Informed Consent in the NICU? Bioethicists Disagree

Teaching the regulation of human subject research gives me the ability to demonstrate, just about every class period, how blurry the line can be between what is legal and what is ethical.  What individuals must do as a matter of law and what they cannot do as a matter of law are very different from what they should do.  I tell my students that outside the assessment of legal risk, "should" is a business decision, a science decision, an ethics decision, a public relations decision or some combination of all four--and it's one other people (clients) are going to make for themselves. 

A tip of the hat Fran Miller who clued me in to some very recent events  that provide a perfect example of the relationship between law, ethics and science in human subject research.   Many will have read the New York Times article about a letter  sent by the Office of Research Protection (OHRP) to the lead researcher University of Alabama at Birmingham (UAB) criticizing a study they had run in 23 major medical centers involving infants requiring oxygen support in the neonatal intensive care unit (NICU).     Called the SUPPORT Study (and please follow the links--the complexities here are beyond a blog post), it was intended to find out the safe, but effective, limits for providing a premature infant supplemental oxygen.  Too little oxygen, of course, affects breathing but too much oxygen, we have known for a long time, causes blindness. The babies were randomized to receive different levels of oxygen and the results measured.

Whether or not the study should have ever been approved is a matter of debate-the fact that many of the babies involved had worse results than they would have under standard of care and even the fact that one of the babies involved does not, in and of itself, mean that the study was illegal or unethical. Here's the explanation by the researchers themselves. This is the Government version.  

 The issue under dispute is not the study itself--it's the consent process.  Soon after the letter became public and OHRP began the process of assessing wehther there should be sanctions, what in theory is OHRP's sister institution, the NIH which provided funding for the study, criticized the warning and supported the SUPPORT study (these puns are invevitable).   And soon afterwards OHRP backed down--agreeing to hold a public hearing.

What's so interesting about this dispute for lawyers is cogently explained by Lois Shepherd, the Peter A. Wallenborn, Jr. and Dolly F. Wallenborn Professor of Biomedical  Ethics, Professor of Public Health Sciences, and Professor of Law at the  University of Virginia in her analysis posted at the Hasting's Center Bioethics Forum Blog.    She points out that the ethicists and scientists supporting UAB don't necessarily disgree that the parents lacked complete information about the risks.    That the law, in other words, wasn't complied with.   But, they argue, the importance of the study outweighed a flawed consent process--and moreover, in a letter published by the New England Journal of Medicine they challenge OHRP's ability to, in essence, substitue it's judgment of whether disclosure was sufficient for that of the IRB giving initial approval. 

 

 That's a big deal.   45 CFR 46.116 specifies that consent for human subject research funded by the federal government must include (among other things--read the whole thing yourself) that "a description of any reasonably foreseeable risks or discomforts to the subject”; and “a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.”  According to OHRP and those who support it, UAB's experiment did not meet that standard because, among other things, it did not disclose to the parents that there was a risk of death.  

But who decides whether or not the information was sufficient?

As a lawyer, I would say that the fact that Congress, in its infinite wisdom, set up a system in which OHRP has the power to review the decisions of individual IRB's answers this question immediately.  Of course OHRP can substitute its judgment for that of the individual IRBS approving this study-that's what it's there for.  

 But in the real world, things are not so clear and it's always possible for Congress to change the balance of power.  In my view that would be a huge mistake--it's hard to imagine what else has to happen in order to prove the point that when it comes to protecting human research subjects science cannot reglate itself.  There must be outside oversight that reflects the view of the electorate at large--the general population of human subjects--rather that of those whose primary goal is to advance science.

Is it possible to have a system where the needs of the many outweigh those of the few?  Where in the face of great benefit to all future premature infants it is acceptable to give some premature infants less than the standard of care?  Sure--it's possible.  But it's not how, so far, the United States has chosen to regulate human subject research.

 

JSB