1

Framing the Issues

James LeDuc, workshop co-chair, explained the origins of the workshop: It was based on a similar workshop that convened experts from 32 nations in Istanbul, Turkey, in 2011.¹ At the end of that workshop, attendees visited a BSL-3 laboratory that was under construction in the outskirts of Istanbul. At the workshop, LeDuc met a bright young veterinarian with a Ph.D. in virology who had a special interest in tickborne diseases. Subsequently, she went to the University of Texas Medical Branch (UTMB) for a fellowship to conduct research and to work on biosafety and biosecurity at LeDuc’s laboratory. During the year-long fellowship, she went through the entire training program, along with mentorship, to learn how the laboratory is managed and how to ensure that it is working efficiently. At the end of the fellowship, she had full and complete independent access to the lab.

When she returned to Turkey, having conducted transmission studies on Crimean-Congo hemorrhagic fever and published her research, she observed a tremendous demand, not only for good science, but also for hands-on training in biosafety and biosecurity. She then offered a class on biosafety and biosecurity to participants in Turkey, based on materials provided by UTMB. This is a success story, both in a scientific sense and in terms of capacity building—the ultimate in the train-the-trainer concept. LeDuc expressed hope that New Delhi workshop participants would identify similar kinds of opportunities where people can have honest exchanges and true partnerships.

LeDuc continued by framing the issues related to the overall workshop goals. Ebola is clearly a global issue that deserves significant attention. LeDuc recalled that his home state of Texas received an

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¹ National Research Council. 2012. Biosecurity Challenges of the Global Expansion of High-Containment Biological Laboratories. Summary of a Workshop. Washington, D.C.: The National Academies Press.

imported case.² This provided real, firsthand experience of what happens when someone arrives at a hospital with Ebola. No country is immune from the possibility of disease importation. What would happen if a case were imported to Asia? The U.S. response and prevention strategy focused on points of entry for people coming from West Africa, but that strategy would have to change if Ebola or another disease were to come from many points around the world.

There has been a proliferation of new biocontainment laboratories around the world, including in India. As more laboratories are built, there are more people involved in the handling of pathogens. This requires us to seek to maximize the benefits from laboratory research while minimizing or managing the risks that they can pose. Biocontainment training is one element of addressing those risks, but even in the best programs, the most conservative environments, accidents still occur. In the United States, three recent incidents have garnered a great deal of attention: the release of potentially infectious anthrax; the transport, unknowingly, of highly pathogenic avian influenza; and the discovery of 60-year-old smallpox virus stored away in the corner of a laboratory at the National Institutes of Health.³ Any one of these incidents alone would have been a significant issue. The U.S. government described the incidents as unacceptable and decided to take action. The White House has encouraged all U.S. research organizations to suspend research with dangerous pathogens and to review their current biosafety and biosecurity protocols. These organizations are also being directed to conduct an inventory to make certain that there are no additional smallpox caches and to increase awareness about biosafety and biosecurity more generally.

In addition, there is ongoing discussion of the great benefits and potential risks arising from the tremendous advances being made in biotechnology, including the dual uses of research of concern. Gain-of-function studies, in particular studies enhancing transmission of influenza viruses, have been among the most contentious issues. The United States recently instituted what is called a “pause” on gain-of-

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² For more information, see the Centers for Disease Control: http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/united-statesimported-case.html; accessed April 10, 2016.

³ Julie Steenhuysen. “White House Issues Report on Improving Biosafety at Federal Labs,” Reuters. October 29, 2015. See: http://www.reuters.com/article/usa-whitehouse-biosafety-idUSL1N12T4EV20151029; accessed April 10, 2016.

function research while the community reexamines these issues.⁴ Different countries have different perspectives on these issues and there is no single “right” answer. Nonetheless, LeDuc said, problems encountered in this type of research should be examined in the context of a global, interconnected environment: An outbreak anywhere is a threat everywhere. Ebola is a prime example. Another critical set of issues surround the topic currently called One Health: The lines between animal health and human health continue to blur, with many diseases originating at the intersection of animals and humans. Addressing all of these issues well requires the sharing of experiences and lessons learned from both sides.

