Professional Ethics Report: Volume XXVI, Number 3, Summer 2013

Professional Ethics Report (PER), which has been in publication since 1988, reports on news and events, programs and activities, and resources related to professional ethics issues, with a particular focus on those professions whose members are engaged in scientific research and its applications.

Each quarterly issue is comprised of a cover story addressing one particular issue or event, sometimes written by an expert outside the AAAS; a series of timely, in the news stories; brief updates from the societies; and useful resources and announcements.

PER was first published on the web in the Spring of 1995. Archives of Professional Ethics Report are available here.


Volume XXVI, Number 3, Summer 2013

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Contributing Staff

  • Rebecca Carlson, Deputy Editor
  • Terrell Brotherton, Contributing author
  • Mark Frankel, Editor
  • Michael Lerner, Contributing author
  • Amanda Shea, Contributing author

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This newsletter may be reproduced without permission as long as proper acknowledgement is given. ISSN: 1045-8808


Cover Story

Collaborative International Research - Planning for Success

F. Gray Handley

F. Gray Handley is the Associate Director for International Research Affairs at the National Institute of Allergy and Infectious Diseases, NIH. He has developed, coordinated and managed bi-lateral and multi-lateral science and public health programs for over 30 years at multiple NIH Institutes and Centers, the U.S. Department of State, and overseas postings in Asia and Africa.

This article provides observations on some factors that lead to research accomplishment while fostering enduring partnerships among scientists in multiple countries. The focus, in particular, is on factors that foster successful research collaborations engaging "developed" and "developing" country scientists - where all the participants perceive mutual benefit.

Engaging effectively in collaborative international research and establishing a foundation for future collaboration often demands managerial skills and contextual understanding beyond what is associated with domestic research. Specifically, achieving sustained success in international research requires that U.S. investigators and their teams understand the (often unfamiliar) institutional and social environments of their foreign collaborators. Armed with this understanding, successful investigators use strategic planning to address the challenges inherent in many international collaborations, especially those that cross wide cultural divides.

This strategic planning is most effective if it is grounded in principles (observable across many types of science) that usually underlie mutually beneficial international research. Effectiveness is also enhanced when planning is oriented toward clarifying assumptions, preventing misunderstandings between individuals and institutions, and sharing in preparation for the inevitable challenges.

Principles of Mutually Beneficial International Research

  1. The research should be related to the missions of all the partnering institutions.
  2. The research should be a shared interest among the primary researchers (basic science, improved clinical care, intervention assessment, etc.).
  3. The collaborating researchers, engaged institutions and study participants (or their communities) should derive some benefit.
  4. The research question, study design, methodology and anticipated outcomes should be based on the best available information and an understanding of the research field shared by all the collaborators.
  5. The research results should have the potential to be "significant."
  6. The research, especially studies involving humans or animals, must comply with the highest ethical and regulatory standards.

Factors that Influence International Research Success

Assuming that those principles are accepted and understood, there are a number of factors that can influence the success of international research collaboration. The degree to which these factors are present or absent may become evident only when a research team attempts to continue collaboration after an initial venture. This is particularly true in conflict-averse cultures or institutions, where difficulties or disappointments may be masked for the duration of an active collaborative effort to avoid confrontation. Sometimes a research collaboration ends because one or more partner believes that one or more of the previously described principles was not well-followed.

Factors that Can Foster International Research Success

  1. The degree to which there truly are shared or complementary interests and research objectives.
  2. The visibility and validity of mutual benefits as perceived by the researchers, any essential mentors or overseers, and the involved institutions.
  3. The level of "host government" support, particularly when the research is implemented in a developing country.
  4. When human participants in non-institutional settings are involved, the level of genuine community (i.e., family, work group, social network, etc.) engagement and support.
  5. The level of personal trust among research team members, particularly the leadership, and the degree to which this trust also is manifest among the engaged institutions.
  6. The level of investment in research capacity, both personnel and institutional, such that capacity will remain after completion of a collaborative project.
  7. The evident commitment of all partners, but especially the "developed country" partner, to the establishment of sustainable research capacity at the site of the research.

Challenges and Pitfalls that Can Limit International Research Success

The challenges that confront international research teams are predictable and sometimes avoidable, especially if addressed prior to and throughout the collaboration. Manifestations of problems arising from these challenges include both "internal" and "external" pitfalls that can serve almost as a checklist for investigators seeking to prevent or identify broader challenges that can hinder international research partnerships.

