Via Eurekalert: Science article has implications for all rapidly developing fields
NIH struggle holds lessons for decision-makers in numerous research arenas
Global climate change and other fast-developing scientific fields can take a cue from a prolonged process that eventually led to a workable compromise regarding the release of new data by human genome researchers.
A new study by a Washington University in St. Louis School of Law professor in the July 23 issue of the journal “Science” chronicles a 15-year struggle around the competing needs inherent in data-release decisions.
In the first comprehensive examination of its kind, Jorge Contreras, JD, explains that the U.S. government must weigh the rights of researchers, also called data producers, against those of data users. The scientific community needs the latest data as soon as possible in order to drive further research. But researchers may want time to prepare for publication and apply for patents.
The result is a balancing act between the interests of these two groups. Although Contreras’ study focuses on human genome research, the same dilemma holds true for research in many other areas of study.
“I think you must have a compromise. Otherwise these commons, or bodies of data, aren’t going to be created,” Contreras says.
NASCENT FIELD DEMANDS NEW POLICIES
At the dawn of human genome research two decades ago, more than 1,000 researchers were working around the globe. To facilitate knowledge sharing, the U.S. government sought to coordinate their efforts.
In the past, government-funded human genome researchers had a 12-to-18 month latency period between the generation of data and its required release.
In 1992, the National Institutes of Health (NIH) and the Department of Energy (DOE) reduced that period to six months. Four years later, government and scientific leaders determined that six months was still too large a gap.
They then decided that human genome research findings must be released prior to publication, within 24 hours after generation. The legacy of that determination, called the “Bermuda Accord,” still affects genomic research projects today and makes it difficult for data generators to publish their findings before competitors who have free access to their data.
“While it would be preferable, from a pure scientific advancement standpoint, to have every piece of data released immediately to the public, that doesn’t give data-generating scientists the opportunity to publish and advance their careers through publication,” Contreras says.
The agreement also inhibits the ability of researchers to obtain patents, as patents cannot be obtained on information that is already known to the public.
COMPROMISE RESOLVES SOME PUBLISHING ISSUES, STILL THWARTS PATENTING
With the arrival of the 21st century, genomic research began to evolve from sequencing to associating variants in the genome with specific traits and conditions, known as genome-wide association studies (GWAS). This development brought about a 2007 compromise decision, in which the NIH again altered its rules.
The newer policy, which applies only to GWAS, still requires quick data release but it also prevents users from publishing the data or presenting related information for up to 12 months. The shift is significant in that GWAS now make up a large portion of human genome research.
Still in effect, this set of rules allows GWAS researchers time to publish their own work. In the meantime, other scientists can use the data for their research and future publications.
The 2007 policy does not improve the likelihood of scientists patenting their work, but that issue is secondary to publication for most researchers, according to Contreras.
Contreras sees implications for his study in numerous scientific fields beyond genomics, including not only global climate change, but also chemistry and astronomy.
“As policy makers begin to develop commons in different areas, rather than going back to the drawing board and starting from scratch, they’ll be able to look at this systematic analysis of how timing variables have played a role in genome science, and take it from there,” Contreras says.
Contreras, WUSTL’s deputy director of the Intellectual Property Program and senior lecturer in law, serves on the NIH Council of the National Human Genome Research Institute; is chair of the Committee on Technical Standardization of the American Bar Association Section of Science & Technology Law; and has published numerous articles relating to science and technology law.
It’s a wonderful thing to watch the popular media trying to reduce the Science of climate change into fast food grabs that the average person can understand. The medias need for controversy is well known. Scientists have some learning to do if their work isn’t abused by some media hack looking for a hot story.
Memo to all; Science is not a 60 second news bit.
“Global climate change and other fast-developing scientific fields….”
I’d characterize the scientific field of global climate change as fast-unravelling!
The only thing those folks have developed quickly have been newer & better methods for obfuscation, evasion, and dishonesty.
