JMIR Publications

ABSTRACT

Background:

Deep phenotyping in psychiatry research offers great promise for intervening early with precision and bringing interventions to patients where they are in the real world in a convenient, efficient, effective and timely way. But the road to this innovative future is fraught with ethical dilemmas. Existing ethical guidance and legal regulation are not sufficient, as there are regulatory gaps, inconsistency across research teams in ethics protocols, and a lack of consensus amongst IRBs in when and how deep phenotyping research should proceed. Until the field develops more robust consensus guidelines, the onus clearly falls on individual research teams to take the lead in shaping the applied ethics of deep phenotyping.

Objective:

To help guide researchers in deep phenotyping, this Comment introduces an Ethics Checklist for Deep Phenotyping Research (“DP Ethics Checklist”). The goal of the Ethics Checklist is to promote careful design and execution of research. It is not meant to mandate particular research designs; indeed, at this early stage and without consensus guidance, there are a range of reasonable choices researchers may make. But the checklist is meant to make those ethical choices explicit, and to require researchers to give reasons for their decisions related to ELSI issues. The Ethics Checklist is primarily focused on procedural safeguards, such as consulting with experts outside the research group and documenting standard operating procedures for clearly actionable data (e.g., expressed suicidality) within written research protocols.

Methods:

For the past year, supported by an NIH Bioethics Administrative Supplement award (NIH 1U01MH116925-01) we have been exploring the ethical, legal, and social implications (ELSI) of digital health research in psychiatry, with a particular focus on what we label “deep phenotyping” psychiatric research, which combines the potential for virtually boundless data collection and increasingly sophisticated techniques to analyze that data. We convened an interdisciplinary expert stakeholder workshop in May 2020, and this checklist emerges out of that dialogue. The Ethics Checklist is composed of 20 key questions, sub-divided into six (and interrelated) domains: (1) informed consent, (2) equity, diversity, and access, (3) privacy and partnerships, (4) regulation and law, (5) return of results, and (6) duty to warn and duty to report. The questions included in the checklist are presented in Table 1, and Appendix A provides the Ethics Checklist as a user-friendly instrument for research teams. Each of the 20 ethics checklist questions are phrased so that they can be answered with a Yes, No, or Pending response. In our view, deep phenotyping research in psychiatry should not proceed until a research team answers Yes or Pending to each checklist question. To arrive at Yes or Pending for each question will require research labs to carefully consider a complex interplay of ethical and legal considerations.

Results:

Deep phenotyping research offers a vision for vastly more effective care for people with, or at risk for, psychiatric disease. The potential perils en route to realizing this vision are significant, however, and researchers must be willing to address the questions in the Ethics Checklist before embarking on each leg of the journey. The illustrative examples discussed in the essay make clear that deep phenotyping researchers have few guideposts and little empirical data with which to address many pressing ethical and legal questions critical for their research. In the absence of consensus best practices, researchers and IRBs are making it up as they go along—likely guided more by intuition than by empirical data on most of these Ethics Checklist questions. To make progress toward consensus guidance, we identify two immediate action items. First, ethics should be integrated into the practice of deep phenotyping research. Second, professional organizations such as the American Psychiatric Association and the Digital Medicine Society, along with institutions such as the NIH and National Academies, are well positioned to convene an interdisciplinary team to conduct in-depth analysis and produce foundational reports to guide the field.

Conclusions:

Deep phenotyping research offers a vision for vastly more effective care for people with, or at risk for, psychiatric disease. The potential perils en route to realizing this vision are significant, however, and researchers must be willing to address the questions in the Ethics Checklist before embarking on each leg of the journey. The deeper you go in deep phenotyping research, the deeper the ethical and legal challenges. But with timely, concerted action, the research community can promote ethically sound and legally compliant digital health research in psychiatry. Clinical Trial: Not applicable.