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.

‘Secret’ Ebola Treatment And Other Stories

The outbreak of Ebola virus disease (formerly known as Ebola hermorrhagic fever) in western Africa is no laughing matter.  The way it’s been inserted into fights over immigration reinforces the need to fight misinformation.  (That one of the politicians concerned that Ebola will come into the U.S. via Central American immigrants is a retired doctor reinforces my belief that not all doctors are scientists.)

Here’s what the Centers for Disease Control (CDC) has to say (effective August 6).

“The World Health Organization, in partnership with the Ministries of Health in Guinea, Sierra Leone, Liberia, and Nigeria announced a cumulative total of 1711 suspect and confirmed cases of Ebola virus disease (EVD) and 932 deaths, as of August 4, 2014. Of the 1711 clinical cases, 1070 cases have been laboratory confirmed for Ebola virus infection.”

Contrary to the concerns of several elected officials and media outlets, there is no significant risk of Ebola in the United States.  Two researchers with the disease were evacuated to the United States for treatment at Emory University in Atlanta.  As long as a hospital follows CDC infection control recommendations and can isolate the patient, it can contain the disease.

There is word of a ‘secret serum’ that the U.S. has, but is not currently going to send over to Africa.  This likely refers to the experimental treatment ZMapp, which has not undergone testing on humans.  While it was used in connection with one of the U.S. cases, neither the National Institutes of Health nor the CDC were involved in procuring the experimental treatment or getting it to the infected person in Africa. Continue reading

Google’s Baseline Study – Will It Avoid 23andMe’s Pitfalls?

Last week The Wall Street Journal reported on a new project from Google.org – the Baseline Study (H/T ScienceInsider).  Starting with a pilot group of 175, the study would collect anonymous genetic and molecular information (according to the article) to construct a more comprehensive data-based model of what a human is.  Such a picture would ideally help researchers better identify symptoms and causes of various diseases.  A desired outcome would be the ability to find markers of various diseases much earlier in people than is currently possible.

Of course, such a long-term study is not new.  What would be different here is the potential scope of the project, should it expand beyond the initial population of 175.  The project is lead by Dr. Andrew Cohen, a molecular biologist whose previous major achievement has been in high-volume HIV tests of blood plasma.  Working in volume is something he’s comfortable with.  The project is mindful of the need to preserve anonymity, and has stated information will be used strictly for health and medical purposes and not shared with insurance companies.  Institutional review boards will be involved with the study, and once it grows beyond the initial group of 175, boards at the medical schools at Duke and Stanford Universities will be involved in controlling access and use of the information.

For reasons that escape me, I can find little mention of the project on the Google.org website.  Even the mentions found on Google + don’t connect to the organization.  It would seem to me that the Wall Street Journal article, and the subsequent press on it, could be part of an effort to gauge public interest and concerns with the project.  The lack of details (the articles have little more to go on than the information provided to The Wall Street Journal) are frustrating.

And then there’s 23andMe.  Continue reading

A Persistent Cloud In The Rise Of Chinese Research

Part of the arguments for increased scientific funding, regardless of country, focus on international competitiveness.  And the rise of China’s scientific enterprise is usually mentioned, especially in the countries already established in the research firmament.

However, what doesn’t get as much attention – perhaps because it undercuts the desired external threat – is the health of China’s research system.  The latest problems to come to light (it’s the third science-related incident reported by the Chinese antigraft committee this year) involve fraud in grants managed by China’s Ministry of Science and Technology and awarded to Fudan University in Shanghai (H/T ScienceInsider).

The specific concerns should be familiar to anyone concerned with ethics.  Conflicts of interest, too many outside appointments, and in some cases outright skimming of funds.  The rapid increase of investment in research and development certainly invites attention from researchers and those seeking to exploit an opportunity.  Only now does the Chinese government appear to be catching up with the latter category.  Whether university oversight has remains to be seen.

Now the problems plaguing Chinese research are not unique.  Every country needs to be vigilant with the research investments it makes and in making sure its personnel conduct themselves and their work in ways consistent with accepted ethical practices – scientific and otherwise.  But until oversight and proper research controls are better institutionalized in China, the problem could affect the quality of research output from that country.  As that output becomes a larger share of global output, concerns over the quality of Chinese research should be a concern for anyone seeking to rely on it – regardless of where they reside.

Science Establishes Editorial Review Board For Its Data

In the editorial for the July 4 issue (free with registration), Editor-in-Chief Marcia McNutt outlines a new review board for articles submitted to Science.  Joining the magazine’s Board of Reviewing Editors is a Statistical Board of Reviewing Editors.  The American Statistical Association was an important partner to Science in developing the Statistical Board.

Members of the Statistical Board will be experts in the fields of statistics and data analysis.  They will review articled identified by editors, members of the Board of Reviewing Editors or even reviewers as possibly needing additional scrutiny of the data analysis or statistical treatment.  The Statistical Board member would identify any statistical issues with the paper and suggest experts to perform additional review.

The Statistical Board started on July 1 and is intended to help assess the possibilities of bias in data collection and presentation.  With any luck they will collect data and conduct statistical analysis on its own work – and let the public see it.