Session 9: Rapporteur Summary on Policy Implications

7/26/2019 Session 9: Rapporteur Summary on Policy Implications

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Policy


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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


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-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.


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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?


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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.


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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)


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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


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Where is the work done?

Many regulatory options reflect a point-

source approach

But if this work decentralizes, non-point

source approaches are needed


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Major ChallengeGlobal Nature of Work

National culturesto what extent is there a communal agreement about the

general balance between risk avoidance and innovation/research support?

Governmental powerswhich 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 ruleswith force of law or by advice and voluntary actions?

Relative resourcesgiven 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 governancehow should regulation or prohibition be managed in

cases of collaborations that cross borders?

Session 9: Rapporteur Summary on Policy Implications

Documents

Transcript of Session 9: Rapporteur Summary on Policy Implications