Secrecy in Tests Led to Trouble

Parents of babies not told of therapy

Plain Dealer – December 18, 1996
SERIES: DRUG TRIALS – Do People Know the Truth About Experiments?


Doctors confront a dilemma when they experiment on people: Are they healers or scientists? Should they give a patient the best treatment possible, or do they use their patients as a means to discover better treatment for others?

Harvard University researchers at a Boston hospital faced a twist on the familiar conundrum: What if the better treatment seemed to be the experimental one? What if people receiving conventional therapy appeared more likely to die? Should they be told?

The ethics committee decided they should not, and wound up with a federal reprimand – the first for failing to seek informed consent.

It happened six years ago. For the sake of a comparison trial, desperately ill newborns at Children’s Hospital were placed in two groups.

Twenty were hooked up to an artificial heart and lung machine, called ECMO, a potentially lifesaving procedure.

Ten others were given conventional respiratory therapy, and their parents weren’t told of the alternative.

Purpose of the Harvard research: to compare survival rates. At the time, some medical studies indicated some ECMO babies did better.

It was “inappropriate” to tell parents “about a procedure that would be unavailable to them, when standard treatment held so little hope of success,” the ethics committee chairman, Dr. Peter Wolff, wrote a federal investigator in January 1990.

Wolff explained that obtaining informed consent “would impose unacceptable psychological burdens on the parents of children not included in the ECMO arm of the study.”

Four of 10 conventionally treated babies died.

Nineteen out of 20 babies who got ECMO lived.

Dr. Robert Truog, a Harvard medical professor critiqued the experiment in a professional publication for having “serious ethical problems.”

“The death of an infant on conventional therapy generally involves hours to days of slow but inexorable deterioration and often occurs after a prolonged period” of oxygen starvation, Truog wrote.

“As difficult as it was for the staff to care for these patients, it would have been more difficult for the parents had they been aware of the truth regarding the situation.”

A hospital spokeswoman, Bess Andrews, said Truog’s critique “says everything we would say.”

The federal Office for Protection from Research Risks, after a 1990 investigation, said a desire “to spare parents the anguish of decision-making” was no excuse; informed consent should not be waived.

As Charles R. McCarthy, who headed the federal investigation, put it: “Every research subject [or their parents] must be afforded the opportunity to consent voluntarily to participate in research.”

The hospital’s ethics committee promised never to do it again.