By Ana S. Iltis, Grace Koster, Emily Reeves & Kirstin R. W. Matthews

Abstract

Recent advances in methods to culture…

Scientists and members of the public exploring the controversial area of U.S. human embryo and embryoid research will find a complex and sometimes bewildering assortment of federal and state laws. The authors recommend additional guidance, but note slow progress in the development of embryo research policy.

The authors examine a proposal for new human embryo and embryoid guidelines, writing that before conducting any research beyond day 14, scientists must develop clear, thoughtful and culturally sensitive guidelines that include limitations and oversight procedures to ensure that science responds to societal needs and values.

This journal article explores why the public and stakeholders should help develop guidelines and policies governing scientific practices for controversial biomedical research issues, such as genetically editing human embryos.

It now seems technically feasible to culture human embryos beyond the “fourteen‐day limit,” which has the potential to increase scientific understanding of human development and perhaps improve infertility treatments. Robust stakeholder engagement preceded adoption of the fourteen‐day limit and should arguably be part of efforts to reassess it, write the authors.

To understand the variations and impact of national policies, the authors reviewed and analyzed IVF, hESC and human embryo research laws or national guidelines currently in place in the top R&D-investing nations. Regenerative Medicine, Aug. 17, 2020.

Gene editing in humans raises ethical and safety issues that require further discussion to identify a responsible way forward.

A growing number of stem cell clinics treat a variety of illnesses and injuries, yet few have conducted the necessary clinical research to ensure safety and efficacy. The authors highlight the importance of collaboration between scientists, regulators, patients and patient advocates in developing effective policies and practices for unproven stem cell-based intervention clinics.

The authors explore the different scientific values and priorities that should be considered in setting the policy agenda for effectively combating neglected tropical diseases (NTDs) and argue that researchers and physicians should participate in this process.

This journal article examines the risks patients face in seeking experimental stem cell-based interventions from clinics outside the United States. The authors advocate for new public policies that encourage patients to remain in clinical trials in the U.S.