**Attachment C**

\--Draft\--\
Operational Protocols\
Public Engagement Pilot Project on Pandemic Influenza\
*(as of July 8, 2005)*

## [I. Purpose/Outcomes]{.underline}

This project has a dual purpose to evaluate a new mechanism for engaging
the public on vaccine policy decisions and to better inform a pending
government decision on priorities for the use of limited supplies of the
influenza vaccine during the early days of an anticipated pandemic.

There are many important policy questions related to pandemic influenza
planning, however, the focus of this project is on the narrow question
of priorities for the use of influenza vaccine.

#### 

#### Outcome 1: 

a.  Develop a ranked list of immunization goals to guide prioritization
    of vaccine use during a pandemic event.

b.  Conduct and document a rich discussion of stakeholders' and the
    public's underlying values/principles and interests related to the
    ranked goals; and

c.  To the extent possible--reference the work of other groups'
    recommendations regarding sub-populations designated under specific
    goals, determine the degree to which the recommendations resonate
    with the values and interests expressed by participants in this
    effort, and, if necessary, make alternative recommendations
    regarding sub-populations for specific goals.

#### Outcome 2: 

Pilot test several approaches to engage the public to determine their
efficacy and usefulness in informing wise decision-making in the vaccine
policy arena.

## [II. Overall Project Design]{.underline}

The project is designed to engage stakeholder representatives from a
spectrum of organized and pertinent interest groups (**The National
Stakeholders Group**), as well as the general public (**Local Citizen
Dialogue and Feedback Sessions**), comprised of individual citizens at
large not representing any organization or interest group. Both types of
participation are important to include because each has a different set
of experiences and perspectives to contribute, each may differently
value the tradeoffs in proposed solutions to problems, and both must
support any decisions made if policy implementation is to succeed.

#### 

#### 

#### National Stakeholder Meetings: 

Below is a summary of interest categories included in the National
Stakeholders Group and general logistical information:

-   Non-governmental organizations which represent the range of
    interests related to pandemic flu events and vaccine priorities;

-   Government agencies and their advisory committees involved with
    vaccines;

-   Health care workers and provider organizations;

-   Vaccine industry representatives;

-   State and local government agencies;

-   Minority group organizations;

-   Emergency preparedness and bioterrorism professionals; and

-   Private health insurers.

###### Meeting I -- Institute of Medicine, Washington D.C.

> July 13, 2005 \| 8:00 AM -- 5:00 PM
>
> July 14, 2005 \| 8:00 AM -- 3:00 PM

###### Meeting II -- Institute of Medicine, Washington D.C*.*

> September 7, 2005 \| 8:00 AM -- 5:00 PM
>
> September 8, 2005 \| 8:00 AM -- 3:00 PM

#### Local Citizens Dialogue and Feedback Sessions

Participants from the general public will be chosen from the four
principal areas of the United States−the North, South, Mid-west, and
Western regions−and will plan to include at least 100 citizens from each
region. The first general public event, the Local Citizens Dialogue
Session, will be conducted in-between the two National Stakeholders
meetings and will be designed to allow for large group dialogue and
deliberation. The three final Local Feedback Sessions will be conducted
after the National Stakeholder Sessions (as brief evening sessions) to
vet and solicit input regarding the proposals from the National
Stakeholder Group and the Local Citizens Dialogue Session. Below is
general logistical information regarding these sessions.

###### Local Citizens Dialogue Session -- Atlanta, Georgia

Saturday \| August 27, 2005

###### Feedback Sessions

A Saturday session in September/October in:

-   Massachusetts

-   Nebraska

-   Oregon

**[III. Roles]{.underline}**

#### Stakeholder Participants

Stakeholders committing to participate in the National Stakeholder
Meetings will be expected to:

-   Attend both two-day sessions in July and September;

-   Adhere to the protocols adopted by the group;

-   Engage in collaborative problem solving to address the range of
    interests brought to the table; and

-   Work with their group/organization/constituency to understand their
    interests, to secure their on-going input, and to build support for
    final proposals.

#### Co-Chairs

The National Stakeholder Sessions will be chaired by Ed Marcuse M.D.,
Associate Medical Director, Seattle Children's Hospital, and Roger
Bernier, PhD, MPH, Senior Advisor for Scientific Strategy and
Innovation, National Immunization Program, CDC.