Challenges

  1. Well-planned and -managed international research often requires intense time commitments, often by the senior investigators and particularly in collaborations where research capacity among the partners is unequal.
  2. Sustained international research partnerships can be expensive and difficult to maintain over time, especially when limited-term funding provides the core resource base and when major investments are needed to enhance the research capacity of one partner.
  3. Particularly in developing countries, investigators often must integrate their research engagement with other demands that require extensive time and intellectual investment, such as their primary employment responsibilities or the pursuit of supplemental income.
  4. Timely and mutually understood communication is very difficult and requires constant feedback to assure that linguistic, cultural and temporal differences do not generate dysfunction.
  5. Institutional objectives and investigators' academic or career requirements, when unrelated to the collaborative research objectives, can create unforeseen and poorly understood burdens or distractions for a research partnership.
  6. Research cooperation can be strained when there is a dichotomy between objectives considered important to collaborators in the country where the research is being done (for example, obtaining access to therapy) and objectives considered important by the "non-local" investigators (for example, testing a hypothesis).
  7. It can be difficult to resolve problems effectively, particularly where there are unexpressed cultural differences or where a power imbalance inhibits achieving true consensus.
  8. Some of the greatest difficulties faced by researchers are external, including bureaucratic obstacles, lack of regulatory clarity, infrastructure and transportation inadequacies, and, occasionally, corruption or resource misuse.

Examples of Internally-generated Pitfalls

  1. Either partner is too busy to meet commitments related to the research plan.
  2. Unusual demands are placed on some of the scientists, like the imposition of unexpected non-research responsibilities.
  3. In biomedical research, particularly, severe problems can arise when data or biological materials need to be shared but regulations restrict such exchanges.
  4. Weak scientific management leads to poor implementation of standard operating procedures or unclear fiduciary recordkeeping.
  5. Linguistic challenges continue or worsen over time, leading to evident differences in comprehension.
  6. Staff members are found to be incompetent or ill-prepared for assigned functions.
  7. As a project approaches its temporal end there is no agreed "exit strategy" in place to provide some mutual benefits.

Examples of Externally-generated Pitfalls

  1. Unexpected institutional or personnel changes, for example, loss of staff or space, unexpected demands from institutional leadership, or government instability.
  2. Delays of unclear origin with little information on cause or means of amelioration.
  3. Outright graft that may be either overt or covert.
  4. Legal and regulatory uncertainties or changing requirements.
  5. Unfavorable public attention that can be due to inaccurate press reporting or generated by individuals with ulterior motives.
  6. Unreliable utilities and institutional support that is unanticipated in the program plan and budget or worsens during the collaboration.

Strategies that Foster International Research Success

It is important to acknowledge that only some of the challenges and pitfalls sometimes seen in international collaboration can be avoided; others are dependent on local or changing circumstances and unpredictable events. Furthermore, different types of research have varying challenge profiles. For example, clinical studies are often more difficult than basic research because of the added complexities of human participants. Moreover, the challenges that confront a research endeavor can and usually will change over time, with the greatest intensity of challenge usually early in the collaboration.

Nevertheless, many long-standing international scientific partnerships have identified strategies that generate scientific success and sustained, mutually-beneficial, collaboration. Some of these include:

  1. Conscientiously seek support for the research at many levels, including government, institution, community, and professional associations.
  2. Develop leadership at the research locale.
  3. Know the local "context" within which each investigator works.
  4. Collaborate with multiple stakeholders, some of whom may initially seem peripheral to the actual research.
  5. Invest in capacity enhancement - both human capacity and institutional capacity - to plan, manage and execute high-quality research.
  6. Commit senior personnel to a long-term investment of significant time and resources.
  7. Seek and access complementary resources and expertise that will support the research team or institutions.

To implement such strategies, research teams and leading investigators will increase their likelihood of success if they are able to: (1) establish a strong foundation for their research partnership; (2) complete and maintain a thorough contextual analysis of the multi-national and multi-cultural research environment; and (3) undertake careful cooperative planning phased to match the evolving needs of the partnership.

Establish a Strong Foundation for Collaboration

The core factors that establish a foundation for sustained collaborative research excellence are linked to the individuals involved and their support systems. Each individual must be convinced they have a partner whom they can trust, professionally respect and interact with comfortably, with a high degree of honesty. Each collaborator needs to understand their counterpart's personal, academic and professional needs and expectations. This may include, for example, an expectation to publish as lead author, or a need to ensure that family obligations are met. Each collaborator also must have a clear-eyed understanding of their collaborator's capabilities - both strengths and limitations. The foundation for such an understanding is open communication and trust - perhaps the core for all enduring partnerships.

In addition to the all-important core personal relationship among the investigators, the research team must assess its capability to resolve issues that might arise and consider adding to its membership (either directly or through consultants) when the need for additional skillsets becomes evident. This will help ensure that all the partners understand what they are expected to provide and that the team has access to supporting talent (for example, legal advice), if and when it is needed. One way this might be accomplished is through a clear understanding of the nature of the support that the investigators' "home institutions" are prepared to provide. Problems frequently arise when scientists' expectations of institutional support are not met. This can occur when the expected institutional support is not clearly specified early in the partnership or formally stated in interactions with institutional leadership. And perhaps most importantly, but often under-emphasized, all the partners must commit to sustained, rigorous planning and shared management.

Conduct a Thorough Contextual Analysis

Although often neglected, the likelihood of success in an international endeavor is enhanced if all partners understand the context within which their counterpart(s) works and lives. Potential partners should consider, if at all possible, investing in a thorough, independent situational analysis to provide an unbiased assessment of the cultural contexts, competencies, institutional realities, governance, regulatory structures, and past experiences that can profoundly influence the anticipated collaboration. Even if such an analysis is undertaken only by a graduate student or junior investigator, its value can be significant when it leads to broader and more informed mutual understanding.

