I’m sorry we do this

1 07 2014

I pretty much ignore all things Facebook (because I can!), but I do want to comment on the blatantly unethical study of newsfeed algorithms.

My ire is focused on both the researchers and on the Proceedings of the National Academy of Sciences for engaging subjects in research without their knowledge and consent (the former) and not flagging this lack of consent in their publication (the latter).

Since the promulgation of the Nuremburg Code following the trial of Nazi doctors, informed consent has been a cornerstone of research ethics. The World Medical Association followed with its own guidelines in the early 1960s (revised many times since), and in 1974, the US Department of Health, Education, and Welfare (now Health & Human Services) promulgated 45 CFR 46 (also updated numerous times); the US regs were later reinforced by the Belmont Report.

My point is, these rules are not new, and any social scientist trained or working in in the US (Adam Kramer received his PhD from the University of Oregon, and Jamie Guillory and Jeffrey Hancock work at UC San Francisco and Cornell University, respectively) should know the basics of them.

And the most basic of the basics about these rules is the necessity of obtaining informed consent from potential research subjects.

You don’t get to say, as Kramer did in a recent Facebook post,

Having written and designed this experiment myself, I can tell you that our goal was never to upset anyone. I can understand why some people have concerns about it, and my coauthors and I are very sorry for the way the paper described the research and any anxiety it caused. In hindsight, the research benefits of the paper may not have justified all of this anxiety.

and expect that your emotional sorriness  makes up for your ethical sorriness.

Not that Kramer even gets the ethical problem: he’s sorry for the way the paper described the research and sorry that the results did not justify the anxiety, but nowhere is he sorry for violating the dignity of his subjects.

Which, by the way, is the whole point of the regs: the recognition and protection of the dignity of human beings.