#### 

**[Meeting Host]{.smallcaps}**\
The Institute of Medicine (IOM) will host the National Stakeholder
Sessions. In this role, the IOM--in consultation with the
stakeholders−will coordinate the technical consultants and other
presenters to the Stakeholder Group.

#### 

#### Expert Consultants

Expert consultants asked to present and provide resource assistance to
the Stakeholder Group will sit at the table with the stakeholder
representatives and participate fully in plenary discussions*.* During
small group discussions, expert consultants will be welcomed as
observers and may be requested to provide resource advice to the
stakeholders.

#### Observers

Observers may be invited to attend the July and September National
Stakeholders Meetings. Plenary and Small Group sessions will be open to
observers. Observers will have clearly designated times for comments at
the plenary and small group sessions.

#### 

#### Steering Committee

The Steering Committee is comprised of a representative cross-section of
stakeholder interests from the National Stakeholder Group. Their role is
to provide on-going process and substantive guidance to support the
deliberations of the National Stakeholder Group (list is attached).

#### 

#### Facilitation and Process Support

The Keystone Center will provide neutral facilitation and overall
process support to the project. In consultation with stakeholders, The
Keystone Center will assist with the convening, agenda development,
facilitation, logistical support and coordination of and drafting of the
meeting summaries and final report.

**[Working with the Press\
]{.smallcaps}**The press is welcome to attend all plenary sessions of
the National Stakeholder Group. The press will be notified/invited to
the Atlanta Citizens Dialogue and the three Feedback Sessions. The
Stakeholder Group will decide jointly if it desires to release a press
statement about the group, the process, and/or outcomes and will jointly
determine the method(s) and message. Individual stakeholders may talk
with the press regarding their own perspectives/interests related to
pandemic flu but will not characterize other stakeholders' comments or
speak on behalf of the whole group.

**[Financial Sponsors:]{.smallcaps}**

-   Lounsbery Foundation

-   Institute of Medicine

-   The Keystone Center

-   CDC National Immunization Program

-   HHS National Vaccine Program Office

-   Study Circles Resource Center

## [IV. Deliberating Guidelines and Approach to Developing Final Recommendations]{.underline}

#### General Approach

The National Stakeholder Group will approach their deliberations as
collaborative problem-solvers seeking to produce proposals which satisfy
all interests to the highest degree possible. The group will first work
to jointly educate and build understanding regarding the participants'
values and interests related to the issue while also developing a
baseline understanding of essential scientific and technical
information. Collaborative problem-solving is successful when parties
agree that their major interests have been heard, taken into
consideration, and respected, the other participants have made every
effort to address their interests in the final proposals, and the final
proposals accurately characterize any outstanding differences.

#### Specific Deliberating Guidelines

#### 

a.  It is presumed that comments made during the meetings are not for
    attribution and should not be assumed to be an official
    organizational position unless otherwise indicated.

b.  Participants will listen respectfully to and honor the dignity of
    all the members of the group.

c.  Participants agree to focus on the articulated purpose of the
    deliberations and respect the issues that are designated as "off the
    table."

d.  Participants will not make use of the content from the deliberations
    in other areas unless authorized by the group.

e.  The group will strive for agreement among all members. The group
    will work to build proposals by identifying and exploring all
    parties' interests and attempting to satisfy these interests to the
    greatest extent possible. When agreement is not possible, the group
    will work to accurately and respectfully understand and document the
    different perspectives on an issue.

f.  Effective deliberations hinge on the attendance and participation of
    the named representatives.

#### Meeting Summaries

The Keystone Center will prepare draft summaries of the meetings.
Summaries will capture key issues, conclusions, and agreed-upon next
steps. Summaries will not attribute statements to individuals, except
where specific commitments are made by individuals on behalf of his/her
constituency. Participants will have the opportunity to correct the
draft meeting summary prior to finalization.

