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“Actionability” and the Ethics of Communicating Results to Study Participants

By Patrick Monette

To what end does a physician have a responsibility toward a research participant? Specifically, what data may be considered “actionable” for the physician to disclose to the patient, and when and how might this be done?

In the clinical setting, contemporary medical ethics address a physician’s “fiduciary responsibility.” That is, there is a well-established professional expectation that the physician will place the patient’s interests above their own and advocate for their welfare. This post focuses on an alternative dyad, that of physician and research participant, to explore how the field has broached the topic of actionability in the setting of clinical research.

How can we think about “actionability”?

“Actionability,” clinically defined, is a measure of whether a piece of information known to the physician is worth acting on with a patient.

Currently there is no clear definition for “actionability” regarding findings in clinical research. As one research group put it, “Findings are not actionable in themselves; they are actionable for an individual—or a set of individuals—in specific situations.”

This same group split actionability into three categories with implications for what refusing to return results would entail at each level.

At the first level, “well-established medical actions,” there is a clear breach of duty if the clinician does not share the finding and associated recommendations. An example of a finding bearing this type of actionability is a positive genetic test result for a mutation associated with an increased risk of developing cancer.  The second level, “patient-initiated health-related actions,” involves the kind of findings that are not associated with any established medical standards, but which nevertheless could inform a patient’s decision to make various lifestyle or other modifications with their health in mind. Finally, the third level, “life plan decisions,” refers to findings that could influence a patient’s actions beyond the realm of health, such as professional decisions. “For instance, the knowledge of a mutation causing an untreatable disorder, such as retinitis pigmentosa, can guide patients’ professional decisions (avoidance of certain activities requiring good vision),” the authors explain.

From which perspective does “actionability” matter? The researcher? The clinician? The patient?

But who defines actionability as it relates to the dyad?

The perspective from which actionability is determined has important implications: A patient may define a particular result or piece of data as “actionable” differently than would a physician involved with clinical care or a clinical trials investigator.  This subjectivity led one group to reason that actionability should necessarily be understood from the patient’s perspective. A research finding may have impact beyond clinical action – socially and emotionally, for example – which may still be important to patient.

A researcher may want to stay out of clinical care and recommendations, and instead opt to send any questionable findings to a physician for interpretation within the clinical context. But the certainty behind those findings may be a question of active investigation, which again poses concerns as to whether the findings are truly actionable. In 1999, the National Bioethics Advisory Committee (NBAC) recommended that disclosure of research findings should be “an exceptional circumstance,” and only if they are “scientifically valid and confirmed,” “have significant implications for subjects’ health concerns,” and “a course of action to ameliorate or treat these concerns is readily available.”

How does “actionability” relate to ethical principles?

Do researchers have obligations to the participants in their studies?

Beskow and Burke suggest researchers have some ethical obligations to their subjects. A duty to rescue, they write, applies “when, in the course of research, an investigator discovers genetic information that clearly indicates a high probability of a serious condition for which an effective intervention is readily available.” They emphasize this duty is not the same as that of a traditional doctor in relation to the patient. A separate author, Pilar Ossorio, expands the researcher’s obligation beyond Beskow and Burke’s recommendation, suggesting that researchers have a duty to disclose in cases where it would be “morally superior to not doing so.

This is a particularly strong, though less well-defined, recommendation compared to the NBAC’s. Still, some contend that no ethical responsibility/duty exists between researcher and participant.

Interestingly, reliance on respect for autonomy as a guiding principle does not directly indicate whether to return findings. On one hand, a respect for the individual could entail offering access to obtain all data, results, or other subjectively useful information. Conversely, there is an argument that for a participant to make a truly informed and autonomous choice, the information given to them must be clinically meaningful and interpretable, which may not be possible given the complex data sets, algorithms, imaging modalities, and uncertainties that exist in clinical research.

This post highlights just a few of the complexities at play when considering if, when, and how a researcher may or should act when confronted with “actionable” data. A full discussion on the ethics of returning research results (other ethical pillars, actions based on findings from deidentified data, etc.) is outside the scope of this post and an area of active research.

 

Patrick Monette is a medical student at Harvard Medical School.

 

This post is part of our Ethical, Legal, and Social Implications of Deep Phenotyping symposium. All contributions to the symposium are available here.

The Petrie-Flom Center Staff

The Petrie-Flom Center Staff

The Petrie-Flom Center staff often posts updates, announcements, and guests posts on behalf of others.

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