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In the News: Professional Ethics Report Spring 2016

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Pfizer Will No Longer Supply Products for Lethal Injections
by Claire Sabel

The pharmaceutical company Pfizer released a statement on May 13, 2016, announcing that it would no longer allow its products to be used in lethal injections. [1] The new policy restricts the sale of seven products, pancuronium bromide, potassium chloride, propofol, midazolam, hydromorphone, rocuronium bromide and vecuronium bromide, to distributors and wholesalers “under the condition that they will not resell these products to correctional institutions for use in lethal injections.” Government agencies purchasing these products must certify that these drugs will not be used for capital punishment, and that they will not make them available to any organization that would do so.

Executions nearly always use the combination of the barbituate sodium thiopental with paralytic and heart-stopping drugs, typically pancuronium bromide and potassium chloride. The only federally approved factory producing sodium thiopental closed in 2009 due to technical difficulties. [2] Pfizer is the last FDA-approved manufacturer to declare that it will not supply drugs for lethal injections. Difficulty in obtaining these products has already forced states to pursue other methods of execution. [3]

Many of the 32 states that allow capital punishment have faced difficulties in executing prisoners in recent years due to a range of obstacles including the seizure of non-FDA approved drugs and drugs sourced from non-approved suppliers, and delays in executions because of drug-shortages or legal issues related to the use of alternative drugs in lethal injections. [2]

Pfizer’s statement confirmed that it would continue to make the drugs available “because they save or improve lives” and emphasized that the new system of monitoring their distribution was “designed to ensure that these critical medications will remain immediately available to those patients who rely on them every day.” [1]

[1] http://www.pfizer.com/files/b2b/GlobalPolicyPaperLethalInjection.pdf
[2] http://www.nytimes.com/2016/05/14/us/pfizer-execution-drugs-lethal-injection.html
[3] http://www.deathpenaltyinfo.org/state-lethal-injection 


National Academies Support Further Gene Drive Research
by Claire Sabel

The National Academies of Sciences, Engineering, and Medicine released a report on the current and future directions of gene drive research on June 8, 2016. [1] A gene drive is a method of genetic engineering that enables the rapid inheritance of a desired trait throughout a population of organisms. Recent research into the applications of gene drives focuses on two areas: the control and potential eradication of vector-borne diseases, and the reduction of threats to biodiversity due to invasive or endangered species. The report concludes that current research is insufficient to support the release of gene drives into the environment at the present time, and warns against potential pressure to do so in the context of severe public health crises. However, the technology has substantial promise, and the Academies support further research in this field.

Gene drives have interested geneticists for some time, but research into the technology has accelerated since the development of genome editing techniques such as CRISPR/Cas9. In early 2015, the first gene drive was demonstrated in yeast [2], and since then three more “proof of concept” studies have been completed in fruit flies and mosquitos.

The National Academies report summarizes the current state of research in molecular biology, population genetics, and ecology, and presents seven case studies of plausible applications of gene drive technology to address challenges in public health, conservation, agriculture and basic research. These are areas facing “complex, difficult-to-solve issues, particularly those where solutions are limited or entirely lacking,” such as the transmission of malaria, or the eradication of invasive species, which makes the potential impacts of gene drive technology highly significant. [1] The case studies serve as examples and reference points throughout the report to highlight various ethical, policy, and governance issues raised by the implementation of gene drives, such as the coordination of consent from inhabitants of large transnational environments that support a particular population of insects or plants. [3] In contrast to genetically modified organisms in agriculture, there has been very little study of the ethical issues related to gene drives.

In addition to research on the challenges to successful implementation, the report calls for further study of the potentially harmful genetic, ecological, and environmental impacts of gene drive technology. It is not yet known how genetic modifications might spread to related species or encourage new resistances to diseases or pesticides. Gene drives can be used to pass on traits that make an organism unfit for the environment or disproportionately produce offspring of one sex, which could lead to the deliberate eradication of an entire population or species. The National Academies study calls for more robust and comprehensive regulations and ecological risk assessments before any gene drives are released into the environment.

The report was commissioned by the National Institutes of Health (NIH) and the Foundation for the National Institutes of Health (FNIH), which received funding from The Bill and Melinda Gates Foundation and the Defense Advanced Research Projects Agency (DARPA).

[1] http://www.nap.edu/catalog/23405/gene-drives-on-the-horizon-advancing-science-navigating-uncertainty-and
[2] DiCarlo, J. E., Chavez, A., Dietz, S. L., Esvelt, K. M. & Church, G. M. Safeguarding CRISPR-Cas9 gene drives in yeast. Nat Biotech 33, 1250–1255 (2015).
[3] 1.Oye, K. A. et al. Regulating gene drives. Science 345, 626–628 (2014).


Canadian Scientists Now Free to Speak to Press and Public
by Ellen Platts

In the months since the election of the Liberal party in October 2015, the morale and attitude in the Canadian scientific community has transformed, especially for government scientists. During the election, the Liberals made amending the damage done to the relationship between the government and the scientific community a central part of their platform. In November 2015, Kirsty Duncan was appointed as the new Minister for Science. [1] Part of her remit is to create the position of Chief Science Officer to “ensure that government science is fully available to the public, that scientists are able to speak freely about their work, and that scientific analyses and evidence are considered when the government makes decisions.” [2]

This promised a sea change from the restrictions put into place by the previous government, which created a new Science and Technology Innovation Council (STIC) to provide “confidential advice” to the government and operated behind closed doors. [2, 3] That administration also prioritized the economy, including increasing the extraction of resources. This prioritization happened simultaneously with the easing of environmental regulations to speed these projects along and with the creation of tight restrictions on communication between government scientists and the media.

