Appendix E
Background Information on Neuroethics

The most recent authoritative document on research ethics is the International Ethical Guidelines for Biomedical Research Involving Human Subjects, issued by the Council for International Organizations of Medical Sciences (CIOMS) in 1993 and revised in 2002 (Council for International Organizations of Medical Sciences, 2002). CIOMS is an international, nongovernment, nonprofit organization established jointly by the World Health Organization1 (WHO) and the UN Educational, Scientific and Cultural Organization (UNESCO)2 in 1949. The CIOMS guidelines are based on the stipulation that all research involving human subjects should be conducted in accordance with three basic ethical principles: respect for persons, beneficence, and justice. It is generally agreed that those principles, which in the abstract have equal moral force, guide the conscientious preparation of proposals for scientific studies. The CIOMS guidelines are directed at the practical application of the three principles to human-subjects research.

The 1993 CIOMS guidelines provided a concise and clear overview of the existing ethical guidance for human-subjects research (Council for International Organizations of Medical Sciences, 2002):

The first international instrument on the ethics of medical research, the Nuremberg Code, was promulgated in 1947 as a consequence of the trial of physicians (the Doctors’ Trial) who had conducted atrocious experiments on

1

For additional information, see WHO’s Web site, http://www.who.int. Accessed on December 20, 2007.

2

For additional information, see UNESCO’s Web site, http://www.unesco.org. Accessed on December 20, 2007.



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Appendix E Background Information on Neuroethics The most recent authoritative document on research ethics is the Inter­ national Ethical Guidelines for Biomedical research Inoling Human Sub­ jects, issued by the Council for International Organizations of Medical Sciences (CIOMS) in 1993 and revised in 2002 (Council for International Organizations of Medical Sciences, 2002). CIOMS is an international, nongovernment, non- profit organization established jointly by the World Health Organization1 (WHO) and the UN Educational, Scientific and Cultural Organization (UNESCO) 2 in 1949. The CIOMS guidelines are based on the stipulation that all research involving human subjects should be conducted in accordance with three basic ethical principles: respect for persons, beneficence, and justice. It is generally agreed that those principles, which in the abstract have equal moral force, guide the conscientious preparation of proposals for scientific studies. The CIOMS guidelines are directed at the practical application of the three principles to human-subjects research. The 1993 CIOMS guidelines provided a concise and clear overview of the existing ethical guidance for human-subjects research (Council for International Organizations of Medical Sciences, 2002): The first international instrument on the ethics of medical research, the Nuremberg Code, was promulgated in 1947 as a consequence of the trial of physicians (the Doctors’ Trial) who had conducted atrocious experiments on 1 For additional information, see WHO’s Web site, http://www.who.int. Accessed on December 20, 2007. 2 For additional information, see UNESCO’s Web site, http://www.unesco.org. Accessed on December 20, 2007. 

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 AppENDIX E unconsenting prisoners and detainees during the second world war. The Code, designed to protect the integrity of the research subject, set out conditions for the ethical conduct of research involving human subjects, emphasizing their voluntary consent to research. The Universal Declaration of Human Rights was adopted by the General Assembly of the United Nations in 1948. To give the Declaration legal as well as moral force, the General Assembly adopted in 1966 the International Covenant on Civil and Political Rights. Article 7 of the Covenant states “No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation”. It is through this statement that society expresses the fundamental human value that is held to govern all research involving human subjects—the protection of the rights and welfare of all human subjects of sci- entific experimentation. The Declaration of Helsinki, issued by the World Medical Association in 1964, is the fundamental document in the field of ethics in biomedical research and has influenced the formulation of international, regional and national legis- lation and codes of conduct. The Declaration, amended several times, most recently in 2000 . . ., is a comprehensive international statement of the ethics of research involving human subjects. It sets out ethical guidelines for physicians engaged in both clinical and nonclinical biomedical research. Since the first publication of the CIOMS 1993 Guidelines, several inter- national organizations have issued ethical guidance on clinical trials. This has included, from the World Health Organization, in 1995, Guidelines for Good Clinical practice for Trials on pharmaceutical products; and from the Interna- tional Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH),3 in 1996, Guideline on Good Clinical practice, designed to ensure that data generated from clinical trials are mutually acceptable to regulatory authorities in the European Union, Japan and the United States of America. In his 2005 article, John Williams, member of the Ethics Unit of the World Medical Association, laid out exactly on which points the documents essentially are in agreement (Williams, 2005): Despite the different scope, length, and authorship of these documents, they agree to a very large extent on the basic requirements of research ethics, namely: • every proposal for medical research on human subjects must be reviewed and approved by an independent ethics committee before it can proceed; • a medical research project involving human subjects must be justifiable on scientific grounds; 3 For additional information, see ICH’s Web site, http://www.ich.org. Accessed on December 20, 2007.

