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

Last week The Wall Street Journal reported on a new project from – 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 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.

Lethal Lab Safety Could Get You Community Service

That’s the message you might take from the recent announcement of a deferred prosecution agreement reached between the Los Angeles County District Attorney’s Office and UCLA chemistry professor Patrick Harran.  The agreement resolves the criminal charges Harran faced resulting from the death of research assistant Sheharbano Sangji.  She died in January 2009 as a result of burns suffered in the lab in December 2008.  UCLA reached a settlement agreement with the District Attorney back in 2012.

For the most thorough coverage, go read what Chemical and Engineering News has been writing on its safety blog since at least 2010.  Their reporting deserves wider readership and recognition – if for no better reason than to help shame some people who seem to think .

The agreement requires Harran to perform community service in the L.A. Hospital, pay $10,000 to a burn center, and teach organic chemistry courses to incoming college students from inner-city schools for five years.  For all this Harran avoids a trial, and admits no wrongdoing.  This press release from UCLA suggests Harran will continue to run a lab.

If you’re upset at this, like Sangji’s family is, I don’t blame you.  It certainly seems like a slap on the wrist.  For better or for worse, Harran was up on charges of willfully violating occupational health and safety standards.  This would be harder to prove than simple negligence, and might have prompted the District Attorney’s office to settle.

But it’s hard – at least on a visceral level – for me to accept that the best way forward is to keep Harran around running a lab as a cautionary tale.  Time may prove me wrong, but given the consequences of the kind of rigor his lab applied to safety, this might be a situation where a second chance isn’t reasonable.  Continue reading

Bioethics Commission Continues Assessment Of Neuroscience Research

The Presidential Commission for the Study of Bioethical Issues will hold its next meeting on Monday and Tuesday, June 9 and 10, in Atlanta.  Per the draft agenda, it will continue the work it started last summer on the ethics of neuroscience research and its applications.  As is customary, the meeting will be webcast, simply visit the Commission website during the meeting.

On the first day the Commission will hear from experts on data sharing in neuroscience research, the potential in the field, and the differences in neuroscience research for various stages of life.  On the second day the focus shifts slightly to the ethical and social implications of neuroscience research.  The material on the second day will likely inform the second volume of the Commission’s report, Gray Matters.  The first volume was released in May and focuses more on how to better integrate ethical principles into neuroscience research.  During this meeting, the Commission may give some idea of when that report might be available.

Gene Therapy May Have Revised Oversight

The National Institutes of Health (NIH) will stop requiring special review of gene therapy trials (H/T ScienceInsider) currently conducted by the Recombinant DNA Advisory Committee (RAC).  NIH Director Francis Collins justified the decision, which is based on recommendations from a study it requested of the Institute of Medicine, by noting the progress in the field since the formation of the RAC over 40 years ago, as well as the additional regulatory reviews in place for this kind of research.  The RAC would remain to review special kinds of gene therapy trials, provided they meet the following requirements:

  1. The protocol review could not be adequately performed by other regulatory and oversight processes (for example, the institutional review boards, institutional biosafety committees, and the FDA).
  2. One or more of the following criteria are satisfied:
    • Protocol uses a new vector, genetic material, or delivery method that represents a first-in-human experience, thus representing unknown risk.
    • Protocol relies on preclinical safety data that were obtained using a new preclinical model system of unknown and unconfirmed value.
    • Proposed vector, gene construct, or method of delivery is associated with possible toxicities that are not widely known and that may render it difficult for local and federal regulatory bodies to evaluate the protocol rigorously.

I understand the idea that the RAC likely conducts a certain amount of review that is redundant.  Given the challenges facing other bodies with NIH-relevant ethics responsibilities, I would certainly understand if anyone took pause in response to the decision.  Especially since the NIH has yet to decide whether to follow another IOM recommendation – to replace the RAC with another body focused on gene therapy and other kinds of risky research.

NIH Needs Help In Its Ethics House

This week we can read about how National Institutes of Health (NIH) and Department of Health and Human Services (HHS) officials may have influenced the investigation of a study by the HHS Office of Human Research Protections (OHRP).  In short, Public Citizen is claiming, based on documents obtained from a Freedom of Information Act request, that NIH and HHS officials worked to change the response of OHRP to concerns about informed consent procedures in a study involving premature babies.  Public Citizens complaint is with the HHS inspector general and at least one member of Congress, Rosa DeLauro of Connecticut, has expressed interest in the case.

