European Dual-Use Procedures

Abstract

The proposed shift in dual-use research oversight in the United States [([ 1 ][1]); “U.S. agencies to start screening biomedical proposals for dual use,” D. Malakoff, News & Analysis, 6 April, p. [21][2]] resembles the procedural concept applied by the European Commission Ethics Review and Audit system ([ 2 ][3]). For more than 10 years, research proposals funded by the European Commission (the largest research funding institution in Europe) have been systematically reviewed and audited for potential misuses in a dual-use context; if appropriate, safeguards to mitigate such risks have been introduced. The guidance document on minimizing the risks of misuse of research ([ 3 ][4]) provides a list of potential safeguards to reviewers and addresses the potential need to obtain export licenses in certain circumstances—a precaution that would have mitigated the problems related to the National Institutes of Health—financed Dutch H5N1 study ([ 4 ][5]). The two concepts differ substantially in scope. The U.S. plan is solely focused on a selected list of biological agents. The European Commission's Ethics Review includes dual-use research in other areas, such as chemical, radiological, nuclear, and explosive research. The wider definition, based on lessons learned from past occurrences of dual-use issues in reviews, aims to be consistent with relevant international and national arrangements addressing dual-use risks of research [e.g., ([ 5 ][6]–[ 7 ][7])]. As the United States assesses its current strategies in dual-use oversight, it may be worthwhile to consider a more comprehensive approach in order to be in line with the international and national legal framework and the complexity of dual-use in research. 1. [↵][8]United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern ([http://oba.od.nih.gov/oba/biosecurity/PDF/United\_States\_Government\_Policy\_for\_Oversight\_of\_DURC\_FINAL\_version\_032812.pdf][9]). 2. [↵][10]European Commission, Research and Innovation—Science in Society, Ethics Review ( ). 3. [↵][11]Research Ethics: A Comprehensive Strategy on How to Minimize Research Misconduct and the Potential Misuse of Research in EU Funded Research ([ftp://ftp.cordis.europa.eu/pub/fp7/docs/guidelines-on-misconductmisuse-of-research_en.pdf][12]). 4. [↵][13]1. M. Enserink , Science 336, 285 (2012). [OpenUrl][14][Abstract/FREE Full Text][15] 5. [↵][16]The Australia Group, Relationship with the Biological Weapons Convention ([www.australiagroup.net/en/bwc.html][17]). 6. Organisation for the Prohibition of Chemical Weapons, Convention on the Prohibition of the Development, Production, Stockpiling, and Use of Chemical Weapons and on their Destruction (Chemical Weapons Convention) ([www.opcw.org/chemical-weapons-convention][18]). 7. [↵][19]Export Control: A Resource Nonproliferation Export Controls ([www.exportcontrol.org][20]). [1]: #ref-1 [2]: pending:yes [3]: #ref-2 [4]: #ref-3 [5]: #ref-4 [6]: #ref-5 [7]: #ref-7 [8]: #xref-ref-1-1 View reference 1 in text [9]: http://oba.od.nih.gov/oba/biosecurity/PDF/United_States_Government_Policy_for_Oversight_of_DURC_FINAL_version_032812.pdf [10]: #xref-ref-2-1 View reference 2 in text [11]: #xref-ref-3-1 View reference 3 in text [12]: http://ftp://ftp.cordis.europa.eu/pub/fp7/docs/guidelines-on-misconductmisuse-of-research_en.pdf [13]: #xref-ref-4-1 View reference 4 in text [14]: {openurl}?query=rft.jtitle%253DScience%26rft.stitle%253DScience%26rft.aulast%253DEnserink%26rft.auinit1%253DM.%26rft.volume%253D336%26rft.issue%253D6079%26rft.spage%253D285%26rft.epage%253D285%26rft.atitle%253DWill%2BDutch%2BAllow%2B%2527Export%2527%2Bof%2BControversial%2BFlu%2BStudy%253F%26rft_id%253Dinfo%253Adoi%252F10.1126%252Fscience.336.6079.285%26rft_id%253Dinfo%253Apmid%252F22517831%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [15]: /lookup/ijlink/YTozOntzOjQ6InBhdGgiO3M6MTQ6Ii9sb29rdXAvaWpsaW5rIjtzOjU6InF1ZXJ5IjthOjQ6e3M6ODoibGlua1R5cGUiO3M6NDoiQUJTVCI7czoxMToiam91cm5hbENvZGUiO3M6Mzoic2NpIjtzOjU6InJlc2lkIjtzOjEyOiIzMzYvNjA3OS8yODUiO3M6NDoiYXRvbSI7czoyNToiL3NjaS8zMzYvNjA4Ni8xMjMxLjEuYXRvbSI7fXM6ODoiZnJhZ21lbnQiO3M6MDoiIjt9 [16]: #xref-ref-5-1 View reference 5 in text [17]: http://www.australiagroup.net/en/bwc.html [18]: http://www.opcw.org/chemical-weapons-convention) [19]: #xref-ref-7-1 View reference 7 in text [20]: http://www.exportcontrol.org