#### Final Report

The Keystone Center will work with participants to draft proposals and
the final group report. All documents will be subject to group review
and support prior to finalization. The final report will be forwarded to
the Department of Health and Human Services, their appropriate advisory
committees \[National Vaccine Advisory Committee (NVAC), Advisory
Committee on Immunization Practices (ACIP)\], and the National Vaccine
Program Office.\
\
[Input from the Atlanta Citizens Dialogue Sessions:]{.underline} A
summary of the input from the Atlanta Citizens Dialogue Session will be
presented to the September session of the National Stakeholder Group for
their consideration and will also be attached as an independent section
of the final report.

[Input from the Three Feedback Sessions:]{.underline} The input from the
three Feedback Sessions will be summarized and forwarded to the members
of the National Stakeholder Group for their consideration prior to
finalizing their report (and will also be attached to final report as
independent sections). The Keystone Center will coordinate−via emails
and conference calls−with the National Stakeholder Group so that they
may incorporate in the input from the Feedback Sessions into their final
report.

![](media/image1.jpeg){width="0.5597222222222222in"
height="0.4666666666666667in"}**\
Public Engagement Pilot Project on Pandemic Influenza**\
**Steering Committee *(revised April 22, 2005)***

Roger H. Bernier, Co-Chair

Senior Advisor for Scientific Strategy and Innovation National
Immunization Program, MS E-05\
Centers for Disease Control and Prevention\
Atlanta, GA 30333

Phone: 404-639-8875

Fax: 404-639-8626

Cell: 678-361-5170

<rbernier@cdc.gov>

Louis Z. Cooper

Professor Emeritus of Pediatrics\
Columbia University

Past President, American Academy of Pediatrics\
80 Central Park West\
New York, NY 10023

Phone: 212-580-3721\
Fax: 212-712-0189

<lcooper@aap.org>

Jennifer A. Logan Coyle

Catalyst Consulting

P.O. Box 66253

Auburndale, MA 02466

Phone: 617-620-9615

Fax: 617-964-7626

<jencoyle@catalyst-consulting.net>

[[www.catalyst-consulting.net]{.underline}](../www.catalyst-consulting.net)

Geoffrey Evans

Acting Director

National Vaccine Injury Compensation Program

Healthcare Systems Bureau

Health Resources and Services Administration (HRSA)

5600 Fishers Lane

Room 11C-26 [\
]{.underline}Rockville, MD 20857

Phone: 301-443-6593 (front office)

301-443-4198 (direct line)

Fax: 301-443-8196

e-mail: <gevans@hrsa.gov>

Mark Feinberg

Vice President

Policy, Public Health and Medical Affairs

Merck Vaccine Division

Merck & Co., Inc.

WP97-A337

770 Sumneytown Pike, PO Box 4

West Point, PA 19486-0004

Phone: 215-652-8664

Fax: 215-652-8918

<mark_feinberg@merck.com>

Assistant: Arlene Brown

<arlene_brown@merck.com>

Amy Fine

Private Consultant

372 Styvesant Place

Washington, D.C. 20015

Phone: 202-966-6361

Fax: 202-966-8439

<afinehome@aol.com>

Barabra Loe Fisher

Co-Founder/President

National Vaccine Information Center

421-E Church Street

Vienna, VA 22180

Phone: 703-938-0342

Fax: 703-612-3376

<BarbLoe@aol.com>

Alan R. Hinman, MD, MPH

Senior Public Health Scientist

Public Health Informatics Institute

Task Force for Child Survival and Development

750 Commerce Drive, Suite 400

Decatur, GA 30030

Phone: 404-687-5636

Fax: 800-765-7520

<ahinman@taskforce.org>

Sarah Landry

Associate Director for Communications and Legislation

National Vaccine Program Office

Department of Health and Human Services

200 Independence Ave, SW Room 433H

Washington D.C., 20201

Phone: 202-205-2982

<slandry@osophs.dhhs.gov>

Donna Lazorik

Adult Immunization Coordinator

Massachusetts Department of Public Health

Phone: 617-983-6821

<donna.lazorik@state.ma.us>

Jeffery Levi

Associate Professor\
Department of Health Policy\
School of Public Health and Health Services\
The George Washington University Medical Center\
2021 K Street NW, Suite 800\
Washington, D.C. 20006\
Phone: 202-530-2363