How can the earliest possible release of data and code not seen as a ‘matter of honour’
Perhaps the best question in the future will be – ‘Did your predecessor release their data in a timely fashion, for the benefit of the human race….. or did they follow the routine of the former so-called climate scientists’
The Write Way:
1. Write
2. Read
3. Edit
4. Re-read
5. Re-edit
(5a. Habitually skip steps 4 & 5)
6.Post
….code not ‘BE’ seen as …
No need to wonder why higher school grades forever eluded me…. 🙁
(But I was remarkably consistent with step 5a )
Sorry, OT [snip]
[reply] tips and notes please. RT-mod
Time was not too far back when DNA was seen only via x-ray crystallography, and a hint of structure depicted, uniting least partly the disciplines of physics, maths and engineering. A key regret I have was not taking up Alan Robertson’s (SRO Aberdeen) offer to ‘fire -up the machine’ on a Sunday morning showing atomic structure via bounced electrons in the Department! What’d I miss?
The NIH recommendation that users not be allowed to publish info derived from the quick release of others – deos this apply to blogs? One of the strengths of the blog system is the early detection of errors, a detection that should be immediately possible and corrected promptly. It’s a troublesome area.
Re Crossopter: You missed the formative work that allowed the later designers of DNA sequencers to design the appropriate machines. Of course, nobody knew then of the huge impact of the coming polymerase chain reaction. (i.e. chemists played a part also).
The basic issue is who has a right to see what, and when.
Research scientists who are paid with public funds at public universities, doing research paid by public funds (think NSF, DOE, etc.), using equipment and facilities paid for and maintained with public funds have an inherent duty to demonstrate their results to….the public. In a timely manner.
I bought it, I paid for it, I wanna see it…..especially if you’re getting patent rights from it.
So if you tell me that the earth is melting, show me how you got to that conclusion.
Crossopter: July 24, 2010 at 3:10 am
What’d I miss?
I had one of those moments, once, and never again turned down a chance to “see something neat” whenever a lab-guy offered.
Any piece of science can be logically ripped apart to see how the conclusion was arrived at.
1) If it is good science, it will stand up to any research and questions.
2) If it’s iffy science, then it will work for now until the correct science is found.
3) If it is terrible science, it will fall apart under the weight of actual physical evidence.
So far medicine stand in the 1) position for the massive amount of research and experimentation.
The rest of science falls into 2) and 3) do to individualizing science into designated areas even though mechanics plays a BIG role in science.
Physical evidence is ignored to protect theories and the system of “PEER-REVIEW”.
Put mechanics and the evidence in front of any scientist or physicist and it becomes an attack on their schooling and knowledge. Meanwhile they keep passing on this incorrect science to a new generation.
The taxpayers are paying to fund the advancement of the science not the advancement of the scientists careers. Climate science is not a field where scientists should have expectations of getting lucrative patents from tax payer funded research and data.
No patent should ever be issued on anything which has received (even indirectly) one cent of public money.
Bill Tuttle and Crosscopter-ditto! missed a chance like that myself…
Missed seeing how a Sodium Cooled Reactor was built and worked-first hand
by the guy who helped design it. Went with his daughter, and she wasn’t interested..
Kick myself to this day….
Climate scientists work for us. We pay thier salaries out of our taxes. It is We the Company who own the rights to the data.
That is why the data belongs in the public domain, not in the hands of unethical law twisters and revisionists.
This is the basis for the FOI Acts that the world knows.
I am scratching my head trying to imagine what research from dendrochronology might lead to a patent application.
Isn’t it funny how most of the problems crop up in “Government funded research.”
Quick digression:
Note that the progress in “Medicine” has largely been progress in Pharmacology. The Medical Profession has vastly fewer innovators, those it does have are rightly celebrated. Barnard, DeBakey, Cooley, Salk, Sabin, the whole world knows their names. By innovators, I don’t mean finding a new scalpel blade, new forceps, new retractor, these are people who fundamentally changed treatments. Medicine must, perforce, be conservative, but I suspect legal threats keep many innovations on the shelves way too long.
