# NIH Blue Ribbon Panel for the Risk Assessment of the National Emerging Infectious Disease Laboratory

# at Boston University Medical Center

### Working Group of the Advisory Committee to the Director

## Summary of

## Public Meeting

####### July 16, 2008

The NIH Blue Ribbon Panel for the Risk Assessment of the National
Emerging Infectious Disease Laboratory (NEIDL) at Boston University
Medical Center (BUMC) (Blue Ribbon Panel \[BRP or "the Panel"\]), a
working group of the Advisory Committee to the Director (ACD) of the
National Institutes of Health (NIH), was convened for its fourth meeting
at 8:00 a.m. on July 16, 2008, at the NIH, Building 31-C, Conference
Room 6, Bethesda, Maryland. Dr. Adel Mahmoud (Chair) presided. In
accordance with Public Law 92‑463, the meeting was open to the public
from 8:00 a.m. until 2:00 p.m. on July 16, 2008. Notice of this meeting
was published in the *Federal Register* on July 3, 2008 (73 FR 38235).
The purpose of this meeting was to discuss foundations for community
engagement and partnerships between research institutions and local
communities.

#### Panel Members Present

Donald S. Burke, M.D., University of Pittsburgh

George Friedman-Jiménez, M.D., Bellevue Hospital Center

Margaret A. Hamburg, M.D., Nuclear Threat Initiative

Dennis L. Kasper, M.D., Harvard Medical School/Brigham and Women's
Hospital

Johnnye Lewis, Ph.D., DABT, University of New Mexico

W. Ian Lipkin, M.D., Northeast Biodefense Center/Columbia University

Adel Mahmoud, M.D., Ph.D., Princeton University (Chair)

Thomas H. Murray, Ph.D., The Hastings Center

Mary E. Northridge, Ph.D., M.P.H., Columbia University/*American Journal
of Public Health*

Jean Patterson, Ph.D., Southwest Foundation for Biomedical Research

Mark Gregory Robson, Ph.D., M.P.H., Rutgers, The State University of New
Jersey

Samuel L. Stanley, Jr., M.D., Midwest Regional Center of Excellence for
Biodefense and Emerging Infectious Diseases Research/Washington
University in St. Louis

Wayne Thomann, Dr.P.H., Duke University/Duke University Medical Center

###### *Ex Officio* Member Present

Rima F. Khabbaz, M.D., Centers for Disease Control and Prevention, U.S.
Department of Health and Human Services

#### NIH Staff Members Present

Amy P. Patterson, M.D., Office of the Director, NIH

######### Invited Speakers

Klare Allen, Safety Net and STOP the Bio-Terror Lab Coalition

Ruth Barkley, Cathedral United Tenant Organization

Glen Berkowitz, J.D., M.P.A., Community Liaison Committee, Boston Biolab

Barbara Ferrer, Ph.D., M.P.H., M.Ed., Boston Public Health Commission

Elmer R. Freeman, M.S.W., Center for Community Health Education Research
and Services, Inc.

Michael Kineavy, M.P.A., City of Boston

Thomas J. Moore, M.D., Boston University Medical Center

David Mundel, Ph.D., Consultant

Carmen Nazario-Vega, M.Ed., Tenants in Victory

Peggy M. Shepard, M.P.H., WE ACT for Environmental Justice

Michael A. Trush, Ph.D., Johns Hopkins Bloomberg School of Public Health

**Others**

Approximately 58 people attended this public BRP meeting.

#### I. Welcome and Opening Remarks/Dr. Mahmoud

Dr. Mahmoud, BRP Chair, called the meeting to order at 8:00 a.m. on July
16, 2008. BRP members introduced themselves with name, professional
affiliation, and primary area of professional activity.

Dr. Mahmoud reiterated the BRP's charge. He stated that the goal of the
meeting was to provide information to the BRP on community engagement,
with stakeholders invited to talk about ways and means to have an
effective and sustained dialog between BU and the surrounding community.

#### II. Partnerships Between Research Institutions and the Local Communities: Important Principles, Key Attributes, and Lessons Learned

*Presenter: Elmer R. Freeman, M.S.W., Executive Director, Center for
Community Health Education Research and Services, Inc.*

Mr. Freeman discussed core aspects of building public trust in research.
The Council of Public Representatives (COPR) advises the NIH Director
along with the ACD, which is composed of scientists. He discussed the
history of the COPR, its roles and functions, and the reports it has
generated.

