Ethical gray zones in biomedical research: Who are you going to call?

Can a husband give permission for his wife to participate in a clinical trial if she has dementia? If a researcher finds genetic markers for Alzheimer’s disease in an individual during an unrelated clinical study, should the participant be informed? What should researchers do with unused human eggs after an in vitro fertilization procedure? What ethical considerations should researchers take into account when using artificial intelligence to analyze visual or clinical data streamed from exam rooms or inpatient hospital rooms?

These are the types of questions that the Stanford Center for Biomedical Ethics addresses in its mission to provide moral and ethical guidance to researchers grappling with the gray areas of biomedical research.

“It’s a brave new world for researchers who are sometimes faced with tough decisions related to emerging technologies such as computer-aided decision making, genetic testing, and gene editing,” says David Magnus, PhD, director of the center. “What our center provides is real-time advice to guide the value-laden decisions that researchers make, and to help them consider downstream consequences of their options.”

To help researchers with these types of questions, the Bioethics Center and Stanford Medicine’s ethics committee provide around-the-clock consultations for both bedside and research-related issues.

For second opinions, researchers can access resources at the Clinical Research Ethics Consultation Collaborative, co-led by Mildred Cho, PhD, the assistant director of the Stanford Center for Biomedical Ethics, and Benjamin Wilfond, MD, of the Seattle Children’s Research Institute and University of Washington. Established in 2014, the Collaborative is funded by Clinical and Translational Science Awards program from the National Center for Advancing Translational Sciences. The Collaborative curates a collection of ethics case studies based on consultations on a range of research areas, including social science research, clinical trials, genetics, pediatrics, research misconduct, and surrogate decision making. They also provide online consultations.

To further this work at a national level, Stanford’s Bioethics Center was recently named as the coordinating hub for information on the ethical, legal and social implications of genetic research, funded by a $7.1 million award from the National Human Genome Research Institute. Cho will also lead this effort, which will draw relevant information from scientific and academic research, news stories and commentary, scientific journals, laws, and legal briefings.

To request a consultation about biomedical research, contact the Stanford Benchside Ethics Consultation Service:

https://med.stanford.edu/cirge/consultation/request.html 

To access case studies or general literature on research ethics consultation, visit the collaborative website at: https://www.ctsabioethics.org.

To request an ethics consultation about patient care, there are experts on call 24/7 at both Stanford’s children’s and adult hospitals. Visit this webpage for details:  https://med.stanford.edu/bioethics/service/bedside.html.