This crackdown was especially focused on those working on environmental and climate science. Scientists working on the unusually high death rate of salmon in British Columbia’s Fraser River, the toxic effects of mercury and organic pollutants on ocean wildlife, and the sensitivity of polar bears to climate change and loss of sea ice all spoke to Nature about their experiences attempting to communicate their work. [4] Scientists were required to get approval from many tiers of government to speak to reporters, which one official called “the black box of decision-making.” [4] This was a slow process, and often resulted in no permission being granted for any communication to media. The excessive scrutiny and media muzzling had an adverse effect on morale and the communication of scientific information. Some scientists retired early in part because of the restrictions placed upon them by the government. [4]

The new developments aim to increase transparency, take decision-making out from behind closed doors, and allow for open communication of scientific information to the press and the public. Scientists can now do interviews with reporters, though they may still have to inform communications officers beforehand. At some agencies, like Fisheries and Oceans Canada, however, scientists can speak to the media first, without the need for any special permission. [4]

The change at some government agencies has not occurred as quickly as hoped, and recovery from the tight restrictions could take years. Gretchen Goldman of the Union of Concerned Scientists, who studied the suppression of scientists in the United States during the Bush administration, says that “practices often lag the policy,” and that it may take years for the culture in the scientific community to change to one of greater transparency. [4] To learn more, click here to read the lead article from Professional Ethics Report Vol. 28 No. 4 that provides more information about this issue and how scientists and funders are addressing it: “Building Science Integrity Principles.”

[1] http://www.nature.com/news/canada-s-top-scientist-faces-tough-challenge-1.19075
[2] http://www.aaas.org/news/building-science-integrity-principles  
[3] http://www.nature.com/news/canadian-election-spotlights-scientists-frustrations-1.18381
[4] http://www.nature.com/news/nine-years-of-censorship-1.19842 

NIH Announces a Single IRB Policy for Multi-site Clinical Research
by Claire Sabel

The NIH announced a new policy for ethical review of domestic multi-institutional studies funded by the agency on June 21, 2016. [1] The “NIH Policy on the Use of a Single Institutional Review Board (IRB) for Multisite Research (sIRB)” requires studies involving human subjects taking place across multiple sites to use a common IRB for ethical reviews of research. [2] Currently, almost half of NIH-funded studies involve multisite research. [3]

The Director of NIH, Francis Collins, issued a statement explaining that the new policy will improve the review process of multisite trials by making it more efficient, eliminating the “duplicative reviews that slow down the start of the research” without demonstrably enhancing patient protection. [4] NIH is the first agency of the Department of Health and Human Services to implement a sIRB policy, although the National Cancer Institute already has a centralized review process. The federal agencies seeking to revise the regulations governing human subjects research known as “the Common Rule” (45 C.F.R. 46) (9 LSLR 1031, 9/18/15) have proposed a sIRB requirement for all federally-funded research. [5] In his 2015 commentary on the broader Common Rule regulations, including mandatory sIRBs, in the New England Journal of Medicine, Collins urged the scientific community to embrace “long-overdue” changes in order to “take a giant leap forward in showing respect for research participants.” [3]

The move to a streamlined sIRB process is one of the most divisive of the proposed Common Rule revisions. [6] According to the analysis of the public comments by the Council on Government Relations and the Association of Public and Land-grant Universities, 49% of respondents favored a single IRB, and 51% of respondents opposed the change. Advocacy groups and professional societies tended to support sIRBs, while many universities and medical centers did not support the change. [7] Opponents feared that a single IRB process would actually increase the administrative burden of ethical reviews. NIH had its own public comment period for the draft of its new sIRB policy, and has made comments available online. [8] About 70% of NIH respondents favored sIRBs. [5]

Collins’ recent statement addressed a different concern, namely that the new procedure would leave collaborating institutions uncertain about who would be held accountable in the event of a regulatory violation. Collins clarified that the IRB of record and not the institution relying on an external IRB would be responsible for any IRB regulatory violations. [4]

The new policy will not take effect until May 2017 to allow the research community to prepare adequately for the change, and will not apply to overseas sites or to career development, research training or fellowship awards. To help researchers understand the new policy, NIH has issued an FAQ document [9] and is in the process of developing a model sIRB toolkit for multi-site research. [10] NIH sees its sIRB model and the move to simplify the IRB process as a “unique opportunity to harmonize the standards and agreements used in clinical research.” [1]

[1] http://osp.od.nih.gov/under-the-poliscope/2016/06/accelerating-clinical-research-streamlining-multi-site-review-human-subjects-research
[2] http://osp.od.nih.gov/sites/default/files/NIH_sIRB_Policy_Multi_site_Research_UPDATED2016.pdf
[3] Hudson, K. L. & Collins, F. S. Bringing the Common Rule into the 21st Century. New England Journal of Medicine  373, 2293–2296 (2015).
[4] https://www.nih.gov/about-nih/who-we-are/nih-director/statements/single-irb-policy-streamline-reviews-multi-site-research
[5] http://www.bna.com/nih-finalizes-single-n57982074496/
[6] https://www.federalregister.gov/articles/2015/09/08/2015-21756/federal-policy-for-the-protection-of-human-subjects
[7] http://www.cogr.edu/Human-Subjects-and-Animal-Research
[8] http://osp.od.nih.gov/sites/default/files/resources/sIRB%2007-21-2015.pdf
[9] http://osp.od.nih.gov/sites/default/files/sIRB_FAQs_Final_UPDATED2016.pdf

[10] https://ncats.nih.gov/expertise/clinical/smartirb

 

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Author

Joel Ericsen

Program Assistant