As a part of the context, it is also important that all collaborators understand the expectations, policies and procedures of the organization funding the research and providing higher-level oversight. Few research partnerships can survive without a shared understanding of their responsibilities to their funder(s) and a specific plan to meet those responsibilities. Similarly, key investigators need to have an understanding about the institutions within which their collaborators work. This should include the identities of supportive leaders, the institution's capacity for administrative and fiduciary management, its comfort and experience with transparency, and its overall orientation toward international cooperation. A thorough contextual analysis also will include the identification of potential allies who might be approached if challenges arise that require external advocacy or specific (usually non-scientific) expertise such as public relations or legal representation.

Plan Specifically to Enhance Success

Consciously preparing a series of mutually developed and endorsed background documents or plans can enhance the establishment and productivity of an international research partnership, as well as its resiliency in the face of challenges.

  1. Specifically describe all the partners' individual responsibilities and their anticipated benefits, including those that may seem "obvious."
  2. Articulate a strategy with a timeline to jointly identify and engage allies in both countries at the institutional, community (if appropriate), and external organizational levels.
  3. Conduct a careful analysis of the legal and regulatory needs or obligations the research project will engender (in all the engaged countries or locales) and outline how these will be met.
  4. Prepare a scientific and financial monitoring plan that all the involved institutions agree to implement. The plan should identify responsible individuals charged to execute this monitoring plan, a timetable with milestones, and provisions for accountability and sanctions.
  5. Identify all the technical, logistic and personnel requirements that need to be met to fully execute the joint research plan and specify the steps that will be taken, and by whom, to meet these requirements as they emerge over time. Subsections of such a plan might include human resource recruitment and training or the purchase of special equipment to maintain a supply chain or necessary utilities.
  6. Carefully plan to meet both internal and external communications needs so the collaborators, their teams and external stakeholders are included and informed about the project and its results/benefits. This plan also should anticipate communication needs linked to unanticipated challenges.
  7. Within the early phases of project implementation, an "end-of-project" plan should be developed so that all collaborators have an understanding of what future they may anticipate. Such a plan could include initiation of new funding applications or the rational re-deployment of team personnel. Having such a plan in development and eventually in place demonstrates a commitment to the current research team and it can signal a sustained commitment to future cooperation.

In conclusion, the formation of mutually beneficial and resilient partnerships that can successfully undertake international research is a challenging proposition. Nevertheless, such collaboration is increasingly important and is being driven both by scientific opportunities and increasing research capacity, particularly in many developing countries. As investigators pursue the many opportunities offered by international cooperation, they may avoid problems if they work to achieve a high level of trust among the collaborating researchers, and ensure careful planning and situational awareness.

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In the News

Publication of Car Security Code Hack Under Gag Order in UK

The UK High Court has banned scientists from publishing a paper describing the vulnerabilities of a code used to verify the identity of keys of millions of cars before starting the ignition. The three researchers at the University of Birmingham and The Netherlands' Stichting Katholieke Universiteit reverse-engineered the algorithm, named Megamos Crypto, using publically available information on the code's software. They planned to explain their methods and propose three ways to bypass immobilizers, a type of computer chip, at the August 2013 Usenix Security Symposium in Washington, DC [1]. Originally developed in the 1990s, cars made by Volkswagen, Porsche, Audi, Bentley, and Lamborghini continue to use this system [2].

According to the Dutch university's spokeswoman, Thales, a French defense company, was notified nine months before the intended publication date. Though Volkswagen claims not to have been alerted until three months later, the spokeswoman explained, "The Dutch government considers six months to be a reasonable notification period for responsible disclosure. The researchers have insisted from the start that the chipmaker inform its own clients." [3] While the paper does not actually describe how to apply the knowledge of Megamos Crypto's weaknesses, Volkswagen and Thales believe this publication would be "highly damaging" and "facilitate the theft of cars." [4] The researchers were first asked to publish a version of their paper with the key codes redacted, but after they refused, claiming the information had been available on the Internet since 2009, Volkswagen and Thales decided to ask the High Court for a gag order on the publication of their research [5].

The researchers defended their work by arguing that they were "responsible, legitimate academics doing responsible, legitimate academic work" with the ultimate goal of identifying the code's weaknesses in order to protect people from sophisticated criminal gangs. They urged the court to allow the public "to see weaknesses in security on which they rely exposed," warning only the "industry and criminals know security is weak but the public do not." [6] Jaap-Henk Hoepman, a colleague and supporter of the researchers, called for increased focus on corporate responsibility: "Large companies should not be allowed to hush up when they screw up." [7]

High Court Justice Colin Birss issued an interim injunction siding with the plaintiffs, writing in early July 2013 that, though he "recognize[s] the high value of academic free speech," publishing the formula would be "highly damaging" and "facilitate theft of cars." [8] Following the ruling, the University of Birmingham released a statement saying it was "disappointed with the judgment which did not uphold the defense of academic freedom and public interest," but that it "respects the decision" and would "defer publication" of the paper for an indefinite amount of time [9]. Birmingham has appealed the injunction but it is unclear if the case will go to trial. One of the authors will speak at the Usenix conference, but he has announced that he will not discuss the technical aspects of the paper [10].