Promising practices of public involvement and community engagement
include using a variety of approaches to obtain as much input as
possible, involving the community/public and governance and policymaking
bodies such as institutional review boards and boards of trustees, and
taking advantage of existing relationships and partnerships.

Lessons learned from strategic partnerships include that the public
maintains a general mistrust of scientists, that science is often
political and driven by self-interest, that public engagement changes
people, and that public involvement in science and biomedical research
is inevitable.

*Presenter: Michael A. Trush, Ph.D., Johns Hopkins Bloomberg School of
Public Health*

Dr. Trush offered a laboratory scientist's perspective on community
relationships and outreach. He noted that building trust and
communication is the most significant issue and is the key ingredient in
building positive community relationships. Dr. Trush illustrated his
points with three examples: Wagner's Point in Baltimore, a bus depot in
a Baltimore neighborhood, and demolition of the East Baltimore Biotech
Park.

To get to know its surrounding community, an institution should conduct
an inventory of the community, looking for assets such as businesses,
churches, and leaders; discern who lives in the community and appreciate
the culture of those residents; identify community leaders; and
recognize and understand the needs of the community. An institution
should include the community in all aspects of a proposed project
(including the initial planning), be prepared to be flexible, be
respectful of the community's culture, and deliver on its promises.
Evaluating progress and processes and returning to the participating
community with interim findings are also important.

*Presenter: Peggy M. Shepard, M.P.H., WE ACT for Environmental Justice*

Ms. Shepard discussed her work in Harlem and north Manhattan communities
for 20 years, in which she helped mobilize communities with regard to
sewage treatment plants and diesel bus bins. Her method is to organize
proactively to create community benefits; Ms. Shepard is currently
negotiating a community development agreement with Columbia University
Health Services.

Community risk perceptions are based on personal risk evaluations, and
communities rarely derive any benefits, such as jobs, from the
construction of biosafety laboratories. When risks and benefits are not
evenly distributed, conflict is inevitable. A growing mistrust of expert
knowledge exists, especially in science. In most instances, the public
is generally left out of policymaking, and progress cannot be made if
residents are not included in reaching solutions.

#### BRP Discussion

BRP members discussed with the presenters whether and how institutional
change can occur, the lack of real benefits but the perception of real
risk when research laboratories are built, tangential benefits to the
community that BU might want to pursue (e.g., parks and schools), and
building trust between BU and the community.

**Final Speaker Comments/Responses**

Mr. Freeman noted that one of BU's challenges is that the building is
already there. Institutional expansion in every major city in the
northeast United States is a problem; as more land is taken off the
property tax rolls, residential tax rates increase and make it more
expensive to live in that city. BU must offer tangential benefits to
residents.

Dr. Trush opined that the NIH has moved away from public health as its
research mission. The community around the NEIDL knows what they would
like to have around them; BU should engage them and listen to them.

Ms. Shepard noted that there is not enough oversight or inspection and
that mayors in many cities are encouraging bioresearch facilities as
economic development. Academic research institutions are expanding, and
as landowners, this expansion creates tension. These institutions can
provide benefits that are created in concert with community residents,
such as social service facilities, dental clinics, and affordable
housing. All communities know what they need and are willing to voice
those needs.

#### III. Foundations for Community Engagement: Trust and Transparency

*Presenter: Barbara Ferrer, Ph.D., M.P.H., M.Ed., Boston Public Health
Commission*

Dr. Ferrer discussed building effective partnerships to promote and
sustain healthy communities. She noted that public health work can be
accomplished effectively only through the use of partnerships;
preventing disease must include partnerships with people who get those
diseases. Without information from the community, serious mistakes are
made in policies and initiatives. Dr. Ferrer focused on two
examples---building Neighborhood Peace Councils (NPCs) and community
involvement in a citywide working group to establish policies regarding
biological research laboratories.

NPCs were targeted to four poor neighborhoods in Boston that had higher
rates of violent crime than other Boston neighborhoods. The purpose of
these NPCs was to provide an opportunity for residents and local
agencies to work together to build a safe and vibrant neighborhood by
ensuring the provision of city services, supporting civic engagement,
and ensuring accountability. Goals included defining a neighborhood
vision, building relationships, constructing solutions, and creating
opportunities for youth involvement. Successes included a reduction of
violent crime in the first 4 months in each NPC neighborhood, visible
improvements in each of the four neighborhoods (street signage,
cleanliness, and lighting), establishment of resident leadership, and
activities sponsored by the NPC.

