Public Deliberation and Gain-of-Function

Research Policy: Putting It into Practice

Monica Schoch-Spana, PhD
Senior Associate

Overview
Outline basic questions about public deliberation
design (ie, public, purpose, problem, process).
Discuss how to operationalize standard elements
of public deliberation (ie, inclusivity, information,
value-based reasoning, common ground outputs).
Make recommendations on how to (continue to)
apply public deliberation within the GOFR context

Public Deliberation Design Questions

Design Issue #1: Which Public(s) to

Involve in Deliberations
What authorities typically have in mind is the disinterested,
representative, and publicly spirited ordinary person (Martin
2012); often conflated with idea of non-expert lay public
3 fuzzy, overlapping categories are more useful when thinking
about design (Degeling et al 2015):
- Pure Public: nave citizens
- Affected Public: persons/groups whose lives are altered or
influenced by a policy decision
- Partisan Public: representatives of groups with vested interest or
expertise in the policy matter

Each type of public has surfaced in GOF reports, discussion,

and commentary
4

Affected Publics Implied in the

Risk-Benefit Analysis (RBA)
determine if GoF experiments could create pathogens
that are more likely to cause laboratory acquired
infections, to create a local outbreak or to cause a global
outbreak (Biosafety Risk Assessment, RBA, p1).
Affected publics in this scenario include:
- Infected lab workers and their contacts
- Local residents/responders during outbreak
- Global inhabitants/responders during pandemic

Pure Public and Affected Public

Noted in Ethics Analyses
Many of the hard ethical questions raised by GOFR, that
is, should be resolved in a way that reflects the values
and risk-taking strategies etc. of the people.
-- Selgelid 2015, p26
Incorporating principles of human subjects research
ethics that are of particular relevance to GOF/PPP
studies will mean considering the benefits of this
research in the context of its capacity to benefit or harm
humanity.
-- Evans et al 2015, p907
6

Some Partisan Publics Named in

GOFR Publications and Comments
[T]his must be a discussion that moves beyond flu
researchers, some of whom have personal interests at
stake, and beyond microbiologists, to the whole
scientific and medical community and others who
would be directly affected the general public.
-- Lipsitch in Duprex et al 2014, p5
[M]uch of the [GOF public dialogue] has been steered
by members of the microbiology and policy
communities. There remains room for additional input
from clinical and public health practitioners.
-- Kilianski et al 2015, p1
7

Design Issue #2: What Purpose for

the Deliberating Public(s)
A few legitimate, though distinct aims:
Knowledge Exchange: convey information from policy maker to
public; transmit views/opinions/attitudes from public to policymaker
Innovation: elicit rich unpredictable insights that come from crowdsourcing a problem or from experiential, on-the-ground knowledge
Democratic Accountability: ensure broad representation in a
decision about the common good
If the goal of democratic accountability is desired:
Then one is obligated to give people the time, info, space, and
authority they need to perform that role.
Merely bringing ordinary people or a cross-section of society
together to deliberate does not automatically achieve this aim.
Martin 2012, Degeling et al 2015
8

Desires in the GOFR Context: Diversity,

Balance, Civility, Accountability, Consent
If the discussion has been flawed, it is becausethe tone of the
discussion [has been] too personalized and emotional, and the
diversity of participants too narrow. Relman in Duprex et al 2014
A wide net should be cast when meetings and symposia are
arranged by scientific societies and national academies. - Duprex in
Duprex 2014
Public involvement in this deliberative process is key, and the
process is thus designed to be transparent, accessible, and open
to input from all sources. - Statement on Funding Pause, NIH, 2014
If the benefits are considered to exceed the risks, the researchers
should ask the society about their research idea and need to get
peoples consent. - Shinomiya comments to NSABB, Jan, 2016
9

Design Issue #3: Which Process

Enables Public to Fulfill its Purpose
Continuum of Public Participation in Policymaking

Based on Rowe and Frewer 2005

10

Public Participation in GOF

Research Policymaking
Communication Press releases, educational
websites, and summary reports on NAS and
NSABB GOF meetings; RBA on-line
Consultation Public comments on draft
NSABB recommendations to USG on future
funding and oversight policy
Collaboration Deliberative option with broad
public has not yet been explored; life sciences
and other partisan publics have had strong
input
11

Design Issue #4: What Problem

for Public(s) to Deliberate
Conflicting values about the public good
- Tension between 2 equally valued things (security vs privacy)
- Lack of an absolute hierarchy among a group of valued items

