6

Moving Forward

In concluding remarks, workshop planning committee co-chair David Relman recognized the importance of the workshop as a venue wherein individuals from a broad range of interests and perspectives might ask important questions. He suggested that the participants reflect both upon lessons learned from the H5N1 controversy and on where ongoing discussions should occur and among whom. He stated that ongoing conversations should be open, transparent, and frank and might include questions of:

 

•    How general or specific would a regulatory mechanism need to be? To what degree would it be designed to defer to case-by-case considerations? Conversely, to what degree might it apply to a range of disciplines?

•    Who should be involved in decisions about risk/benefits and determinations regarding regulations?

•    What are possible mechanisms for accomplishing the proper involvement?

•    What is the role of universities as it relates to the need for better education of scientists in research ethics?

REGULATORY PATHS, GRAY ZONES, AND AVOIDING UNDUE BURDENS

Throughout the workshop, the absence of “bright lines” and, conversely, the specter of “gray zones” was a recurring theme. If the scientific and biosecurity communities were to consider creating a new mechanism to



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6 Moving Forward In concluding remarks, workshop planning committee co-chair David Relman recognized the importance of the workshop as a venue wherein individuals from a broad range of interests and perspectives might ask important questions. He suggested that the participants reflect both upon lessons learned from the H5N1 controversy and on where ongoing discus- sions should occur and among whom. He stated that ongoing conversations should be open, transparent, and frank and might include questions of: • How general or specific would a regulatory mechanism need to be? To what degree would it be designed to defer to case-by-case considerations? Conversely, to what degree might it apply to a range of disciplines? • Who should be involved in decisions about risk/benefits and deter- minations regarding regulations? • What are possible mechanisms for accomplishing the proper involvement? • What is the role of universities as it relates to the need for better education of scientists in research ethics? REGULATORY PATHS, GRAY ZONES, AND AVOIDING UNDUE BURDENS Throughout the workshop, the absence of “bright lines” and, con- versely, the specter of “gray zones” was a recurring theme. If the scientific and biosecurity communities were to consider creating a new mechanism to 45

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46 PERSPECTIVES ON RESEARCH WITH H5N1 AVIAN INFLUENZA address research that falls within a gray zone—i.e., research that is neither freely shared nor classified—what are the appropriate considerations? How should research that, at its inception, is not seen as research of concern but that, in the course of its performance, becomes so, be addressed? Of related interest was the question of appropriate document control or information management measures for research of concern whose findings may have already been dispersed. Several participants cautioned against focusing on regulatory frame- works to the point of relegating discussions about ethics to a separate sphere. They expressed concerns that a system consumed with checking boxes on regulatory paperwork might draw attention away from the thoughtful ethi- cal considerations that they felt should accompany life sciences research. A related discussion issue was the importance of informal aspects of scientific culture that can play a role in protecting the public health. DUAL-USE RESEARCH: WHAT’S IN A NAME? Several workshop participants voiced dissatisfaction with the term “dual-use research of concern.” Dr. Franz suggested that using the term “dual-use” orients a conversa- tion in a narrowly regulatory direction. In Franz’s view, this may give rise to a risk that the burden of the regulation outweighs any potential protection. He cautioned that excessive regulation might “hobble the entire enterprise because of the behavior of a few.” Franz favored the terms “responsible life sciences research” and “culture of responsibility,” as they are oriented toward leadership, honesty, healthy scientific culture, and acceptance of responsibility. Franz suggested that current efforts to oversee the funding and publication of life sciences research are, in their current form, suffi- cient. Rather than impose additional layers of regulation, Franz advocated a change in behavior and in the scientific culture. An audience member relayed what she has heard from people in a net- work of high-containment laboratories funded by the National Institute of Allergy and Infectious Diseases. When scientists are asked to state whether a specific research project is or is not “dual-use research of concern,” she remarked, it is difficult for them to provide an answer. However, if the re- search is simply described and a question posed to the researcher about how to manage the research responsibly, then the researcher will deliberate on the question and give serious thought to the management of the research. Dr. Brent raised several points about practicality and ethics in the context of dual-use. He noted that it is not possible to know what the near-term or long-term benefits and potential for misuse are, and he expressed the opinion that scientific (or technological) experts tend to underestimate both benefits and risks. He observed that researchers consider themselves to have positive,

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MOVING FORWARD 47 well-intentioned motives for conducting research and that the person who misapplies the results of the research is always thought to be someone else. Moreover, Brent observed that “use” is not the only consequence of “dual- use research.” He stated that the mere existence of the knowledge about how to create a transmissible, lethal virus may itself constitute harm. RISK Many of the workshop discussions were related to the questions of what constitutes risk, how is risk determined, and by whom? Related to these questions were observations that: • No consensus exists within the scientific community about what constitutes right action. • It is impossible to predict all of the ways in which a particular piece of research could be utilized for harm. • It is impossible to predict the ways in which a particular piece of research could be utilized for harm in the future. • Knowledge cannot be unmade; therefore, the estimation of risk (and acting on that estimation) is critically important. In the specific case of the H5N1 controversy, several questions repeat- edly emerged: • Is “nature” performing these experiments in the wild? If so, does that provide justification for scientists’ to perform them in the laboratory? • Are certain experimental questions particularly high risk? • Are there some areas of research that should not be pursued? BROAD AND INCLUSIVE PARTICIPATION The role of public inclusion in the process of formulating and carrying out an effective mechanism of oversight was a topic of several questions: • Should non-scientist members of the public be included in the devel­ pment of oversight mechanisms, and if so, who, how, and o at what point(s)? • What are the characteristics of effective oversight mechanisms that prompt public confidence? Many participants saw the need for an internationally agreed upon system for the regulation of research of dual-use concern and stated that

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48 PERSPECTIVES ON RESEARCH WITH H5N1 AVIAN INFLUENZA while the process may be led, to some degree, by the United States, it cannot be dominated by the United States. THE NEED TO REVAMP THE EDUCATION OF OUR NEXT GENERATION OF SCIENTISTS Workshop planning committee co-chair David Korn, Consultant in Pathology, Massachusetts General Hospital and Professor of Pathology, Harvard Medical School, concluded the workshop by calling on U.S. uni- versities to be more proactive in educating their students and junior faculty in the ethical conduct of research. Korn placed particular emphasis on the importance of ethics in the sharing of data, disclosures of conflict of interest issues, and the conduct of risk/benefit estimations. In Korn’s view, institu- tional efforts designed to promote the ethical and responsible conduct of research would be much more effective than any oversight that might be imposed from the outside.