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 EMErGING COGNITIVE NEUrOSCIENCE AND rELATED TECHNOLOGIES • a medical research project must contribute to the well-being of society in general; • the risks to the research subjects must not be unreasonable or dispropor- tionate to the expected benefits of the research; • research on human subjects cannot proceed without their informed consent; • research subjects have a right to privacy with regard to their personal health information; • research results must be reported accurately; • anyone who has knowledge of unethical research has an obligation to disclose this information to the appropriate authorities. Not specifically concerned with biomedical research involving human sub- jects but clearly pertinent, as noted above, are international human-rights instru- ments, mainly the Universal Declaration of Human Rights (United Nations, 1948), which, particularly in its science provisions, was highly influenced by the Nuremberg Code;4 the International Covenant on Civil and Political Rights (United Nations, 1966a);5 and the International Covenant on Economic, Social and Cultural Rights (United Nations, 1966b). Since the Nuremberg experience, human-rights law has expanded to include the protection of women (Conven- tion on the Elimination of All Forms of Discrimination Against Women, United Nations, 1979) and children (Convention on the Rights of the Child, United Nations, 1989). Those and other such international instruments endorse, in terms of human rights, the general ethical principles that underlie such documents as the CIOMS International Ethical Guidelines. Principles guiding the ethical treatment of human research subjects have been incorporated into the laws or regulations of many countries and international organizations, including those which deal with the approval of drugs and medical devices. Not all aspects of research ethics enjoy general agreement. As medical science continues to advance in, for example, genetics, the neurosciences, and organ and tissue regeneration, questions arise regarding the ethical acceptability of new techniques, procedures, and treatments for which there are no ready-made answers. The source of one of the most well-known documents guiding human- subjects research, the Declaration of Helsinki (DoH), The World Medical Asso- ciation (WMA) (1964)6 is the global federation of national medical associations representing millions of physicians worldwide. Acting on behalf of patients and physicians, WMA endeavors to achieve the highest possible standards of medi- 4 Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 0, Vol. 2, pp. 181-182. Washington, D.C.: U.S. Government Printing Office, 1949. 5 For additional information, see the UN Office of the High Commissioner for Human Rights Web site, http://www.ohchr.org/EN/Pages/WelcomePage.aspx. Accessed on March 28, 2008. 6 For additional information, see WMA’s Web site at http://www.wma.net. Accessed on Decem- ber 20, 2007.

