Ethics Debate for Medical Research on Preemies: How Much Should Parents Be Warned of Risks?

A fierce ethical debate is raging regarding just how much information patients or the parents of patients should be told of the risks when consenting to participate in medical research. More specifically, the debate involves studies where doctors don't have evidence as to what treatment option works best.

As the Associated Press put it, "There's no requirement that they tell their patients when they're essentially making an educated guess, or that they detail the pros and cons of each choice."

The current debate centers around a study enrolling nearly 2,000 preemies with anemia to figure out when it is most effective to administer a blood transfusion. The hope is to find whether early or later transfusions could help reduce deaths and brain damage.

Shawn and Carrie Pratt of Kingwood, W.Va., with their daughter Dagen, speak to the media outside a federal health meeting in Washington, Wednesday, Aug. 28, 2013. Dagen was part of a controversial study of premature babies that has sparked questions about how to inform patients about the risks of medical research. (AP)

But it's not the study itself that groups have a problem with -- it's the parental or patient consent form and what it says about risks -- or rather doesn't say about the risks.

The U.S. Department of Health and Human Services on Wednesday hosted a forum to discuss whether the consent form in this study -- and others like it -- do not include enough information regarding the heath risks.

The Associated Press reported the perspective of families who enrolled their children in a medical study and now regret doing so, feeling they were ill informed based on what they signed:

Dagen Pratt's parents enrolled their tiny premature baby in a study of oxygen treatment believing she'd get the best possible care. They didn't understand it was an experiment to test what dose works best. No one mentioned any risks.

Now 6, Dagen struggles with cerebral palsy, and they wonder: Is that long-ago study to blame?

"Tell me that the Support study did not hurt Dagen in any way," her father, Shawn Pratt, challenged a government panel on Wednesday as his daughter, dressed in a bright sundress, stood quietly by.

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"I unknowingly placed my son in harm's way," said Sharissa Cook of Attalla, Ala., who wonders if vision problems experienced by her 6-year-old, Dreshan Collins, were caused by the study or from weighing less than 2 pounds at birth. "The only thing a mother wants is for her baby to be well."

Dagen's mother, Carrie, was more blunt with reporters: "Why is omitting information not considered lying?" she said. "We were told they would give her the best care every day."

The SUPPORT study was conducted from 2004 to 2009, involving 1,300 preemies. Different dosages of oxygen were given to the extremely premature infants -- parents did not know what dose they would receive -- to figure out which was most effective at avoiding blindness and reducing death.

In March 2013, the HHS Office for Human Research Protections concluded that patient consent forms did not adequately describe “the reasonably foreseeable risks of blindness, neurological damage and death."

Although some children in this study now suffer health problems, as the Associated Press and other experts have pointed out, it is unclear whether the problems are the result of the study or of being a preemie. It has also been noted that for studies like this, there are times when the researchers aren't sure what the best option for care is -- it is what they are trying to figure out from the study in the first place.

Those who advocate for not including an in-depth, spelled out list of all the risks on a patient consent form argue that doing so might also "put many volunteers off, because they might mistakenly think that the research itself is adding risk of harm," according to an editorial in the journal Nature last week.

But the journal goes on to state, as many others are advocating as well, that "research is still research in whatever context, and the duty to protect human subjects must remain paramount."

Given the issue with consent forms involved in the SUPPORT study, groups have brought up similar issues with the NIH-funded Transfusion of Prematures study, which is currently recruiting participants.

The advocacy group Public Citizen last week reported that through Freedom of Information Act requests, it found failures in the consent forms to inform parents of the risks:

Of the 17 institutional review board-approved consent forms obtained by Public Citizen, only one mentions the foreseeable risk of death or disability. Five say the research poses no risk, and 15 conflate risks of the research with risks of routine medical care. All but two of the forms fail to explain that part of the primary purpose of the research is to see which transfusion group is more likely to suffer death, and 12 fail to indicate the study’s equally primary goal of seeing which group shows more signs of neurodevelopment impairment.

“This continued pattern of egregious informed consent deficiencies in NIH-funded trials involving the most vulnerable of human beings is deeply troubling,” Dr. Michael Carome, director of Public Citizen’s Health Research Group, said in a statement. “These ethical lapses may represent the tip of the iceberg.”

Given these findings and the experience had with the SUPPORT consent forms, the group is urging HHS Secretary Kathleen Sebelius to halt the recruitment and inform parents of babies already enrolled of the risks.

“The fact that HHS is having a public discussion about this indicates that an enormous amount of pressure is being brought to bear by people who are trying to weaken the current standards of research with human subjects,” Carome said in another statement associated with Public Citizen's press conference outside of the HHS ethical debate Wednesday. “The debate goes to the heart of how research is conducted in the United States and could have far-reaching, negative implications if changes are made to weaken the ethical and regulatory standards by which trials are run. We cannot let that happen.”

Featured image via Shutterstock.com.

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