The major success of the citywide working group was passage and
implementation of biosafety regulations. Boston is the only city in the
Nation that regulates biosafety level (BSL)-3 and BSL-4 laboratories and
bans BSL-4 research with recombinant deoxyribonucleic acid (DNA). In
addition, this group organized a structure for ongoing oversight of
BSL-3 and BSL-4 laboratories.

Dr. Ferrer noted that Boston has a unique opportunity to address issues
related to research with unknown components while paying significant
attention to the safety of workers and residents.

*Presenter: Michael Kineavy, M.P.A., Chief of Policy and Planning, City
of Boston*

Mr. Kineavy discussed the general efforts of the City of Boston to
promote community engagement and noted that Boston Mayor Thomas M.
Menino considers BU to be one of the most responsive institutions in
Boston.

Before city approvals were granted for the NEIDL and after the proposed
project was vetted, the city required satisfactory answers to the
following questions:

-   Was the voiced opposition to the project representative of
    neighborhood opinion?

-   Was there merit to the opposition's issues?

-   Has the opposition been given the opportunity to state its case in
    an open and fair manner?

-   What are the safety considerations with regard to the project?

-   What mitigation measures are needed to ensure that the City of
    Boston and its neighborhoods are compensated adequately for the
    additional burden the project may place on the community?

Mr. Kineavy explained that a credible, scientifically valid risk
analysis is needed to advance the NEIDL project and to assure community
residents that the laboratories within the NEIDL will be safe. Unless
the risk analysis suggests differently, the city's position remains that
the project bears true merit if BU can operate the facility safely.

*Presenter: David Mundel, Ph.D., Consultant*

Dr. Mundel discussed strategies for rebuilding trust and creating
transparency. He noted that research in many domains demonstrates that
trust and open communication are necessary for effective, cooperative
decisionmaking and information sharing.

The history of public debate and deliberations regarding the proposed
NEIDL indicates that trust was, at best, low at the beginning and became
much lower over time. Community concerns were trivialized, questions
from the community remained unanswered, promised information was not
provided, inadequate risk assessments were repeatedly quoted rather than
corrected in subsequent documents, and communication was accomplished
primarily through written reports and oral presentations rather than
through conversations and discussions.

Given this history, Dr. Mundel offered six suggestions for the BRP to
transmit to the NIH Director, in the form of needed actions, analyses,
and processes.

*Presenter: Glen Berkowitz, J.D., M.P.A., Member, Community Liaison
Committee, Boston Biolab*

Mr. Berkowitz noted that his home is about 1,000 feet from the NEIDL
site and that his comments were not officially sanctioned by either the
neighborhood or BU. He was appointed to the Community Liaison Committee
(CLC) in 2006. Between 2004 and 2006, what was planned as a hotel became
the NEIDL, without the public process that has been employed on other
occasions.

BU deserves credit for its appointments to the CLC, including known
opponents. The educational forums planned and offered by the CLC were
not well attended, because most people are resigned that the BSL-4
laboratory will open in the NEIDL. A large number of community members
are neutral about the BSL-4 laboratory, but little knowledge has been
gained while the court cases remain pending.

Mr. Berkowitz suggested that BU open the NEIDL laboratories at the BSL-2
and BSL-3 levels only and then work to build trust with the community,
putting off the opening of the BSL-4 laboratory. He then offered the
story of "Cinda and Helaine," two activists who were so put off by being
disenfranchised by BU that they no longer participate in the community
involvement process. Nonetheless, a large group of community members
look forward to hearing the new risk assessment and the results of the
BRP's deliberations.

*Presenter: Thomas J. Moore, M.D., Associate Provost and Director,
Office of Clinical Research, BUMC*

Dr. Moore explained that BUMC is the affiliation of the BU School of
Medicine and the Boston Medical Center (which was Boston City Hospital
until a merger in the 1990s). The mission of the BUMC remains to provide
care regardless of an individual's ability to pay, and therefore BUMC is
a major provider of care to Boston's underserved communities. Benefits
to the community provided by BUMC include a cancer screening unit, a
medical outreach van that provides health care and clothing for homeless
people, an elderly home visit program, a food pantry that feeds 4,000
people per month, and scholarship support for CityLab Academy, which
acquaints students with science.

