SHARED PATHOLOGY INFORMATICS NETWORK

Release Date:  March 27, 2000

RFA:  CA-01-006

National Cancer Institute

Letter of Intent Receipt Date:  June 19, 2000
Application Receipt Date:       July 24, 2000

PURPOSE

The Resources Development Branch of the Cancer Diagnosis Program, Division of
Cancer Treatment and Diagnosis, National Cancer Institute (NCI) invites
applications for cooperative agreements (U01) from consortia (composed of a
parent institution or organization and 2 or 3 additional institutions or
organizations) capable of working together to form a Shared Pathology
Informatics Network (hereafter called “Network”).

The objective of this initiative for a Shared Pathology Informatics Network is
to create a model Web-based system to access data related to archived human
specimens at multiple institutions.  The data to be accessed will be derived
from existing medical databases. The ability to automatically access
information from medical databases is the first step toward the long-term goal
of developing informatics systems to support NCI’s efforts to improve
researchers’ access to human specimens and clinical data.  The system to be
developed by the Network should be able to automatically respond to authorized
queries by identifying, obtaining and returning data for those cases that meet
defined search criteria.  The patient’s name and other identifying information
must be encrypted or otherwise modified to protect patient confidentiality and
to comply with applicable confidentiality regulations.  In addition to
improving access to clinical data, the system is expected to provide
researchers with the means to quickly identify and determine the availability
of archived specimens with defined characteristics.  The proposed system is
described in more detail in the Research Objectives and Applications
Procedures Sections of this RFA.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This RFA, Shared Pathology Informatics
Network, is related to the priority area of Cancer.  Potential applicants may
obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS


Applications may be submitted by U.S., Canadian and Mexican for-profit and
non-profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and Local governments, and eligible
agencies of the Federal Government.  Foreign institutions from countries other
than Canada and Mexico are excluded from participation in this RFA.  Minority
individuals, women, and persons with disabilities, are encouraged to apply as
principal investigators.

MECHANISM OF SUPPORT

The administrative and funding instrument to be used for this program will be
the cooperative agreement (U01), an "assistance" mechanism, in which
substantial NIH scientific and/or programmatic involvement with the awardee is
anticipated during performance of the activity.  Under the cooperative
agreement, the NIH purpose is to support and/or stimulate the recipient's
activity by involvement in and otherwise working jointly with the award
recipient in a partner role, but it is not to assume direction, prime
responsibility, or a dominant role in the activity.  Details of the
responsibilities, relationships and governance of the study to be funded under
cooperative agreement(s) are discussed later in this document under the
section "Terms and Conditions of Award.” The total project period for
applications submitted in response to the present RFA may not exceed 5 years.
 The anticipated award date is April, 2001.

Awards and level of support depend on receipt of a sufficient number of
applications of high scientific merit.  Although this program is provided for
in the financial plans of the NCI, awards pursuant to this RFA are contingent
upon the availability of funds for this purpose.

The RFA is a one-time solicitation.  However, the model system to be developed
as part of this initiative is expected to form the basis for subsequent NCI
efforts to provide specimen and specimen-related data resources to support
cancer research.

FUNDS AVAILABLE

The NCI intends to commit approximately $2.75 million (total cost) in FY 2001
and expects to fund 2 consortia for up to 5 years in response to this RFA.
The total intended set-aside covering direct plus facilities and
administrative (F&A) costs to support 2 consortia over the 5-year period is
$13.5 million (total cost).  Because the nature and scope of the applications
may vary, it is anticipated that the size of each award will also vary.
Although the financial plans of the NCI include support for this program,
awards pursuant to this RFA are contingent upon the availability of funds and
the receipt of a sufficient number of meritorious applications.

RESEARCH OBJECTIVES

Background


Pathology laboratories contain a wealth of specimen-related data.  Most
pathology departments have at least 10 years of electronically archived
pathology reports containing diagnostic, demographic and clinical information.
While this valuable research information is stored electronically, most
institutions limit the ability for unlimited searches of electronic patient
data to a small number of individuals.

Internet technology provides new opportunities for accessing information
related to tissue specimens.  It is now feasible to search the electronic
archives of multiple institutions for specimen-related data via Internet
queries.  Security protocols can automatically encrypt or modify patient
identifiers to ensure the confidentiality of patient-related data.  In such a
system, the information systems at participating institutions respond to
researcher-initiated queries with a listing of specimens and related data that
meet the query criteria.  Including multiple institutions allows access to
many more cases than are presently available in any single tissue resource.
The need for expensive centralized tissue banks would be greatly reduced if
information Networks were developed that could utilize existing data
resources.