LeDuc said that as research and laboratory capacity are developed, it is clear that both strong technical competence and responsible leadership are needed. The Turkish veterinarian who trained at UTMB returned to Turkey not only with technical skills, but also leadership skills on how to run a laboratory safely and securely; experience that is scarce and valuable. Grooming leaders going forward is an essential area that deserves discussion and suggestions.

DETERMINING AND DEVELOPING THE RIGHT ELEMENTS FOR SAFE AND SECURE RESEARCH

David Franz opened his remarks by recalling his early experiences as a researcher and as the director of a high-containment laboratory prior to the September 11, 2001 attacks on the United States (9/11). At that time, he would have led a command briefing by stating that his three top priorities were biosafety, biosafety, and biosafety. Also, when he took over as commander, he changed the organizational diagram so that the safety officer reported directly to the commander instead of lower down in the chain of command. Franz stated that he took those actions not because he was particularly smart or wise, but because he was afraid and did not want anything to go wrong on his watch. He realized that if a researcher in a BSL-4 lab sticks a needle through a glove or if a bone fragment of a laboratory animal punctured a glove while a researcher

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⁴ For more information, see: White House, “Doing Diligence to Assess the Risks and Benefits of Life Sciences Gain-of-Function Research,” October 17, 2014. Available at: https://www.whitehouse.gov/blog/2014/10/17/doing-diligence-assess-risks-and-benefits-life-sciences-gain-function-research; accessed April 10, 2016.

was conducting a postmortem, it could mean certain death for that person. This realization was a strong motivator.

With that context, Franz described a conversation he had at a biosafety and biosecurity meeting in Casablanca in May 2013. Participants were discussing how to make biosafety and biosecurity part of the scientific and research culture. In other words, how do we move beyond just a certificate on the wall and a checkbox in some book that says someone has been trained? Although nearly all participants at the meeting in Casablanca were biologists, one Tunisian engineer and a former government minister were also involved, and the engineer said, “It has got to be in the soup. It has got to be in the soup.” He explained that biosafety and biosecurity have to be part of the culture of laboratory research, along with scientific knowledge, experience, and many other factors. Each factor acts as an ingredient in soup, essential to both taste and nutritional value.

One category of ingredients required in the “soup” is infrastructure, which might include a legal framework, animal and human use, marketing, patent law, risk assessment, management, and/or technology. A second category is leadership, which is also absolutely necessary. Leadership might provide strategy, it might encourage collaboration, it might provide a personal, and subsequently a corporate, set of ethics or a sense of corporate responsibility, honesty, vision, and integrity. A third category is culture, which Franz calls a healthy enterprise culture or a healthy laboratory culture. That culture includes outcomes such as innovation, growth, loyalty, quality, values, and so on. The entire system has to work together, including safety and security, to differing degrees in different types of organizations or facilities. In these research endeavors, we are all working toward something of societal value. However, there is no market for safety: Security does not feed hungry children, and fences around labs do not make vaccines available to animals or humans.

As the United States, particularly the government, has been in a hurry to make the world a safe and secure place, American experts have traveled around the world and trained many people. However, a training certificate alone is not enough; biosafety and biosecurity have to be part of the culture of a healthy research enterprise, a healthy laboratory culture.

Franz recognized that there are many different circumstances around the world. When he was in Sierra Leone in May 2012, he talked to a health ministry official and naively asked about their life sciences research. The official replied that research occurs where the basic needs have already been met, but Sierra Leone’s basic needs have not been met, so they essentially do not conduct research. In that situation, for many people the most important enterprise is finding food, or firewood to cook food for the next day, and so on.

In nations with more means, Franz continued, researchers have the luxury of working to develop agriculture, public health, and food. In still others, such as in India and the United States, experts have the greater luxury of working on all of these areas to provide all of these products for the citizens of our countries. In those enterprises, each of us needs safety and security of some kind to differing degrees. However, there are challenges resulting from differing government visions; differences within governments and between governments. For example, right after 9/11 and the anthrax letters, it seemed that all of the emphasis in the United States was on security. Over time, the emphasis has drifted

increasingly toward safety. During the Cold War, U.S. researchers working in biocontainment laboratories focused on threat agents: anthrax, plague, tularemia, and Q fever. Since then we have moved much more toward naturally emerging diseases, which Franz believes is the right approach.

