Two recent items from The Scientist poke at a question that, unfortunately, needs to be asked more often – can someone who conducted research misconduct be rehabilitated? Certainly those who are found guilty, and have received bans from federal funding, can eventually re-apply for funds. (I would suspect that only the established researchers will be able to return to the granting fold after a forced absence.) But does the ban enough to make sure that a researcher won’t re-offend?
Duplicating efforts underway to rehabilitate misbehaving doctors and other professionals, the Restoring Professionalism and Integrity in Research (RePAIR) program is trying to help researchers make better professional decisions (H/T The Scientist). The program is funded by the National Institutes of Health (though it wouldn’t hurt for the National Science Foundation to get in on this action). And perhaps in acknowledgement that not everyone is willing or able to mend their ways, RePAIR only accepts those researchers who have the backing of their institutions. I’m one of those that is skeptical of those found guilty of misconduct, but I have to recognize that efforts to rehabilitate those researchers, and mitigate at least some of the damage caused by their conduct, is something worth exploring.
That there is a need for rehabilitative programs suggests, as discussed in this other piece from The Scientist, that ethics training is not as successful as one might expect. But, as James Hicks discusses in the piece, the issue of success depends on what the program is supposed to be successful in doing. On the face of it, the primary goal would be a decline in research misconduct. As the trend has been in the opposite direction, there has not been success. But it is plausible that the ethics training, and the associated research infrastructure to address ethical concerns, has helped make it easier to call out such bad actions. It’s like an increase in incidence of a disease because the tests to diagnose it have become much more effective.
Then there is the matter of the increasingly competitive and administrative research environment. With attention from the bench competing with the need to get ahead and the need to keep up with the running of a lab, there is room for error to creep in. And while research infrastructure has grown to address ethical concerns pre-research, there has not been a corresponding growth in people and institutions focused on correcting the research record. In this tight budgetary environment, addressing this need will be challenging. But it may be even more necessary, as a trend noted by Hicks suggests that as success rates for grant applications goes down (likely in a flat or declining budgetary environment), retractions increase.
In what Nature has characterized as the first time a scientist has gone to trial over an academic laboratory accident, University of California, Los Angeles faculty member Patrick Harran will stand trial over the 2008 accident involving research assistant Sheharbano Sangji. Sangji died as a result of burns suffered as a result of handling tert-butylilithiumm. Chemical and Engineering News has covered the case extensively, and I would encourage you to read it to better understand the specifics of the accident and associated charges.
Harran and the University of California Regents were charged in late 2011 with willful violation of laboratory health and safety guidelines. In the summer of 2012 the Regents were dismissed from the case after a plea agreement. This agreement included an admission of responsibility for substandard lab conditions, improved support of comprehensive lab safety, a scholarship in the victim’s name, and monetary penalties (in addition to fines already assessed). Harran’s attorneys have offered a vigorous defense, and given that the charges in question involve willful violation of regulations (rather than negligence, which could be an easier charge to prove), the outcome of the trial is far from certain. A settlement/plea bargain may still take place, Dr. Harran may be found not guilty, or he could serve as many as four and one-half years if convicted.
What is even less clear is the impact this case may have on the behavior of universities, lab directors and supervisory researchers. Lab safety seems to an afterthought in way too many labs. Perhaps someone going to jail may prompt a change in action, but I’m afraid it won’t be sufficient. It could be too easy to dismiss this case as an outlier, and continue with the lax attitude toward safety that has claimed too many lives.
Two recent news items suggest that venture capital firms are taking extra care to make sure scientific research can properly inform their investment decisions.
A brief item in Science-Business Exchange (full article requires subscription) notes that at least one firm – Atlas Venture – has taken to hiring contract research organizations to independently validate academic science prior to making significant investment. One could consider this simply conducting proper due diligence on the firms in which it may invest. However, this could speak to the increases in retractions and other instances of scientific misconduct. (That I saw this first via a Tweet from one of the folks behind Retraction Watch suggests the second possibility is at least plausible.)
Another venture capital firm will work with a scientific academy to help it assess future opportunities in late-stage biomedical companies. The Academy of Medical Sciences in London will work with Park Vale Capital to connect its Fellows to investment advisors at the firm. The Academy will receive a retainer to assist with administrative costs and receive a certain percentage of performance fees Park Vale receives on its investments. In an effort to manage potential conflicts and avoid disclosures of proprietary or confidential information, the Academy will establish an oversight committee. Relationships that go past the initial Academy-facilitated meetings will be handled through the researchers’ home institutions.
