IU School of Nursing

A new commentary in the medical journal Pediatrics raises important concerns about the ethics of stopping clinical trials before they are completed, especially when those studies involve children and teenagers.

As of July 2025, the National Institutes of Health had cut about 4,700 grants connected to more than 200 ongoing clinical trials. These studies planned to involve more than 689,000 people, including roughly 20% who were infants, children, and adolescents. Many of these young participants were dealing with serious health challenges such as HIV, substance use, and depression, and the studies specifically focused on improving the health of people who identify as Black, Latiné, or sexual and gender minority.

Amelia Knopf, PhD, MPH, RN, FAAN, associate professor at the Indiana University School of Nursing, and her co-authors Kathryn Macapagal, PhD, and Kimberly Nelson, PhD, of Northwestern and Boston universities, respectively, examined what happens when these research studies end abruptly. They argue that such sudden closures can break trust and harm participants, especially when the research involves young people. They also note that these actions conflict with long-standing ethical principles outlined in the Belmont Report—federal guidelines published in 1979 that outline three main principles for human research: respect for persons, beneficence, and justice.

Knopf, who studies HIV prevention and bioethics in her research, said everyone should be concerned.

“In the short-term, children, adolescents, and their families are experiencing disruptions to or the termination of benefits that research participation provides,” she said. “In some cases, the disruption to funding has resulted in contamination of the study design and participants have had to be withdrawn and their data will not be usable. The long-term impact may be lower trust in research, less willingness to participate, and slower scientific progress.”

The authors, all adolescent health researchers, have enrolled thousands of young participants in their clinical trials, and further explain the effects of ending these studies suddenly. First, participants are not informed that their studies might be defunded or shut down for political or funding reasons, which challenges the idea of true informed consent. Secondly, closing studies abruptly also makes it harder to know whether treatments work, reducing the value of contributions from participants who agreed to take part to advance public health.

The authors call for better ways to track the effects of study terminations on participants and stronger guidelines to ensure that research projects end in an ethical way.

The commentary, “Ethical Implications of Study Terminations,” appears online in the October issue of Pediatrics.

###

Founded in 1914, Indiana University School of Nursing is one of the largest nursing programs in Indiana that offers programs from the BSN through the doctorate. The school is composed of campuses in Bloomington, Fort Wayne, and Indianapolis.   

Media Contact: Glenda Shaw | 317-278-2048 | glenshaw@iu.edu