There are also resource imbalances around the world and even within countries. There are always political barriers and there will always be some hurdles to overcome in that regard. However, there are many opportunities as well. There are many common views among individuals, and many similar needs, such as public health, security, and energy. We are fortunate to live with enormous technological capabilities and improvements that have occurred over the past 15 to 25 years. Yet without collaboration those technological tools are not enough to address the needs of our societies. That is why Franz thinks collaboration is so critical, within our organizations, between our organizations, and between our countries.

Returning to the soup, Franz underscored that biosafety and biosecurity act as metaphorical immune-enhancing vegetables, which is important. However, biosafety and biosecurity are necessary but not sufficient. Over the last 10 years, the United States has engaged with scientists around the world to consolidate pathogens into central laboratories. U.S. programs have tried to improve the security of select agents, trained and certified people on biosafety and biosecurity, and helped to start biosafety associations around the world. Yet the long-term positive effect of these efforts, that is their sustainability, is still unknown. If these elements are embedded in a healthy research laboratory culture, they will be sustainable.

Where do we go from here? There are many ongoing global efforts on risk assessment, infectious disease detection and reporting, collaborative life-sciences research, and so on. In recent months, the International Health Regulations, which have existed for many years have received more attention.⁵ These new efforts have been more “bottom up,” arising from interactions among practitioners. The new Global Health Security Initiative is more of a “top down” approach to

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⁵ For more information, see: World Health Organization, International Health Regulations. Available at: http://www.who.int/topics/international_health_regulations/en/; accessed April 10, 2016.

engagement, with the goals and framework provided by governments.⁶ It is important that at the laboratory leadership level or at the ministry level, people are involved in understanding the value of safety and security in our organizations. Leaders who value these programs must support them and ensure that the communities with in these organizations know that this is critically important.

The question is, How can we move beyond the status quo? Franz then shared an example about the large aluminum company Alcoa. When Paul O’Neill became the new chair of this corporation in 1987, he gave a briefing for the shareholders. He started by discussing worker safety. There had been many problems in the company, and many accidents. When O’Neill began speaking about worker safety, some of the shareholders actually ran for the door and called their brokers to sell Alcoa stock, because they thought he was crazy.

He persuaded them to stay by saying that if the company moves forward and becomes more prosperous, it will be because individual workers at this company have agreed to become part of something important; they will have devoted themselves to creating a habit of excellence. Safety became an indicator of progress in changing habits across the entire institution. O’Neill assumed his position in 1987 and retired in 2000. Over that time, the company’s market value increased from $3 billion in 1986 to $27 billion in 2000, while net income increased from $200 million to $1.4 billion. Even though O’Neill is now long retired, safety is still a high priority for the company. He left a legacy that changed the culture of the company. Franz believes it is possible to have this type of impact in laboratories as well.

Franz shared his thoughts about how leaders can influence the culture of a laboratory. If we all lead with science, and emphasize quality, safety, vision, education, responsibility, accountability, honesty, transparency, and ethics, then a culture of trust will result. We could also lead with regulatory oversight and security, guns, gates, guards, background checks, psychological evaluations, lists, and pathogen controls. We experienced this in U.S. laboratories post-9/11 and after the anthrax letters. A culture of trust, Franz believes, is more effective than the alternative.

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⁶ For more information, see: Global Health Security Initiative. Available at: http://www.ghsi.ca/english/index.asp; accessed April 10, 2016.

In his book, The Speed of Trust,⁷ Stephen M.R. Covey describes the characteristics of high-trust and low-trust organizations. Leaders like Alcoa’s Paul O’Neill, and like any of us, can establish high trust organizations with that kind of culture, Franz said. We have the power as leaders to do that if we have the will to do so. In a healthy laboratory culture, safety, security, and also scientific productivity are all present.