[1] http://arstechnica.com/tech-policy/2013/07/high-court-bans-publication-of-car-hacking-paper/ 
[2] http://www.theguardian.com/technology/2013/jul/30/car-hacking-ignition-injunction 
[3] http://www.bbc.co.uk/news/technology-23487928 
[4] http://www.washingtonpost.com/business/cybersecurity-flaws-in-volkswagen-cars-to-go-unreported-after-uk-judge-issues-injunction/2013/07/30/cce1b7b4-f925-11e2-a954-358d90d5d72d_story.html 
[5] http://spectrum.ieee.org/riskfactor/computing/embedded-systems/researchers-stopped-from-revealing-key-to-bypassing-car-key-encryption 
[6] http://www.theguardian.com/technology/2013/jul/26/scientist-banned-revealing-codes-cars 
[7] http://blog.xot.nl/2013/07/30/volkswagen-vs-my-colleagues-a-fight-for-academic-freedom-and-against-security-by-obscurity/ 
[8] http://abcnews.go.com/International/wireStory/volkswagen-gags-academics-revealing-car-flaws-19814732 
[9] http://www.supanet.com/high-court-stops-paper-that-could-unlock-porsches-a11790.html 
[10] https://www.usenix.org/press-release/usenix-association-promotes-academic-freedom

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 Non-publication of Clinical Trial Results is Misconduct, Says British Medical Association

At the recent British Medical Association (BMA) Annual Representative Meeting, the BMA voted that the non-publication of clinical trial results should be considered research misconduct [1]. Additionally, the BMA voted that doctors implicated in withholding clinical trial results should be referred to the General Medical Council (GMC). Specifically, the motion holds that:

  1. Selective non-publication of unflattering trial data is research misconduct; and
  2. Registered medical practitioners who give ground to believe they have been involved in such conduct should have their fitness to practice assessed by the GMC.

This motion was in response to calls to increase clinical trial transparency. Past studies indicate a large number of clinical trials never make it to publication [2], whether because the data are considered to be 'non-interesting', due to publication bias, or because the data are outright unflattering or contradictory to clinical claims. This is damaging for both medical and economic reasons; medically, patients could be treated with potentially hazardous or ineffective agents, and economically, trials and experiments may be unnecessarily repeated. Under prior recommendations, clinical trials that yielded unfavorable or inconsistent results could simply be filed away, thereby giving the medical and patient communities an inaccurate or incomplete understanding of a treatment's efficacy. Whereas previous motions have required certain clinical trials to be registered, increasing the knowledge of what research is being done, this motion is unique in that it requires publication of all clinical results, increasing public knowledge of what has been discovered. The decision by the BMA reflects the larger movement of increased transparency in research, both at the basic and clinical level.

[1] http://ecancer.org/journal/news/4200-bma-----non-publication-of-trials-results-is-research-misconduct.php 
[2] NHS NIHR Health Technology Assessment programme 2010 http://www.hta.ac.uk/fullmono/mon1408.pdf

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Restrictions on Human Embryo Research Relaxed in France

The French National Assembly voted on 16 July, 2013 to relax regulations governing the use of human embryos in biomedical research. Proposed by the Radical Left, the minority partner in the governing coalition, the law now allows French research teams to conduct embryonic stem cell research so long as they convince government regulators at the Agency of Biomedicine of a project's scientific relevance, potential for medical applications, and adherence to ethical requirements, as well as the impossibility of performing the research with other techniques [1].

The new law's stipulations are significantly less demanding than those in force between 2004 and 2013, when embryonic research was made illegal in France. Researchers were allowed to receive exemptions but were forced to meet strict criteria. The cells available for research were limited to unused embryos conceived in vitro during medically-assisted procreation and given with consent of the infertile couple.

Though the members of the governing coalition, especially Geneviève Fioraso, the Minister of Higher Education and Research, argued that French researchers were impeded by the now-superseded restrictions, statistical evidence suggests otherwise. The Agency of Biomedicine's 2011 annual report indicates that between 2004 and 2013, the agency approved 190 of 215 (88%) project proposals for research on embryonic development or to develop stem cell lines [2]. In addition, the 36 research teams to receive authorization did not face a scarcity of embryos at their disposal. As of December 31, 2010, there were 17,179 embryos from 4,854 couples available for use in research in France. The number of research teams is stable and the agency believes it meets the demand for such research in France [3].

