trial, it is important to consider whether the subject actually gave informed consent.
Barriers to Informed Consent
Why do we need to ask if it is possible for subjects to give informed consent when the researcher is that subject’s physician? As the article underscores, “patients with illnesses are eager for treatment,” and as a result “desperate hopes are easily manipulated.”
Given that many patients put the utmost trust in their physicians to act in their best interest, when a researcher/physician recommends that a patient get involved in a drug trial, it is very possible that the patient might see this as a recommendation for treatment from a physician (and not from a researcher). And in such cases, a patient might not actually be giving informed consent. To be sure, the patient might not understand that the drug trial is not a treatment recommendation from a physician, but rather a study suggestion from a researcher.
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