PCAST And Bioethics Commission Double Up On BRAIN

Both the President’s Council of Advisers on Science and Technology (PCAST) and the Presidential Commission for the Study of Bioethical Issues will meet next month.

The Bioethics Commission will meet November 5 and 6 in Salt Lake City, Utah.  As is customary, the meeting will be webcast and updates will be posted on the Commission’s blog.  The agenda is not yet available, but based on the Federal Register notice, the BRAIN Initiative will be one focus of the meeting, as will education and deliberation in bioethics.

The next PCAST meeting is on November 14th.  As has become custom, the public session will be from approximately 9 to noon on a Friday in Washington, D.C., and the meeting will be webcast.  No agenda, draft or otherwise, is presently available.  Per that meeting’s Federal Register notice the meeting should cover the BRAIN Initiative as well (though with an emphasis on the private sector investments).  Other topics will likely include Ebola, space sciences and science and technology related to national security.

Study That Prompted Allegations Of NIH Interference Found Wanting

In March 2013 the Office for Human Subjects Research Protections (OHRP) at the Department of Health and Human Services (HHS) found that some of the informed consent provisions associated with the a study at the University of Alabama, Birmingham were lacking.  In June OHRP sent a subsequent letter to the researchers indicating it would put its planned sanctions on hold.

In between March and June, HHS and National Institutes of Health officials interacted with OHRP staff, and that interaction prompted allegations of improper influence.  The HHS Office of the Inspector General found no evidence of wrongdoing in its investigation.

But that doesn’t end the story, since OHRP put its actions on hold.  That hold ended on Friday.  Rather than implement sanctions against the researchers, OHRP has issued a call for comments on proposed informed consent guidelines.  The proposed guidelines affect the application of human research protections to cases of ‘standard of care research.’  The major questions concern what risks could be considered ‘reasonably foreseeable’ and how those risks should be described to prospective subjects.

In the case of the SUPPORT study that prompted this whole process, there was disagreement over whether or not the study protocols put subjects at risks that warranted disclosure.  OHRP felt that since the risks were greater than what subjects would reasonably expect without treatment, notice was required.  Others argued that because the treatment under study was within the standard of care for the condition, that no disclosure was required.

OHRP is taking comments until December 24, and will issue final guidance sometime in early 2015.

China’s Rising Scientific Enterprise Still Has A Big Quality Control Problem

Yes, China is increasing its scientific enterprise in terms of people and research output.  And while the relative quality of that research is likely improving to the level found in more established research systems, there appears to be at least one significant impediment to that improvement.

Nature News reports on another instance of corruption affecting Chinese scientific research.  This time its the misuse of over $4 million U.S. awarded to five research universities.  Seven scientists were named, and six are currently detained.  Two of those six have already started prison terms.

(For what it’s worth, even though it’s Chinese prison, I’m sympathetic to this level of punishment for the kinds of misconduct involved here.)

I suffer no illusion that other research systems are perfect.  But the kinds of scientific misconduct in other countries do not raise to the level I’ve seen reported in China.  Hopefully that will change, but in the meantime, I think it is something that should be part of any thorough analysis of the value in research, regardless of country.

Nobel Laureate Has A Play On Science Ethics

Should’ve has been around since 2007, but I didn’t discover it until I saw this notice of an upcoming reading at the National Academy of Sciences building.  Written by Roald Hoffman, a Nobel Laureate in Chemistry and member of the National Academy of Sciences, Should’ve traces the impact of one scientist’s suicide on members of his family.  The suicide was prompted (at least it seems), by the social implications of the man’s research, but the picture is more complicated than that.

Hoffman has written or co-written two other plays.  Oxygen wrestles with the late-18th century ‘discovery’ of the element and the associated theories around what the element actually is.  Something That Belongs To You is a semi-autobiographical work.  This is in addition to his research output and his poetry.  He also founded and helps organize the Entertaining Science cabaret series at the Cornelia Street Cafe in New York City.  (and yes, I’m envious.)

Follow-up Saturday – NIH Cleared On Ethics Case, May Proceed On Common Rule

Earlier this year I wrote about a case where the National Institutes of Health (NIH) was alleged to have acted improperly in a case involving a research study.  Public Citizen lodged a complaint with the Department of Health and Human Service’s (HHS) Office of Inspector General claiming that senior officials from the NIH and HHS interfered with the decision process of the Office for Human Subjects Research Protection (OHRP).  The specific case involved a research study on premature infants and optimal oxygen levels.

Earlier this month the Office of Inspector General issued its report on the allegations (H/T ScienceInsider).  The main conclusions were that senior NIH and HHS officials did not interfere in the initial decision of the OHRP, and that the subsequent communications between those officials and the OHRP was permissible under the law.  The OIG issued a separate report on how OHRP conducted its evaluation of the research study.  Public Citizen is not happy with the decision, characterizing the investigation as a ‘whitewash.’

While the OIG report indicated that OHRP is not an independent organization, part of the Public Citizen complaint indicated (page 2) that moving OHRP out of the NIH was done in part to insulate the office from interference by NIH officials.  It seems worth revisiting whether or not OHRP and related ethics organizations within HHS and NIH should be independent from those entities.

In related news, the ScienceInsider article (and the behind a paywall, Chronicle of Higher Education reporting it references) suggests that OHRP may soon be ready to issue new proposed rules on human subjects research.  This would seem to be forward progress on the Common Rule, which was the subject of a public comment period back in 2011.  As it hasn’t be revised in decades, it’s long overdue.

Next Bioethics Commission Meeting Exlpores Applications of Neuroscience

The next meeting of the Presidential Commission for the Study of Biomedical Issues is in Washington on next Wednesday, August 20.  The agenda is now available, and the meeting will be webcast via a link on the meetings page of the website.

The focus of this one day meeting is on neuroscience.  Panels will focus on cognitive enhancements, direct-to-consumer neurotechnology and neuroscience research.  As I speculated in May, these topics are part of the second volume of the Commission’s report on the brain.  Perhaps the Commission will hint at when Volume 2 will be ready (I’d guess by the end of the year.)

Public comments will be accepted before the meeting.  Email the commission at info at bioethics dot gov.

At Least One Congressman Is Concerned About Future Robot Overlords

There is a Congressional Robotics Caucus, which was formed in 2007.  Its focus is on positive and peaceful uses of robotics technology.  It’s often difficult for advocacy groups to address the beneficial and dangerous aspects of their focus in equal measure.  So I’m not surprised that a Congressional briefing on killer robots was not sponsored by the Robotics Caucus.  Credit the Campaign To Stop Killer Robots, an international coalition of NGOs concerned about autonomous weapons, for last month’s event.

What both groups have in common is Massachusetts Representative Jim McGovern.  He served as emcee of the killer robots event and is a member of the Congressional Robotics Caucus.  The other speakers were there to discuss how autonomous weapons/killer robots could be controlled pre-emptively.  McGovern is persuaded that there is enough time before these technologies are mature enough that the proverbial cat is out of the bag.

These aren’t lone voices speaking on the subject.  The Department of Defense has its own policy on autonomous and semi-autonomous weapons systems.

Yes, McGovern and others are really concerned about Terminator-style fighting robots.  This is arguably a subset of the more familiar concern over artificial intelligence.  And Elon Musk recently weighed in on his concerns in that area, indicating that trying to avoid negative consequences of artificial intelligence has motivated some of his investment decisions.