Back to the topic:
So why is it that “innovation” in the “Climate Research Area” consists largely of agreeing with a scientifically unverifiable hypothesis, followed by a “Its worse than we thought,” or “In the future, models show…”, while demonstrating a remarkable lack of knowledge of the scientific method?
PJP says:
July 24, 2010 at 6:39 am
“No patent should ever be issued on anything which has received (even indirectly) one cent of public money.”
Now THAT would make a good WUWT readers poll and the subsequent comments, given that quite a few researchers frequent this blog, would be interesting to me.
Would that be asking too much, Anthony?
“Global climate change and other fast-developing scientific fields …”
Since when is “Global climate change ” a rapidly developing field? It it were, how could the science be settled? I thought Hansen et.al. defined the narrative in 1988 and just filled out their roles in that framework since that time.
Patent, publication and tenure dynamics are often limited to a relatively small set of individuals. In some cases it can have broader economic consequences but the general population is not forced to act on the research claims.
Climate research however has accused our Nation’s culture, economy and citizens of heinous acts. The “research” serves as prosecutor, judge and jury. It demands we change our lifestyles. It demands control over winners and losers in our economy. It demands of us money, resources and risk. Climate science most importantly demands the use of government force.
When science becomes the basis for an indictment -new standards must apply. We as a people have been accused by the climate science community –this is not about patent or publication rights– and we as a people have a right to the evidence!
A quick and simple interim solution:
– if code, data etc is not made available – the related research cannot be used to either set or guide government policy nor can it be used in lobbying efforts for public policy.
PJP says: July 24, 2010 at 6:39 am
No patent should ever be issued on anything which has received (even indirectly) one cent of public money.
I agree that no patents should issue on govt funded research, but given the fungible nature of money and the acquisitive nature of the current regime, we might find our rulers expropriating privately funded patents based on tax credits granted the funder for entirely unrelated expenses.
wsbriggs at 7:48 am . . .
We actually do get a lot of innovation in medicine. Think of eye surgery, or arthroscopic surgery. Perhaps I hear about it more because I live in Houston.
.
A lot of confusion seems to exist about the government.
You don’t own govt property, the govt does. You don’t pay for govt-funded projects, the govt does. The govt did not ask you whether you wanted to give up a large portion of your earnings, it merely takes it as its right.
At this blog, we are not in the business of perpetuating myths.
Geoff Sherrington says:
July 24, 2010 at 3:46 am
One semi-regret I have is in high school in the late 1960s I was fascinated with the idea of designing enzymes, which implied knowing what in the enzyme, which meant decoding genes, and that seemed like such a daunting task that I went to CMU as a Chemistry major instead.
However, once there I got hooked by my first programming course so I wound up implementing some of the fundamental application level protocols on ARPAnet that are still used today, tweaked for the Internet’s TCP/IP. (Spam wasn’t my idea, though!) Pretty good trade, so things worked out fine.
For a few days I did have a superuser password at Celera Genomics in the midst of their race to be the first to decode the human genome. They used DEC computers, I worked for DEC at the time, and they pushed a few things into areas we hadn’t reached.
These days, that Herculean effort costs $50,000 – http://www.nytimes.com/2010/03/11/health/research/11gene.html
Dummy me.
For years I had just assumed all data from all research was freely available to anyone interested.
Then, as I started to research AGW, I find the cesspool modern science has become.
What’s the root problem?
Pride? Vanity? Financial incentives? Nationalism? Institutionalism? Back to some sort of feudal society where each specialty, university, govt agency has a little castle complete with ramparts and moats? In return for your admittance here, you must give all to the ‘group’?
Why cant’ I write a polite letter or email to a researcher asking for the data upon which an article I read is based, and get a polite response to the effect; ‘Not just now, because I haven’t published yet, but will be ready later. Thank you for your interest’ or ‘Sure, it’s here at this location…’?
Why isn’t there a data repository, web accessible, where all data for all research is stored?
I once wrote a quick email to Dr. Lindzen pointing out a minor typo error in one of his papers. Got an almost instant response, thanking me for the observation.
