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?


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.