Institutional Biosafety Committees

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INSTITUTIONAL BIOSAFETY COMMITTEES

Institutional Biosafety Committees (IBCs) are review boards appointed by an institution to evaluate and approve potentially biohazardous lines of research. IBCs were established in 1976 by the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules (Guidelines). Their function is to provide local institutional oversight and approval of nearly all forms of NIH-sponsored research utilizing recombinant DNA (rDNA) in order to ensure that such research is in compliance with the Guidelines. IBCs were developed in response to fears about the risks posed by genetic engineering and guided by principles considered at the Asilomar Conference on recombinant DNA molecules.

Although IBCs still serve as the cornerstone for oversight of this research, their role has also been expanded to include review and supervision of a variety of experiments involving biological materials and other potentially hazardous agents. The potential threats posed by "dual use research" has prompted the National Science Advisory Board for Biosecurity (NSABB) to consider further expanding the role of IBCs to monitor research that may have implications for bioterrorism. There are doubts, however, about the ability of some IBCs to perform this expanded function. Furthermore, controversy exists not only about the performance of certain IBCs in their main role of ensuring safety, but also about how transparent their work should be. Judging the validity of these concerns is hampered by a general paucity of evaluations and assessments of individual IBCs and the system as a whole.

Background, Development, and Institutionalization

The risks presented by emerging techniques in rDNA research during the early 1970s led scientists to implement a brief self-imposed moratorium on this work. Research with rDNA eventually continued under the principles and guidelines established at the 1975 Asilomar Conference. A mechanism for institutionalizing review and approval of proposed research was considered but not formally adopted at Asilomar. However, in 1976 such a mechanism was created by the NIH Guidelines in the form of IBCs. The model of local, decentralized review committees created and guided by a mandate at the federal level already existed in the form of Institutional Review Boards (IRBs), formalized by the 1974 National Research Act, to monitor human subjects research. Like IRBs, IBCs serve as a mechanism for delegating oversight and approval responsibilities to the local institutions performing research supported by federal grants.

The 1976 Guidelines created Institutional Biohazards Committees, but in 1978 there was a formal shift in focus from "biohazards" to "biosafety." The same year also brought other changes, including more emphasis on ensuring appropriate review, the appointment of a Biological Safety Officer (BSO) at each institution, and improved training protocols and implementation procedures. In 1984 IBCs became responsible for oversight and approval of human gene transfer research. Two years later, the IBC system formally incorporated the "points to consider" developed by the Recombinant DNA Advisory Committee (RAC) Working Group on Human Gene Therapy, and in 1990 the emphasis was shifted to gene transfer rather than gene therapy. The NIH Guidelines were further expanded with additional appendices during the 1980s and 1990s as emerging techniques presented novel regulatory requirements. In 2000 the gene transfer protocols were amended to require RAC review prior to IBC approval (Grilley and Gee 2003).

Although the core responsibilities (review and oversight of rDNA research) of IBCs have remained stable throughout these changes, they have also been expanded to include oversight of other potentially hazardous research, including work on such materials as infectious agents and carcinogens. In March 2004, the U.S. government announced plans to create a National Science Advisory Board for Biosecurity (NSABB), which would identify possible "dual use research" (legitimate scientific work that could be misused to threaten public health or national security) and develop guidelines and recommendations for oversight. The task of implementing the board's recommendations will fall mostly on the roughly 400 IBCs (Couzin 2004).

Each IBC must be composed of no fewer than five members, and at least two members must be unaffiliated with the institution and represent the environmental and public health interests of the surrounding community. Members must be selected in a manner that ensures adequate expertise in rDNA technology and competence in assessing potential risks of proposed research. The functions and responsibilities of IBCs include: assessing containment levels required by the Guidelines for the proposed research; implementing contingency plans; maintaining proper facilities; ensuring adequate training of personnel; ensuring compliance with all surveillance, data reporting, and adverse event reporting; and additional responsibilities for human gene transfer experiments in accordance with Appendix M of the Guidelines. The NIH Office of Biotechnology Activities (OBA) manages and evaluates the conduct of the IBCs as part of its broader mandate to implement oversight mechanisms and information resources to promote the science, safety, and ethics of rDNA research (Shipp and Patterson 2003).