Both of these events are new in the area of venture capital. Whether or not they will be the beginning of trends may depend on how well such arrangements work. But at least in the case of Atlas Venture, these developments should remind us that the reliability of the research data and the processes behind it matter. Put another way, while the moves could bring additional money to research, the additional scrutiny comes at least in part over increasing concerns about the quality assurance behind scientific research.
In what appears to be a classic case of agencies not talking to each other, the Food and Drug Administration (FDA) and the Department of Justice are sending mixed messages in response to a recent court decision on the emergency contraception Plan B.
On Tuesday the FDA announced that they have approved a petition to allow the marketing of Plan B One-Step to women 15 years and older without a prescription. The court order stipulated that emergency contraception should be made available without age restrictions, and is supposed to take effect on May 6. The FDA apparently is trying to dodge the order in its announcement by stating this is a separate petition from the one subject to the court order.
To complicate matters a bit, the Justice Department has announced it will appeal the court order. It has filed a petition for a stay of the order pending the appeal. It’s grounds for appeal relate to what the Department sees as an overreach of the judge’s authority. There’s a touch of irony here as the judge claimed that the actions of the Secretary of Health and Human Services in this matter were unprecedented, at least implying an overreach of her authority (pages 37 and 39).
Independent of the litigation over access to Plan B without age restrictions, the FDA announcement lowering the age restriction (without a prescription) to 15 will take effect immediately. Per the announcement:
“The product will now be labeled “not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified.” Plan B One-Step will be packaged with a product code prompting a cashier to request and verify the customer’s age. A customer who cannot provide age verification will not be able to purchase the product. In addition, Teva has arranged to have a security tag placed on all product cartons to prevent theft.”
The petition requesting a stay of the court order requested a decision by the end of today, as the order is due to take effect soon.
Nature has taken steps to make it easier to try and reproduce the results it publishes in its pages (and online). Starting in May, the journal and associated publications will require more disclosures of data and methods from researchers submitting manuscripts.
There is now a checklist for prospective authors to complete with their manuscript(s), which explicitly connects portions of their articles with relevant methods (the page restriction on methods has been abolished, and Nature maintains a protocol exchange), statistics, reagents, animal models, human subjects protections and data depositories. Nature does not consider the checklist exhaustive, and may, depending on the input of editors and referees, take additional steps to assess methods and statistics for submitted papers.
This is just the first step of a long journey. Nature, and Science (based on Congressional testimony earlier this year from its then-Editor-in-Chief) are trying to make it easier for other researchers to do what it expected of them by the norms of most scientific communities – check the claims of their colleagues for accuracy and reproducibility. If the moves toward increased public access to scientific information continue, the expectations that this information can be verified will likely increased. It’s nice to see journals trying to be ready. Hopefully researchers will be able to keep up, and this collection of articles on reproducibility will have more positive additions in the future.
In late 2011 Health and Human Services Secretary Kathleen Sebelius overruled the judgment of the Commissioner of the Food and Drug Administration (FDA) to prevent the availability of emergency contraception over the counter for girls under 17 without a prescription. The decision was the culmination of a review ordered by a federal judge in 2009 in part to counter political interference in a scientific review of emergency contraception. The Secretary attempted to provide scientific justification for her decision, which included concerns that the studies used in the review did not cover all ages that could possibly be provided access if the drugs were made available over-the-counter. As I noted shortly after the decision, she made her decision a fight over science. That reflected my lack of knowledge of the ongoing case.
Last week the federal judge that ordered the review issued another order chastising the Department for its decision. As it did back in 2011, the Obama Administration stands by Secretary Sebelius and her decision.
The judge essentially concluded that the kinds of political interference that prompted the first review – connected to a previous administration – persisted into the current administration. From page 11 of the Order:
“In my 2009 opinion, I traced the evidence demonstrating that the conduct of the FDA was influenced by the Bush White House, acting through the Office of the Commissioner of the FDA, and I held that this kind of political interference called into serious question the legitimacy of the FDA’s decision. In the present circumstances, the political interference came directly from the Secretary of Health and Human Services, a member of the President’s Cabinet.”
The case that he is dealing with is a Citizen Petition (filed in 2001, with the lawsuit following in 2005) to have the FDA “make all levonorgestrel-based emergency contraception, including Plan B, available for over-the-counter sales without age or point of sale restrictions.”
The judge has ruled that the FDA must make levonorgestrel-based emergency contraception available over-the-counter without a doctor’s prescription or point-of-sale or age restrictions. The agency has 30 days from the date of the order (April 4) to comply.