Discussion

The discussion following Franz’s presentation focused on ethics; incorporating ethics, biosafety, and biosecurity formally into education and training curricula; the need for guidelines; the roles of practitioners and leaders in improving biosafety and biosecurity; and other topics.

Ethics

A participant asked whether ethics is part of Franz’s conception of essential ingredients in the research endeavor he calls “the soup.” Franz replied affirmatively, saying that scientists should be aware of relevant treaties, norms, and codes. As the discussion continued, ethics, biosafety, and biosecurity were sometimes referred to with blurry definitional boundaries or as a common category.

A participant from the National Institute of Immunology in New Delhi stated that the institute has a robust human ethics committee of seven members: a lawyer, a layperson, two practicing clinicians, two medical researchers, and a basic scientist. Each research project is evaluated on the basis of how human material is going to be used ethically. The institute also has an equally robust system regarding animal biotechnology. This is a slightly tricky and sensitive issue because there is an attempt by the animal biotechnology committee to reduce the number of animals used in research, which creates a problem when trying to obtain statistically significant findings.

Another participant from India refined this point, saying that the ethics being taught in India do not address biosafety as discussed to that point in this workshop. What is taught addresses the procedures used to determine the number of animals needed for an experiment, whether the animals will experience pain, and whether they will be sacrificed during

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⁷ Covey, S.M.R. and Merrill, R.R. The Speed of Trust: The One Thing that Changes Everything. Free Press, New York: 2008.

the experiment. However, laboratory procedures by which workers should be safe and secure is not addressed by the ethics committee.

Franz noted that over the course of his career, similar programs have been developed, such as those required under the Animal Welfare Act.⁸ Scientists may initially ask why they need to reduce the number of mice. It is important to have someone who can articulate this goal and help implement those measures at the scientist level. It is also helpful if the director of the institute emphasizes the need to fulfill the spirit and the letter of the Animal Welfare Act, or the Human Ethics Act.

Another participant said that the All India Institute of Medical Sciences has a biosafety committee, which also looks into the safety of work on recombinant DNA.⁹ It is now mandatory in India that every institution have such a committee to examine biosafety issues as well as the safety of projects involving recombinant DNA. The participant serves as a member of the institute’s ethics committee and has served as a member of the biosafety committee. The biosafety policy states that if a question is referred to the human ethics committee and it has issues related to biosafety, then the matter is referred to the biosafety committee, and the researcher must acquire clearance from both the ethics and biosafety committees before proceeding with the experiment.

Another participant noted that biosafety committees in India address primarily recombinant DNA issues and to a lesser extent chemical hazards. They do not address more difficult issues of biosafety and biocontamination; that is still not mandatory. Another participant noted that there are also separate safety committees for stem cell research. In some cases, researchers follow the guidelines for the biosafety committee, the bioethics committee, and the stem cell committee. Currently, the Department of Biotechnology (DBT) and the Indian Council of Medical Research (ICMR) insist that every project submitted have bioethics clearance or human ethical committee clearance. Biosafety clearance is not required, which according to the participant is why it is not frequently addressed. The regulations exist on paper, but frequently they are not followed; these guidelines are also not very clear.

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⁸ For more information on the Animal Welfare Act, see the U.S. Department of Agriculture at: https://awic.nal.usda.gov/government-and-professionalresources/federal-laws/animal-welfare-act; accessed April 10, 2016.

⁹ For more information on the All India Institute of Medical Sciences, see: http://www.aiims.edu/en.html; accessed April 10, 2016.

B. M. Gandhi noted that ethics is related to the attitude of the scientists. ICMR already has a code of conduct—an ethics code—which clearly spells out how researchers should proceed, which direction should be taken, and so forth. This is the same with the 2000 guidelines, which has a code of ethics for researchers. There is another guideline from DBT from 2002 for preclinical testing.

Gandhi agreed that with regard to biosafety, researchers do not always follow the code of ethics. He added that if they follow this code properly, they automatically address biosafety as well. Nath, however, was not certain about that. Another participant stated that, as of the time of the workshop, there was no guideline written on biosafety, as being discussed in this context. Nath agreed with this impression. Biosafety and biosecurity, she said, are still not sufficiently taken into consideration by India’s leaders.

