Balancing External Validity and Concern for Psychosocial Harms in Translational Genetic Research

Abstract

In this commentary we explore a challenge to translational genetic research: how to balance protecting research participants with ensuring the external validity of research so that research results are implemented in ways that protect future patients. Using our experience with a recently awarded National Institutes of Health (NIH) grant, we highlight the importance of external validity in ensuring that the results of translational studies are responsibly and ethically implemented in clinical practice and do not compromise the welfare of future patients whose care the study results are meant to inform. Future patients will be even more diverse and broad than study populations, and we urge researchers, and IRB and grant reviewers, to keep in mind the translational pathway that lies ahead of a study.