Researchers admit that the changes will have little effect in their day-to-day operations, but they hope the new law will reduce red tape and encourage collaboration with international researchers, as well as companies looking to test potential therapies in clinical trials. As Cécile Martinat, a cell biologist at the Institute for Stem Cell Therapy and Exploration of Monogenic Diseases, explained, "We hope to unlock doors that were stupidly closed." [4]

[1] http://www.slate.fr/france/75464/recherche-embryon-autorisee
[2] http://news.sciencemag.org/2013/07/new-law-france-loosens-restrictions-human-embryo-research 
[3] http://www.agence-biomedecine.fr/IMG/pdf/ra_biomed_2011_bd_web.pdf
[4] http://www.genomeweb.com/blog/france-changes-embryo-research-law

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Georgia-Pacific and the Rise of Litigation Science

On June 6, 2013, a New York state appeals court ruled unanimously that the Atlanta-based paper company Georgia-Pacific (GP) must hand over all internal documents pertaining to studies it commissioned on the safety of its products [1]. GP had funded studies to test the effects of an asbestos-containing joint compound it had previously manufactured. While GP has not sold the compound for more than 30 years, litigation is pending in which individuals claim exposure to the products [2]. In an effort to strengthen its defense, GP hired experts to downplay the cancer risk posed by chrysotile asbestos, resulting in the publication of eight research articles between 2008 and 2012 (in journals such as Inhalation Toxicology, The Journal of Occupational & Environmental Hygiene, Annals of Occupational Hygiene, and Risk Analysis) [1, 3]. The authors neglected to declare the conflict of interest.

To oversee the efforts, GP hired Stewart Holm as its Director of Toxicology and Chemical Management. Holm co-authored nearly all of the articles and of those he did not, he was a significant contributor, along with GP's in-house counsel [1]. None of the articles disclosed that GP's counsel and lawyers had been heavily involved in the manuscript preparation and publication process and two articles falsely stated that "[GP] did not participate in the design of the study, analysis of the data, or preparation of the manuscript." [1] Additionally, David Bernstein was frequently a lead author on the articles and has also been a GP expert witness in New York City Asbestos Litigation since 2009, has testified as a defense expert for Union Carbide Corporation in asbestos litigation, and has been associated with the Chrysotile Institute. For articles authored by Bernstein and Holm, the only disclosure was that the research was "sponsored" or "supported" by a grant from GP [1].

In 2011, plaintiffs requested that GP be ordered to turn over internal communications and raw data related to the studies. GP submitted some documents and a privilege log stating that all other communications within the company or with its consulting experts were protected by the attorney work-product privilege and/or the attorney-client privilege. However, the Special Master, an authority appointed by the judge to ensure that judicial orders are followed, declared that the documents may be subject to the crime-fraud exception to attorney-client privileges and required production of all materials and raw data underlying the published studies as well as an in-camera review of all documents identified in GP's privilege log. Although GP appealed, the 2013 decision by Justice Richard Andrias, upheld that of 2011, stating that GP must turn over all documents and data pertaining to the studies in question as it would not be fair for GP to commission studies and use them as scientific evidence unless the plaintiffs were also able to evaluate the information [4].

Some primary concerns are that "large corporations often invest strategically in research agendas whose objective is to develop a body of scientific knowledge favorable to a particular economic interest or useful for defending against particular claims of legal liability," that "[w]ell-financed industries have the resources to seed the literature with strategic science," and that "doing science for the purpose of supporting one side or another in a legal proceeding would seem to have built-in incentives to 'paint the target around the arrow'." [5] Thus, the rise in scientific conflicts of interest via litigation-generated science and academia-industry relationships may be compromising the integrity of the scientific enterprise. Indeed, studies have found correlations between financial relationships with industry and issues with research, including a tendency to produce pro-sponsor results, increased secrecy, and poor study design [6]. Alternatively, academia-industry relationships can be beneficial by increasing national funding of research through the private sector, quicker translation of science into products, more educational opportunities in industry settings, and greater access to some data, equipment and materials. New policies will be important in determining what conflicts are considered acceptable, how they must be identified, and how violations are handled.

[1] http://goo.gl/Q4iymB 
[2] http://informahealthcare.com/doi/full/10.3109/08958378.2012.655000 
[3] http://www.ucsusa.org/publications/got-science/2013/got-science-july-2013.html
[4] http://www.dailyreportonline.com/PubArticleDRO.jsp?id=1202604110573&GeorgiaPacific_Told_To_Hand_Over_Documents_In_NY_Asbestos_Case&slreturn=2013062315375
[5] http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2199311/pdf/ehp0116-000117.pdf 
[6] http://www.thehastingscenter.org/Publications/BriefingBook/Detail.aspx?id=2156

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Can Your Data Doom You to a Defamation Suit? ONY Inc. c. Cornerstone Therapeutics

The Second U.S. Circuit Court of Appeals in New York recently addressed whether claims presented in scientific articles are legally actionable [1]. The plaintiff in this case, ONY Inc., alleged that a scientific article published by the co-defendants Cornerstone Therapeutics and Chiesi Pharmaceuticals violated laws against false advertising (the Lanham Act), deceptive practices (New York General Business Law § 349), and New York's common law tort of injurious falsehood. The plaintiff further alleged that Cornerstone's distribution of materials resulting from and related to the original article interfered with ONY Inc.'s prospective economic advantage. The initial ruling on this case in May 2012 dismissed the plaintiff's complaints in their entirety. Following an appeal by the plaintiff, the original ruling was upheld.