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 AppENDIX E cal care, ethics, education, and health-related human rights for all people. Otmar Kloiber, WMA secretary general, reported on inquiry7,8 that: the World Medical Association entrusts it completely to its members to imple- ment and monitor the implementation of WMA policy. The office of the WMA has neither the means nor the task to investigate the application in the countries. With the Declaration of Helsinki the implementation has been fairly success- ful but yet we don’t have reliable country data. For a country such as Iran we simply don’t know. That implies that although the DoH has international authority, it is not known how well it is respected or even enforced across the globe. Dr. Kloiber continued: “A very strong role lies in the hand of the publishers of international professional journals. Requirements to give proof of the observation of the DoH certainly help to get those standards accepted.” That last remark shows that overt research that is submitted for publication to (ideally) peer-reviewed professional journals must meet the highest standards of human research-subject protection as exemplified by the DoH and the CIOMS guidelines. Covert or classified military research findings will probably not be submitted for publication in the international literature, so they will escape the attention of publishers and peer reviewers. Thus, human-subjects protection in this sector of biomedical research cannot be guaranteed or assessed. Military use of advances in biomedical science is extremely difficult to investigate, because of the classified status of most such research. To safeguard their national security, nations that are actively pursuing biotechnology useful to the military are highly unlikely to advertise their accomplishments in the biomedical literature or else- where. Moreover, an inverse relationship seems apparent: countries that are most likely to be pursuing neuroscientific and other biotechnological developments for military or intelligence use are least likely to be direct or transparent about such activities. The international community is concerned about the reactivation of the nuclear program in Iran. The recent visit of the Iranian president to the UN in New York has not relieved any of the fears associated with Iran’s development of nuclear power (Hoge, 2007). And the development of other forms of military technologies, such as neurotechnological devices, to build Iran’s national defense and perhaps even offense remains largely unknown. It poses a threat to interna- tional stability, and we are compelled to learn more about ethical regulations for biomedical research in Iran. 7 Forthis report, representatives of WMA, CIOMS, and the International Association for Bioethics were approached with specific questions about the scope of and international compliance with their guidelines. Only WMA responded to the committee’s request. 8 Otmar Kloiber, WMA, personal communication to committee member Jonathan Moreno on September 18, 2007.

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 EMErGING COGNITIVE NEUrOSCIENCE AND rELATED TECHNOLOGIES Bioethics in Iran is largely influenced by the Islamic underpinnings of its society but reportedly takes international documents and guidelines into account. In a 2007 article, Iranian physicians Larijani and Zahedi give an extensive overview of the status of medical ethics in their country (Larijani and Zahedi, 2007): Establishment of Medical Ethics Research Center by Ministry of Health and Medical education (MOHME) in 1993, formation of Medical Ethics Research Committees at National level (1997), formation of Medical Ethics Research Committees at University level for monitoring research, implementation of the National Code for ethics in Biomedical Research all over the country, and trans- lating and authoring books on medical ethics and ethics in research have been the early activities in Iran. “Medical Ethics with a Brief Overview of Medical History” (1991) is one of the reference books for medical students in Iran which was published by MOHME in collaboration with the faculties of the Tehran University of Medical Sciences. The First International Conference on Medical Ethics (Tehran, 1993), semi- nars and short-courses on medical ethics for physicians, nurses and pharmacists, weekly workshops on research ethics for medical researchers in different regions of the country are being conducted. The National Codes of Ethics for biomedical research (26 codes) was pre- pared by MOHME in 2000. These codes are in accordance with the international declarations such as Helsinki Declaration and have been customized according to Islamic codes and Iranian cultural issues. Consequently, the Specific National Ethical Guidelines for Biomedical Research were compiled in 2005. The primary draft has been reviewed by some law, ethics, medical and religious experts. The guidelines contain “Ethical Guidelines for Clinical Trials”, “Ethical Guidelines for Research on Vulner- able Groups”, “Ethical Guidelines for Genetic Research”, “Ethical Guidelines for Gamete and Embryo Research”, “Ethical Guidelines for Transplantation Research”, and “Ethical Guidelines for Research on Animals”. The Guidelines have been ratified and forwarded to the universities and research centers in spring 2006. The concept of human dignity is rooted firmly in Islam, and respect for human participants in biomedical research should follow directly from it. In addi- tion, Iran is a member state of the UN and has confirmed its adherence to UN and UNESCO documents on human rights. However, the Iranian record of question- able treatment of (assumed) homosexuals, women, and secular scholars does not bolster confidence that both international and Iranian bioethics guidelines will always be complied with by Iranian government biomedical researchers. Iran has a strong tradition of scientific inquiry and scholarly activities. Uni- versities foster national and international scientific collaboration and exchange of ideas, as exemplified by a recent international conference on biotechnology. The conference was organized by the National Institute for Genetic Engineering and

