IRB review is a very important part of modern science, and the system is simply not setup to deal with research that hasn't been throughly cleared by a review board. You could consider IRB approval the first step in peer-review: your study is worthwhile and you aren't going to do anything unethical.
IRBs are designed to protect the subjects/patients, the researchers, and the institutions. To skip that step is pretty unusual, and some hoops had to be jumped through in order to deal with it. I think the fact that the 23andMe study was published at all was a big leap, and represents the flexibility inherent in the scientific community.
The response to "new and cool" wasn't "you didn't do it according to protocol". It was: since you didn't do it according to protocol, we need to verify that you did this ethically.
Imagine what would have happened if they used someone's DNA in their study without their knowledge. When you're talking about publishing links between diseases and people's DNA, you better be damn sure you have permission to use their genetic data. That is what IRBs are good for.
In a world where movies constantly are pointing out how scary/evil/unethical scientists can be (Andromeda strain, Splice), these checks are very important, even if it slows things down a little.
> Imagine what would have happened if they used someone's DNA in their study without their knowledge. When you're talking about publishing links between diseases and people's DNA, you better be damn sure you have permission to use their genetic data.
Apart from privacy and "ownership of one's genetic material", why?
Saying "Joe Smith's DNA contains a vital clue to solving parkinson's" doesn't affect Joe's ability to monetize.
Saying the same about "unspecifed_37" doesn't affect anyone's privacy.
There was a good episode of Radiolab about her, as well as a good interview on Dr Kiki's Science Hour with the author of the book written about her life and legacy.
Her family was deeply disturbed by what was happening at first. Progress is necessary, but so is people's dignity.
Her family was deeply disturbed by what was happening at first. Progress is necessary, but so is people's dignity.
I don't want to be callous, but look at the cost-benefit calculation:
Cost: One disgruntled family.
Benefit: Polio vaccine. Treatments for cancer, HIV, various toxins, and other stuff I don't know about in the 50,000 research papers on HeLa. I am not exaggerating. There really are over 50,000 papers about HeLa.
That doesn't really change the fact that there were issues with her informed consent. When HeLa cells were first derived, most of the benefits weren't even on the radar. I don't think the initial investigators could have imagined what would have happened, let alone the patient.
I think this is a case where the system didn't work... but more because the science got ahead of the ethics. Sure, excellent science has been done with HeLa cells, but it all started with an ethically ambiguous beginning. For example: why do we know her name? This alone should never have happened.
When HeLa cells were first derived, most of the benefits weren't even on the radar.
Excuse me? It was the first human cell line that could grow in culture indefinitely. Doctors and researchers immediately recognized the potential of HeLa cells. It took less than three years before the cells were used to mass-produce Jonas Salk's polio vaccine.
I am not exaggerating when I say that millions of people today owe their lives to HeLa. Had doctors been forced to do what you call ethical, those people would be dead. With so many lives at stake, the objections of the family (or the individual) simply don't matter.
For example: why do we know her name? This alone should never have happened.
Originally she was anonymized. Later, researchers wanted to get genetic information from her living relatives. Somehow the press found out. Perhaps a relative told them.
The thing here is that this is the start of a different way of doing science, and as such you want to be careful of the precedents you set.
It's a good thing that someone is thinking about how all this stuff is going to be protected.
The protocol there is one of ensuring anonymity for people that want to remain anonomous. Making sure that that sentiment is retained moving forward is not a bad thing.
I do not read the editorial you linked as saying, "You didn't do it according to protocol." The editorial, in fact, is explaining why PLoS Genetics thought the study was okay to publish, how the 23andMe study strictly complied with existing protocol and went above and beyond its requirements, and how the IRB system needs to be improved to deal with GWAS.
http://plosgenetics.org/article/info:doi/10.1371/journal.pge...
When the response to new and cool is "you didn't do it according to protocol", something is definitely wrong.