Research Integrity Reporting Apparently Depends On What Should Means

Back in 2012 Universities UK released The concordat to support research integrity.  The document was developed by representatives from UK research universities, funding institutions and government agencies.  Among other things, the concordat recommended that employers of researchers should submit annual statements to their governing body outlining activities done with research integrity and research misconduct.

The UK Research Integrity Office (UKRIO, and I didn’t know about it either) decided to survey institutions about whether they were submitting these reports.  In a survey of 44 institutions that subscribe to UKIRO, 27 responded and 9 of them had submitted the annual reports.  Of another 44 institutions that did not subscribe to UKIRO, only 3 institutions submitted those reports.  (The survey will be published at a later date, so I do not know the response rate of the non-UKIRO subscribing institutioins.)

As described in this Nature article, there is a difference of opinion on the meaning of should in this context.  Not all institutions assumed that should means the reports are required.  (I wouldn’t automatically assume it did, but I’d advocate for submitting such reports regardless.)

The survey should provide additional insight once it’s released later this year.

Bioethics Commission Will Explore Deliberation And Education In Next Meeting; PCAST Might Tackle Capitalism

As occasionally happens both the Presidential Commission for the Study of Bioethical Issues and the President’s Council of Advisers on Science and Technology (PCAST) will meet in the same month.  The PCAST meeting is on May 15th, and while I have posted about it already, there is now a draft agenda available for review.  The session on business had already piqued my curiosity, and the agenda has only fueled my speculative interest.  The panelist named in the agenda, Rebecca Henderson of Harvard Business School, has been working on disruptions to capitalism and how that economic system could manage major transitions.

The Bioethics Commission will meet in Philadelphia on May 27.  No agenda is currently available, but the Federal Register notice indicates the meeting will focus on public engagement on bioethics issues (using deliberation) and bioethics education (also involving deliberation).

Deliberative democracy is a research interest of the Commission’s Chair, and ethics education was part of the Commission’s recommendations in its Gray Matters report, so it makes sense that these would be subjects of a Commission meeting.  Additionally, the Commission issued this request for comment in April for information relating to both public deliberation and education on bioethical issues.  The call will be open until July 20, so you may wish to watch the meeting (in person or online) before submitting your comments.

American Psychological Association Settles Lawsuit Over Lobby Fees

From today’s Washington Post is word that the American Psychological Association (APA) has settled a class-action lawsuit with its membership.  At issue was the contention that the association had required several of its members to pay a voluntary fee to the group’s lobbying arm, the APA Practice Organization.  The alleged deception dates back to 2001.  The total cash payments of the settlement will be nine million dollars.

The settlement process is ongoing, and the court will either approve or reject the settlement later this year.  As you might expect, the terms of the settlement agreement include language asserting that there is no admission of any claims levied in the suit or any acknowledgment of liability.  The agreement also means the association will be more explicit in communicating that fees paid to the APA Practice Organization are optional.

The way the APA has a separate lobbying arm brings up the matter of how scientific societies do or do not engage with advocacy.  The particular issue here is only tangentially related to the question, in that members can opt to provide support of association lobbying independent of their membership dues.  I don’t have any particular recommendation of the best way to handle this matter, but I think it highlights how agreement of a scientific association on the state of the field doesn’t necessarily translate into agreement on policy choices.  Nor do I think it should, but that’s a separate discussion.

NIH Reiterates Opposition To Funding Gene Editing For Human Embryos

In light of Chinese researchers reporting their efforts to edit the genes of ‘non-viable’ human embryos, the National Institutes of Health (NIH) Director Francis Collins issued a statement (H/T Carl Zimmer).

(For what it’s worth, the research indicated a very low success rate in editing the gene.)

The statement mentions the various legal and regulatory prohibitions on funding the kind of research the Chinese conducted.  In this case, the editing was of a gene responsible for a particular blood disorder.  But the changes to the gene would be heritable by the descendants (if the embryos in question were viable), and that is the source of concern.

From the Director’s statement (CRISPR/Cas9 is the editing technique in question):

“NIH will not fund any use of gene-editing technologies in human embryos. The concept of altering the human germline in embryos for clinical purposes has been debated over many years from many different perspectives, and has been viewed almost universally as a line that should not be crossed. Advances in technology have given us an elegant new way of carrying out genome editing, but the strong arguments against engaging in this activity remain. These include the serious and unquantifiable safety issues, ethical issues presented by altering the germline in a way that affects the next generation without their consent, and a current lack of compelling medical applications justifying the use of CRISPR/Cas9 in embryos.”