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 AppENDIX E Biotechnology in Tehran; the Asian and Pacific Centre for Transfer of Technol- ogy in New Delhi, India; and the Korea Research Institute for Bioscience and Biotechnology in Daejeon, Korea. During a presentation about the development of expertise in nanobiotechnology, Mohsen Jahanshahi, of the University of Mazandaran in Iran, discussed the neuroscientific uses of nanotechnology in Iran (Jahanshahi, 2005). Specifically, techniques for monitoring human performance, brain-machine interfaces, modulation of brain structure, and artificial brains with natural intelligence were mentioned. That shows that at least at one center in Iran with expertise in neuroscience is being developed, although not specifically for military use. It is easy to find information on biotechnology, with respect to both the research setting and biotechnology companies, on Iranian Web sites, but it is not at all straightforward to find out how much of the research is connected to cognitive neuroscience and possible advances in science related to national defense. China is fast becoming an international superpower and a haven for biotech- nology research. Relatively inexpensive labor and the presence of biotechno- logical expertise in universities and companies make China an attractive location for international biomedical research. China seems to have been taking steps in recent years to increase transparency and accountability in biomedical research (Jia, 2006). In May 2007, Qiu Renzong, honorary director of the Centre for Applied Ethics at the Chinese Academy of Social Sciences in Beijing, wrote in a Web publication about the proposed new ethics regulations to govern biomedical research (Renzong, 2007): Until recently, there has been little control of ethical review in these sectors [biomedical research]. In January this year—following around nine years of debate among Chinese scientists, bioethicists and policymakers—China’s Min- istry of Health finally approved the country’s first general regulations on ethical review of biomedical research involving human subjects. Renzong goes on to state: The new Chinese regulations successfully fit ethical review within the country’s own laws and regulations while also abiding by international bio- ethical principles. They clearly state that the process of ethical review should be independent, objective, just and transparent. The regulations encompass a three-tier infrastructure made up of national, provincial and institutional ethical committees. They outline the wider principles of ethical review, the requirements for obtaining informed consent or establish- ing a research protocol, and the penalties that will be applied for violating the rules. The new regulations prioritise individuals’ health and safety over scientific and societal interests.

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 EMErGING COGNITIVE NEUrOSCIENCE AND rELATED TECHNOLOGIES However, implementation of the new regulations is not final, as Renzong explains: But drafting the regulation is only the first step in making human subject protection sustainable. Implementing it, and ensuring its widespread adoption will be a far more demanding and formidable task—but one that, if success- ful, will give much-needed impetus to building Chinese capacity in research ethics. Much should—and is—being done to help China succeed. The Ministry for Health’s ethics committee is busy drafting key documents such as the con- stitutions of the proposed ethics committees and application forms for principal investigators to use when seeking ethical approval that can be used nationwide. Existing institutional ethics committees are also being monitored by the ministry and provincial healthcare administrations to assess how and if they work, and to consider where they need re-organising or re-establishing. Great efforts are also being made to train researchers, ethics committee members and healthcare administrators responsible for governing ethical review. National and foreign institutes—including the Peking Union Medical College, Huazhong University of Science and Technology and Fudan University in China and the US-based universities of Harvard, California, Chicago and Yale, among others—have been collaborating since 2004 to provide such training. They have organised research ethics workshops for Chinese stakeholders across the country. Those are promising, yet early, developments in the protection and safety of human participants of biomedical research, especially in a country that has a questionable record of abuse of prisoners for medical purposes, such as organ transplantation. It should also be noted that the formal document with the bio- ethics regulations discussed by Renzong was not available at the official Web site of the Chinese government as of September 2007. Humane treatment of military personnel as human research subjects is still not readily assessable, although there seems to be some transparency in the workings of the Chinese military (China Internet Information Center, 2007). The State Council Information Office issued a white paper on China’s national defense in 2006 at a press conference on December 29 (State Council Information Office, 2007). The document, composed of 10 parts, summarizes the country’s national-defense policy and the administration system, logistical support, sci- entific research, and international cooperation for national defense. In it, China proclaims that it will: take the scientific development outlook as an important guiding principle for the building of national defense and military affairs, vigorously advance the revolu- tion in military affairs with Chinese features, and strive to realize an all-round, coordinated and sustainable development in our country’s national defense and military capabilities.

