Patient Awareness and Approval for an Opt-Out Genomic Biorepository

Abstract

Aim: In this study, we sought to assess patient awareness and perceptions of an opt-out biorepository. Materials&methods: We conducted exit interviews with adult patients and parents of pediatric patients having their blood drawn as part of their clinical care at Vanderbilt University Medical Center (TN, USA). Results: 32.9% of all patients and parents of pediatric patients report having heard of the opt-out biorepository, while 92.4% approve of this research effort based on a brief description. Awareness that leftover blood could be used for research increased among adult patients during the study period, from 34.3 to 50.0%. Conclusion: These findings will inform ongoing assessments of the suitability of opt-out and opt-in methods as alternatives to written informed consent for inclusion in a biorepository.

KEYWORDS::

• biorepository
• exit interviews
• human nonsubjects biorepository
• opt-out research
• research ethics

Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at: www.tandfonline.com/doi/suppl/10.2217/3dp-2022-0019

Acknowledgements

The authors would like to acknowledge the contributions of D Roden, W Chen, E Bowton, M Basford and D Lillard to this work.

Financial&competing interests disclosure

These studies were funded by the Vanderbilt Genome-Electronic Records Project, NIH/NHGRI grant 1U01HG006378–01 and the Vanderbilt Institute for Clinical and Translational Research, NCATS/NIH grant UL1TR000445. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.