Indira Nath noted that a bill slated to go before parliament is about ethics (see Chapter 5), and she asked Franz to share his thoughts about the separation of ethics issues from biosafety issues, and about biosafety issues not falling under the ethics committee. Nath expressed concern that if there are too many committees from which an institution and a researcher must obtain research approval, a disincentive for creativity and for conducting scientific work will be created. Should these two elements be combined? Franz replied that his experience is perhaps outdated. He believes in establishing a culture of personal responsibility and corporate responsibility. Then, if these exist, it becomes a matter of just knowing what is right and wrong, and doing what is right. That, however, does not necessarily scale well. Some ethics training includes topics like dual-use research of concern. Traditionally, ethics committees in the United States addressed issues such as plagiarism, and now some of the other issues raised in this discussion have been brought together in certain settings. One committee may not be able to cover it all. The technical needs for the human use committee and the animal use committee are going to be different. Nath noted that ICMR and DBT jointly released a code of conduct especially for dual-use researchers. For the past 2 years, however, it has not functioned.

Nath also noted that still other issues fall under the Environmental Protection Act such as guidelines addressing risk management, detection, and other topics. These issues are not part of the training, so there is a disconnect. This new code of conduct, which is on the ICMR website, addresses dual-use research, researchers’ responsibilities, institutions’ responsibilities, and issues of compliance. There is a need to discuss

biosafety and biosecurity further, because there are people who do not understand these issues, she said.

A U.S. participant, who serves on a committee on genetic manipulation, noted that most organizations have three separate committees: One for animal ethics (the Institutional Animal Care and Use Committee or IACUC),¹⁰ one for human ethics, and one for institutional biosafety. If a researcher is conducting research on recombinant DNA and a high-risk pathogen, approval is also required from the institutional biosafety committee (IBC). If an animal experiment is involved, the researcher has to gain approval from the IACUC, and if samples are being taken from humans or if experiments are being conducted on humans, then the human ethics committee approval is required. In the IACUC, the animal ethics approval form has a question at the end of a column which asks the researcher about the use of a recombinant organism or a high-risk category organism. If the answer is yes, then the IBC must also grant approval.

Incorporating Ethics, Biosafety, and Biosecurity Formally into Education and Training Curricula

Gopal Pande noted that a workshop on biosafety and biosecurity was held at Punjab University, and he found the overall response from students to be striking: The student community really sought greater understanding about general research methods regarding safety and security pertaining to microbiology and wanted it incorporated into the curriculum. He asked how much biosecurity and biosafety are part of the curriculum in the United States and whether they could be discussed in a joint meeting. Another participant from India stated that biosafety and biosecurity should be incorporated into the curriculum of all the sciences that deal with organisms from the fields of human health, veterinary health, and homeopathy.

Franz replied that there are some centers in the United States that teach ethics, safety, and security (see Chapter 6). Joseph Kanabrocki stated that the University of Chicago has developed methods to try to impress upon faculty, staff, and students at all levels the importance of improving the culture of safety and security. There are lessons learned through experience, but he agreed that education has to begin early in a

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¹⁰ The IACUC addresses ethics issues as well as the daily care of animal, training, compliance, etc.

person’s career. At the University of Chicago, the concepts have been incorporated into basic microbiology courses. He has been asked to lecture in medical microbiology programs, in undergraduate microbiology courses, and in ethics training courses at the university.

A participant stated that India has training programs on biosafety and biosecurity for those working in biocontainment facilities. Similarly, they have been conducting training programs on the code of ethics for human and animal use and safety. There are very few training programs integrating these two components—codes of ethics and security issues—together because often researchers do not understand the need for one or the other component. The participant said that there ought to be training programs combining these two so that there is a total awareness of the entire set of issues. Problems arise because people are not clear about how the issues are related.