The scientific article in question compared the efficacy of medical products produced by both the plaintiff, ONY Inc., and the co-defendant, Chiesi Pharmaceuticals. These products, synthetic surfactants, facilitate the transfer of oxygen into the blood stream and are marketed as the primary treatment for Respiratory Distress Syndrome among infants. A Chiesi funded study comparing surfactants produced by the two companies demonstrated superior performance by the Chiesi surfactant; these findings were subsequently presented at medical conferences, published in the Journal of Perinatology, and summarized and distributed in promotional materials. Of note, the published article did not include the entirety of data presented at medical conferences, an omission the plaintiff argued was an attempt to mask errors in the study methodology. As a consequence of this perceived study misrepresentation, ONY Inc. alleged the defendants were engaging in false advertising and deceptive practices.

The court concluded that the primary issue in question in this case, whether published scientific findings are legally actionable, is ultimately a question of whether scientific findings are legally understood to be presented as fact or opinion. ONY Inc. argued that the article's findings were presented as fact, and thus were subject to laws of false advertising. The court, on the other hand, found that "for purposes of the First Amendment and the laws relating to fair competition and defamation, [scientific findings] are more closely akin to matters of opinion, and are so understood by the relevant scientific communities." As such, scientific statements are protected under the First Amendment. The court addressed the issue of whether distributing the article's findings interfered with economic advantage separately. The plaintiff here alleged that distribution of the article's findings in promotional materials interfered with ONY Inc.'s potential to obtain future contracts. Of interest, the plaintiff did not assert that these findings contained false or fraudulent data, merely that the distributed data would decrease the plaintiff's future contract abilities. The Appeals Court upheld the initial dismissal of this charge on the grounds that the materials did not contain misleading information.

In summary, the initial ruling dismissing ONY Inc.'s case against Chiesi and Cornerstone was upheld. The Court ruled that scientific statements regarding matters of scientific dispute cannot result in liability charges for defamation, and furthermore, that distribution of secondary materials summarizing scientific statements also cannot result in liability charges if the material does not contain fraudulent or false statements.

[1] http://scholar.google.com/scholar_case?case=13693993228122768528&hl=en&as_sdt=2&as_vis=1&oi=scholarr 
[2] For a general discussion of the case, see: http://tushnet.blogspot.com/2013/06/disputed-scientific-conclusions-not.html

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Companies Put Scientific Methods on Trial

In Federal court in mid-July 2013, scientists and lawyers debated the merits of a 30-year old laboratory assay. Tennessee-based Eastman Chemical resorted to federal court in search of the payment of approximately $5 million from two small Austin-based companies, CertiChem and PlastiPure, for damages caused by false advertising under the Lanham Act. The court was asked to decide if a study of an Eastman plastic resin's propensity to leach potentially harmful chemicals was sufficiently clear to allow the defendants to make claims about Eastman's products based on the results. On 24 July 2014, a federal jury ruled against CertiChem and PlastiPur on counts of false advertising, conspiracy, and unfair competition. The two companies have not announced whether they would appeal the decision [1].

The financial stakes are high for both the plaintiffs and the defendants. If the defendants decide to accept the ruling or lose their appeal, they will most likely go out of business [2]. Eastman decided to pursue the case in order to defend the reputation of Tritan, a popular plastic resin line marketed as an alternative to polycarbonate plastics.

In July 2012, the Food and Drug Administration banned the use of the estrogenicactive compound bisphenol A (BPA) in baby bottles and sippy cups in the face of mounting evidence linking even very-low-dose exposure to BPA and other estrogenicactive compounds with chromosomal abnormalities, early puberty, decreased fertility, and obesity in fetuses, infants, and children [3]. Eastman was perfectly positioned for the FDA's decision, having marketed Tritan as a BPA-free and estrogenicactive compound-free "drop-in" alternative since 2007 [4]. Tritan is now used in over 600 products, including water bottles by Nalgene, sippy cups by Thermos Foggo, and wine glasses by Sonoma [5].

The lawsuit is over the conclusiveness of a study performed by scientists from the University of Texas at Austin, the Lombardi Comprehensive Cancer Center at Georgetown University and CertiChem. They decided to test 455 commercially-available consumer products, including 102 containers made of three Tritan resins, for estrogenicactivity (EA) with an in vitro assay called MCF-7. The scientists found that 92 percent of the BPA-free products leached EA compounds before stressing. The experiment was then repeated after stressing the products to simulate normal usage (exposure to light, microwaving, washing in detergents, being left in a hot car), resulting in increased rates of leaching in 95% of the products, including Tritan. The results of the study were published in Environmental Health Perspectives in 2011 [6].

