Synopsis

The Indo-U.S. Workshop on Challenges of Emerging Infections and Global Health Safety, held November 18-20, 2014 on the campus of the Indian National Science Academy (INSA), encouraged scientists from both countries to examine global issues, to share experience and approaches, and to identify opportunities for cooperation to improve practice and research in these areas. The workshop was convened by INSA and the U.S. National Academy of Sciences (NAS) to enhance partnership among the scientific and technical communities of the two countries on urgent and relevant areas of global health and biological safety. The plan for the workshop is described succinctly in the statement of task in Box S-1.

GOALS AND OBJECTIVES FOR JOINT WORKSHOP

The primary goal of the workshop was for experts from both countries to share challenges and lessons learned regarding biological safety, laboratory management, and the general efficient and sustainable operation of laboratories for public and animal health research, and clinical applications for improving global health safety. A second goal was to encourage collaborative partnerships between Indian and American scientists in areas identified by both groups during the workshop, keeping in mind the existing multilateral agreements between the two countries. The workshop was not intended to provide a particular plan of action or specific concrete next steps for this collaboration. Rather, it was intended to identify a variety of areas in which experts from the two countries can proceed with cooperative efforts pursuing mutual goals and priorities.

Workshop speakers outlined the burden of infectious diseases and the importance of antimicrobial resistance, pathogen identification, infectious disease control (including the global challenges of influenza and Ebola), and provided an overview of laboratory diagnostics for virulent and drug resistant pathogens. Discussion of biotechnology and modern biology, such as synthetic biology, was also raised as absolutely essential to discuss since the rate of scientific advancement is rapid and is only increasing, posing both potential benefits and hazards to global health safety.

BUILDING ON THE SUCCESS OF THE WORKSHOP

Technical experts in a variety of fields associated with global health security provided presentations and engaged in frank discussions. These

experts were chosen by the workshop organizers from among the countries’ leading infectious disease researchers, laboratory managers, biosafety managers of high-containment laboratories from academia and relevant government agencies and organizations. Over the course of the three-day workshop, they provided their perspectives, knowledge, and experience and shared ideas for possible future joint collaborations between India and the United States.

Several speakers from the government of India emphasized the urgent need for advice regarding biosafety guidelines for laboratories, effective training for researchers and clinicians dealing with infectious and zoonotic diseases, and enhanced public engagement and outreach on the importance of safe and secure laboratories.

Beyond India and the United States, multiple speakers and participants discussed the needs of the broader South Asian region for more robust laboratory capacity to address diagnostics, response and research regarding public health challenges. Given India’s existing and planned laboratory capacity, capabilities in global health research, and expanding international partnerships, if high standards of safety and security are maintained, the country is well situated to become a regional and global leader in human and animal health safety research.

KEY ISSUES FROM WORKSHOP

The key issues noted here are some of those raised by individual workshop participants during workshop breakout sessions and do not indicate a consensus of workshop participants overall.

• Strengthening management practices to support biosafety in laboratories
• • Good management is necessary for good decision making prior to establishing biological safety level 3 and 4 (BSL3 and BSL4) laboratories, during laboratory operation, and in sustaining laboratories over the long term.
  • Safety is dependent on responsible leadership. It is critical that laboratory leadership supports biological safety culture. Culture trumps rules because strong culture results in responsible practices. Good biosafety cultures are created by good leadership or destroyed by poor leadership.

• • Regular assessment of good laboratory management practices can identify best practices and provide options for improvement.
  • Good laboratory management assessments could be included as part of the laboratory accreditation process, conducted by an independent third party.
  • Accreditation, repeated on a regular basis, is necessary but not sufficient. Accredited labs can hide poor culture.
  • Biosafety training in undergraduate and post-graduate course curricula could enhance the culture of laboratory safety by introducing these concepts to researchers early-on in their careers.
• Levels of Biocontainment Facilities: Answering research questions at economically viable containment levels or with alternative methods
• • Good quality training and manuals are essential to the safe, effective operation of any laboratory, and video training may be an efficient supplement to other forms of training.
  • Recategorization of biological agents based on the specific research being conducted rather than just on the pathogen itself may allow for more cost-effective and lower-risk research. Submission of protocols to institutional review boards regarding specific research can improve risk assessments and an overall understanding of biosafety needs.
  • Certification, inspection, third-party assessment and reassessment are essential to credible evaluation of laboratory safety.
• Establishing and sustaining low-cost and safe BSL-3 facilities
• • A country could determine the number of biocontainment facilities it will have based on the country’s needs, which may vary with time.
  • Biocontainment labs may be specialized for diagnosis of specific agents and specific diseases of national, regional, or global importance.
  • Appointment of maintenance engineers and technicians to contribute at the beginning of the laboratory construction process itself very frequently improves biosafety at the facility.

• • Continuous monitoring of the construction process by trained engineers helps to ensure that they are familiar with the details of the facility’s infrastructure, and improves their ability to harmonize design and biosafety measures or practices into the building from the outset.
  • Annual certification and validation of the facility by a certified third party should help to ensure the continuity of biosafety and biosecurity.
  • Biocontainment facilities function properly when managed by well-trained and certified scientists and technicians. This is a prerequisite for the effective surveillance and monitoring of public and animal health.
  • Sustaining safe and secure biocontainment facilities can be aided by allocating dedicated funds for such purposes into all grants for research to be conducted at the facility, and by the development of a group of researchers who can use the facility on a cost-sharing basis.
• Research of concern on new pathogens: Regulations and codes of ethics
• • Research on new organisms would benefit from the study of those organisms before they are classified at high levels of biosafety to avoid over-classification.
  • Focusing on naturally-occurring diseases over laboratory-created pathogens may better align research resources with public health needs.
  • All organisms need to be studied, not only a select few; if little or nothing is known about a particular organism, then greater oversight is needed when researching that organism.
  • There is currently no consensus within the global research community on how to address the continuation and/or the publication of research of potential concern.
• Laboratory-Acquired Infections (LAIs)
• • The primary causes of LAIs include:
  • • Cross-contamination
    • Faulty procedures (causing the majority of LAIs) and facilities/equipment (causing the minority of LAIs)
    • Inadequate inactivation procedures, and
    • Underreporting of laboratory incidents that may lead to LAIs.