And PNAS? Shame on them for publishing such egregiously unethical work.

~~~

h/t Robinson Meyer of The Atlantic, for Kramer’s Facebook link





Helpless, helpless, helpless

11 04 2013

Useless.

As David Brown at the Washington Post wrote,

A clinical experiment involving 1,300 premature infants at two dozen hospitals “failed to adequately inform parents” of the risks of the treatment, which included blindness, brain damage and death, according to a watchdog agency at the Department of Health and Human Services.

Where the hell was the Institutional Review Board (IRB)? If they do nothing else, IRB’s are to ensure that risks are clearly and correctly spelled out in the consent form.

“The consent form was written in a slanted way,” said Jerry A. Menikoff, director of the Office for Human Research Protections (OHRP), which found that the study was “in violation of the regulatory requirements for informed consent” required by federal law.

“They went out of their way to tell you that your kid might benefit,” he said in an interview. “But they didn’t give the flip side, which is that there is a chance your kid might end up worse off. You can’t have it both ways.”

To repeat, where the hell was the IRB?

They don’t design studies, don’t enroll subjects, don’t collect data; the IRB is there to review the study, make sure it is valid and designed to reveal reliable results, scrutinize the risk/benefit tradeoffs, and make sure the consent form gives potential subjects sufficient information of all of the above so that they can make an informed decision of whether or not to participate.

Absent that information, it cannot be said that subjects gave informed consent.

The study was an important one—what is the optimal range of oxygen to be given to premature infants to ensure survival—and apparently yielded significant results which will lead to changes in the treatment of preemies. That good information was extracted from the research does not, however, justify the slipshod manner in which subjects were enrolled.

The consent form made a big point that all babies would get oxygen within the “acceptable” range of 85 to 95 percent. It noted that babies in the lower range might have less eye damage. But it didn’t mention that those in the higher range might have more eye damage. And there was no mention that in the days before oximetry — when oxygen was measured more crudely — that premature infants that got higher concentrations of oxygen tended to have greater survival, although often at the cost of their eyesight.

Instead, the only risk the consent form mentioned was skin irritation from the oximeter device, a trivial problem.

What wasn’t made clear to parents was that the study created two groups of babies with different treatments — although both fell within “standard of care” treatment — for which the researchers expected there would be different outcomes. That was the point of the study.

No mention of serious risk. No clear discussion of differential treatment. These are basic basic basic components of any minimally-decent informed consent form.

People associated with SUPPORT defended the consent form and noted that it was approved by 23 “institutional review boards’” (IRBs), which are the committees each research hospital must have to oversee the design and ethics of medical studies involving human beings.

“I don’t have any regrets. Everybody went into this with their best intention. Nobody was trying to deceive anybody,” said Neil N. Finer, a neonatologist at the University of California at San Diego who ran the trial.

Excuse me while I scream GOOD INTENTIONS ARE NOT ENOUGH! It is not about the intentions of the researchers, but about their actions and, importantly, about the well-being of the subjects themselves.

Those IRBs should be re-organized, re-constituted, and all members and researchers retrained as to the conduct of ethical research.

Because this, this ain’t it.





And I said “nothing”

7 02 2013

Was I gaslighting myself?

I was sure I had seen this book review at one of the places I frequent online, and I didn’t write it down or bookmark it, so that meant I’d be able to find it easily when I decided to go back and use it as a springboard for a post.

Except I couldn’t find the damned thing.

Slate? Nope. HuffPo? Nope. I knew it wasn’t Sully (who’s being a real prick about the whole retail servitude thing, by the way), wasn’t TNC. Someplace on the Atlantic site? Books? Health & Medicine? Tech? Nope nope nope. Didn’t think it was ThinkProgess or CrookedTimber, but checked anyway—nada. Christianity Today? Fred Clark? Nuh-uh. Really hoped it wasn’t Brad DeLong or Marginal Revolution or Pharyngula because it would be a total pain in the ass to try to dig it out.

It didn’t help that I didn’t know the title and I didn’t know the authors—although I did know there were two authors.

And I did know the topic: something about genetics and society. So, off to Amazon to try to track down the book. “Human genetics” didn’t get me there; neither did “genes” or “genetics” or these subjects coupled with “2013” (I knew the book was new). Nothin’. Same at Barnes & Noble.

What gives?! Did I NOT see a review of a recent book on genes and society? Was I imagining all of this? Jay-zeus Christie.

So: onward to the Giant Omnivorous Omniscient Grabbing of Life and Everything search, with different terms. At some point I plugged in “genetics ethics” and there on the top of the third page, a piece from the Guardian:

Genetics | Science | The Guardian

Video (5min 28sec), 30 Jan 2013: Hilary Rose, co-author of Genes, Cells and Brains, argues that we should treat the medical claims made for genetic research

Bingo! Hilary Rose! So back to the aforementioned sites and plug in Hilary Rose and. . . NOTHING! DAMMIT.

And then I thought: What about The Daily Beast? They do books, don’t they? And lo! There it was:

The Selfish Gene: The Broken Promises of the Human Genome Project

Jan 29, 2013 2:39 PM EST

What did the Human Genome Project give us? Better shampoo and billions of dollars’ worth of economic projects, but what happened to improving our lives? By Michael Thomsen.

There is a point to all of this, I promise you, but since it’s really just another way for me to lash myself over the stupid, stupid decisions I’ve made regarding my dissertation and career, I think I’ll save that for another post.

For this one, let’s end on the happy thought that I am not, in fact, crazy. At least on this.





Comment on a ‘no comment’

22 12 2010

Remember that nun in Arizona who was excommunicated for sanctioning life-saving surgery for a pregnant woman, surgery which resulted in the termination of her 11-week pregnancy?

Well, now the entire hospital has been disciplined, losing its official Catholic affiliation.

Bishop Thomas Olmsted called the 2009 procedure an abortion and said St. Joseph’s Hospital and Medical Center – recognized internationally for its neurology and neurosurgery practices – violated ethical and religious directives of the national Conference of Catholic Bishops.

“In the decision to abort, the equal dignity of mother and her baby were not both upheld,” Olmsted said at a news conference announcing the decision. “The mother had a disease that needed to be treated. But instead of treating the disease, St. Joseph’s medical staff and ethics committee decided that the healthy, 11-week-old baby should be directly killed.”

St. Joseph’s president Linda Hunt took the outrageous position that

“If we are presented with a situation in which a pregnancy threatens a woman’s life, our first priority is to save both patients. If that is not possible, we will always save the life we can save, and that is what we did in this case,” Hunt said. “Morally, ethically, and legally, we simply cannot stand by and let someone die whose life we might be able to save.”

It was precisely this attitude, as well as the unwillingness of administrators and doctors to promise never ever ever again attempt to save a pregnant woman’s life when that procedure might end the life of the fetus that led the diocese to strip its affiliation from St. Joseph’s.

Now that’s life.

h/t: Huffington Post





No comment, no. 2

11 11 2009

Quote of the day: bishop says no to homo tourism at Vatican

ETN asked the Bishop [Janusz Kaleta of Holy See, the Apostolic Administrator of Atyrau] if the Vatican’s stand was clearly against [gay] tourism, and the Bishop answered: “The church teachings are from the Bible. If we change this teaching, we will not be the Catholic Church. Don’t expect the Catholic church to change these issues, because it is our identity.” When asked if the Vatican is open to dialogue about welcoming such homosexual groups of tourists in the future, Bishop Kaleta responded that “such demonstrations are just not ethical.”

Publisher Steinmetz clarified that what was meant by gay travel was traveling for the purpose of a visit, not as a demonstration. To this the Bishop replied, ”I consider if someone is homosexual, it is a provocation and an abuse of this place. Try to go to a mosque if you are not Muslim. It is abuse of our buildings and our religion because the church interprets our religion that it is not ethical. We expect respect of our church as we expect to respect that a person does not have to belong to the Catholic Church. If you have different ideas, go to a different location.”

(h/t Pandagon [w/its emphases], cribbing from eTurboNews)








Follow

Get every new post delivered to your Inbox.

Join 1,317 other followers