Blurring the line between scientist and parent

Being involved in clinical research makes me aware of the ethical quandaries that can arise. Fortunately for me, for the most part my studies are straightforward and don’t provoke much in the way of angst over whether what I am doing is ethical or whether I’m approaching a line I shouldn’t approach or crossing a line I shouldn’t cross. However, there’s lots of research that flirts with the unethical and sometimes even crosses the line. Institutional review boards are there to oversee the ethics of clinical trials and protect the human subjects who participate in them, but they don’t always function as they should. Moreover, even clinical trials that are not at all unethical can be compromised if the investigators cross the line in other ways.

Ways such as using their own children for research subjects.

There was a fascinating article in the New York Times over the weekend that didn’t come to my attention until yesterday and that I’m surprised not to have seen mentioned more in the blogosphere. It was entitled Test Subjects Who Call the Scientist Mom or Dad, and it disturbed the hell out of me.

Even before his son was born, Pawan Sinha saw unique potential.

At a birthing class, Dr. Sinha, a neuroscience professor at the Massachusetts Institute of Technology, stunned everyone, including his wife, by saying he was excited about the baby’s birth “because I really want to study him and do experiments with him.” He did, too, strapping a camera on baby Darius’s head, recording what he looked at.

Dr. Sinha is among a new crop of scientists using their children as research subjects.

Other researchers have studied their own children in the past, but sophisticated technology allows modern-day scientists to collect new and more detailed data. The scientists also say that studying their children allows for more in-depth research and that the children make reliable participants in an era of scarce research financing.

“You need subjects, and they’re hard to get,” said Deborah Linebarger, a developmental psychologist who directs the Children’s Media Lab at the University of Pennsylvania, who has involved her four children in her studies of the effect of media on children.

Am I off base in thinking this thing gives me a serious case of the heebie-jeebies?

Worse, in many cases I would argue that not only is this bad parenting and unethical, but it’s bad science as well. It’s drifting towards a line that none of these scientists would acknowledge that they are drifting towards, but the parallels will be disturbing.

As the article points out, it’s not as though this is a new phenomenon, although it appears as though it may be more prevalent than in the past and becoming more so. For example, Jonas Salk injected his own children with the polio vaccine. Of course, back in those days, it may have been a bit more understandable. Polio was a scourge; it was feared. Public swimming pools were shut down in the summer because of polio outbreaks, and panics regularly occurred as recently as 50 or 60 years ago. A parent’s desire to protect his children from this disease may have overridden Salk’s caution, and back then there were no institutional review boards, at least not in anything near their current form or level of rigor, to supervise and judge the ethical conduct of clinical trials. No doubt Salk was also interested in proving to the world that his vaccine was also safe, and what better symbolic demonstration of its safety than for him to give it to his own children?

So what about experiments that do not provide what is potentially such a huge benefit, experiments that are being done strictly for knowledge? For example, what should I make of the case of the scientist who subjected his children to MRIs, justifying it thusly:

Dr. Toga said some nonscientists have said: “Why would a parent subject their kid to the dangers of M.R.I.? You should be ashamed of yourself.”

His response: “All I’m doing is taking a picture. Nobody loves my kids more than me. Would I ever do something that would endanger them?”

I smell the rancid stench of rationalization here.

Although very, very safe, MRIs are not without risk. No medical procedure is. Also, they are more than just “taking a picture.” For one thing, many types of MRI require the injection of intravenous contrast agents, agents that can cause adverse reactions, sometimes even life-threatening. True, the chance of such a reaction is very, very small, on the order of 1 in 100,000 or even lower, but why on earth would a parent subject his child to even that risk for no benefit to the child? Also, consider that an the administration of contrast requires that an IV be placed, or, at the very least, that an intravenous injection of the agent be given. Children in general do not like having IVs placed; they are painful. Adults can deal with such minor pains as an IV or injection quite well, but children often cannot. Then there is the issue of having to lie very, very still inside of a large metal tube with machinery that clanks. I’ve known adults who completely freak out with claustrophobic sensations when inside the MRI machine. It takes them an enormous effort of will in order to keep still. I’ve even had the occasional patient for whom I’ve had to prescribe a sedative or anti-anxiety drug for them to make it through the procedure. Imagine placing a child in such a machine. Indeed, for really young children, general anesthesia may be required to do imaging studies such as CT or MRI scans, because they simply cannot stay still long enough.

All of this, however, is relatively peripheral to the real reason why using one’s children as a research subject in one’s own research protocol is unethical, and it’s an incredibly obvious one. Specifically, it’s a huge and unreconcilable conflict of interest:

The role of the parent is to protect the child,” said Robert M. Nelson, director of the Center for Research Integrity at Children’s Hospital of Philadelphia. “Once that parent becomes an investigator, it sets up an immediate potential conflict of interest. And it potentially takes the parent-child relationship and distorts it in ways that are unpredictable.”

