This week’s Research Ethics Roundup looks at the ethical implications of inserting human brain organoids into laboratory animals, the need for deep brain stimulation researchers to think about the potential long-term ethical dilemmas involved in their work, the argument for classifying certain kinds of organ recipients as research subjects, and President Trump’s new pick to be the secretary of the Department of Health and Human Services (HHS).
Tiny Human Brain Organoids Implanted Into Rodents, Triggering Ethical Concerns
In this STAT piece, Sharon Begley explores the ethical questions that arise when researchers insert human brain organoids (tissue from the human brain) in the brains of lab mice. While this technique would allow researchers to learn more about brain diseases, Begley points out that there has been no national discussion on the ethical implications of such research. The Hastings Center’s Josephine Johnston and other bioethicists argue that these unexplored issues include how human organoids could affect an animal’s intelligence and how scientists need to closely monitor any behavioral changes seen in laboratory animals.
Researchers Grapple with the Ethics of Testing Brain Implants
In this Science piece, Emily Underwood highlights BROADEN—a clinical trial on deep brain stimulation (DBS) where people with severe depression received metal electrodes implants. The BROADEN study’s sponsors ended recruitment after six months, when none of the subjects showed statistically significant improvements in their conditions. However, 44 of the 90 participants asked to keep their implants, raising the question of who should pay for the long-term maintenance of the devices. A forthcoming National Institutes of Health report will cover the ethical issues researchers should consider when conducting DBS research including informed consent concerns.
When Are Organ Recipients Human Research Subjects?
In this Hastings Center essay, Lois Shepherd and Ruth Macklin (recipient of PRIM&R’s 2017 Lifetime Achievement Award for Excellence in Research Ethics) respond to a recent Hastings Center Report article on recipients of organ transplants, and argue that such individuals have a right to know whether the organ they received was part of a research study, and that they should be considered research subjects. The authors point out that since this group of transplant recipients’ treatment is altered for the purpose of a study, IRB oversight is needed. The aforementioned recipients also deserve greater protections because they are put in an “a take-it-or-leave-it position” in deciding whether to accept a donated organ.
Trump Nominating Azar as Next HHS Secretary
Rachel Roubein reports for The Hill that President Trump’s nominee for the secretary of HHS, Alex Azar, is a former HHS general counsel and deputy secretary with pharmaceutical company experience. Experts note Azar’s previous HHS experience means he will be able to use his knowledge of the administrative rule-making process to the administration’s benefit. President Bush’s deputy head of the White House Domestic Policy Council told the publication that Azar “would bring ‘competence, leadership, a smart, conservative agenda, and also an understanding of how the regulatory process works, which I think is important given that the Trump administration is trying to accomplish a lot of its health policy goals via the administrative process.’ ”