A participant stated that scientists need to understand that biosafety and biosecurity can be beneficial for them. The amount of training required on these issues is astounding. However, many scientists think that most of the training is for liability purposes, for the institution, and not at all for them. It is becoming very cumbersome for a scientist to be required to take even more training such as human trafficking training, for example, because it has nothing to do with scientific work in any way. He said that the most challenging question is how to consolidate these issues for the benefit of both the institution and the individual.

The time has come, agreed another participant, to combine education about laboratory procedures with biosafety and biosecurity training so that people are aware of these issues in totality, especially at the university level. However, it is currently not possible to introduce core ethics training into the curriculum at universities or in medical schools, the participant said. Biosafety is even further away.

Another participant added that laboratories should also be concerned about dual-use research. This may be discussed at some labs where basic research is conducted, but comprehensive information is lacking and more training needs to be developed. These kinds of courses already exist in many U.S. universities, and the participant suggested that these courses should be examined and such a program should be developed in India, especially at the undergraduate and graduate levels. Other participants also stated that such courses are currently nonexistent in India and are urgently needed.

A participant from India asked other participants from India who have more experience with regulations and guidelines about whether

such an integrated curriculum would be advisable. There may already be too much information being added to the curriculum to be effective, since undergraduates are also trying to learn the science itself. One participant replied that this integrated approach will become part of the system as they learn the content matter; they ought to learn the safety issues simultaneously because it cannot be disaggregated, and it is more difficult to add this information after the fact. If this material is incorporated from the beginning, it is not an additional burden and students learn from the beginning that this is necessary.

The Need for Guidelines

Another participant sought clarification regarding whether national guidelines for biosafety exist in India. A participant replied that they do not and added that such guidelines must be developed within a framework that follows from national policy.

A participant noted that regardless of national-level initiatives, individual institutions and individual scientists are the ones closest to the research. The institution has ultimate responsibility, but the researcher assumes the obligation to conduct research appropriately, according to the framework of the guidelines that have been provided by the national authority and by the institution. To leave these issues to a committee that has no national guidelines, for instance, is not something that would work well.

Umesh Datta Gupta added that there are biosafety guidelines for institutions in India. However, there is a great deal of emphasis on genetically modified organisms, and there is a great deal of plant research involved. In a way, the guidelines are there, but they are also not there because they do not cover the topics that were being discussed at this workshop. As a member of the Institutional Biological Safety Committee, and as a DBT representative, Gupta said that the full extent of the questions currently asked is the following: Will you use a vector? If so, will it be a bacterial vector or a viral vector? If a researcher uses a viral X-vector for a protein expression, the researcher is to follow biosafety measures. But if the researcher uses plasmids, there are no questions. These types of inconsistencies exist in the current guidelines, and they need to be addressed.

A participant noted that there is a need for guidelines to be published in advance because when each new epidemic emerged, like HIV, there was such initial fear that few doctors were willing to treat patients. HIV patients were admitted to hospitals only after procedures clearly stated

how to control the spread of the virus. The same thing happened with Ebola as with any new infection. Similarly, there was a time when almost no one was willing to go to a tuberculosis hospital, although the statistics indicated that the incidence of tuberculosis among hospital workers with close contact with the patients was far lower than that in the general population. Yet until these statistics were released, it was difficult to find medical people who were willing to work in such a hospital. This indicates the importance of the type of guidelines being discussed and the need for recommendations to be formulated regarding research and treatment procedures.

The degree to which guidelines about the movement of people from countries experiencing an epidemic to other countries should be implemented was raised by another workshop participant. Under which circumstances should movement be restricted? Are there some guidelines available? If not, should they be prepared? Franz replied that this is exactly what the United States was going through with respect to Ebola at the time of the workshop. Different countries and regions of the world set different standards for acceptance of travelers into and out of their countries. The World Health Organization provides guidelines, which are sometimes followed.

Nath added that the problem really emerges at the nascent stage of an epidemic, when knowledge is still not sufficiently developed. Guidelines can be developed after an epidemic has occurred, such as with Ebola. Likewise, the early stage of research is still very vulnerable because it is a very creative stage. Franz agreed that the most valuable resource we have at that stage is smart subject-matter experts around the world who have worked on a variety of outbreaks in many geographic areas, who know each other, and who know whom to call. It is more important than having a drug or vaccine because we are always dealing with the unknown, and we cannot predict outbreaks very effectively.

