Table 1. Identifying the ethics most applicable to each stage of translational genomics.

The definitions used for stages T0–T4 are based on, but modify the stages suggested by Khoury and colleagues.

Translational Stage	Core questions include	Guiding Ethics
T0—basic genomic research (Early Discovery)	◦When is consent needed for use of human data and specimens? ◦How to protect source privacy?	Ethics of “human non-subjects research” Ethics of biobanks & data archives Ethics of human subjects research
T1—early clinical research (Later Discovery)	◦What preclinical results warrant moving to human trials? ◦How to protect participants in first-in-human trials? ◦When to use Phase 0 design?	Ethics of “human non-subjects research” Ethics of biobanks & data archives Ethics of human subjects research
T2—late clinical research to early implementation (Development)	◦Is intervention research, clinical, or both? ◦Are professionals acting as investigators, clinicians, or both? ◦Should results remain in research record, be placed in medical record, or other? ◦How to provide research protections and clinical accountability?	Ethics of human subjects research Ethics of professional clinical care
T3—dissemination and implementation, in clinical care and in screening for public health purposes (Delivery)	◦How to advance practice based on solid evidence, among professionals & institutions? ◦When is use of genomics in screening to achieve public health goals appropriate? ◦How to create & sustain learning healthcare systems that will systematically scrutinize & improve genomics in care and screening?	Ethics of professional clinical care Ethics of public health Organizational ethics Ethics of learning healthcare systems
T4—securing health benefit for patients & populations (Outcomes)	◦How to continually assess and refine use of genomics in clinical care & public health? ◦How to ensure equitable access and benefit? ◦How to ensure public accountability?	Ethics of outcomes assessment, including comparative effectiveness research Ethics of learning healthcare systems Ethics of evaluating & addressing health disparities

^*The additional parenthetical label noted for each stage is based on, but slightly modifies the labels offered by Kelley and colleagues.

^**As this Table indicates, our approach works regardless of which labeling system is used for the stages of translational genomics.

^*M. J. Khoury et al., “Knowledge Integration at the Center of Genomic Medicine,” Genetics in Medicine 14, no. 7 (2012): 6432013;647.

^**M. Kelley et al., “Values in Translation: How Asking the Right Questions Can Move Translational Science Toward Greater Health Impact,” Clinical and Translational Science 5, no. 6 (2012): 445–451.