You Can Have Too Much Automation

I’ve discussed this idea before – that automation can cause problems due to the loss of skills taken over by the technology.  The machine will take care of things, so the operators no longer have to worry about it.  In my post two years ago the automation in question was for trains.  The most recent example concerns commercial aircraft.  Edward Tenner at The Atlantic describes the problem as a decline in emergency skills due to increasing reliance on automation. Pilots are less likely to know what to do when problems arise because they have been using automation much more frequently than before.  (Perhaps its worth noting that Captain Sully had to deal with the bird collision shortly after takeoff, long before an auto-pilot would have been used.)

But he also links this dependence on technology to a seemingly unrelated field – agriculture.  Apparently (though not really a surprise) several herbicide-resistant strains of seeds have been used so much that pests have evolved in response.  Overuse of these strains, and the herbicides associated with them, has led to a loss of effective pest control.  In this case its not a loss of knowledge, but an increase in monoculture, where single threats are more effective against a large homogenous target.

In his article Tenner argues for a “more tentative approach to innovation.”  I think this glosses over an important distinction between the development of technology and its implementation.  I read Tenner to mean that we should be more tentative in broadly using new technologies and be more sensitive to potential – if not yet demonstrated – adverse consequences.  But that does not mean a tentative approach toward researching and developing new technologies.  Arguably such dependence on technology would support additional use-oriented research during technology development.

Either way, the loss of skill happens.  The rush to new technologies should not immediately place the ‘old’ on the dustbin.  Archived, maybe, but not disposed.  Let’s chalk this up to another instance of the seductive nature of technological fixes.

The Ethical Violations in Guatemala Were Likely Worse than You Expected

While not exactly a surprise, it’s worth noting the discussion Monday of the study examining the U.S.-led research in Guatemala that breached human subjects protections on a scale comparable to the Tuskegee syphilis study that withheld treatment of the disease for decades after a cure was developed.  The U.S. acknowledged the unethical nature of the research and formally apologized to Guatemala, the victims and their families last year when the project was discovered.  While I hope we will never find another example of a medical study so grossly cruel, I shall not hold my breath.

Yesterday was the first day of the latest meeting of the Presidential Commission on the Study of Bioethical Issues, and a final report will be delivered to the President in September.  Review the Commission’s blog for details from both days of the meeting.  The Commission will now focus on present-day clinical trial practices to see what problems exist, and have a report ready on that subject by the end of the year.

But the study in Guatemala, found only through historical research that prompted this effort, needs to be confronted (the Tuskegee study came to light only after it was leaked).  Legal and diplomatic action seems likely, regardless of whatever compensation systems are established.

• Researchers knowingly sought out vulnerable populations that would not likely object to the studies.  These groups included Guatemalan army personnel, orphans, sex workers, and prisoners.
• Comparable studies in the U.S. included consent procedures not followed in Guatemala.  In other words, even in the 1940s, the research conducted in Guatemala could not be allowed in the United States.
• More than 1300 Guatemalans were exposed to various sexually transmitted diseases in a two-year period.
• Eighty-three participants died during the period, though it is possible that some of them died due to unrelated causes.
• Few records were kept, and none of the research appears to have been published in journals.

The research was mismanaged, badly done, and barely disseminated.  Add the human rights violations associated with it and you have a study which manages to do nearly everything you’re not supposed to do.  And the people who conducted the study knew better.  This shame should linger.

Science and Technology Guests on Late Night, Week of August 29

Still a lot of repeats this week.  Of note, in case you missed them a couple of weeks ago, will be the re-airings of The Colbert Report with hacker Kevin Mitnick (Wednesday) and the astronauts from STS-135 (Thursday).  Of course, both programs are available online, at least for those in the U.S.  Mark Adams’ recent visit to The Daily Show re-airs on Thursday, but his work on Machu Picchu is more historical than scientific.

There are appearances this week that sort of qualify.  I’m not keen on most animal segments, but Julie Scardina will visit The Tonight Show this evening, and Jeff Musial is scheduled to chat with Jimmy Fallon on Wednesday.

And in the category of ‘well, they might talk science and technology’ we have the appearance tonight of Bettina Luescher from the World Food Programme.  She will sit with David Letterman to discuss drought in the Horn of Africa and the consequences for hunger.  Letterman has had focused on the World Food Programme before, but more on the humanitarian response than technical aspects of hunger and food delivery.