Eastman's complaint of false advertising relates to an instance where a representative of PlastiPure, CertiChem's sister company, approached an Eastman client and described Tritan as having EA. In addition, PlastiPure described Tritan resins as having EA in brochures distributed at two product expos. Eastman did not refute the results of CertiChem's experiment, but rather the validity of representing an in vitro test for estrogenicity as definitive evidence of EA. Eastman argued the possibility of false positives in in vitro testing renders the MCF-7 assay incapable of giving definitive evidence of chemical leaching [7]. An Eastman spokesman claimed, "Contrary to PlastiPure's statements, testing by independent third-party laboratories using well-recognized methods have confirmed that Tritan does not exhibit EA." [8]

Jane Robbins, a senior lecturer at the University of Arizona McGuire Center for Entrepreneurship, predicted that Eastman would have a difficult time convincing the judge, since a "suit requires showing the findings were wrong, and more likely intentionally wrong and, in particular, wrong within the measures used." Robbins characterized the case as, rather than one based on legal merits, as simple competition between two companies [9]. At this point, Eastman, appears to have emerged the winner.

Whatever the final outcome of the case, however, it appears that Eastman has managed to undermine Tritan's reputation all by itself. The discovery process revealed troubling concerns about Eastman's conduct and Tritan itself. The lead author of the "independent third-party" study, toxicologist Thomas Osimitz, was, in fact, paid $10,000 by Eastman for the study. Osimitz's conflict of interest was never disclosed online or in print by the study's publisher, Elsevier. In addition, it appears Osimitz intentionally suppressed test results showing Tritan resins contain Triphenyl phosphate (TPP), a plasticizer known to be estrogenicactive. Beyond what expert witness Michael Denison, a toxicologist at the University of California at Davis, described as "many unexplained omissions" and lack of statistical analysis, scientists have also questioned Osmitz's decision to expose rats known to be insensitive to estrogen to dosages far below the detectable range [10]. However, despite losing face, Eastman managed to seal the documents showing the financial link between Osimitz and Eastman and restrict the court's consideration to the results of tests done by CertiChem in the lawsuit.

[1]http://www.austinchronicle.com/news/2013-08-02/eastman-wins-jury-still-out-on-plastic/ 
[2]
http://www.npr.org/blogs/health/2013/07/15/201523240/bpa-free-plastics-going-on-trial-in-texas 
[3] http://www.prnewswire.com/news-releases/david--goliath-match-up-pits-independents-certichem-and-plastipure-against-industry-giant-163681876.html 
[4] http://www.npr.org/blogs/health/2012/07/30/157592882/legal-battle-heats-up-over-whose-plastic-consumers-should-trust 
[5] http://www.washingtonspectator.org/index.php/Main-Feature/silencing-science-what-you-may-never-know-about-plastic-baby-bottles.html 
[6] http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3222987/#__ffn_sectitle 
[7] http://www.washingtonspectator.org/index.php/Main-Feature/silencing-science-what-you-may-never-know-about-plastic-baby-bottles.htm
[8] http://www.plasticstoday.com/articles/Eastman-Chemical-files-lawsuit-over-Tritan-estrogenic-activity-claims-0615201201 
[9] http://www.insidehighered.com/news/2013/07/08/lawsuit-filed-against-two-labs-founded-ut-austin-professor-raises-questions-conflict 
[10] Ibidem.

 

*ML

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In the Societies

Consensus Statement on Ethics in the Geosciences*

Washington, DC, 16 September 2013

We, the undersigned representatives of national and international geoscientific societies and professional associations, assert the fundamental importance of protecting scientific integrity and of upholding ethical standards and behavior in the geosciences.

Geoscientists have considerable understanding of the processes that have formed and continue to shape our planet, and of the history of change to Earth and life through deep geological time. This understanding of our physical and biological environment is scientifically valid and has a role to play in the formation of policy, our use of the planet and its resources, and in developing our conception of the common good in relation to the Earth.

As concerned geoscientists, we wish to ensure that members of our societies, associations, and organizations behave at all times in an ethical manner.

We agree to work together to:

  • Promote informed understanding of the role of ethics in the geosciences
  • Raise standards of professional practice among our memberships
  • Develop and promote a common Code of Ethics for geoscientists

*This statement was agreed to without objection at the American Geosciences Institute's Leadership Forum convened on September 16, 2013. It will be circulated to AGI's member societies for their consideration, and AGI will coordinate any action that the societies and organizations feel is appropriate. AGI's member societies represent approximately 250,000 geoscientists.

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Anthropological Association Disapproves of "Dig Wars"

The Travel Channel's new reality television show, "Dig Wars," is causing controversy in the anthropology community [1]. The show, which premiered on June 12, features three teams of two that use metal detectors to search for "loot" at different historical sites. Some of the featured locations include Fort Phantom Hill, a 19th-century Texas fort; Georgia Landing, a Louisiana sugar plantation that was the site of a pivotal Civil War battle; and Antietam Overlook Farm in Maryland, which sits next to the site of the Battle of Antietam. At the end of each episode, the excavated goods are evaluated for monetary worth to determine which team found the most valuable treasure [2].