We anticipate that the model system proposed for development under this RFA
will eventually see broader application.  One of the efforts of this Network
will be to define generalizable and flexible procedures for adding additional
institutions to an existing network, systems for creating new networks, and
procedures for interfacing with other networks.

Objectives and Scope

The objective of this initiative, the Shared Pathology Informatics Network, is
to create a single Web-based system capable of requesting and receiving
clinical data related to archived specimens at multiple institutions.
Searchable databases with patient data exist at hospitals and medical
institutions.  Increasingly sophisticated software tools are now available
that can facilitate communications among disparate computer systems, even
among those that employ different architectures and search strategies.  The
Shared Pathology Informatics Network will employ Internet technology and these
software tools to process researcher-initiated queries on multiple
institutional databases.  Search engines that are integral to the pathology
informatics systems at each institution will interrogate the database and
produce query replies.  The query replies will then be translated into a
structured reply format, standardized for all the institutions in the Network.
These replies will be merged into a single document that will be sent
electronically to the researcher who placed the query.

A Coordinating Committee will plan the Network (see “Terms and Conditions of
Award”). Over the five year project period, the Network will develop and test
the communications protocols needed to access data by means of Internet
queries distributed simultaneously to multiple institutions.  The data to be
searched will include, at a minimum, patient demographics, vital status,
clinical history, histologic information, and, whenever possible, outcome data
and information related to recurrence and treatment.  Data returned by
participating institutions will be automatically collated and returned to the
requestor as a structured report.  The Network will also define generalizable
and flexible procedures that should allow more institutions to be added to an
existing network and developing additional networks.


The following timeline for the Network divides the development of the system
into three phases: an organization phase; a component selection, development
and implementation phase; and a testing and validation phase.  It provides a
general guide to understanding the broad objectives of the Network.

a.  Organization Phase (Years 1 & 2): In the Organization phase, the
Coordinating Committee will meet to discuss plans from consortia and to agree
on a general implementation plan.  In the organization phase, common data
elements will be chosen, and work will be started on choosing coding rules to
automatically translate free text pathology reports into a standard
nomenclature.

The Coordinating Committee will develop a standard query reply format so that
query replies returned from multiple institutions can be seamlessly merged
into a single coherent report.  The Coordinating Committee will develop
strategies to preserve patient confidentiality.  It must also identify those
data elements that must be encrypted, truncated or deleted in order to protect
patient identity.

b.  Component Selection, Development and Implementation Phase (Years 2-3.5):
In this phase the Coordinating Committee will select and develop mechanisms to
distribute queries to Network institutions via the Internet.  This includes
defining how queries will be processed and distributed to the consortium
institutions; selecting software to provide the security function that
authenticates queries and safely allows queries through the Consortium
institution fire walls; and selecting “handshaking software” to establish
connections to the existing data systems at each participating institution.
The handshaking software is the link that permits queries to enter
institutional databases as though they originated within the institution.

The Network will implement protocols to securely transmit query results over
the Internet and protocols to ensure patient confidentiality using automatic
encryption, deletion or truncation of sensitive or identifying information.
Network institutions will obtain approval from institutional IRBs for access
to patient information.

c.  Testing and Validation Phase (Year 3.5-5): In this initial testing phase
of the system, participants should demonstrate that all components work at
each institution.  The consortium will correct software and hardware errors
and improve performance of the system.  The Coordinating Committee will
develop operation and repair protocols for the system.  In the alpha test
phase, the performance of the Network will be evaluated by the Coordinating
Committee.  In the beta test phase, queries from selected members of the
research community will be solicited, the effectiveness and ease of use of the
system evaluated, and the system optimized.

Each phase contains research objectives (milestones) that must be accomplished
before succeeding phases can be achieved.   Milestone 1 is the selection of a
set of common data elements that can be searched in every Network institution.
Milestone 2 is the creation of a set of parsing rules that can be implemented
in a software application to automatically map concept terms contained in
surgical pathology report free-text to one or more common medical
terminologies (e.g. SNOMED or UMLS) with implementation of the parsing rules
in a way that preserves the conceptual content of the free-text diagnosis with
high accuracy.  Milestone 3 is the construction of a workable schema in which
useful patient-related information can be transmitted in Network query replies
in a manner that is compliant with applicable local, state and federal
regulations and that is acceptable to the institutional IRBs.