Indeed. Some of these investigator-parents even sign their children’s consent slips for participation in the study, which is truly appalling from an ethical standpoint. How any scientist can justify that simply boggles the mind. It doesn’t matter if the study is benign and totally safe. It doesn’t even matter if both parents are in agreement. If one of the parents of a child being considered for a study is an investigator in the study, there is an unacceptable conflict of interest. The parent can’t be an objective advocate for his or her child because emotional and professional investment in the clinical research precludes it, and the researcher testing his own child cannot be an objective collector of data. Such parents may delude themselves into thinking that they are their child’s staunchest advocates, but they cannot be if there is a professional advantage to enrolling their own children in their study. They may also delude themselves into thinking that they can be objective when taking measurements based on their children, but they cannot and their bias runs a huge risk of tainting whatever observations they make. Yes, they may, as described in the article, justify to themselves enrolling their own children in their research protocols by arguing that the study must be perfectly safe, so safe that they see no problem in enrolling their own child into it. But that is not enough. They may also minimize risks and maximize their estimate of potential benefits–so much so that they might even go as far as this:

Some researchers sign required parental consent forms, and some have spouses sign.

“I sign my own permission slips,” said Gedeon Deak, whose three sons have participated in his cognitive science studies at University of California, San Diego. He tells review boards his subjects are a “sample of convenience,” not randomly selected, but he has seen no need to specify that his sons are among the participants.

“If they’re your kids and you want to ask them questions, you can,” he said. “If you want to put your kid into a drug trial, that’s different.”

No, it’s not. Really, it isn’t, except perhaps in degree. Worse, it’s arguably bad science, particularly in behavioral studies, because the pre-existing parent-child relationship can color how the children behave as research subjects and thus affect the actual results obtained in the study:

Dr. Toga said research had allowed his children to “come to work with Dad,” and get brain-scan printouts for show-and-tell. “They were so determined to please their father that they would lie still,” he said.

And how might that desire to please the parents affect research in other ways? Think about that for a moment.

Also think about this. Remember Dr. Jon Poling and his daughter Hannah? Of course you do. Hannah Poling is a child with a mitochondrial disorder who developed symptoms suggestive of regressive autism that her parents (and the antivaccine movement) blamed on vaccines. Less than a year ago, she became the poster girl for the “reinventing” of the antivaccine movement, which tried to use her case as “evidence” that vaccines cause autism in children with “genetic susceptibility.” Unfortunately, Hannah Poling was also the poster child for why parents should not be investigators who enroll their children in clinical studies that they are involved with. This is how I put it last year:

Dr. Poling was a co-author on a case report in 2006 about a girl with a mitochondrial disorder who underwent developmental regression after being vaccinated, a case report that has been widely cited as “evidence” for the claim that vaccines can cause autism in the presence of mitochondrial disease (which, conveniently enough, we’re told is much, much more common than previously thought). He disclosed neither that he was a plaintiff in the Autism Omnibus nor that the subject of the case report for which he was co-author was in fact his daughter, both serious breaches of reporting potential COIs, as far as I’m concerned.

What really shocked me about this article is that parents could not only enroll their children in clinical studies for which they were the principal investigator, but they could even do it without informing the institutional review board charged with protecting human subjects. The only word I can think of for this is appalling. If it is possible for a scientist to ethically enroll his own child in a clinical study for which he is the principal investigator (and I do not believe that it is, except perhaps under a few very limited situations), at the very minimum I would argue that full disclosure to the committee charged with overseeing the study and guarding the welfare of its human subjects would be a bare minimum requirement that would have to be met before researchers could enroll their own children in their own studies. Apparently it’s not.

If any of these scientists who have enrolled their own children in their own clinical trials happen to see this post, he or she will not be happy at what I am about to write next. Being as involved as I am in the movement to combat the antivaccine movement, I am reminded by parents such as those described in my article of another group of parents willing to turn their children into guinea pigs. I’m talking, of course, about parents who fervently believe that vaccines or the thimerosal that used to be in vaccines can cause autism. In their search for a cure, these parents will “study” their own children and subject them to woo after woo. Remember what Jenny McCarthy said about her son Evan: “He is my science.” Or consider Kent Heckenlively, who has subjected his daughter to quackery after quackery. Or what about the “studies” of Mark and David Geier using Lupron to treat autistic children? At least one of the parents on the actual dubious IRB that was supposedly charged with overseeing the study actually had a child whom she had enrolled on the study. If researchers can enroll their own children on their own study, why would it be wrong for parents with children on a study to be on the IRB overseeing that study?

Think I’m being harsh? Consider this: At least Jenny McCarthy and her ilk fervently believe that what they are doing is the only hope they have to “cure” their children of autism. They’re wrong–totally deluded, even–so much so that it’s not unreasonable to speculate that if they didn’t believe so fervently that biomedical quackery could cure their children of autism they wouldn’t subject them to it. If you put yourselves into their world view, you can see how they might think that the benefits of “curing” autism would far outweigh the risk involved.

What’s the excuse of investigators like the ones desscribed in this NYT article?