Leadership

Franz added that workshop participants, as leaders, have to live the values of ethical, safe, and secure research so that the people working for them can see that they believe and know the importance of those values. All of these essential components need to be integrated into the culture as a whole package.

Another participant added that biosafety classes are an excellent way, especially for the bench scientist, the microbiologist, and the student, to begin to strengthen the culture of safety and security. There

has been success in twinning or mentoring where people do not just go to classes and lectures to absorb the material. Rather, people who are in leadership positions, usually in biosafety leadership, go to the labs and spend months with the scientists to see how operations are conducted. Part of the success comes from knowing and understanding the intricacy of how all these issues fit together. It is not just the physical building or the safety equipment, but also the people and how they work and operate, their procedures and policies, that are all critical to establishing and maintaining a biosafety culture.

A participant from the United States who works on HIV relayed that at least once a month a member of a committee visits the lab and ensures that procedures are followed, for example, that items are not put in the corridor and that items are being discarded in a way that does not result in aerosolization. There may be a way for institutional committees in India to similarly visit labs once a month.

Another issue of leadership is linking compliance to funding. A participant noted that this approach gives credibility to the biosafety program; it is an initial foot in the door, so to speak. Following from this, a participant proposed the idea that labs and institutions could be accredited. This would cover all critical aspects of research oversight.

Encouraging the Participation of Scientists

A participant from the United States pointed out that the “soup” is fantastic, but following the metaphor, there needs to be an incentive to eat it. Although it is not a popular thing to say, most people who work in science have certain self-interests, such as seeing their work published, improving their standing in the scientific community, and so on. These interests may take priority over biosafety issues. One of the easiest incentives to encourage researchers to fully embrace biosafety, norms, ethics, biosecurity, and so on, is international collaboration. It is incredibly difficult to collaborate with scientists from other countries and to publish the results if the standards are not the same in the different laboratories. By establishing common guidelines, young scientists could more easily be convinced to absorb these norms as part of the culture if they know that they will be able to publish.

Nath contributed an idea regarding publication. Scientific journals can be very powerful by establishing requirements for publication. For example, ethics really improved after ethical clearance was required by publications. They have a great deal of power, which they are not using to advance these issues. Since they require ethics committee approval,

they could also ask for biosafety committee approval from authors as a prerequisite to publishing.

Further, a participant pointed out that it has been challenging to publish with international collaborators because many of the journals require authors to provide the numbers of the institutional biosafety committees’ (IBC) discussions and the numbers for grants and so on. These numbers do not exist in all countries. Although the laboratory where the experiments are being conducted adheres to U.S. specifications and committees evaluate their work, official evidence of this is difficult to acquire in many countries, so they cannot send their results to any journals. This is a double-edged sword: On the one hand, people want these institutions to be established, which is very good. At the same time, many people cannot become visible as researchers because journals are asking for several requirements that are difficult for individual scientists to obtain.

Balanced Regulations

A workshop participant discussed the need for balance between creativity and regulation. The consequences of an imbalance are faced at the laboratory level when a regulation becomes too strict and constrains scientific creativity. Franz agreed that this balance needs to be addressed, and he provided an example from his own experience. At one very good laboratory, he met with eight principle investigators. Three or four of them said that if they had to do it again, they were not sure that they would become infectious disease researchers because it was becoming so difficult to conduct research, and there is little research funding available. Franz said that if we do not make conditions better for scientists, they will go into different fields.

Infectious Diseases Kill

Another participant and Franz noted that while there is some awareness in the general population that weapons used in war can kill many people, very few people realize that pathogens, what the participant called “agents of mass destruction,” kill many more people than any weapon of mass destruction. What mostly kills people is not weapons, it is drug resistant tuberculosis, HIV, hepatitis, soil parasites, and so forth. They kill approximately 15 million people a year globally.