Reflexive Research Ethics in Fetal Tissue Xenotransplantation Research

Abstract

For biomedical research in which the only involvement of the human subject is the provision of tissue or organ samples, a blanket consent, i.e., consent to use the tissue for anything researchers wish to do, is considered by many to be adequate for legal and Institutional Review Board (IRB) requirements. Alternatively, a detailed informed consent provides patients or study participants with more thorough information about the research topic. We document here the beliefs and opinions of the research staff on informed consent and the discussion-based reflexive research ethics process that we employed in our fetal tissue xenotransplantion research on the impact of environmental exposures on fetal development. Reflexive research ethics entails the continued adjustment of research practice according to relational and reflexive understandings of what might be beneficent or harmful. Such reflexivity is not solely an individual endeavor, but rather a collective relationship between all actors in the research process.

Keywords:

• bioethics
• fetal tissue transplantation
• informed consent
• reflexive research ethics
• research ethics

ACKNOWLEDGMENTS

This research is supported by grant 1P20ES018169 from the National Institute of Environmental Health Sciences and Environmental Protection Agency. Additional support comes from the Brown University Office of the Vice President for Research. We are grateful to Kim Boekelheide, David Ciplet, Alissa Cordner, Linda Covington, Kristen Delayo, Monique Depaepe, Richard Freiman, Leah Greenblum, Philip Gruppuso, Susan Hall, Mary Hixon, Elizabeth Hoover, Tania Jenkins, Stefan Kostadinov, Mercedes Lyson, Stephanie Malin, Margaret Mulcahy, Maureen Phipps, Jodie Pietruska, Jennifer Sanders, Tyson Smith, and Chris Thanos for comments on various drafts of the article.

Notes

1. Respondents are referred to by these identifiers, signifying “Project staff.”