Most shows will be back with all-new episodes come Tuesday, September 6.

Mooney Gives Up on the First “Republican War on Science” and Starts Another

For the shrinking group of people interested in both the Obama Administration’s scientific integrity policies and the musings of science blogger Chris Mooney, his recent silence on scientific integrity policies seems odd.  Since those policies target much of the behavior he described in his polemical opus “The Republican War on Science,” I would think he’d be interested in what might pass as arms control agreements in this so-called war.

Recently he has claimed that the “Republican War on Science” has returned (not for the first time).  Much like his last attempt at resurrection, the new “RWOS” has almost nothing to do with what the first one tried to address.  Where the first attempt to rouse the rabble focused (or at least seemed to) on how government officials were restricting or repressing the research of government scientists and other parts of the scientific advisory apparatus, that no longer interests Mooney.

“we’ve swapped the relatively genteel “war on science” of the George W. Bush administration (which was prosecuted in top-down fashion from the White House and administration, largely in service of what various staff believed that the president wanted, or what should or shouldn’t be on the public agenda or in the media) for a more populist and bottom-up strain associated with the rise of the Tea Party.”

So the Bush Administration was ‘genteel’?  Let that steep in your mind for a bit.

The rest of Mooney’s newest attempt to revise the “Republican War on Science” has shifted from a focus on how government has inappropriately restricted scientists and their research to one where “the war isn’t really on science at all, but on reality.”

Hey Chris, a former Vice-President already tread this ground.  Absent your efforts at pop psychology, the best you’re going to be able to do here is update the names and dates.  You’re wasting your time.  But that’s been the case for a while.

Creation of NCATS Suggests Other Changes in Store for NIH

ScienceInsider has an interview from the departing head of the National Center for Research Resources (NCRR), Barbara Alving.  NCRR is going away to make way for the National Center for Advancing Translational Sciences (NCATS).  This transition has not been universally welcomed, and Alving would be one of those that would prefer an expansion of NCRR to the creation of a new center in place of it.  But adding a new center or institute to the National Institutes of Health would require Congressional authorization, while replacing one with another requires notification.

It certainly seems that this reorganization suffers as much from procedural problems as from any objections to form.  The consolidation of the addiction institutes has not suffered – at least publicly – from the same complaints as the reorganization of the NIH capacity for translational research.

The changes at NCRR reflect other elements of uncertainty at NIH.  The likely failure to pass the Fiscal Year 2012 budget on time (the new fiscal year starts in roughly five weeks) suggests the center will continue for a while as the government will most likely pass a continuing resolution at the current year’s levels.  Since the NCATS budget is tied to the new fiscal year, it will not exist without a passed budget, unless there’s language in the continuing resolution saying otherwise.

Besides the budgetary concern – which is not unique to NIH – there are the vacancies.  Alving’s departure means that there will be vacancies for five directors of centers or institutes.  Now, there will be acting directors, and acting directors at NIH have sometimes served for years (including at the top), but it does not send a message of stability to have so many empty chairs at the largest science agency in the federal government.

Interior Gets a Scientific Integrity Test Case

I was avoiding posting about the case of Charles Monnett, a government scientist working for the Department of the Interior’s Bureau of Ocean Energy Management, Regulation and Enforcement.  Since July his name has popped up in The New York Times, ScienceInsider and other places in connection with an investigation by the Office of the Inspector General at the Department.  There are at least two distinct issues involved.  One concerns contract management, and the other deals with a 2005 paper in which Dr. Monnett observed polar bear deaths.

The press coverage and Department of Interior statements within have whipsawed back and forth over whether or not the investigation of Monnett dealt with possible fraud with that paper.  Even Senator Inhofe, no friend of the policies associated with Monnett’s finding, is confused on the issue.  This is where the Department’s scientific integrity policy comes into play.

In late July, Public Employees for Environmental Responsibility filed a complaint with the Department alleging that Department employees violated the Department’s scientific integrity policy.  Specifically, that the process of the investigation subjected Monnett to outside interference in his work and serious departures from accepted practice where scientists are concerned.  The Department’s Scientific Integrity Officer responded to the complaint indicating that he would investigate the allegations.

