A novel 'social contract' - An attempt to harmonize a sponsor's exploratory research with a clinical study participant's data rights.

Laurence Mignon¹, Kim Doan¹, Michael Murphy¹, Lauren Elder², Chris Yun¹, Jeff Milton³, Shruti Sasaki¹, Christopher E Hart⁴, Dante Montenegro⁵, Nickolas Allen¹, Dany Matar⁶, Danielle Ciofani⁷, Frank Rigo¹, Leonardo Sahelijo⁸

¹Ionis Pharmaceuticals, Carlsbad, CA, USA.

²Ambry Genetics, Aliso Viejo, CA, USA.

³La Jolla Labs, San Diego, CA, USA.

⁴Creyon Bio, San Diego, CA, USA.

⁵Instill Bio, Dallas, TX, USA.

⁶Color Genomics, San Francisco, CA, USA.

⁷The Broad Institute, Boston, MA, USA.

⁸Ionis Pharmaceuticals, Carlsbad, CA, USA. Electronic address: lsahelijo@ionisph.com.

PubMed DOI

Abstract

BACKGROUND: Pharmaceutical drug development rarely addresses a study participant's control of their genomic data, how to return individual incidental findings, and how to make use of genomic data more efficiently for exploratory research purposes. Mutually beneficial solutions to these issues are needed, as whole genome sequencing (WGS) is increasingly adopted in human research and as access to su…

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