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Return of results in translational iPS cell research: considerations for donor informed consent

Geoffrey P Lomax and Kelly A Shepard

Author Affiliations

210 King Street, San Francisco, CA 94107, USA

Stem Cell Research & Therapy 2013, 4:6  doi:10.1186/scrt154

Published: 21 January 2013


Efforts have emerged internationally to recruit donors with specific disease indications and to derive induced pluripotent cell lines. These disease-specific induced pluripotent stem cell lines have the potential to accelerate translational goals such as drug discovery and testing. One consideration for donor recruitment and informed consent is the possibility that research will result in findings that are clinically relevant to the cell donor. Management protocols for such findings should be developed a priori and disclosed during the informed consent process. The California Institute for Regenerative Medicine has developed recommendations for informing donors in sponsored research. These recommendations include obtaining consent to recontact tissue donors for a range of scientific, medical and ethical considerations. This article reviews the basis for these recommendations and suggests conditions that may be appropriate when reporting findings to donors.