Revising biomedical research reviews

In biomedical research involving human subjects, research ethics committees around the world have traditionally emphasized individual rights and protections for participants, including informed consent. The emerging field of translational bioethics maintains that the social, economic and psychological implications of pioneering health research – such as gene therapy, xenotransplants and artificial intelligence – should also be considered.

Mark A. Rothstein, director of translational bioethics at the University of California, Irvine’s Institute for Clinical and Translational Science, is lead author of a Science magazine article published recently that explores the matter. For the piece, experts in research ethics and law from 22 countries evaluated current international regulatory practices and analyzed the legislative authority of their review bodies to approve, conditionally approve or disapprove of proposed research based on established criteria.

The profound social and long-term implications of biomedical research include the potential use of discoveries to develop biological weapons, genetic interventions that could lead to eugenics and even fundamental changes to our concept of “human” through xenotransplants or neuro implants. There are also important sociopolitical issues, such as equitable access to the benefits of discoveries and protections from their discriminatory use.

“Our study reveals that the U.S. is an outlier. Of all the countries we examined, it’s the only nation that explicitly prohibits institutional review boards from factoring in social implications,” Rothstein says. “This international collaboration indicates an overwhelming consensus that the societal and long-term implications of biomedical research are extraordinarily important and should be considered in ethics assessments.”

The U.S. restriction seems to hamper the kind of comprehensive research that translational bioethics aims to promote, the article says. The authors believe that gaining insights into international practices can foster better understanding and lead to the implementation of policy changes that incorporate these considerations into research ethics frameworks.