Controversial and divisive topics where

- Outcomes are perceived to produce winners and losers
- Goal is to generate a better field of options

Hybrid topics where

- Technical and normative aspects are interwoven or
- Technical and experiential knowledge can be synergistic

Low trust issues in which govt and/or scientific community

can earn, retain, or lose the publics trust
Solomon and Abelson 2012
12

(A Few) GOF Research Funding and

Oversight Questions that Fit this Profile
Despite potential contributions to public health, should studies
that could produce a pathogen of pandemic potential (PPP)
be performed at all? conflicting values
Are finite dollars better spent on PPP creation experiments
(which produce unique knowledge) or on strengthening the
rest of the flu preparedness portfolio? conflicting values;
divisive topic
If any, what added steps should trustee institutions (USG,
research entities) take to strengthen PPP biosafety and
biosecurity protections and public confidence in them?
hybrid topic; low trust issue
13

How to Operationalize Public Deliberation

No Single Methodology for

Public Deliberation
Review of public deliberation in public health and health policy
research (1996-2013) Degeling et al 2015
- 62 events
- 10 distinct methods (eg, citizen juries, deliberative polling)

Review of studies involving citizen juries in health policy

decision making (1995-2010) Street et al 2014
- 66 juries
- 20 different recruitment methods
- From 1-2 day sessions to meeting 11 times over 16 weeks

Why such diversity?

- No settled account of what constitutes PD in theory or practice
- Nuanced issues and idiosyncratic contexts
- Real world limitations: logistics, budgets, politics
15

Minimum Standards for

Public Deliberation
Ensure sufficiently diverse representation to:
- Compensate for disproportionate participation by privileged
classes of people
- Uncover points of view and conflicting interests that might
otherwise be missed

Supply balanced, factual information that strengthens

participants knowledge of the issue
Provide participants the opportunity to:
- Reflect on and discuss freely a wide spectrum of viewpoints
- Test competing moral claims
- Locate common ground (though not always reached or desired)
Blacksher et al 2012; Abelson et al 2013
16

Inclusivity/Diversity
Standard in Action
Deliberation requires small group interaction - not everyone in a
pure/affected/partisan public can participate.
Whose interests are represented in the deliberation? Who gets to
represent those interests? What mixture, if any, of pure/affected/
partisan publics?
How are deliberants selected? Randomly, purposively, open to all?
- Pure public: cross section of public by random sampling frame and
stratification
- Note: Recruitment method does not necessarily assure sufficiently
diverse range of perspectives/positions nor equal participation among
deliberants (eg, facilitation matters).

What concrete evidence can organizers/policymakers show that

deliberation was not captured by special interests?
Blacksher et al 2012, Goold et al 2012, ODoherty 2012,
Abelson et al 2013, Street et al 2014

17

Information Provision
Standard in Action
How will the issue be selected for deliberation and then
framed, and effectively presented: information,
problem(s), arguments, positions?
Will organizers lay out prepared policy options for
deliberants or will deliberants have power to define
options? What expectations do deliberants have about
their role?
How will expert/technical knowledge be incorporated?
Will partisan and pure publics deliberate together or will
experts provide testimony to stand on its own?
Solomon & Abelson 2012, ODoherty 2012,
Abelson et al 2013, Degeling 2015

18

Value-Based Reasoning
Standard in Action
How to assure non-coerced, respectful reflection on preferences,
values, and concepts so as to evoke potential common ground?
- Value of steering committee oversight, explicit ground rules, and
supportive/independent/skilled facilitation

Are resources available to give participants sufficient time and space

to digest information, acclimate to process, and deliberate?
How will deliberant input be elicited, synthesized, and represented
to decision makers? How will it be consumed by policymaker?
- Does process encourage consensus or conflict and difference?
- Who will compile and interpret deliberant input? Participants, facilitator,
or organizers?
- Is desired output a verdict, recommendations, or a set of majority and
minority opinions?
Blacksher et al 2012, Goold et al 2012, ODoherty 2012,
Abelson et al 2013, Street et al 2014

19

Measuring Success
Procedures Quality Information
- Criteria: comprehensive, accessible, and balanced
- Instrument: post-deliberative survey