In response to the show, the American Anthropological Association (AAA) wrote to the Travel Channel asking that it withdraw or modify "Dig Wars," stating that "the looting portrayed on the show is deeply disturbing." The association claims that the show promotes the portrayal of historical sites as places to plunder and establishes the value of artifacts in dollars instead of in historical importance. They suggest that the show could be improved by using objects found at historical sites to interpret the past instead of appraising them. The AAA even offered to help locate trained archaeologists to "communicate the excitement of discovery in a more responsible, ethical and engaging manner." [3]

A spokeswoman for the Travel Channel noted that no laws were broken in the making of the show and that the items found are either returned to the land owners or given to local museums. She also stated that the company respects the many opinions in regards to the gathering and preservation of artifacts and that an open dialogue on the issue is welcomed [1]. Additionally, the Travel Channel's website has now posted that, "All permissions to film on locations featured in the series were granted by the landowners," and "Metal detecting enthusiasts should always abide by state and federal laws." [2] The Travel Channel has not made any statements about withdrawing or modifying the show.

[1] http://www.insidehighered.com/quicktakes/2013/07/22/anthropology-group-objects-tv-show-dig-wars 
[2] http://www.travelchannel.com/tv-shows/dig-wars 
[3] http://www.aaanet.org/issues/policy-advocacy/upload/Dig-Wars-Travel-Channel.pdf

*AS

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Announcements

Call for Papers - The Twenty-third Annual Meeting of The Association for Practical and Professional Ethics (APPE) will be held February 27-March 2, 2014 in Jacksonville, Florida. APPE invites submissions on ethical issues in all fields, including: Business, Engineering, Government, Journalism and Media, Law, Medicine, Social Work as well as interdisciplinary and multi-disciplinary topics that cut across professions such as Action Research, Biomedical, Education Environmental, Public Health, and Research Ethics. The deadline for paper submissions is November 1, 2013. For more information, see http://appe2014amcallforpapers.wordpress.com/.

Call for Proposals - The International Center for Academic Integrity Annual Conference will be held in conjunction with the APPE Annual Meeting, from February 28-March 2, 2014 in Jacksonville, Florida. The theme of this conference is 'Academic Integrity: Confronting Issues'. Proposal submissions are requested on the following subjects: promoting scholastic and research integrity, fundamental values in education, discouraging, reducing, and dealing with instances of cheating, and establishing and nurturing cultures of integrity around the world. Proposals must be submitted by November 15, 2013. Additional information is available here: http://www.academicintegrity.org/icai/home.php.

Conference - The UNESCO Chair in Bioethics 9th World Conference on "Bioethics, Medical Ethics, and Health Law towards the 21st Century" will take place in Naples, Italy from November 19-21, 2013. The Conference is designed to offer a platform for the exchange of information and knowledge and to hold discussions, lectures, workshops and exhibition of programs and databases. The Conference will cover a variety of aspects, including: bioethics & law, environmental ethics & law, ethics & religions, immigration & bioethics, health law & bioethics, and philosophical ethics. Register to attend the meeting: http://www.isas.co.il/bioethics2013/.

Fellowship - The University Center for Human Values at Princeton University invites applications for Laurance S. Rockefeller Visiting Faculty Fellowships for the academic year 2014-15. Fellows will devote an academic year in residence at Princeton to do research and writing about topics involving human values in public and private life. The program is open to scholars in all disciplines provided their research plans qualify. Candidates should have a doctorate or equivalent professional degree and a strong record of research publications appropriate to their career stage. The program does not generally consider candidates who will have held the Ph.D. for less than two years at the time of appointment. The fellowship period extends from September 1 to July 1. Materials should be submitted online by November 4, 2013. For more information, visit: http://uchv.princeton.edu/fellowships_awards/lsr_visiting_fellowships.php.

New Offerings - The National Center for Professional & Research Ethics (NCPRE) at the University of Illinois is offering a new service to measure research integrity climates in academia, and another opportunity to earn a Teaching the Responsible Conduct of Research (TRCR) certification (ethicscenter.csl.illinois.edu). The Survey of Organizational Research Climate (SORC) is the only validated instrument that provides empirical measures of the climate for research integrity in academic organizations. NCPRE offers a fee-based service that administers SORC, encompassing online survey administration, analysis and reporting, as well as developing a national comparison database. SORC provides a snapshot of institutional climate that can help institutions assess the efficacy of their RCR approaches. The survey's confidential results have been shown to correlate with self-reported research behavior. In addition, NCPRE is now accepting applications for its next cohort in its Certificate program in Teaching the Responsible Conduct of Research. This two-semester program is open to advanced graduate students and postdoctoral fellows. For more information, visit www.nationalethicscenter.org. Or email ethicsctr@illinois.edu.

Position - The University Center for Human Values and the Woodrow Wilson School of Public and International Affairs of Princeton University invite applications for postdoctoral positions in Values and Public Policy. The programs aim to support highly promising scholars trained in moral and political philosophy, political theory, normative economics and related areas to develop a research agenda in the ethical dimensions of public policy. Candidates selected will undertake a research project exploring a normative problem arising in an area of public policy in which the Woodrow Wilson School conducts research. Applicants must have completed the requirements for the Ph.D. by September 1, 2014 and must not have held the degree for more than three years by that date. The term of appointment is one year, normally beginning September 1, 2014. Candidates should submit an online application at http://jobs.princeton.edu. Search for requisition number #1300483. Materials should be submitted online by November 18, 2013.

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