This matter comes to light just as a sister office at HHS, the Office of Research Integrity (ORI), is closing the submission process for its Director search.  The former Director, David Wright, resigned in March due to what he characterizes as a ‘remarkably dysfunctional’ bureaucracy.  He served for just over 2 years, and the office was without a director for two years before then.  He described his frustrations to a Science reporter in April, and felt that greater authority, if not outright independence, would make it easier for ORI to deal with its caseload.

While the two offices, ORI and OHRP, and separate, and deal with different parts of the scientific process, they both serve the broader interest of providing guidance toward more ethical research conducted with federal dollars.  But these two incidents suggest the Department, and NIH, are not committed to that goal.  The lack of progress on proposed changes to the ‘Common Rule’ that guides research involving human subjects adds to this negative impression.

If an Inspector General investigation recommends changes to the authority and resources of OHRP, it seems likely such changes could benefit ORI.  Hopefully a new HHS Secretary will have the interest and will to make the necessary changes to demonstrate the Department’s commitment to ethical research oversight and guidance.  (And if they shove the changes to the Common Rule forward, all the better.)

Bioethics Commission Isn’t Waiting For Next Meeting To Issue BRAIN Report

The Presidential Commission for the Study of Bioethical Issues has a lot to say about the BRAIN Initiative.  So much that the Commission report will take at least two volumes.  The Commission released Volume One of Gray Matters: Integrative Approaches for Neuroscience, Ethics, and Society today.  It’s the seventh report of the Commission since it was formed in late 2009.

The report was prompted by a request from President Obama to “identify proactively a set of core ethical standards – both to guide neuroscience research and to address some of the ethical dilemmas that may be raised by the application of neuroscience research findings.”  The recommendations in Volume One of the report are focused on achieving a more explicit integration of ethics into neuroscience research throughout the life of a research program.  There are four main recommendations:

  1. Integrate ethics early and explicitly throughout research
  2. Evaluate existing and innovative approaches to ethics integration
  3. Integrate ethics and science through education at all levels
  4. Explicitly include ethical perspectives on advisory and review bodies

Of specific application to the BRAIN Initiative is the need to include professionals with expertise in ethics in advisory boards and similar entities conducting research in this area.

Volume Two will focus more on the social and ethical implications of neuroscience research, topics likely to appear on the agenda of the Commission’s next meeting.  As a hint of what may be in that report, the Commission notes four examples that demonstrate the need to better integrate ethics throughout the course of neuroscience research:

  1. Neuroimaging and brain privacy;
  2. Dementia, personality, and changed preferences;
  3. Cognitive enhancement and justice; and
  4. Deep brain stimulation research and the ethically difficult history of psychosurgery.

The Commission did not give a deadline for when Volume 2 would be ready, but it may provide some insight on that front during the June meeting in Atlanta.

Next Bioethic Commission Will Keep BRAIN on the Brain

Continuing from its last meeting (in February 2014), the Presidential Commission for the Study of Bioethical Issues will continue working on the BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative in its June 9-10 meeting in Atlanta, Georgia.  An agenda is still forthcoming, but the Federal Register notice confirms that the Commission will have BRAIN as the main focus of the meeting, also covering relevant work in neuroscience.  The event will be webcast, so check the Commission’s website on June 9 and 10 for the relevant link.

I speculated recently that the successful in vivo replication of synthetic DNA with artificial base pairs would attract the Commission’s attention.  Without an agenda, it’s harder to be sure, but it seems that this development may have to wait for the next next meeting of the Commission.

In other developments, Commission staff are apparently going to examine some efforts to engage bioethical issues through plays.  Continue reading

Nominations Corner – Health And Human Services

The recent resignation of Secretary of Health and Human Services Kathleen Sebelius prompts a revisit of the slow march from nominee to confirmation.  While the President acted quickly to nominate Sylvia Burwell (current Director of the Office of Management and Budget) to replace Sebelius, the continuing paralysis of the Senate may mean it will be several months before she takes the job.

Normally the Secretary is, oddly enough, distanced from many of the science and technology functions the Department deals with.  But with the National Institutes of Health, Food and Drug Administration (FDA), Public Health Service (headed by the Surgeon General), the Presidential Commission for the Study of Biomedical Issues, and various research programs connected to Medicare and similar health programs, it would be tough for a Secretary to be completely detached from such actions.  In the case of Secretary Sebelius, perhaps her most controversial science and technology action is her decision to overrule the FDA in connection with the availability of emergency contraception.  While I doubt it will come up during the confirmation hearings, I think there will be an attempt to revisit the decision with a new person in charge of the Department.

(While we’re on the subject of Health and Human Services nominations, it’s worth noting that the latest attempt to nominate a Surgeon General has been blocked due – at least in part – on the refusal of some Senators to accept the nominee’s opinion that gun violence is a public health issue.)