Bioethics Commission Finds National Ebola Response Lacking

Earlier today the Presidential Commission for the Study of Bioethical Issues released a brief (90 pages, so your mileage may vary), Ethics and Ebola.  The report is intended to provide an assessment of the current Ebola outbreak (particularly of the response to cases diagnosed in the U.S.) and recommendations for becoming better prepared for future outbreaks.

The report’s recommendations cover how to prepare for outbreaks, ethical reasons for intervention in outbreaks, guiding principles for deciding to use restrictive public health measures (such as quarantines), and how to conduct research (if warranted) in outrbeak situations.  The recommendations are summarized below: Continue reading

February Bioethics Commission Meeting Tackled Medical Emergencies

The Presidential Commission on Bioethical Issues met earlier this month in Washington, D.C.  The meeting focused on two major topics – medical emergency research and neuroscience.  The first day dealt with medical emergency research and was heavily influenced by the ongoing Ebola epidemic in west Africa.  The Commission heard from researchers, public health personnel and practitioners on the epidemic in Africa, efforts intended to prevent the spread of the virus in the United States, and the ethical issues associated with research on something like Ebola during an epidemic or other medical emergency.

The Commission is conducting a review of the U.S. response to the Ebola epidemic, with a focus on three issues:

  • The ethics of placebo-control trials in the context of public health emergencies;
  • The ethics of U.S. public policies that restrict association or movement; and
  • The ethical considerations relevant to collecting and storing biospecimens during a public health emergency and sharing them for future research.

On the second day, the meeting shifted to the Commission’s ongoing work in neuroscience.  The Commission intends to release volume two of its report Gray Matters sometime in the spring.  Volume 1 was released in May 2014, and focused on the integration of ethics into neuroscience education.  Volume 2 will tackle neural modifications, neuroscience in the legal system, and how neural capacity can affect the ability to consent in neuroscience research.

The next meeting will take place in Philadelphia May 27 and 28.

Appointment Heading For The Exits

While the confirmation challenges continue, at least one high-level science and technology appointee is stepping down.  Margaret Hamburg, Commissioner of the Food and Drug Administration, will step down at the end of next month (H/T ScienceInsider).  Even with slightly less than two years remaining in the Obama Administration, there is a chance Dr. Hamburg’s successor may not be confirmed before a new President is sworn in.  (I am encouraged by indications that a nominee has already been identified.)

Hamburg’s tenure is one of the longest in the agency’s history.  When she took over, the agency was struggling, with ethical challenges over drug approvals.  The agency is currently in the middle of regulatory changes for food safety oversight and medical device approvals, and it has not been perfect.  There were complaints over the agency’s inaction over compounding pharmacies (which are not presently regulated by the FDA), and Hamburg was overruled by Health and Human Services Secretary Sebelius over Plan B emergency contraception (though the courts eventually sided with the FDA).

Maybe OSTP Should Have Done Scientific Integrity The Canadian Way

It’s perhaps wishful thinking on my part, but I kind of envy how Canadian scientists are approaching the scientific integrity issue with the Canadian government.  You’ve probably heard about the concerns over what Canadian scientists are calling a muzzling by the government of scientists’ ability to communicate their work to the public. What has happened is that the public sector union representing scientists is including scientific integrity in its latest collective bargaining with the Canadian government (H/T umuzzledscience).  Yes, this is novel, and may not fit within the tradition of collective bargaining.  And it’s certainly true that U.S. government scientists are not as unionized as their Canadian colleagues (if they are at all).  But what I appreciate is that this process could – if the arguably resistant Harper government agrees to any kind of scientific integrity policy – provide for a truly national policy on scientific integrity.

What we see in the United States is a collection of agency policies with an inconsistent record of implementation.  The Office of Science and Technology Policy has effectively ceded any interest in overseeing or supervising the implementation of these policies.  Perhaps this is due to a lack of institutional power, a lack of interest, or some other cause(s).  But it leaves the promise of the initial effort toward U.S. scientific integrity policies a bit tarnished.

I should be more tempered at this news of Canadian negotiation over scientific integrity.  After all, it’s just starting, and it’s possible only one side is really interested in having something come out of the discussions.  But I’m a bit starved for any progress in this field.

NIH IRB Proposal Reflects Proposed Common Rule Changes

The National Institutes of Health (NIH) has issued a request for comments on a draft policy concerning Institutional Review Boards (IRB).  The NIH proposes allowing multi-site research studies to use a single IRB for approval.  The idea is that concentrating the human subjects review approval to one IRB would reduce the administrative burden.  It is even possible that a single IRB review for multi-site research might increase protections by focusing the oversight to a single body.

Comments are accepted on the policy through January 29, 2015.

This draft policy reflects changes proposed in 2011 when the Department of Health and Human Services proposed changes to the Common Rule – the suite of regulations on oversight of human subjects research.  IRB approval is just one facet of those changes, so maybe there are additional policy proposals coming.  Even in today’s dysfunctional environment, 3 years is a long time to wait.

The APA Continues To Handle Its Own Scientific Integrity Complaint

In October the American Psychological Association released a statement in response to allegations made by author James Risen.  In his book Pay Any Price: Greed, Power, and Endless War Risen alleges that the Association colluded with the Bush Administration in developing ‘enhanced interrogation’ techniques that most would consider torture.

It’s a very serious allegation, and the APA has taken pains to rebut the allegation through describing Rosen’s very limited interaction with the Association during the writing of his book, as well as its official policy on torture.

Not satisfied with those efforts, the APA announced that it has hired counsel to conduct an independent review of Risen’s claim.  Three members of the APA Board of Directors will coordinate the review, but APA promises an independent review.

“The review will include but not be limited to the following three issues: 1) whether APA supported the development or implementation of “enhanced” interrogation techniques that constituted torture; 2) whether changes to Section 1.02 of the APA Code of Ethics in 2002 or the formation and/or report of the APA Presidential Task Force on Psychological Ethics and National Security (PENS Task Force) were the product of collusion with the government to support torture or intended to support torture; and 3) whether any APA action related to torture was improperly influenced by government-related financial or policy considerations, including government grants, contracts or adoption of government policy regarding prescription privileges for psychologists serving in the military.”

Once the independent investigator completes the investigation Continue reading

Biomedical Journals Lay Down Some Transparency Markers

Both Nature and Science are noting in their latest issues the results of a June conference they co-convened with the National Institutes of Health (NIH).  At that conference, editors from over 30 journals, along with other scientific leaders in biomedical fields, met to discuss principles and guidance for reporting pre-clinical research.

A proposed list of principles and guidance were developed at the conference.  While the emphasis is on biomedical research, the principles strike me as generalizable to other fields of research.  I’ve summarized them below:

  • Rigorous statistical analysis – checked by the journal and policies disclosed in information for authors
  • Transparency in reporting – use a checklist to ensure reporting relevant methodological and analytical information to reviewers and readers.  Have ample space for methods sections, either in print or online.  Establish a clear set of reporting standards, which would include statistics, randomization, replication, presence of blinds, estimation of sample size, and inclusion/exclusion criteria.
  • Data and material sharing – All datasets should be made available on request during manuscript review, and based on reasonable request following publication.  Datasets should be placed in public repositories when possible, and in machine readable format
  • Refutations – Journals should have a policy assuming responsibility to consider publishing refutations of papers it has published.
  • Best Practice Guidelines – Journals should consider such guidelines for image based data, and descriptions of biological material (sufficient to uniquely identify source and relevant data)

May I suggest that if you are considering a journal for publication, that you see how many of these guidelines (or their discipline-appropriate equivalents) the journal follow?