Because of the experimental nature of clinical research, legal questions arise quickly, especially for people who are thinking of joining a trial as a patient.
Patients will want to know what legal protections they have against harm, for example. And as issues of personal data sovereignty continue to arise, patients will want to know how their medical data will be used in a given trial (and thereafter).
Answers to these questions continue to unfold, and they will likely define the boundaries of clinical research for years to come, as well as how patients’ rights are defined.
Below are three of the most pressing legal questions for clinical research patients.
What Happens When a Patient Is Harmed or Dies?
This is, understandably, a top-of-mind concern for patients, and that’s why there are safety protocols and informed-consent procedures in place.
Still, there are cases in which a patient suffers harm during or after a trial, and sometimes there are cases in which a patient dies. In those cases, there are still some legal gray areas that courts have yet to explore.
For example, in early 2018 Michelle Llamas at Drugwatch reported on a case involving a patient who suffered heart problems and died after enrolling in a clinical trial for Johnson & Johnson’s antipsychotic drug Risperdal.
The patient’s parents later sued the drug manufacturer and the patient’s psychiatrist, claiming that “J&J’s employees [ignored] abnormalities in his heart, which, the lawsuit says, led to his death,” Llamas writes.
Llamas reports that, in 2015, a jury found both the drug company and the psychiatrist shared culpability in the patient’s death. However, an appeals court three years later ruled that the drug company does not “owe the deceased a duty of care for a preexisting heart condition.”
It’s this duty-of-care question that could impact the way future clinical trials are conducted.
Eric Alexander, a partner at the law firm Reed Smith LLP, wrote about this in 2018 in reference to the case Wholey v. Amgen, Inc., in which the plaintiff claimed injury “from the use of a well-known and often-studied FDA-approved prescription drug both during and after a clinical trial,” he writes.
In that case, a New York appellate court ruled that the drug manufacturer “owed no duty to the plaintiff.”
“... Thus, her claims concerning the drug Enbrel must be limited to those that allegedly arose after she stopped participating in the trial and was prescribed the drug as a patient.”
This is where legal counsel will be helpful in drafting future informed consent documents. The problem, however, is these documents are already difficult to read. It’s a lot to ask patients to be literate in medical and legal concepts.
That’s why David Rosen, a partner at the law firm Foley & Lardner, argues it’s time to reassess how informed-consent documents are presented. “I think those who are administering consent need to take the time to make sure potential subjects fully understand and appreciate those risks and benefits of participating in the study, have the opportunity to ask any questions, and have ample time to make an informed decision,” Rosen tells Clinical Leader.
What Trial Data Can Become Public Information?
The FDA has clear guidelines on how clinical trial data must be reported. The results of all studies must get shared, regardless of whether the trial was successful.
That law went into effect in 2007. However, as Nick Paul Taylor at FierceBiotech reports, the FDA interpreted that law as such that only the sponsors of trials from early 2017 onward had to share all results. Trials from late-2007 until then “only had to report results if the tested product came to market.”
That’s a major gap in the field’s collective knowledge. So in 2018, the Media Freedom and Information Access Clinic filed a complaint on behalf of the Yale Collaboration for Research Integrity and Transparency that challenged the FDA’s interpretation of the law.
A judge accepted that argument and ruled that the law “‘unambiguously’ requires the reporting of results from studies that finished before the FDA’s final rule took effect in January 2017,” Taylor writes.
In and of itself, this reinterpretation of the law doesn’t affect individual trial participants. What it does demonstrate, however, is that trial results and trial data still exist in a somewhat fluid legal realm.
Case in point: In a 2014 paper published in JAMA Internal Medicine, researchers Walter N. Kernan, Catherine M. Viscoli and Mathew C. Varughese explore how a handful of cases create a precedent in which “researchers conducting randomized clinical trials may find themselves subject to legal subpoenas for interim data.”
If courts view clinical trial data as a public good, they argue, that could lay the groundwork for a case in which a plaintiff successfully argues for the unblinding of a treatment assignment. The scientific method could conceivably be pitted against public interest in that case.
In an October 2019 article for the Journal of Law and the Biosciences, researcher Lisa Eckstein reviewed how U.S. courts had ruled on the disclosure of interim trial data from ongoing trials and found that, among other things, the courts tended to demonstrate “[A]n uncritical acceptance of the blinding process.”
That said, this remains a legal area with plenty of unbounded space to explore. Eckstein’s article explores some of that territory as it relates to stopping boundaries of trials, and what the FDA’s role is in establishing that framework.
Expect many further investigations into what trial data should become a matter of public record.
How Can Researchers Use Trial Data in the Future?
This question gets at the heart of the emerging field of data sovereignty, or how much ownership a person has over the data collected about them.
From a patient financial perspective, this question can have major implications, as in the landmark 1990 case Moore v. Regents of the University of California. Helen M. French at Clinical Leader writes about this case, in which a patient was found to have unique blood cells, and the patient’s doctor patented them.
The court ruled that the patient had “no property rights to his discarded cells or to any profits made from them,” French writes, but the physician did have an obligation to reveal their financial interest in using those unique blood cells.
This is important because the California Supreme Court felt that, in 1990, “extending property rights to include tissue or organs would have a chilling effect on medical research,” French notes.
Data sovereignty dovetails with other conversations about informed consent because patients have a right to know what current and future claims they relinquish when they enroll in a trial. The very nature of consent might have to evolve to accommodate future realities.
In a 2019 article for the Computational and Structural Biotechnology Journal, researchers Fida K. Dankar, Marton Gergely and Samar K. Dankar outlined some new models of consent, including:
- Broad consent. This is when the patient authorizes “all future and unforeseeable data uses with no limitation.”
- Tiered consent. This is when the patient selects what research areas their data can be used in. “Subjects can also request to be re-consented for future uses of their data,” the researchers note.
- Dynamic consent. This is when the patient grants consent in real time as research use cases emerge. The patient would have to get pinged with consent requests from researchers, and then the patient could make a case-by-case decision about who gets their data, and for what purposes.
Again, this all adds a layer of complexity to the already complex matter of consent comprehension. Is it even realistic to expect a patient to make an informed, case-by-case decision about their data? Is that a decision that could be delegated to a third party (something that Dankar, et al. suggest in their paper)?
That intersection of data sovereignty and consent creates one more legal frontier that will continue to vex researchers and trial participants alike.
For patients, it’s a good idea to have some grasp of legal challenges such as these before enrolling in a trial. It might even be wise to seek outside legal counsel just so you understand everything you could be consenting to.
As medical science evolves, these questions will likely only get more complex. That legal complexity will then become a major driver in how future clinical trials are designed and organized.