I was a little shocked. He certainly did not need to reply. But he did. Would love someday to meet him.
Let’s just say, not everyone in science is so forthcoming.
Depressed in Denver
Cal Smith says:
July 24, 2010 at 7:48 am
A new line of designer tree thermometers from Martha Stewart?
If I’m reading this right gist of it is:
The public pays for research then has to sit on its thumbs with results withheld for months or years while the hired help mines the results for personal profit through publications and patents.
Is that about right?
I was a hired gun in R&D at a major corporation for many years and am the named inventor on several patents with rights assigned to my employer. It was very well understood that my work was the property of those who paid me for it. I can’t imagine the delays described in the OP aren’t stipulated in a contractual agreement. If they are not then there should be no delay and if there are I can’t hold the researchers themselves responsible for negotiating in their own best interest. I might hold the government agency granting the funding responsible for failure to negotiate in the public’s best interest however.
This is essentially correct. I was on the IP team at the employer mentioned above and participated in the evaluation of over a thousand internal employee and sub-contractor generated patent proposals. We very often had to share information about the invention with third parties prior to filing a patent application. The way around that is simple – anyone who receives the information must first sign an agreement, typically an NDA (non disclosure agreement) that establishes limits on how the data can used by the recipient. Seems simple enough to restrict access to the information to only those members of the public willing to sign an NDA where the NDA prohibits using the data for publications, patents, or disclosure to parties not included in the NDA.
rbateman: July 24, 2010 at 7:37 am
Climate scientists work for us. We pay their salaries out of our taxes. It is We the Company who own the rights to the data.
Can’t argue with that. Anything I produce on company time, using company assets, is the property of the company — I’m allowed credit for producing it, but that’s as far as it goes. Now, my boss might give me a bonus
*waving hiya to the corporate guys*
for producing it, but I’m not entitled to anything beyond my salary.
Research used to set public policy must be held to a different test. Researchers cannot be allowed to declare research property rights when that research is used to deny others their property rights. And Government cannot be allowed to use restricted research to justify public policy.
Patent, tenure, publication rights although worthy of discussion tend deflect attention from this more basic issue.
The property rights of researcher’s using public funds is an issue that requires more attention– however it is not nearly as urgent as addressing the issue of full disclosure in research used
What can and cannot be done with public funding with respect to patents is a separate issue. The most critical issue at the moment is not researcher’s rights but the public’s rightArguing both issues simultaneously deflects attention from how this research is being used.
I fail to see how a data repository like the Genome Data Base has any relevance to climate data (the possible exception being paleoclimate data). Climate data is instantly available to the public and the codes, methods, equations, and software SHOULD be available upon publication for replication. I can’t see any patent possibilities either (profitable ones anyway).
I have been an industrial researcher and have a number of patents along with other inventions that weren’t patented but kept as trade secrets. We lost a patent on a key product because we tested it on a panel of users without securing NDAs. So, one must be careful in disclosing “enabling information” on patentable technologies.
In recent years I have been doing applied research in academia on technologies for safety equipment for military and first responder use. Much of the work is under government contract, and we often collaborate with industrial partners to bring the technology to market. The (US) government acquires the data rights and right to have the data published, but the developers retain IP rights to software and hardware produced. The object is for the government (and other) users to get the technology into their hands, so there has long been a law governing such situations. One example would be developing a new military jet under government contract. The government has decided it needs the technology, and it doesn’t have the expertise to do so. Developers don’t have an incentive to create the technology if they cannot produce it after it is developed. If the developer doesn’t want to commercialize the technology, under the law the government has the right to find someone else to bring it to market.
The government encourages publication and information sharing on the performance testing and technologies used in such cases, including publishing new modeling information for other scientists and engineers to use on future products.
In the case of non-classified material, I think that there should be no right to expect confidentiality for basic science such as climatology reserach. IF IP is at issue, the researcher typically has a reasonable period to file disclosures or copyrights of programs before disclosure. In the case of temperature and other weather and climatic data, there is no inventiveness needed and the public has paid for it. It should be available as soon as it is collected and collated. I could see that instruments, models and software might be subject to IP rights; but they should be publically disclosed as soon as the IP has been protected (i.e., within one year).