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 AppENDIX E Elsewhere, the white paper states that: keeping in mind the future informationized battlefield, the PLA [People’s Libera- tion Army] closely follows the emerging trend of integrated joint operations, conducts integrated training in an innovative way, and actively explores training approaches for the internal integration of fighting units, systems integration of fighting elements and comprehensive integration of fighting systems. The white paper also specifically mentions enhancing the performance of the armed forces with informationization, declaring that: the PLA pursues a strategy of strengthening itself by means of science and tech- nology, and works to accelerate change in the generating mode of war fighting capabilities by drawing on scientific and technological advances . . . as well as defense-related science and technology, and strives to make major breakthroughs in some basic, pioneering and technological fields of strategic importance. Although the paper does not directly mention specific details as to what technologies and science are to be used, it would not be too great a leap to sug- gest that the Chinese government is probably pursuing capability in cognitive neurosciences to enhance its national defense. Several internationally accepted documents guide the ethical treatment of human participants in biomedical research. The most authoritative document is the WMA DoH, which is cited most often in the international literature and with which researchers across the globe at least claim to be in compliance. Although the international community largely accepts and respects the DoH, data on individual states’ compliance are not available. The 1948 Universal Declara- tion of Human Rights in principle has global authority, but it is not invoked as often in the context of human-subjects research, although it does contain clear language about the ethical treatment of human subjects. In a legal context, such as during international tribunals, it is compelling. The oldest document, the 1947 Nuremberg Code, is not often cited directly as a reference document but has served as the foundation of other guiding documents, including the federal regulations in the United States. More recently, CIOMS issued the International Ethical Guidelines for Biomedical research Inoling Human Subjects (Council for International Organizations of Medical Sciences, 2002). Those guidelines are very detailed, practical, and sensitive to cultural differences between nations, but they may not have the same prominence as the DoH. In addition to those primary instruments, other national and international documents offer more specific guid- ance on separate subjects in biomedical research (for example, clinical trials and drug development). The various guidelines agree on some main beliefs: that prior ethical review of research is required, that research must be justifiable and contribute to the well-being of society in general, that risk-benefit ratios must be reasonable, that

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0 EMErGING COGNITIVE NEUrOSCIENCE AND rELATED TECHNOLOGIES informed consent or voluntariness is needed, that privacy a right, that data must be reported accurately, and that inappropriate behavior must be reported. Individual nations may have their own ethical rules and regulations in addi- tion to the international documents. For two nations in particular, Iran and China, we researched the existence and scope of such documents and the existence of evidence of research activity in cognitive neuroscience and biotechnology, specif- ically for military uses. Iran has detailed codes of medical ethics and biomedical research that have been officially ratified, and international documents have also been formally endorsed. There is some evidence that academic researchers may be developing capacity in neuroscience, especially in nanobiotechnology. What that implies for potential human or military uses and for compliance with ethical regulations is extremely difficult to assess. China also claims to comply with the international instruments guiding research ethics. Although there has been considerable discussion in China about improved and more comprehensive guidelines for biomedical research with human subjects, no new documents have been ratified recently by the government. The Chinese government did, however, recently publish its goals for strengthening national defense, including the use of technological innovations and scientific breakthroughs to enhance the military (Cao, 2006; Simon, 2007). From those findings, it follows that more investigation and insight are neces- sary regarding the compliance of several nations, including Iran and China, with international research-ethics directives and regarding their endeavors in biotech- nologies, such as technologies related to cognitive neuroscience. If studies are not submitted for publication or if applications for intellectual- property protection are not filed, there is no guarantee that they will come to the attention of the scientific community or of legal and regulatory authorities. The system for ensuring the ethics of human-research trials relies on a combination of international guidelines, various national regulatory systems, well-managed research institutions, and investigator self-reporting. To judge by long historical experience, system breakdowns are all too common. Therefore, the intelligence community’s understanding of developments in this field cannot simply rely on current arrangements for the regulation of human research, nor can the interna- tional community be assured that human experiments that are exploitative and conducted for nefarious purposes are not taking place. REFERENCES Cao, Cong, Richard P. Suttmeier, and Denis Fred Simon. 2006. China’s 15-year science and technol- ogy plan. physics Today 59(12):38-43. China Internet Information Center. 2007. Official Web site of the Chinese Government. State Council Information Office and the China International Publishing Group in Beijing, December 5, 2007. Council for International Organizations of Medical Sciences. 2002. International Ethical Guidelines for Biomedical research Inoling Human Subjects. Geneva, Switzerland, November 2002. Available from http://www.cioms.ch/guidelines_nov_2002_blurb.htm. Last accessed June 8, 2008.

