Policy

Reducing Risk of Biosafety Failures

-a systems approach involving investigators and research staff,
institutional support and leadership, and reviews by funders are
needed for both the initial proposal and for each change in
protocol.
- reviews should include representation from the wider
community of affected parties, e.g. local law enforcement, fire
departments, medical facilities, public health officials etc.
-stakeholders may well need contingency plans in case of a
community outbreak, as well as special procedures for
management of crises

-In light of the resources needed to do the GoF one might argue that the
money would be better spent if re-directed to more conventional endeavors
but this assumes a fixed budget and zero-sum trade-offs among research
investments and public health investments; recent history of appropriations
process does not necessarily bear this out.
- can also be argued that the risks of GoF research are imposed on the general
public whereas its benefits are unevenly distributed, and weighted toward
those who are better off or countries that are more developed, as an
incidental effect of their economic and health care systems.
-The implication is either that GoF work should not be done, or that if it is
done, then the fruits of the research must be made more broadly available
across all peoples.

Question
Is the issue the value of GoF alone or of its
marginal increase in value when combined with
non-GoF work, including surveillance.
In other words, should conversation be about
marginal possible benefits vs marginal increase
in risks?

Range of Options
Policy options being discussed basically are in two
camps: prohibiting (but which?) or regulating (but
how? how tightly or lightly?).

Must keep in mind that much will be determined by

presumptions
Given that many things will inevitably fall in a grey
zone, the default will determine whether they go
forward or remain stopped.

Effect on Pipeline
Given the key role of the grey zone, it is not
surprising there is so much attention being given
to describing what should clearly be allowed.
Concern that uncertainty or restriction will deter
young scientists from entering the field (c.f. hESC
research)

Approaches
One possibility is to create a threshold beyond
which experiments are given special attention.
Another is pure case by case with each factor
reviewed independently and then holistically

Third is risk-based regulation that reflects

experience with substance or setting

Where is the work done?

Many regulatory options reflect a pointsource approach
But if this work decentralizes, non-point
source approaches are needed

Major Challenge Global Nature of Work

National cultures to what extent is there a communal agreement about the

general balance between risk avoidance and innovation/research support?

Governmental powers which powers are traditionally used to regulate or prohibit

research? Is it done by conditions on receipt of funds, direct regulation of
personal activity, licensing of institutions etc. Is it done primarily through rules
with force of law or by advice and voluntary actions?

Relative resources given that protective measures can be resource intensive

(both equipment and personnel), and countries vary in their capacity, how much
should be spent in order to achieve a minimum level of safety? Optimal level of
safety?

Inter-national governance how should regulation or prohibition be managed in

cases of collaborations that cross borders?