Earlier today, Monnett’s suspension was lifted and he is back at work.  His duties will be changed, pending the investigation.  While there is no indication that the scientific integrity inquiry will find that violations of the policy occurred, it is encouraging to see these policies being put to work.

MythBuster on Late Night Tonight

Well, not Late Night with Jimmy Fallon, but the second home of the MythBusters, The Late, Late Show with Craig Ferguson.

Hey @CraigyFerg ! I'm really looking forward to being on tonight's show on Friday August 26th 2011. #wink #TimeTravelConfusion—
Tory Belleci (@ToryBelleci) August 26, 2011

Check those local listings.

Human Subjects Research From the Population POV

Let me point out first that my experience in biomedical research and research involving human subjects is very thin.  So if I’m just being a newbie, a short note to that effect would be appreciated.

One of the questions in the Advanced Notice of Proposed Rulemaking (ANPRM) on the Common Rule has stuck with me for a while.  My particular interest in bold.

“Question 27: The Common Rule currently states (45 CFR 46.111(a)(2)) that an IRB “should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among the research risks that fall within the purview of its responsibility.” Do IRBs correctly interpret this provision as meaning that while they should be evaluating risks to the individual subjects participating in a study, it is not part of their mandate to evaluate policy issues such as how groups of persons or institutions, for example, might object to conducting a study because the possible results of the study might be disagreeable to them? If that is not how the provision is typically interpreted, is there a need to clarify its meaning?”

Independent of the question, this language raises some questions.  There could be a number of reasons why an institution or group could consider the possible results of a study disagreeable.  Even if it might be appropriate for an IRB to consider those reactions, at best I can see a board looking at those reactions that have an ethical and/or risk-based cause for disagreeableness.  As it’s likely harder to divide between ethical, risk, and other reasons, it makes sense to me for IRBs to avoid dealing with policy issues.

Comments on this and other parts of the ANPRM are due September 26.

Bioethics Commission Will Meet Next Week; Should Release Human Subjects Report Next Month

Yesterday the Presidential Commission for the Study of Bioethical Issues released a press advisory for its meeting next week in Washington.  Reading the press release it seems to me that this will be the last meeting focused on its projects involving human subjects research procedures and the STD inoculation studies conducted in Guatemala during the 1940s.  Both efforts were requested by President Obama late last year.  With the Department of Health and Human Services also examining changes to the Common Rule, I think these projects could have profound impact on how researchers handle projects involving human subjects research worldwide.

The meeting will take place next Monday and Tuesday, the 29th and 30th.  It will be webcast and liveblogged, and you can access those links via the Commission’s website and the Commission blog.  While the reports won’t be released before September, some hints of the findings and recommendations could be revealed during the meeting.

The current agenda has Monday focused on the Guatemala study, with Tuesday concerned with current human subjects research practices and areas for reform.  The Vice President of Guatemala is scheduled to appear on Monday, and several government officials and bioethicists will speak on Tuesday (including former White House health policy adviser Ezekiel Emanuel).

Final Rule Issued for Public Health Conflicts of Interest

Earlier today the Department of Health and Human Services issued a final rule concerning conflicts of interest for research where public health funding is involved. (H/T ScienceInsider)  These regulations apply to the National Institutes of Health (NIH) as well as other aspects of the Public Health Service.

The threshhold for reporting financial conflicts has been lowered from $10,000 per year to $5,000.  Additionally, income considered must also include any equity in a non-publicly traded.  Perhaps most importantly, individual researchers will not decide what of their income qualifies for reporting.  Their institutions will make the judgment.

Regrettably, the final reporting requirements will not be as transparent as originally proposed.  There had been resistance to the proposal that conflicts information be posted online to an institution’s website.  Now the institutions can respond to requests for information, but it will not be posted online, either at the institutions or at a central website.  I’d have settled for the latter, but the NIH rejected it, stating that local institutions were in a better position to collect and post that information.  Perhaps, but I don’t think the solution provides for more accessible conflicts information.

As for whether researchers will still be able to avoid sanctions by going to another institution, I will have to scour all 159 pages of the final rule to know the answer.  The Science reporter couldn’t find an answer, so I’m not terribly optimistic.