Four updates addressing recent developments in ongoing stories:
Several of the Obama Administration’s recent agency nominations have moved forward in the confirmation process. Energy Secretary nominee Ernest Moniz testified at his confirmation hearing last week. In a nice contrast to recent Cabinet-level confirmation hearings, there was little drama. Gina McCarthy’s recent confirmation hearing to become the next head of the Environmental Protection Administration (EPA) was not so genteel. Given that both McCarthy and Moniz come to their agency’s top jobs with prior agency experience, I believe the difference can be attributed to the relatively hostile reaction the EPA generates in many quarter. The Senate confirmed new Secretary of the Interior Sally Jewell last Wednesday. Still no official word on the next nominee to be Director of the National Science Foundation.
The Supreme Court will hear arguments this week in the Myriad Genetics case. It will be limited to whether the genes at issue in the case would be patentable. I would not expect an opinion before the end of June.
Those who get the allusion in the title, the program in question still stinks.
Announced at the beginning of April as one of the Obama Administration’s Grand Challenges, BRAIN (Brain Research through Advancing Innovative Neurotechnologies) is a new multidisciplinary, multi-agency program with roughly $100 million in the President’s recently announced budget for Fiscal Year 2014. (Must note here the chronic failures of Congress in passing budgets make this funding far from a sure thing.)
Besides the federal research component (roughly $100 million from the National Institutes of Health, the Defense Advanced Research Projects Agency/DARPA, and the National Science Foundation) BRAIN will engage several non-governmental organizations to add over $100 million in additional research support. The NGOs are the Salk Institute for Biological Sciences, the Kavli Foundation, the Howard Hughes Medical Institute and the Allen Institute for Brain Science. The funding is anticipated to persist over a ten-year period. So if the federal budget continues to be dysfunctional, there will still be some engagement in 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 in 3 weeks. Given recent developments, it seems likely they will both have a topic in common.
The Commission is scheduled to meet in Washington on April 30. No agenda is available as of the day of this posting, but the Federal Register notice for the meeting indicated that incidental findings would be a focus. Incidental findings have been on the Commission’s agenda for a while. They represent data found from research and experiments that were beyond the scope of the research. Typically this is an ethical challenge because informed consent of human subjects involved in such research is typically focused on the designed purposes of the research.
However, at the beginning of this month the President notified the Commission that he will formally request their input on the BRAIN (Brain Research through Advancing Innovative Neurotechnologies) program. This is a new cross-agency (National Science Foundation, National Institutes of Health, Defense Advanced Research Projects Administration/DARPA) program intended to increase our understanding of how the brain functions; how we think, learn and remember. The Commission will be asked to evaluate the ethical, legal and societal implications of the program and related developments in neuroscience. Comparisons to the Human Genome Project have already been made.
Also interested in BRAIN is PCAST. During the public session (there have always been non-public sessions of PCAST meetings, they just started acknowledging it in print) of its May 3rd meeting (draft agenda), PCAST will hear from the DARPA director and the National Science Foundation Assistant Director for Biological Sciences. PCAST has held discussions on neuroscience before. It is possible that PCAST may pursue a report on this topic, but that likely won’t be clear until at least after the upcoming meeting. The other part of the public session (aside from the usual public comment session) will focus on the impact of technological advances on productivity and employment.
Last month the Interior Department added closed cases to the section of its website dedicated to scientific integrity (H/T Nature News). As of this writing, there are 12 cases listed. The website stats that no pending cases will be listed in any detail. This makes it difficult to determine activity related to scientific integrity concerns at the Department. This lack of information makes it difficult to assess if the Department has any systemic issues with respect to concerns over scientific misconduct and/or interference in scientific activities. That said, what the Department has made available is a lot more than other agencies. It’s really difficult to consider the Office of Science and Technology Policy’s push on scientific integrity a success if its this difficult to know what’s going on. The lack of a policy for the government as a whole suggest this lack of transparency will continue.
On to what we can see from the Interior Department website. It would appear that the scientific integrity complaints lodged by Charles Monnett against the Interior Department Inspector General and the Bureau of Ocean Energy Management were dismissed (they appear to be cases 290 and 295). The review found that the actions under investigation did “intentionally, knowingly, or recklessly cause loss of scientific integrity or constitute scientific misconduct.”
Of the 12 cases listed, only one includes any report or further explanation of the specifics of the case or the decision. This is the case involving Paul Houser. Nature News has a good summary of the report, including comments from Houser. Some of the concerns highlighted in that summary suggest that this process (and perhaps any agency scientific integrity complaint process) is still a work in progress. Hopefully the recommendations for improved scientific communication in the report will be heeded by agency staff.