10 February 2015

Research Ethics and Consent

'A Private Right of Action for Informed Consent in Research' by Valerie Gutmann Koch in (2015) 45(1) Seton Hall Law Review comments
Imagine your doctor tells you that a procedure involving removal of spinal fluid is necessary to diagnose your recurring headaches. He does not tell you — nor do you inquire about — the risks involved in the intervention, which include a very small risk of permanent partial paralysis. Unfortunately, paralysis occurs. American courts have established a rule of consent that provides that the physician has an affirmative duty to disclose the material risks inherent in the proposed therapeutic treatment or surgery. Thus, among other claims, you have a common law right to recover against the physician for failure to provide adequate informed consent.
Now imagine that, instead of seeking care from your physician, you have decided to become a participant in a research protocol that is intended to study the cause of recurring headaches. During the process of enrolling you in the study, the investigator does not tell you — nor do you inquire about — the risk of permanent partial paralysis. Again, unfortunately, paralysis occurs. Although the law governing human subjects research might lead the investigator to lose funding, no equivalent private right of action exists in the research context, and thus you are unlikely to be able to seek damages for the investigator’s failure to provide adequate informed consent.
Finally, consider a complicating detail to the latter scenario: the investigator, in the course of the study, runs a test on a biological sample that he removed during the procedure in order to study a hypothetical correlation between the headaches and a certain genetic defect. He discovers, incidentally, that you carry a gene that predisposes you to Alzheimer’s Disease. Although no law requires the investigator to tell you this information, there is an emerging general consensus that the investigator has an obligation to disclose such findings (or at least the possibility of such findings) to you, which could also potentially enable you to seek damages where the investigator fails to make the appropriate disclosures.
That a patient who is harmed by her doctor due to lack of informed consent has a right to recover is an established tenet of tort law. However, for historic reasons, such a right does not extend to a research participant who is harmed due to a lack of informed consent by the investigator in a research protocol. This distinction between the rights of certain individuals to seek remedies directly from those who neglected to communicate the risks of an intervention has been the subject of extensive literature on the doctrine of informed consent, although courts have generally been either unwilling or unable to extend a private right of action to research subjects.
Significantly, however, the typical research model has evolved since the most notable court efforts to find a duty of care, premised on a special relationship5 between the investigator and research participant. In contrast to research protocols that required more involved medical interventions, protocols that require minimally invasive procedures — e.g., a simple blood draw for a genetic test or the use of magnetic resonance imaging (MRI) — are much more the norm today. Further, with almost daily genetic and medical discoveries, there is an ever-increasing possibility of finding out information about the research participant that is beyond the scope of the protocol. Thus, this Article proposes that the emergence of genetic testing technologies, the proliferation of research involving biological samples, and the escalating use of medical imaging may further transform the relationship between the investigator and research participant. The right to recover for lack of informed consent is premised on the duty that arises out of the relationship between the discloser and the disclosee, which is grounded in the principle of autonomy. In the treatment context, when physicians fail to inform their patients about the risks of an intervention, patients who are then harmed by the undisclosed risks have recourse to a private right of action based in common law - a claim based on the failure to provide informed consent. At its foundation, this recourse is based on the primacy of the doctor-patient relationship and arises out of the provider’s duty to the patient. Breach of that duty - through failure to disclose information material to the patient’s decision to pursue treatment - allows the patient to recover damages.
In contrast, research subjects who are harmed by medical research have no such right of action. The most significant federal regulation related to human subjects research, the Common Rule, includes no private right of action for participants who are harmed as a result of investigators’ failure to disclose the risks of the research; instead, the penalty for violation of the regulations is typically loss of federal funding or suspension of the research. The lack of a private right of action for research harms is often attributed to the absence of a legally recognized relationship between the investigator and the participant. Consequently, this Article focuses on one element of tort liability — the duty of care — because of its centrality to the doctrine of informed consent and the principle of autonomy that it seeks to protect. Arguments for informed consent in both the treatment and research contexts, as well as for disclosure of incidental or secondary findings, are premised on the autonomy principle.
The evolution in the relationship between investigator and participant demonstrates the increasing need for a private right of action for failure to provide informed consent to research. Central to the contention of this Article, the emerging consensus that investigators have some obligation to disclose research findings to research participants reflects an appropriate response to the changing nature of the investigator-research participant relationship, rendering it more like the doctor-patient relationship. The emerging expectation that an investigator should disclose (or offer the research participant the opportunity to receive) findings that are secondary to the research protocol - potentially accompanied by the associated private right of action for failure to do so - makes the lack of obligation to disclose the primary risks of the research protocol itself (and the lack of direct recourse for failure to do so), even more obvious and challenging. Thus, this Article proposes that the ethical duty to disclose research findings represents a shift in the relationship between the investigator and research participant, which therefore supports a private right of action for research participants, who, like patients, are harmed by the failure to provide informed consent. However, the standard of care for such a private right of action for research need not - and probably should not - absolutely mirror the standard of care owed to patients in the clinical setting.
Part I of this Article explores the evolution of, and justification for, a private right of action for harms that occur due to failure to provide informed consent in the treatment environment but not the research setting. Part II then addresses the evolving research model and, in particular, the investigator-participant relationship generally, with a focus on the central principle of autonomy. The Article then turns, in Part III, to the subject of returning or disclosing research findings in research involving imaging and the testing of genetic and biological samples. Finally, Part IV recommends a modified approach to extending the common law claim for lack of informed consent to the research setting.