The figure shows the same series of stages in the in a clinical pathway for a proposed use of HHGE that were shown in Figure 4-1, from basic and preclinical research to clinical use and evaluation. On the right side of this figure is a blue box running in parallel down the side of the pathway. This represents the International Scientific Advisory Panel described in the report, which would serve as a resource for regularly assessing scientific and clinical knowledge and preclinical evidence.

FIGURE 5-1An ISAP would provide regular, independent assessments along the clinical translational pathway, as envisioned in Chapter 4, toward HHGE for certain circumstances of serious monogenic diseases

These assessments would include reviewing advances in preclinical research, providing advice on whether sufficient methodologies to support evaluating a proposed use had been developed, informing the deliberations of a country's own advisory or regulatory bodies if requested, and analyzing the outcomes of any permitted clinical uses of HHGE.

From: 5, National and International Governance of Heritable Human Genome Editing

Cover of Heritable Human Genome Editing
Heritable Human Genome Editing.
The Royal Society; National Academy of Sciences; National Academy of Medicine; International Commission on the Clinical Use of Human Germline Genome Editing.
Washington (DC): National Academies Press (US); 2020 Sep 3.
Copyright 2020 by the National Academy of Sciences. All rights reserved.

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