He characterized the community outreach regarding the NEIDL as the
largest ever undertaken by BU, with information being shared via an
e-mail list and many public meetings, plus a visit to a BSL-4 laboratory
in an Atlanta neighborhood and the formation of the CLC. Indications
that active opposition is no longer widespread include a lack of
requests to speak since 2006 and low attendance at CLC educational
forums. The nature of emerging infectious disease research is
stigmatized, and the benefits are not easy to demonstrate. The presence
of ongoing court cases provides a disincentive to discuss the salient
issues, as opponents to the BSL-4 laboratory believe they can win
through litigation.

BU is committed to improving its community relation strategies in the
future and has hired consultants to assist in this effort.

*Presenter: Klare Allen, Member, Safety Net and STOP the Bio-Terror Lab
Coalition*

Ms. Allen stated that the few residents attending this BRP meeting
should not be viewed as representing the entire community surrounding
the NEIDL. She reiterated that the BRP should meet in Boston, at a day
and time that is convenient for people who work, to discuss concerns
with the community.

Specific points made by Ms. Allen included:

-   Community members have tried for 6 years to talk to Boston Mayor
    Menino, but they have been ignored.

-   There have been laboratory accidents and incidents, and some safety
    procedures did not work right. This BSL-4 facility will work with
    deadly pathogens, and residents cannot afford any mistakes.

-   The CLC has been hard to deal with. Advertisements about its
    educational programs have not been seen.

-   BU and the NIH have done a poor job of risk assessment.

-   The Manhattan Project model should be used instead of building BSL-4
    laboratories around the country.

-   The city and the State are not prepared for a safety-related
    incident at the NEIDL. For example, the fire department is not
    getting relevant training, and residents are not aware of how to
    evacuate.

-   In 2007 Safety Net wrote and submitted a community plan at the
    request of a judge.

*Presenter: Carmen Nazario-Vega, M.Ed., Tenants in Victory*

Ms. Nazario-Vega discussed the history of residential developments in
the area surrounding the NEIDL and presented residents' past and current
concerns, which center on affordable housing, safe neighborhoods, jobs,
and desired services.

She noted that there have not been enough outreach meetings and noted
especially the lack of written and verbal communication in Spanish.

*Presenter: Ruth Barkley, Member, Cathedral United Tenant Organization*

Ms. Barkley reiterated Ms. Allen's invitation to the BRP to come to
Boston for an evening meeting, so that community members can express
their opinions about the BSL-4 laboratory. She explained that the
community wants changes that focus on safe, sanitary, and decent
housing.

Ms. Barkley also expressed concern about anthrax research at the NEIDL.

**BRP Discussion**

BRP members discussed with the presenters how the prior laboratory
accident at BU would have been handled if current regulations had been
in place, the use of recombinant DNA at the BSL-4 research level,
neighborhood priorities as viewed by community residents, and the
definition of biodefense.

#### Public Comment

Sue Gracie, a resident of Brookline, Massachusetts, and a representative
of the Women's International League for Peace and Freedom, talked about
the escape of a monkey that was never found from an AIDS laboratory in
California. This laboratory accident resulted in the community residents
rejecting a BSL-4 laboratory for their city.

#### Panel's Next Steps/Dr. Mahmoud

Dr. Mahmoud stated that the next task of the BRP is to formulate a set
of recommendations about how to accomplish the risk assessment. These
recommendations will be shared with the ACD for its consideration and
eventual transmission to the NIH Director.

#### V. Adjournment

Dr. Mahmoud adjourned the meeting at 2:00 p.m. on July 16, 2008.

\[Note: This summary is based on notes taken at the meeting by a science
writer and NIH staff members. More detailed information will be
available in the minutes of this meeting. Actions approved by the BRP
are considered recommendations to the ACD; therefore, actions are not
considered final until approved by the ACD.\]

Additional information about this Blue Ribbon Panel can be found at:
<http://nihblueribbonpanel-bumc-neidl.od.nih.gov/index.htm>.