Fax: 202-296-0025

<jlevi@gwu.edu>

Paul Lewis, MD

Public Health Physician

Oregon Health Services

800 NE Oregon, Suite 772

Portland, OR 97232

Phone: 503 731 4978 office

Fax: 503 731 4798 fax

<Paul.F.Lewis@state.or.us>

Edgar Marcuse, Co-Chair

Associate Medical Director

Childrens Hospital, Seattle

Box 5371 - CH03

Seattle, WA 98105

Phone: 206-987-2026 (front office)

> 206-987-2027 (direct line)

Fax: 206-987-5105

<ed.marcuse@seattlechildrens.org>

Assistant: Janet Umbers

Phone: 206-987-2026

<janet.umbers@seattlechildrens.org>

Debbie McCune Davis

Program Director

The Arizona Partnership for Immunization

320 East McDowell Road

Suite 225

Phoenix, AZ 85004

Phone: 602-253-0090, ext. 234

Fax: 602-262-2654

<tapi@aachc.org>

Joann Schaefer

Deputy Chief Medical Officer

Nebraska Health and Human Services System

301 Centennial Mall South

P.O. Box 95007

Lincoln, NE 68509-5007

Phone: 402-471-8566

Fax: 402-471-9449

<joann.schaefer@hhss.ne.gov>

[www.hhss.ne.gov](http://www.hhss.ne.gov/)

Mona Steele

President

Wisconsin Womens Network

306 Yosemite Trail

Madison, WI 53705-2438

Phone: 608-833-1778

Fax: 608-827-8786

<rjsteele@tds.net>

**[Project Staff]{.underline}**

Jon Abercrombie

Study Circles Resource Center

214 Wilton Drive

Decatur, GA 30030

Phone: 404-226-5032

Fax: 404-377-8446

<abie@commonfocus.org>

[http://www.commonfocus.org](http://www.commonfocus.org/)

Peter S. Adler

President, The Keystone Center and\
Director, Center for Science and Public Policy

The Keystone Center

1628 Sts. John Road

Keystone, CO 80435

Phone: 970-513-5841

Fax: 970-262-0152

<padler@keystone.org>

Victoria (Vicki) Evans\
Health Communication Specialist\
1600 Clifton Road MS E52\
Team Leader for Partnerships in the Education, Information and
Partnership Branch

National Immunization Program, Centers for Disease Control and
Prevention

Atlanta, GA 30333\
Phone: 404-639-8637\
Fax: 404-639-8288

<VAE3@CDC.GOV>

Mary Davis Hamlin

Senior Associate

Center for Science and Public Policy

The Keystone Center

1628 Sts. John Road

Keystone, CO 80435

Phone: 970-513-5802

Fax: 970-262-0152

<mhamlin@keystone.org>

Alan Janssen

Heath Communication Specialist

Office of Health Communications

National Immunization Program

Centers for Disease Control and Prevention

1600 Clifton Road, NE MS-E05

Atlanta, GA 30333

Phone: 404-639-8517

Fax: 404-639-8626

[axj3@cdc.gov](mailto:dln7@cdc.gov)

[www.cdc.gov](http://www.cdc.gov/)

Tanya Johnson

Office of Health Communications

National Immunization Program

Centers for Disease Control and Prevention

1600 Clifton Road, NE MS-E05

Atlanta, GA 30333

Phone: 404-639-8581

Fax: 404-639-8905

<dln7@cdc.gov>

[www.cdc.gov](http://www.cdc.gov/)

Matt Leighninger

Democracy Workshop

Senior Associate, Study Circles Resource Center

2 Beulah Avenue

Hamilton, ON L8P 4G9

CANADA

Phone: 905-972-0550

Fax: 905-972-0550 (call first)

<mattl@studycircles.org>

<mattleighninger@earthlink.net>

[www.studycircles.org](http://www.studycircles.org/)

Johanna Raquet

Project Support, Center for Science and Public Policy

The Keystone Center

1628 Sts. John Road

Keystone, CO 80435

Phone: 970-513-5839

Fax: 970-262-0152

<jraquet@keystone.org>

Kathleen Stratton

Senior Program Officer

Institute of Medicine

500 5th Street, NW

Washington, DC 20001

Phone: 202-334-1723

Fax: 202-334-2939

<kstratto@nas.edu>