DEVELOPING NORMS FOR
THE PROVISION OF BIOLOGICAL LABORATORIES
IN LOW-RESOURCE CONTEXTS

PROCEEDINGS OF A WORKSHOP

Frances E. Sharples and Micah D. Lowenthal, Rapporteurs

Policy and Global Affairs

Board on Life Sciences
Division on Earth and Life Studies

THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001

This activity was supported by contract/grant S-ISNCT-16-CA-1035 between the National Academy of Sciences and the U.S. Department of State. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

International Standard Book Number-13: 978-0-309-48653-8
International Standard Book Number-10: 0-309-48653-X
Digital Object Identifier: https://doi.org/10.17226/25311

Additional copies of this publication are available for sale from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu.

Copyright 2019 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2019. Developing Norms for the Provision of Laboratories in Low-Resource Contexts: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/25311.

PLANNING COMMITTEE ON DEVELOPING NORMS FOR THE PROVISION OF LABORATORIES IN LOW-RESOURCE CONTEXTS

Ann M. Arvin (Chair), Vice Provost and Dean of Research, Stanford University

Charles Chiu, Associate Professor, University of California, San Francisco

Nancy D. Connell, Senior Scholar, Johns Hopkins Center for Health Security, Bloomberg School of Public Health

David R. Franz, Independent Consultant

Thomas G. Ksiazek, Professor and Director, High Containment Operations, Departments of Pathology and Microbiology & Immunology, University of Texas Medical Branch, Galveston National Laboratory

Staff

Micah Lowenthal, Policy and Global Affairs

Frances Sharples, Board on Life Sciences

La Tasha Morgan, Policy and Global Affairs (until March 2018)

Aanika Senn, Board on Life Sciences (until July 2018)

Hope Hare, Policy and Global Affairs (from July 2018)

Consultant

Barbara Johnson, Biosafety Biosecurity International

This page intentionally left blank.

ACKNOWLEDGMENT OF REVIEWERS

This Proceedings of a Workshop was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published proceedings as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the charge. The review comments and draft manuscript remain confidential to protect the integrity of the process.

We thank the following individuals for their review of this proceedings: François-Xavier Babin, Mérieux Foundation; Giovanni Cattoli, International Atomic Energy Agency; Mitsuo Isono, Japan International Cooperation Agency; and Ken Ugwu, Public Health Agency, Canada.

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the proceedings nor did they see the final draft before its release. The review of this proceedings was overseen by Jerry Keusch, Boston University. He was responsible for making certain that an independent examination of this proceedings was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies.

This page intentionally left blank.

CONTENTS

ACRONYMS

OVERVIEW

1 INTRODUCTION

Historical Overview

Determining and Adopting Appropriate Safeguards

2 THE NEED FOR CONTAINMENT LABORATORIES

Needs and Purposes for Biological Laboratories in Low-Resource Settings

Revision of the WHO Laboratory Biosafety Manual (LBM)

3 THE DONOR POPULATION AND ITS GOALS IN PROVIDING BIOLOGICAL LABORATORY CAPACITY FOR LOW-RESOURCE SETTINGS

Who Funds Laboratories in Low-Resource Settings?

What Needs Are Funders Trying to Meet?

Where Are the Labs That Have Already Been Donated and Are They Operating as Anticipated?

4 MOLECULAR DIAGNOSTICS: AN ALTERNATIVE TO HIGH CONTAINMENT?

5 KEY FACTORS FOR BUILDING AND SUSTAINABLY OPERATING HIGH-CONTAINMENT LABS IN LOW-RESOURCE CONTEXTS: AN OVERVIEW

Summary of Breakout Sessions

6 POTENTIAL NORMS FOR FUNDERS OF BIOLOGICAL LABORATORIES IN LOW-RESOURCE COUNTRIES

Establishing Needs

Constructing New Labs Versus Repurposing Existing Ones

Laboratory Networks

Risk Assessment

Alternative Technologies

Human Versus Animal Health

Regulatory Framework

Infrastructure

Biosafety and Biosecurity and Nonproliferation

Workforce and Training

REFERENCES

APPENDIXES

A STATEMENT OF TASK

B WORKSHOP AGENDA

C WORKSHOP PARTICIPANTS AND CONTRIBUTORS

D WORLD BANK 2017 LIST OF LOW- AND LOWER-MIDDLE INCOME ECONOMIES

E LIST OF LABS IDENTIFIED IN LOW-RESOURCE COUNTRIES

ACRONYMS

OVERVIEW

On June 27-28, 2018, the U.S. National Academies of Sciences, Engineering, and Medicine (the National Academies) convened an international workshop in Amsterdam, the Netherlands, on developing norms for the provision of laboratories in low-resource contexts. The U.S. Department of State’s Biosecurity Engagement Program requested that the National Academies organize this workshop to engage an international group of organizations that provide funding for construction, upgrades, and maintenance of biological laboratories in countries without the means to build such labs themselves. Twenty-one people from 19 organizations participated. The intent was to advance the conversation about the identification and application of guiding principles and common norms for use by these organizations in their grants, partnerships, and aid.