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 AppENDIX E Hoge, Warren. 2007. Iran’s president vows to ignore U.N. measures. New York Times. September 26, 2007. Available from http://www.nytimes.com/2007/09/26/world/26nations.html. Last accessed March 28, 2008. Jahanshahi, Mohsen. 2005. Nanobiotechnology. Paper read at BINASIA-Iran National Workshop, November 8-9, 2005, Tehran, Iran. Jia, Hepeng. 2006. China to release tougher rules for research ethics. Science Deelopment Network, August 14. Available from http://www.scidev.net/News/index.cfm?fuseaction=readnews&itemid =3045&language=1. Larijani, Bagher, and Farzaneh Zahedi. 2007. Medical ethics activities and plans in Iran at a glance. Iranian Journal of Allergy, Asthma, and Immunology 6(Suppl 5):1-4. Renzong, Qui. 2007. China taking the right steps in bioethics. Science Deelopment Network, May 18, 2007. Available from http://www.scidev.net/dossiers/index.cfm?fuseaction=dossierreaditem&dossier= 5&type=3&itemid=611&language=1. State Council Information Office. 2007. China’s National Defense in 2006. Section 8, Science, Tech- nology and Industry for National Defense. People’s Republic of China, December 29, 2006. Available from http://www.china.org.cn/english/Books&Magazines/194419.htm#8. United Nations. 1948. Universal Declaration of Human Rights. Adopted and proclaimed by General Assembly Resolution 217 A (III) of 10 December 1948. Palais de Chaillot, Paris, December 1948. Available from http://www.un.org/Overview/rights.html. United Nations. 1966a. International Covenant on Civil and Political Rights. Adopted and opened for signature, ratification, and accession by General Assembly Resolution 2200A (XXI) of December 16, 1966. Entry into force March 23, 1976. Available from http://www.unhchr. ch/html/menu3/b/a_ccpr.htm. United Nations. 1966b. International Covenant on Economic, Social and Cultural Rights. Adopted and opened for signature, ratification, and accession by General Assembly Resolution 2200A (XXI) of December 16, 1966. Entry into force January 3, 1976. Available from http://www. unhchr.ch/html/menu3/b/a_cescr.htm. United Nations. 1979. Convention on the Elimination of All Forms of Discrimination Against Women. Adopted and opened for signature, ratification, and accession by General Assembly Resolution 34/180 of December 18, 1979. Entry into force September 3, 1981. Available from http://www. unhchr.ch/html/menu3/b/e1cedaw.htm. United Nations. 1989. Convention on the Rights of the Child. Adopted and opened for signature, ratification, and accession by General Assembly Resolution 44/25 of November 20, 1989. Entry into force September 2, 1990. Available from http://www.unhchr.ch/html/menu3/b/k2crc.htm. Williams, John R. 2005. Medical ethics in contemporary clinical practice. Journal of the Chinese Medical Association 68(11):495-499. World Medical Association. 1964. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Adopted by the 18th World Medical Association General Assembly. Helsinki, Finland, June 1964. Available from http://www.wma.net/e/policy/b3.htm. Unpublished Simon, Denis F. 2007. “China’s Emerging Innovation Trajectory: The Competitive Implications.” Presentation to the committee on August 15, 2007.