While Collins also notes the federal laws and regulations that restrict funding, I do not expect the statement to be the end of the discussion around the gene-editing research reported on in China (which is probably continuing).  I suspect many would find the use of non-viable embryos in this research acceptable, even if it punts on the questions of consent to changes for future generations and the safety of the techniques on viable embryos.  After all, stem cell research lines have been derived from non-viable embryos.  I think that the need to (eventually) work with these technologies on viable human embryos makes the stem cell comparison problematic, but that won’t likely matter in the policy debates to come.

 

Second Lawsuit Filed Over Guatemalan STD Experiments

Following the disclosure in 2010 that several Guatemalans were exposed to sexually transmitted diseases without their consent, several parties initiated a class action lawsuit against the government.  That lawsuit was eventually dismissed over the inability to sue the U.S. over actions conducted in another country.  For details on the experiments, consult the report from The Presidential Commission for the Study of Bioethical Issues.

The plaintiffs have not given up, yesterday they filed suit against Johns Hopkins University for its role in the exposures.  Several Johns Hopkins researchers held positions in panels that reviewed federal funding for the studies at issue in the suit.  Other defendants include the Rockefeller Foundation and Bristol-Meyers Squibb.

The suit is filed against these defendants apparently due to the affiliation several officials involved in the exposures had with the named institutions (or in the case of Bristol-Meyers Squibb, its predecessor companies).  Both Johns Hopkins and The Rockefeller Foundation have denied that their institutions were involved in the experiments.  Bristol-Meyers Squibb officials have declined to comment as of this writing.  The suit alleges that the experiments were used as clinical trials for the predecessor companies’ products.

With the dismissal of the previous lawsuit, it is not clear that the current matter will be any more successful.  Arguably the plaintiff’s case here will be harder, as holding an institutional affiliation will not likely be sufficient to demonstrate the institution was responsible for the conduct of particular individuals working for other organizations.

Gray Matters Volume 2 Seeks To Counter Hype With Discussion

Today the Presidential Commission for the Study of Bioethical Issues released the second volume of its Gray Matters report, the ninth report by this commission.  The report was requested by the President following the announcement of the BRAIN Initiative.  He requested that the Commission identify a set of core ethical standards to influence neuroscience research and to address some of the debates emerging from applications of that research.

Volume One, released in May 2014, focused on how to fully integrate ethics into neuroscience research throughout the research cycle.  Volume Two concerns ethics in applications of neuroscience research, with an emphasis on three topics that have attracted some level of debate: cognitive enhancement, the capacity of a being to consent (to research conducted on them), and neuroscience in the law.  Through these cases the Commission wanted to tease out relevant ethical considerations and related tensions brought out by the potential impacts of these technologies.

There are fourteen main recommendations in the report:

Prioritize Existing Strategies to Maintain and Improve Neural Health

Continue to examine and develop existing tools and techniques for brain health

Prioritize Treatment of Neurological Disorders
As with the previous recommendation, it would be valuable to focus on existing means of addressing neurological disorders and working to improve them.

Study Novel Neural Modifiers to Augment or Enhance Neural Function
Existing research in this area is limited and inconclusive.
Ensure Equitable Access to Novel Neural Modifiers to Augment or Enhance Neural Function

Access to cognitive enhancements will need to be handled carefully to avoid exacerbating societal inequities (think the stratified societies of the film Elysium or the Star Trek episode “The Cloud Minders“).

Create Guidance About the Use of Neural Modifiers
Professional societies and expert groups need to develop guidance for health care providers that receive requests for prescriptions for cognitive enhancements (something like an off-label use of attention deficit drugs, beta blockers or other medicines to boost cognition rather than address perceived deficits).
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I Can’t Be The Only One Bothered By The Ease Of Cyborg Insects

I recently read this article from Futurity reporting on cyborg beetle experiments conducted at the University of California at Berkeley.  The study is available in Current Biology (subscription required for the full article), and focused on determining the muscles involved in steering beetles in flight.  There’s video.

I’ve posted before about cyborg beetles, and my misgivings about making cyborg beetle kits available for the general public.  I wasn’t quite as bothered by experiments in laboratory settings, but the notion of people conducting home surgery to attach mechanical parts to living creatures still strikes me as a bit cavalier.

I recognize that other animals are used in scientific experiments, so why is this different?  Are the mechanical changes in these experiments somehow qualitatively different than the genetic modifications to mice that can result in wholly new traits (or parts) for the animal?

I think, besides the possibility of backyard surgery, it comes down to remote control.  That these beetles, as well as other insects (and some higher animals, it turns out) are being manipulated gives me pause.  I still see the value in it, but whatever ethical discussions are going on about this research are not visible to those of us not working in the field.

I think it might make public acceptance of this research a bit easier to let people know what considerations and discussions have gone into this research before we see remote-control cyborg gerbils available at your local pet store at some point a few years from now.