Applications are requested from preformed consortia, each consisting of 3-4
institutions or organizations.  Each application should propose one Principal
Investigator from the parent institution and one principal investigator from
each of the other consortial sites.  Participating institutions must
demonstrate technical expertise and resources sufficient to further the
objectives of the Network and to meet the specific requirements listed in the
Special Requirements and Application Procedures Sections.  The proposed
consortium must include institutions that utilize different pathology
information systems.  The availability of several different commercial
information systems should facilitate the development of procedures for adding
institutions and developing additional networks.  Each participating
institution must have an existing pathology information system that can store
and retrieve patient information, including demographics and pathology reports
that are linked to existing archived specimens.  Access to hospital clinical
data and cancer registry data, in addition to pathology data, is strongly
encouraged and should significantly improve the competitiveness of an
applicant consortium.  Applicants should carefully follow the additional
points listed in the Application Procedures Section.

SPECIAL REQUIREMENTS

Terms and Conditions of Award

The following Terms and Conditions of Award are in addition to, and not in
lieu of, otherwise applicable OMB administrative guidelines, HHS grant
administration regulations in 45 CFR Parts 74 and 92 and other HHS, PHS and
NIH grant administration policies.

The administrative and funding instrument used for this program will be the
cooperative agreement (U01), an "assistance" mechanism (rather than an
"acquisition" mechanism) in which substantial NIH scientific and/or
programmatic involvement with the awardee is anticipated during the
performance of the activity.  Under the cooperative agreement, the NIH purpose
is to support and/or stimulate the recipient's activity by involvement in and
otherwise working jointly with the award recipient in a partner role, but it
is not to assume direction, prime responsibility, or a dominant role in the
activity.  Consistent with this concept, the dominant role and prime
responsibility for the activity resides with the awardee(s) for the project as
a whole, although specific tasks and activities in carrying out the studies
will be shared among the awardees and the NCI Program Coordinator, as
described in these terms and conditions.

1.  Awardee Rights and Responsibilities

Awardees will have primary and lead responsibilities for the project as a
whole, including collaborating with other awardees, defining objectives and
approaches, planning, implementing, and measuring overall progress, preparing
publications, establishing testing and implementing quality assurance measures
for all aspects of the operation of the Network.  Awardees will retain custody
of and have primary rights to the data developed under these awards,  subject
to Government rights of access consistent with current HHS, PHS, and NIH
policies.


PIs are also responsible for maintaining communications with the other PIs,
with the Program Coordinator and with others, including vendors, members of
Institutional Review Boards, administration officials from any of the
consortium members, and any anyone else whose involvement is germane to the
successful completion of the model system.  The PI may be required, at the
discretion of the Chair, to submit a progress report at any meeting of the
Coordinating Committee.

PI’s are responsible for ensuring the full cooperation of his/her consortium
institutions in reaching the following milestones:

Milestone 1: the selection of a set of common data elements that can be
searched in every Network institution. Milestone 1 should show satisfactory
progress by the end of phase 1.  Milestone 2: the creation of a set of parsing
rules that can be implemented in a software application to automatically map
concept terms contained in surgical pathology report free-text to one or more
common medical terminologies (e.g. SNOMED or UMLS) with implementation of the
parsing rules in a way that preserves the conceptual content of the free-text
diagnosis with high accuracy.  Milestone 2 should show satisfactory progress
by the end of phase 2.   Milestone 3: the construction of a workable schema in
which useful patient-related information can be transmitted in Network query
replies in a manner that is compliant with applicable local, state and federal
regulations and that is acceptable to the institutional IRBs. Milestone 3
should show satisfactory progress throughout the Term of Award.	

2.  NCI Staff responsibilities

The Program Coordinator will be designated by the Associate Director of the
Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis
(hereafter called “Associate Director”).
The Program Coordinator will coordinate the development and operations of the
Network and will facilitate the complex interactions of the various
participants. These activities include: ensuring the development of a
standardized report format, including common data elements; ensuring that
network protocols, software and other resources previously developed by or
licensed to the NCI will be made available to the Shared Pathology Informatics
Network; assisting with testing and validating the systems developed by the
Network; assisting in the development of consistent operating policies for the
Network; and assisting the consortia in meeting specified milestones   The
Program Coordinator will also help ensure smooth interactions among the
cooperating organizations, facilitate the exchange of information among the
cooperating organizations and serve as a voting member of the Network
Coordinating Committee.  The Program Coordinator attends and participates
fully but not as the chair, at all meetings of the Coordinating Committee.