Criticisms and Assessments

Transparency, or openness to public review, is the most contentious issue surrounding both the conduct of individual IBCs and the system as a whole. Proprietary rights and privacy issues often conflict with demands for information about research that could threaten public health. IBCs have been targeted by several watchdog organizations, including the Sunshine Project, which investigates activities that could undermine the 1972 Biological and Toxin Weapons Convention and the 1993 Chemical Weapons Convention. The question of transparency is especially contentious when it involves biodefense research. Such activities require secrecy, yet in the absence of public oversight they could cross over into offensive research or generate new risks (Enserink 2004). The increasing awareness that terrorists could misuse some of the research regulated by IBCs only intensifies the conflict as some call for tighter controls on information and others demand increased public involvement.

There are additional concerns that several IBCs are not only reluctant to publicize information but may be lax in their oversight responsibilities. The Sunshine Project (Enserink 2004) and Diana Dutton and John Hochheimer (1982) accused some IBCs of meeting too infrequently or informally to adequately fulfill their duties. This raises further doubts about the ability of certain IBCs to take on the additional responsibilities of monitoring dual use research. The charge could also be made that a more neutral body should be responsible for oversight and evaluation of IBCs, because the OBA is housed within the NIH, which may raise conflict-of-interest issues.

Dutton and Hochheimer (1982) and Philip Bereano (1984) carried out detailed evaluations of IBCs. Both sets of researchers agreed that IBCs represent novel and promising experiments in the joint regulation of technology by lay and technical communities. However, both also argued that several shortcomings in the IBC system have severely limited its potential to forge consensual judgments about the acceptable risks of scientific research. Bereano argued that the Guidelines were developed primarily by the group being regulated, which narrowed their scope and unduly constrained the purpose of the IBC system. In a related critique, he claimed that IBCs are often dominated by rDNA scientists, which leads to a narrow perception of risk and a general hostility toward regulation. Dutton and Hochheimer argued that IBCs rarely realize their potential for genuine public participation, both for the reasons Bereano outlined and because IBCs often lack adequate resources.

Follow-up on these evaluations has been relatively sparse, which may reflect the difficulty in assessing a decentralized system designed to tailor oversight responsibilities to specific project proposals. The paucity of neutral, comprehensive evaluations, however, also means that many criticisms of IBCs are difficult to substantiate and operationalize into reforms that could improve the regulatory system.

ADAM BRIGGLE

BIBLIOGRAPHY

Bereano, Philip. (1984). "Institutional Biosafety Committees and the Inadequacy of Risk Regulation." Science, Technology, and Human Values 9(4): 16–34. Provides a thorough critique of IBCs and argues that they are still primarily a self-serving mechanism for science rather than a genuine opportunity to involve the public in the process of broadly judging the risks of science from political, social, and environmental angles.

Couzin, Jennifer. (2004). "U.S. Agencies Unveil Plan for Biosecurity Peer Review." Science 303(5664): 1595. Discusses the formation of the NSABB as a mechanism for regulating dual use research and the impacts it may have on IBCs.

Dutton, Diana, and John Hochheimer. (1982). "Institutional Biosafety Committees and Public Participation: Assessing an Experiment." Nature 297: 11–15. Study of twenty IBCs in California as experiments in local participation in the regulation of science. Revealed great diversity in performance, but concluded that IBCs do little to support public participation.

Enserink, Martin. (2004). "Activist Throws a Bright Light on Institutes' Biosafety Panels." Science 305(5685): 768–769. Examines the efforts of Edward Hammond and the Sunshine Project to ensure that IBCs are transparent.

Grilley, B.J., and A.P. Gee. (2003). "Gene Transfer: Regulatory Issues and their Impact on the Clinical Investigator and the Good Manufacturing Production Facility." Cytotherapy 5(3): 197–207. Discusses regulatory oversight of human gene-transfer studies and comments on good manufacturing practice issues.

Shipp, Allan, and Amy Patterson. (2003). "The National Institutes of Health System for Enhancing the Science, Safety, and Ethics of Recombinant DNA Research." Comparative Medicine 53(2): 159–164. An overview of the NIH Guidelines, IBCs, and RACs, with a commentary on their relationship to animal research.