• • Cultures of trust in which people are made more comfortable with reporting LAIs are more effective than blaming individuals for laboratory accidents.

    Self-reporting policies that do not focus on attribution are effective models for increasing biosafety.

  • Decision-based management is effective, but requires leadership training for managers and other laboratory leaders.
  • Focusing on procedures over policies may substantially reduce the number of LAIs because if the procedures are safer, they can strengthen safety in the lab on a day-to-day basis.
  • Proper inactivation of organisms is critical to reducing LAIs, therefore standard operating procedures, training, knowledge of kill curve, verification, and validation are essential for researchers.
• Diagnostic and field testing
• • Low-cost and indigenous sample containers could improve the safety and security of samples collected in the field and in emergency situations.
  • There is a need for responsible courier companies within countries to transport biological samples to laboratories.
  • Procedures for the collection, storage, and dispatch of particularly infectious diseases can be most beneficial when the procedures are widely known and followed.
  • Training and retraining programs for medical, veterinary, paramedical, and paraveterinary staff ensure that threats to public and animal health are addressed quickly and effectively in all situations.

SELECTED THOUGHTS ON GOALS AND OPPORTUNITIES FOR COOPERATION

Following are some of the questions raised by individual workshop participants during focused breakout groups that might be addressed through collaboration. They do not represent consensus views of workshop participants overall.

• Risk assessment
  • At the country level: What is necessary for effective laboratory risk assessments? What is the need for research on especially dangerous pathogens? How should risk levels be assigned for specific pathogens, particularly endemic infections?
  • At the regional level: How can labs be consolidated for the greatest efficiency, effectiveness, and sustainability of research? How can collaboration be fostered to share best practices and experiences regarding risk assessments related to right-sized research?
  • At the institutional level: How can and should the effectiveness, efficiency, and sustainability of separate labs best be evaluated? How can risk assessments best be incorporated into these evaluations?
  • At the laboratory level: How can risk assessments and risk-management practices be factored into laboratory designs before new labs are built and existing labs are (re)evaluated?
  • At the procedural level: Are procedures that require higher levels of containment really necessary to answer scientific questions? How can these assessments be made based on evidence in the interests of both science and biosafety and biosecurity?
• Establishing and sustaining safe and secure biocontainment facilities
  • How should the needs of a country, a region, and the world be assessed to inform the establishment of high containment labs?
  • Once established, should high containment labs specialize to avoid redundant research?
  • What makes an organization competent and independent to act as third parties to provide certification and validation of facilities to ensure the continuity of biosafety and biosecurity?
  • What are the best practices associated with training and certifying scientists and technicians?
  • How can sufficient and sustained funds be obtained to ensure the safe and secure functioning of biocontainment facilities?

• Research of concern
  • What are the views and concerns of Indian and U.S. scientists regarding research guidelines for working with pathogens of concern?
  • Is there a core set of “Do’s” and “Don’ts” in both India and the United States as a starting point for understanding each other’s guidelines?
  • How should research on new organisms be prioritized and classified to maintain the focus on public and animal health as well as biosafety and biosecurity?
  • What are the best means of oversight for research in new areas or on new pathogens?
  • How should the issues surrounding research and publication on pathogens of concern be addressed to balance the needs for continued scientific research and biosafety and biosecurity?
• Laboratory-acquired infections (LAIs)
  • How can cultures of trust be developed to encourage reporting of LAIs?
  • What are the best practices for leadership training that can improve the culture of laboratories?
  • What are the means by which procedures can be effectively developed, revised, taught, and followed to reduce the number of LAIs?
  • What are specific examples of self-reporting models that have been proven effective in reducing LAIs?
• Diagnostic and field testing
  • How can equipment currently available for diagnostics and field testing be assessed, and how can improvements be introduced in a low-cost manner?
  • How can the transportation of infectious pathogens be expedited safely in public health emergencies? What agreements and procedures need to be in place within countries, regionally, and internationally prior to a public health emergency? How can India and the United States work to develop the infrastructure necessary to cooperate in a public health emergency?

• • What lessons can be gained from experience with recent outbreaks to inform the training of medical, veterinary, paramedical, and paraveterinary staff as well as scientists?
  • What are the needs nationally and internationally for diagnostic testing for pathogens?
• Strengthening management practices to support biosafety in laboratories
  • How can cooperation and coordination between the regulatory authorities of both countries be improved to synchronize biosafety guidance?
  • How can we ensure that leaders and managers have the skills to do their jobs properly to create an organizational environment of safety and security?
  • Given that biological safety training is most effective when tailored to the level of the student, and that training for leaders and managers will most likely be different, are there effective training models to follow? How can they be specified for the needs of a particular manager and/or laboratory?
  • How should management be included prior to establishing laboratories, during laboratory operation, and while sustaining laboratories over the long term? What training and/or input are needed at which stages?
  • How can laboratory managers lead by example to support a biological safety culture among all laboratory staff?
  • How can regular assessment of good laboratory management practices identify best practices and provide options for improvement where relevant? Is mentoring an option? Within a country? Between the United States and India? Informally? Formally?

The workshop concluded with a spirit of optimism and a desire to follow the bilateral effort by drawing in experts from countries in South and Southeast Asia into similar conversations.

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