AARP on Ethical Breakdown

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Advancing Honest and Ethical Medical Research
 www.ahrp.org

FYI

Disclosure of the egregious ethical, methodological and legal violations outlined in the letter of determination by the Federal Office of Human Research Protections (OHRP) regarding the so-called SUPPORT oxygen experiment conducted on more than 1,300 especially vulnerable premature babies at 23 major medical centers, sponsored and endorsed by the NIH with taxpayer funding, is garnering critical reactions. http://www.hhs.gov/ohrp/detrm_letrs/YR13/mar13a.pdf

The New York Times editorial, “An Ethical Breakdown,” calls the experiment “startling” and “deplorable.”

However, even in light of the number of babies who were killed in the experiment, Dr. David Mangus, Director of the Stanford for Biomedical Ethics, defends the experiment in the NY Times article (below), calling it "research that's not risky."

We are particularly encouraged by the Times’ editorial board’s endorsement of one of AHRP’s recommendations:

 “if the institutions do not offer strong reforms, the agency can suspend their ability to conduct federally financed research on human subjects.” http://www.nytimes.com/2013/04/16/opinion/an-ethical-breakdown-in-medical-research.html

In yesterday’s Infomail, we recommended: “the revocation of the Federal licensure from academic institutions that have been the site of unethical medical research whose subjects suffered permanent injury or death.”

And we also recommended holding medical researchers accountable. See: http://www.ahrp.org/cms/content/view/916/9

But the Times Editorial is silent about personal responsibility--as if medical professionals should be held to lower standards than, say, politicians who violate financial  AHRP recommends holding medical researchers accountable.

An article in the Science section of the Times by Sabrina Tavernise, provides the context within which this experiment—and others like it—are being conducted and the ethical problems of doing research on especially vulnerable premature babies whose life hangs on whether the oxygen level they receive is right for their particular condition.

The article reports that “the study designers agreed that the risk of blindness should have been more clearly explained,” but insisted that the infants were within the standard of care, not at greater risk than any premature infant.  That is a misstatement: being randomly assigned to one of two fixed treatments—without regard for the babies’ clinical condition—is not standard of care.

The principal investigator, Dr. Neil Finer, Professor Emeritus at the University of California, San Diego, claimed “When we designed that study, there was no information from anywhere to suggest that you’d have increased mortality if you stayed within the range.”  He did not comment about failure to disclose the risk of blindness to parents.

Dr. Jerry Menikoff, director of OHRP, said that it was “deeply troubling” that 23 institutions did not catch the failure to warn parents about the risk of blindness. In terms of punishment — which can range from institutions offering corrective action to their being forbidden to use government grants for research with human subjects — he said “everything is on the table.”

Dr. Menikoff added: “My goal is to make sure the parents are appropriately protected. It’s not too much to expect.”

See: http://www.nytimes.com/2013/04/16/health/balancing-risks-and-benefits-in-clinical-trials.html

A letter of apology and full disclosure to the parents of the SUPPORT experiment should be sent as soon as possible.

Vera Sharav



An Ethical Breakdown

By THE EDITORIAL BOARD

Despite reforms to protect patients from being harmed by medical research in recent decades, 23 academic institutions authorized a research project that failed to meet the most basic standard: providing an informed consent document to parents that accurately described the risks and benefits of the research to be conducted on extremely premature babies.
This failure was startling, and deplorable. Federal officials have rightly demanded that the University of Alabama at Birmingham, the lead institution, and Stanford, Duke and Yale, among others, take corrective action to prevent a recurrence. Such actions, which must be approved by federal officials, could include requiring investigators to undergo additional training in the ethical conduct of research, enhancing oversight by institutional boards that monitor research and notifying parents of the ethical breach.
The study involved more than 1,300 premature babies, born between 24 weeks and 27 weeks of gestation. The underdeveloped lungs in such babies are often unable to extract enough oxygen from the air to nourish the brain, so doctors often supply extra oxygen.

The danger is that too much oxygen can cause severe eye damage and blindness, whereas too little can lead to brain damage and death. The current standard of care calls for the blood to be saturated with 85 percent to 95 percent oxygen, but the researchers sought to pinpoint a more exact range that would minimize eye damage without increasing the risk of death.
The study, financed by the National Institutes of Health, was conducted between 2004 and 2009 and published in 2010. The researchers randomly divided the 1,300 babies into two groups; one got oxygen at the low end of the range, while the other got oxygen at the high end of the range. The parents were asked to sign consent forms that had been approved at all 23 medical centers by the institutional review boards that are supposed to ensure ethical conduct of federally supported research.
But, in this case, the federal Office for Human Research Protections concluded that the consent forms failed to reveal that there was a greater risk of dying in the low-oxygen group and a greater risk of severe eye damage in the high oxygen group. The form also stated that, because both groups would receive oxygen within the standard of care, there would be no predictable increase in risk no matter which group a baby was in.

But the federal agency found that many infants could have faced greater risks by participating. For example, if a baby whose clinical needs might ordinarily have led doctors to deliver a relatively high level of oxygen was enrolled in the study, the infant might be randomly assigned to receive lower levels of oxygen. The Department of Health and Human Services needs to investigate how this breakdown occurred. And if the institutions do not offer strong reforms, the agency can suspend their ability to conduct federally financed research on human subjects.