Attachment: Roster

NIH Blue Ribbon Panel

#### *Chair*

**Mahmoud**, Adel, M.D., Ph.D.

Professor

Department of Molecular Biology

Woodrow Wilson School of Public and International Affairs

Princeton University

Lewis Thomas Laboratory

Room 228

Princeton, NJ 08544

##### *Members*

**Burke**, Donald S., M.D.

Dean

Graduate School of Public Health

Associate Vice Chancellor for Global Health

Director

Center for Vaccine Research

Jonas Salk Chair in Global Health

Medical School

University of Pittsburgh

Crabtree Hall, Room A624

130 DeSoto Street

Pittsburgh, PA 15261

**Eubank**, Stephen, Ph.D.

Professor

Virginia Bioinformatics Institute

Deputy Director

Network Dynamics and Simulation Science Laboratory

Adjunct Professor

Department of Physics

Virginia Polytechnic Institute and State University

Research Building XV, Room 1102

1880 Pratt Drive

Blacksburg, VA 24060

**Freimuth**, Vicki S., Ph.D.

Director

Center for Health and Risk Communication

University of Georgia

1672 Gober Road

Bishop, GA 30621

**Friedman-Jiménez**, George, M.D.

Medical Director

Bellevue/New York University

> Occupational and Environmental Medicine Clinic

Bellevue Hospital Center, Room CD349

462 First Avenue

New York, NY 10016

**Hamburg**, Margaret A., M.D.

Senior Scientist

Nuclear Threat Initiative

3415 36th Street, NW

Washington, DC 20016

**Holbrook**, Karen A., Ph.D.

Vice President for Research and Innovation

Office of Research

University of South Florida

Room 175

3702 Spectrum Boulevard

Tampa, FL 33612

**Kasper**, Dennis L., M.D.

William Ellery Channing Professor of Medicine

Professor of Microbiology and Molecular Genetics

Harvard Medical School

Director

Channing Laboratory

Department of Medicine

Brigham and Women's Hospital

181 Longwood Avenue

Boston, MA 02115

**Lewis**, Johnnye, Ph.D., DABT

Director

Community Environmental Health Program

College of Pharmacy, Health Sciences Center

University of New Mexico

MSC09 5360

1 University of New Mexico

Albuquerque, NM 87131

**Lipkin**, W. Ian, M.D.

Principal Investigator and Scientific Director

Northeast Biodefense Center

John Snow Professor of Epidemiology

Director, Center for Infection and Immunity

Mailman School of Public Health

Dalldorf Affiliated Research Physician

Wadsworth Center

Professor of Neurology and Pathology

College of Physicians and Surgeons

Columbia University

Room 1801

722 West 168th Street

New York, NY 10032

**Murray**, Thomas H., Ph.D.

President

The Hastings Center

21 Malcolm Gordon Road

Garrison, NY 10524

**Northridge**, Mary E., Ph.D., M.P.H.

Professor of Clinical Sociomedical Sciences

Mailman School of Public Health

Columbia University

Editor-in-Chief

*American Journal of Public Health*

Room 906

722 West 168th Street

New York, NY 10032

**Patterson**, Jean, Ph.D.

Scientist and Chair

Department of Virology and Immunology

Southwest Foundation for Biomedical Research

7620 NW Loop 410

San Antonio, TX 78209

**Robson**, Mark Gregory, Ph.D., M.P.H.

Director

New Jersey Agricultural Experiment Station

Professor of Entomology

School of Environmental and Biological Sciences

Rutgers, The State University of New Jersey

Martin Hall, Room 104

88 Lipman Drive

New Brunswick, NJ 08901

**Stanley, Jr.**, Samuel L., M.D.

Vice Chancellor for Research

Director

Midwest Regional Center of Excellence for Biodefense and Emerging
Infectious Diseases Research

Professor of Medicine and Molecular Microbiology

Washington University in St. Louis

660 South Euclid Avenue

St. Louis, MO 63110

**Thomann**, Wayne, Dr.P.H.

Director

Occupational and Environmental Safety

Assistant Research Professor

Duke University/Duke University Medical Center

Nicholas School of the Environment and Earth Sciences

Environmental Safety Office, Room 131

Research Drive, Box 3914

Durham, NC 27710

***Ex Officio* Members**

**Bennett**, Steven P., Ph.D.

Weapons of Mass Destruction/Bioterrorism Risk Assessment Program Manager

Biological Threat Characterization Program

National Biodefense Analysis and Countermeasures Center

U.S. Department of Homeland Security

121 C Street, SW

Washington, DC 20024

**Highnam**, Peter, Ph.D.

Senior Advisor

U.S. Department of Health and Human Services

Room G644

330 Independence Avenue, SW

Washington, DC 20201

**Khabbaz**, Rima F., M.D.

Director

National Center for Preparedness, Detection, and Control of Infectious
Diseases

Centers for Disease Control and Prevention

U.S. Department of Health and Human Services

1600 Clifton Road, NE

Mail Stop C-14

Atlanta, GA 30333