The International Human Microbiome Consortium:
A Description of its Goals, Operating Structure and Principles
Developed and approved by an interim IHMC Steering Committee, 1/20/081
Introduction: An organizational meeting to discuss formation of an International
Human Microbiome Consortium (IHMC) was held in Rockville, MD on December 9-10,
2007. Participants agreed that a consortium should be formed with membership to
include funding agencies and Principal Investigators of projects that have an interest in
the comprehensive assessment of the human microbiome and its impact on health and
disease. It was also agreed that an interim Steering Committee (iSC) would be formed
following the meeting to develop criteria for membership in the IHMC by mid-January
(later revised to late-January), 2008 and that the criteria would be provided to those
interested in consortium membership. Potential members would then have two months to
commit to initial membership in the IHMC, so that the consortium could be launched by
mid-March, 2008 (later revised to mid-April, 2008). Participation would continue to be
open to any agency or group that subsequently agreed to the membership criteria.
IHMC Goal: The goal of the IMHC is to work under a common set of principles and
policies to study and understand the role of the human microbiome in the maintenance of
health and causation of disease and to use that knowledge to improve the ability to
prevent and treat disease. The Consortium’s efforts will be focused on generating a
shared comprehensive data resource that will enable investigators to characterize the
relationship between the composition of the human microbiome (or of parts of the human
microbiome) and human health and disease.
Membership of the IHMC: The IHMC will be open, at any time to the funders and PIs
of human microbiome research programs that have the capacity to mount a
comprehensive analysis of the human microbiome in health and/or disease, and that agree
to carry out their efforts according to a set of commonly agreed-upon IHMC policies.
 Consortium members will normally have been identified by their funders as a
research group working at a large scale, doing comprehensive analysis of the
human microbiome and as a Community Resource Project2.
 In those cases where individual research groups that have not been identified by
their funder want to join the IHMC, their request will be subject to approval by
Membership of the interim IHMC Steering Committee included the following: Warwick
Anderson, Martin Blaser, Christian Desaintes, Timothy Dyke, Dusko Ehrlich, Francisco
Guarner, Masahira Hattori, Karen Kennedy, Jane Peterson, Bhagi Singh, Todd Taylor,
George Weinstock, Jijun Xing, and Liping Zhao.
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A Community Resource Project, as defined in the Ft. Lauderdale agreement is a
research project specifically devised and implemented to create a set of data, reagents or
other material whose primary utility will be as a resource for the broad scientific
community.
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IHMC Proposal

the IHMC Steering Committee. They will initially be Adjunct Members and
become full Members once they have demonstrated that they are abiding by the
principles of the IHMC.
Initially, funders who do not have funded programs in place but anticipate they
will fund a program that will adhere to these principles in the next 18 month will
be an Observer Member of Steering Committee without a vote until their research
programs are funded.
Role of the IHMC: The role of the IHMC will be to coordinate the activities and
policies of the international groups studying the human microbiome to promote the
generation of a robust, data resource that is freely available to the scientific community
and that can be analyzed across many groups. The IHMC will undertake to ensure that
large-scale, genomic analysis projects will accelerate progress in human microbiome
research and contribute to development of a robust data set that will advance future
studies of the human microbiome in health and disease by scientists around the world.
The IHMC will also facilitate the adoption of informed consent and recruitment
standards, quality standards and data deposition and release policies that will make high
quality data available to the entire research community as rapidly as possible. Other
functions of the IHMC will include the coordination of research efforts, so that the
interests and priorities of individual participants, funding agencies and nations will be
addressed and so that unnecessary redundancy in human microbiome research will be
minimized.
Proposed Organization of the IHMC: The primary working organizations within the
IHMC will be a Steering Committee (SC) and a Funders Committee (FC). The SC will
be comprised of representatives of each of the participating funding agencies and/or
organizations and the Principal Investigators leading projects in the IHMC. The Steering
Committee will vote on issues if a consensus cannot be reached in an IHMC discussion.
Each funding agency will have at least one member and at least one PI from its research
project on the SC, with large, multi PI consortia having more than one as agreed on by
the Funders Committee (FC). The FC membership will be made up of one representative
from each funding agency. Additional members of the funding agencies and the research
projects will participate in the face to face Steering Committee meetings and on
conference calls. Working groups of the SC may be formed to carry out more in-depth
analyses of issues/policies that arise in the course of the human microbiome projects.
These working groups will be made up of experts in the technology/scientific issue/policy
under discussion, and will not have to be participants in a project included under the
auspices of the IHMC.
Initially, an interim SC (iSC) will be formed. The iSC will be composed of funders from
Australia (CSIRO), Canada (CIHR, Genome Canada), China (MOST), the European
Union (European Commission), Singapore, United States (the NIH) and investigators
nominated by each of those funders. Drs. Jane Peterson (NIH) and Christian Desaintes
(EC) will serve as interim co- chairs of the iSC and provide Secretariat functions. The
iSC will develop a set of principles for membership in the IHMC (see below), and will
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IHMC Proposal
subsequently review applications for membership in the IHMC to decide if they meet the
agreed-upon criteria.