Procedures Quality Deliberations

- Criteria: transformed opinions, respect/tolerance for other views,
satisfaction with decision, sense of political efficacy, social trust/
connectedness, consistency of responses across subgroups
- Instruments: qualitative analysis of dialogue, post-deliberative survey of
deliberants, measure #/length of comments by deliberants

Outcomes Impact on Policy/Policymaker

- Criteria: tangible influence on decision; enhanced level of policymaker
confidence that s/he has made an informed choice
- Instrument: pre-/post interview with policy maker

Outcomes Impact on Participants

- Criteria: deliberant confidence in legitimacy of policy decision
- Instrument: post deliberative and/or post decision survey
Goold et al 2012, Abelson et al 2013, Street et al 2014

20

Continued Application of Public

Deliberation within the GOFR Context

GOFR Deliberative Process

in US, at Present
National Academies (NAS) and National Science
Advisory Board for Biosecurity (NSABB) are the
priority venues for public input.
Meetings to date have engaged individuals from life
sciences, security, public health, biosafety, risk
analysis, and the drug/vax industry.
Their voices largely absent, the general public is still at
the center of GOF discourse: a desire to protect public
well-being motivates all positions in the GOF debate.
Unresolved issue: Should more sophisticated,
resource-intensive deliberative sessions be held
outside the present circle of vested parties?
22

Partisan Publics
Formally evaluate the present GOFR deliberative
process enabled by NAS/NSABB structures
How would the (primarily) partisan publics rate the
quality of deliberations in terms of inclusivity,
information provision, and value-based reasoning
Benefits of formal evaluation
- Strengthens evidence base with which people can
judge the legitimacy of the GOFR policymaking
process (to date)
- Provides useful data with which to plan any additional
deliberative activity, if any
23

Affected Publics
Hold deliberative exercises in communities now
hosting facilities where GOFR is undertaken
Theoretical risk yet grounded input of potentially
affected publics
- Lab workers/contacts and local residents/responders

Democratic accountability (Dewey sense) and

informed consent (Belmont Report sense)
Could pose the PPP experiments if ever question
or the how to strengthen biosafety and security
systems as well as public confidence
24

Pure/Affected Publics
Engage a cross-section of American public in a
deliberative exercise about specific question(s)
Hybrid of pure and affected publics in Dewey
and Belmont Report sense
Potential questions to pose:
- If ever PPP experiments
- Resource allocation: taxpayer support for PPP
experiments or other flu preparedness efforts

Help model activities for other countries

25

References

Abelson J et al. Public deliberation in health policy and bioethics: Mapping

an emerging, interdisciplinary field. Journal of Public Deliberation 2013;
9(1):Article 5, 1-35.
Blacksher et al. What is public deliberation. Hastings Center Report 2012;
Mar-Apr:14-17.
Degeling C et al. Which public and why deliberate? A scoping review of
public deliberation in public health and health policy research. Social
Science & Medicine 2015; 131:114-121.
Duprex WP et al. Gain-of-function experiments: Time for a real debate.
Nature Reviews Microbiology. Advance online publication Dec 8, 2014.
Evans NG et al. The ethics of biosafety considerations in gain-of-function
research resulting in the creation of potential pandemic pathogens. Journal
of Medical Ethics 2014; 41:901-908.
Goold SD et al. What is good public deliberations? Hastings Center Report
2012; Mar-Apr:24-26.

26

References contd

Kilianski A et al. Gain of function research and the relevance to clinical practice. Journal of
Infectious Diseases. Advance publication October 28, 2015.

Martin GP. Citizens, publics, others and their role in participatory processes: A commentary
on Lehoux, Daudelin and Abelson. Social Science & Medicine 2012; 74:1851-1853.

ODoherty K et al 2012. Implementing a public deliberative forum. Hastings Center Report

2012; Mar-Apr:20-23.

Rowe G, Frewer LJ. A typology of public engagement. Science Technology and Human
Values 2005; 30(2):251-290.

Selgelid MJ. Gain-of-function research: Ethical analysis. White Paper. Dec 2015. http://
osp.od.nih.gov/sites/default/files/Gain-of-Function%20Research%20Ethical%20Analysis
%20White%20Paper%20by%20Michael%20Selgelid_0.pdf

Solomon S, Abelson J. Why and when should we use public deliberation? Hastings Center
Report 2012; Mar-Apr:17-20.

Street J et al. The use of citizens juries in health policy decision-making: A systematic
review. Social Science & Medicine 2014; 109:1-9.

27

Thank you.
mschoch@upmc.edu