Several observations made by participants were highlighted at the workshop and are repeated here. Inclusion of an observation does not imply a consensus view of the workshop participants or the planning committee.

1. The community of funders for biological laboratories in partner countries includes development and security agencies of national governments, international organizations, development banks, scientific and clinical health organizations, and foundations. Other stakeholders include the recipient countries, regional health organizations, academic institutions, and private industry, including companies that provide advice, equipment, construction services, and supplies. It is very unusual for representatives of these groups to meet all together.
2. Different funders have different models of assistance and partnership, ranging from limited-duration projects aimed at identifying needs, constructing facilities, and training personnel, to open-ended partnerships with recipients that lead to committed collaborations over decades.

3. According to several participants, there is interest within the funder community to share best practices and information to improve outcomes for all involved. There are other efforts to address difficulties associated with providing biological laboratories in low-resource contexts. For example, the government of Canada is working with the Chatham House, the World Organisation for Animal Health (OIE), and other organizations to develop decision tools and engineering options.
4. There is no comprehensive list of existing laboratory resources in low-resource countries. Indeed, such a list may be both impossible to compile and of limited value because of the differing laboratory purposes and local context (e.g., endemicity of disease). However, the lack of even a partial list of past or ongoing projects impedes the ability of funders to allocate resources without duplications or gaps or to foster the establishment of effective lab networks. (A partial list was developed for this workshop and is presented in Appendix E. Much of the information about laboratories is either unavailable or difficult to source. In addition, some sources of information were probably not found for the compilation of Appendix E.) Some participants indicated that they would benefit from having mechanisms to share plans and coordinate with other funding organizations.
5. Biological containment laboratories pose some safety and security risks. Context matters when assessing risk. Participants suggested several contextual factors: the lab’s purpose (routine clinical diagnostics, disease surveillance, maintenance of reference samples, research, outbreak response); the degree of hazard of the pathogens being handled; whether those pathogens are endemic (containment requirements may differ if the pathogen is already present in the local environment); lab personnel adherence to safety and security protocols; the regularity and effectiveness of inspections; and the adequacy and reliability of funding, electricity, water, waste treatment, transportation, supply chains, and internet and telecommunications. For a partnership to be successful, the stakeholders must work together before the project’s start to align the purpose of the planned laboratory with the needs and capabilities of the host or recipient. This has been a central focus of the Canadian government’s work with Chatham House and OIE.
6. A capable workforce and a strong training program are essential to the proper functioning of a biological laboratory. Many participants

7. suggested that funders should address knowledge gaps in regions with inadequate educational systems and should arrange for provision of training by local sources (preferable, if possible), third parties (professional societies, biosafety organizations, and private companies), or their own personnel (if a technical organization). They also stressed the importance of leadership skills, career planning, and promotion opportunities to retain workers. Funders could also engage with local or foreign universities to provide the appropriate education and training.

8. New molecular techniques that allow for work with inactivated pathogens are already in use for some purposes in low-resource settings. Many of the new diagnostic methods are not, however, mature, standardized, and inexpensive enough to replace work with live pathogens using classical microbiological approaches for most purposes. (See Box 4.1.) Polymerase chain reaction (PCR)–based technology, gene sequencing, and matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometry are considered well established in clinical laboratory medicine and can be cost effective, especially if external funders provide support for the necessary equipment and reagents. However, there have been numerous instances of inter-lab discrepancies in PCR results, indicating that there is performance variation among labs, perhaps due to lack of standardization. Several participants identified molecular diagnostics as increasingly important tools with the potential to increase safety and speed compared to classical techniques, and they encouraged efforts to make them more appropriate for use in low-resource settings.
9. Repurposing or upgrading existing laboratories is sometimes preferable to building new ones, some participants noted. Phased approaches that increase lab capability as well as operating can be appropriate, although it is technically difficult to renovate a lab designed for a lower biosafety level (BSL-1 or BSL-2) into a high-containment (BSL-3) facility.
10. The One Health concept is based on the fact that human and animal health are both important and intertwined. Although the principles behind this concept are sound, several participants noted that developing countries tend to be more interested in public health and that with scarce resources the agricultural sector does not receive nearly the same level of funding and attention.
11. Effective implementation of the International Health Regulations (IHR) requires that all 196 WHO member countries have adequate

11. legal and regulatory frameworks. However, many low-resource countries lack not only such frameworks but also formal requirements for the operation and management of biocontainment labs. Some participants emphasized the need for potential funders to consider the status of a country’s implementation of the IHR in their funding decisions. International organizations could provide guidance to countries that need laboratory support but lack the applicable legal and regulatory frameworks to ensure safe and effective lab operation and maintenance.

12. Biosecurity has not received proper attention in low-resource countries. It is, nevertheless, just as crucial an element in the operation and maintenance of biological labs as is biosafety. Funders should ensure that recipients recognize the importance of biosecurity and biosafety and have plans to adopt and implement all required measures.