Principles for membership in the IHMC
1. Data release
a. Projects participating in the IHMC are Community Resource Projects, as
defined by the Fort Lauderdale principles (see meeting report at
http://www.genome.gov/10506537).
b. Members of the IHMC will agree to immediate release of verified
(technically accurate) sequence data from isolated microorganisms or
metagenomic data from samples taken from healthy and/or diseased
individuals in an appropriate public database.
c. Other types of data, such as gene expression, proteomic or metabolomic
data that might be generated in projects carried out under the auspices of
the IHMC are likely not to have such well-defined quality standards as
sequence data. A working group will be established as soon as the IHMC
Steering Committee is formed to define the minimal quality standards for
such data to allow a definition of what “verified” data are. Once the data
quality standards are approved by the SC, members of the IHMC will
agree to immediate release of data verified according to the standards
agreed to into an appropriate public database.
d. Some IHMC project data, specifically decoded individual-level data, will
be deposited in a controlled access database with the goal of maintaining
the most widespread accessibility consistent with subject consent and with
the submitter’s local regulatory requirements. Access to some of the
individual-level data by investigators, working groups or networks may be
subject to local or regional ethical considerations. A working group will
be established to explore the possibilities of harmonizing the various
international, national or regional ethical authorizations needed to allow
the release of de-identified clinical data.
e. Some large microbiome projects may have small components that do not
fit the description of a Community Resource Project. An example of such
a component is one that is studying the specific function of certain aspects
of the microbiome, such as the role of specific genes. Each project
requesting IHMC membership will need to describe all its components and
the arguments for why a particular component should not be considered a
Community Resource Project. The SC will decide whether it is
comfortable with the project’s request to join the IHMC under the
structure proposed by the project. A small component found not to be a
Community Resource Project (and therefore is not part of the IHMC) will
not participate in IHMC activities as its interests are separate.
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IHMC Proposal
2. Intellectual Property. IHMC members will agree to discourage the filing of IP
claims on pre-competitive, basic data of the type produced by a Community
Resource Project. For example, sequence or expression data from a bacterial
metagenomic study is considered to be precompetitive but data from follow up
studies of the functional role of the metagenomic bacterial community or
individual bacteria in that community are not and it would be acceptable to file for
appropriate findings.
3. Publication
a. The Ft. Lauderdale agreement was intended to promote rapid data release
from a Community Resource Project to the scientific community, while
also supporting the ability of the investigators carrying out the large-scale
data production efforts, in this case IHMC members, to publish the first
global analysis of their own data. The agreement addressed these dual
goals by encouraging the members of the scientific community who used
the pre-publication data sets to act responsibly and to follow high
standards of respect for the contributions of the data generators. The
IHMC Steering Committee will consider whether further steps are needed
to protect the data producers’ interests, but will be mindful of the need to
maximize public benefit by minimizing barriers to data access.
b. The Steering Committee will consider publication of a “marker paper” that
describes the project and informs the research community about the
IHMC’s goals, membership guidelines, and data release and publication
policies.
c. The IHMC will contact journal editors to encourage them to act in accord
with the data release guidelines and principles for IHMC publications. As
a further step, the IHMC will consider drafting a letter of attestation that
would accompany journal submissions affirming that the authors have
properly consulted with the data producers, are not violating any
community ethic regarding publication of their analysis and have properly
acknowledged the data producers in their manuscript. This letter would be
made available to the journals and microbial research community for their
use.
4. Quality assessment
a. Members of the IHMC agree that a quality assessment program is needed
to ensure that the data produced by the Consortium are of high quality.
b. As well as defining minimal standards for the quality of IHMC data, the
Steering Committee will discuss development of a quality assessment plan
for the Consortium to ensure that data produced adhere consistently to
these standards.
5. Standards for consent of participants
a. Members of the IHMC agree that proper informed consent of sample
donors, in accord with local, national and international ethical guidelines
and norms, must be obtained for all IHMC projects in which samples are
obtained from human volunteers.
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IHMC Proposal
b. Members of the IHMC are willing to share their SOPs for donor
recruitment and consent. The Steering Committee will serve as a forum
for discussion of any differences in consent and protocols. A working
group will be formed to discuss a process for how and where this
information will be shared and posted.
Funding: Participants in the IHMC will obtain their own funding for data generation and
specimen collection.
Implementation: The participants in the IHMC organizational meeting agreed that the
iSC will establish an initial set of policies and standards for the Consortium, but specific
research projects likely will be organized and driven by the established human
microbiome research communities, and by national funding policies. Once the SC is
formed it will provide a framework for coordinating and monitoring of IHMC projects. It
is likely that creative and highly flexible approaches will be required.
The iSC will present the proposed principles for IHMC membership to the international
community by late January 2008. Funders and the groups that they support that are
interested in membership will be asked to describe their activities and address how they
will adhere to the principles described above. Funding or governmental organizations
will be given six weeks to decide whether or not to become the initial members of the
IHMC (with an understanding that the opportunity for membership will remain open to
provide additional time for decision-making, to stage peer-reviewed competitions, or for
the development of subsequent interest). It is the goal of the iSC to establish the IHMC
with a fully functioning Steering Committee by the mid-April 2008.
Initial Activities of the IHMC Steering Committee: Once formed, the IHMC steering
committee should develop a set of guidelines for conference calls and face-to-face
meetings to carry out its work. Tentatively, the SC will hold its first conference call
shortly after the mid-April 2008 kickoff.
The attendees at the organizational meeting identified the following as issues that the SC
should consider, using working groups when appropriate:
 Strain selection and coordination for complete genome sequencing projects;
 Quality assessment;
 Data access, release, and consent;
 Publication;
 Intellectual property;
 Requirements of and plans for a web site or portal for sharing information among
members and the scientific community.
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