The unwillingness of the scientists and managers at UEA, Penn State, etc. to disclose information seems to be highly suspect to me, and it violates basic tenets of the scientific method. Such practices place the techniques and data used to generate conclusions that will dominate the world’s economic future behind a curtain. I respect Anthony, M&M and others who have fought for information release to penetrate that veil.
I’m surprised no one has commented yet on Michael Crichton’s stand on patenting of genes. Crichton, author of the excellent Man-Made Global Warming expose, “State of Fear,” also commented on genetic patents in his work, “Next.”
http://www.crichton-official.com/books-next-policy.html
It appears that the courts may, at last, side with him:
http://www.businessweek.com/news/2010-03-29/myriad-loses-ruling-over-breast-cancer-gene-patents-update1-.html
How long until the courts dispose of the CAGW canard?
Ric Werme says July 24, 2010 at 11:06 am
Minor comment, but I bought a PDP-8e in 1970, 8K of ferrite core, mostly taken up by Basic. Booted by toggle switches. Mass storage device was punched paper tape ASR-33. That was before bloatware, but it is amazing what could be achieved – and was – by good machine language work. It was connected to a fast neutron generator I bought for chemical analysis, then extended it to data logging several lab instruments.
The IPCC could, if it wanted to try and restore its reputation, take the lead here by insisting that papers can only be cited if any underlying data and computer code has been made available to the public.
If the science is sound they have nothing to fear.
Stop Global Dumbing Now says:
July 24, 2010 at 12:26 pm
I fail to see how a data repository like the Genome Data Base has any relevance to climate data (the possible exception being paleoclimate data). Climate data is instantly available to the public and the codes, methods, equations, and software SHOULD be available upon publication for replication. I can’t see any patent possibilities either (profitable ones anyway).
If you had perfected a model that could predict with accuracy global weather conditions just 6 months into the future, I could make millions in that time trading agricultural commodities.
Which explains why all the AGW researchers and their fancy computers are still begging the government for money.
@jorge
I’m pretty sure you can’t patent a gene, per se. At least not one found in nature. You can however patent a process that uses a gene found in nature.
That said the patent office isn’t perfect and sometimes the examiners slip up.
In theory mathematical formulas and computer algorithms in and of themselves can’t be patented. I should think a gene sequence falls into the same category. When it comes to computer algorithms you have to patent a novel way of using it rather than the algorithm itself.
Q – What’s the ONE thing that science (and everything/one else on the planet) could sure could use a lot less of?
A – Lawyers!
There otta’ be a law against lawyers!
PS: Personaly, I’d give anyone who works for the government, or in the private sector for some corporate entity, 10% for any patent they were responsible for developing while in “service” to the same. Hmmm… we’d probably need a lawyer to… never mind! NEVER MIND!
Dave Springer says:
July 25, 2010 at 7:01 am
> I’m pretty sure you can’t patent a gene, per se. At least not one found in nature.
Yes, you can, and that’s a large part of the problem. Exactly why, given the patent filer has done nothing novel to invent the gene, makes the process appear completely broken.
And indeed, the rules may be changing. In March a Federal District Court overturned a few patents, see http://www.nytimes.com/2010/03/30/business/30gene.html
It says, in part:
Judge Sweet, however, ruled that the patents were “improperly granted” because they involved a “law of nature.” He said that many critics of gene patents considered the idea that isolating a gene made it patentable “a ‘lawyer’s trick’ that circumvents the prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result.”
The case could have far-reaching implications. About 20 percent of human genes have been patented, and multibillion-dollar industries have been built atop the intellectual property rights that the patents grant.
“The agreement also inhibits the ability of researchers to obtain patents, as patents cannot be obtained on information that is already known to the public.”
Not exactly. Disclosure starts a year-long clock. Patents must be applied for within that year.