WASHINGTON — The United States should have a system in place to compensate medical research subjects for injuries incurred during the trials they were a part of, according to a federal report. Currently, the U.S. requires subjects to seek compensation through the federal court system.

The recommendation was one of several made by the International Research Panel of the President’s Commission for the Study of Biological Issues, which was convened in response to revelations that surfaced a year ago involving the Public Health Service’s involvement in questionable and arguably inhumane research conducted in Guatemala from 1946 to 1948.

In the course of these studies, researchers deliberately infected Guatemalan prison inmates and mental patients with sexually transmitted diseases. The Guatemalan government has condemned the incident, calling the trials a crime against humanity.  A number of subjects from those trials have filed lawsuits against the United States. 

A System for Compensation

The panel was assembled in early March and tasked with advising the commission on the effectiveness of current federal rules regarding human research and how they compared to international standards. It presented its findings last month, making several recommendations focused on ethical treatment of research subjects and transparency of research practices.

The recommendation for a compensation system has drawn the most attention, not only because it points out that the U.S. is an outlier compared to most other industrialized nations participating in scientific research, but also because the recommendation has been made many times before, including by previous iterations of the Bioethics Commission.

“Decades of discussion have occurred about the need for a system for compensation of research injury,” Christine Grady, RN, PhD, one of the panel members, explained at the commission meeting. “National commissions, one after another for 40 years, have recommended a no-fault system of some sort. And although commissions have recommended it, and lots of moral justification has been written about it, no such system has been established.”

Some no-fault systems do exist in the U.S., but in limited areas. For example, there is a system in place for compensating victims who are injured from compulsory childhood vaccines. Such compensation is funded by a surcharge on vaccines and pooled for damages. Also, some U.S. research institutions have moved forward and developed compensation systems on their own.

For the most part, research subjects who are injured are expected to obtain a lawyer and sue if they want compensation. A study looking at 102 medical centers around the U.S. found that fewer than half had no compensation or research insurance practice, and that most injured participants were charged for treatment of their injures either directly or through their own insurance policies.

“None offered compensation for anything beyond medical care,” Grady said. “There was no compensation for lost wages or pain and suffering.”

The question arose as to why research subjects, who are assumed to be informed of the risk involved in a trial, should be automatically compensated. Commission chair Amy Gutmann, PhD, answered  that the panel felt it was wrong that the U.S. was an outlier on this, and that it was an outlier on the wrong side of the ethical line.

“It’s just too difficult for most research subjects [to sue],” Gutmann said. “It’s much more difficult than if somebody hits you with their car.”

She did say that, while the panel felt strongly that a mechanism is needed, it did not know which mechanism was the correct one and that more investigation was required.