The Associate Director will select a panel of program staff to review and
evaluate satisfactory progress toward completion of the three milestones
described in “Awardee Rights and Responsibilities.” The NCI reserves the right
to withdraw funding to one or more consortia if satisfactory progress toward
completion of the milestones is not achieved.


3.  Collaborative Responsibilities

The NCI Program Coordinator and the Principal Investigators for the U01 awards
will be responsible for forming a Coordinating Committee to oversee the
operation of the Network.  The Coordinating Committee will act as the
governing body of the Network and all participants are bound by its actions.
An arbitration system, as detailed below, will be available to resolve
scientific/programmatic disagreements which may arise between the NCI and the
Coordinating Committee.  Coordinating Committee meetings are to review, assess
and facilitate progress by participating institutions; to establish policies
and priorities; and to solve problems.  The Coordinating Committee will
develop a strategy to meet the milestones described in “Awardee Rights and
Responsibilities.” The Coordinating Committee will initially consist of the
following voting members: the consortium principal investigators for the
parent institutions, the principal investigators for each funded consortial
site, and the Program Coordinator.  Additional voting members may be added at
the first or subsequent meetings by a unanimous vote of the Coordinating
Committee.  A representative from the NCI Office of Informatics may attend
Coordinating Committee meetings as a non-voting consultant.  The role of the
informatics representative is to provide advice on implementation of software
developed by the NCI and information on ongoing or planned NCI informatics
efforts relevant to this program.

The Coordinating Committee is responsible for establishing uniform procedures
related to any and all aspects of implementation of the Network.  At its
initial meeting it will review and implement as appropriate, the plans and
timelines for developing the Network that were proposed in applications from
the participating consortia.  This will ensure that the efforts of individual
awardees are compatible with the overall goals of the RFA.  It will also elect
a Chair (who cannot be the Program Coordinator) and establish the Chair’s term
in office.  The Chair of the Coordinating Committee is responsible for
maintaining oversight and assuring progress, for developing agendas and for
chairing Coordinating Committee meetings.  The Program Coordinator is a voting
member of the Coordinating Committee.  The Coordinating Committee will meet
three times in the first year and at least twice a year thereafter and may
hold additional meetings and conference calls as necessary.  Meetings may be
held at any of the participating organizations or another convenient location.

4.  Arbitration

Any disagreement that may arise on scientific/programmatic matters (within the
scope of the award), between award recipients and the NCI may be brought to
arbitration.  An arbitration panel will be constituted, consisting of three
members: one selected by the Coordinating Committee (with the NCI member not
voting) or by the individual awardee in the event of an individual
disagreement, a second member selected by NCI, and the third member selected
by the two previously selected members.  This special arbitration procedure in
no way affects the awardee's right to appeal an adverse action that is
otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50,
Subpart D and HHS regulation at 45 CFR Part 16.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS


It is the policy of the NIH that women and members of minority groups and
their sub populations must be included in all NIH supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification is provided that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research.  This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).

All investigators proposing research involving human subjects should read the
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research," which have been published in the Federal Register of March 28, 1994
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, March 18, 1994, available on the web at the following URL address:
http://grants.nih.gov/grants/guide/notice-files/not94-100.html

NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN
RESEARCH INVOLVING HUMAN SUBJECTS.

It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are clear and compelling scientific and ethical reasons not
to include them.  This policy applies to all initial (Type 1) applications
submitted for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html

Investigators may also obtain copies of the policy from the program staff
listed under INQUIRIES.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within
specified page limitations.  Unless otherwise specified in an NIH
solicitation, internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites.  Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.

LETTER OF INTENT

Prospective applicants are asked to submit, by June 19, 2000, a letter of
intent that includes a descriptive title of the proposed research, name,
address, and telephone number of the Principal Investigator, identities of
other key personnel and participating institutions, and number and title of
the RFA in response to which the application may be submitted.


Although a letter of intent is not required, is not binding, and does not
enter into the review of subsequent applications, the information allows NCI
staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent to Dr. Jules Berman listed under INQUIRIES
by the letter of intent receipt date listed.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev.  4/98) is to be used in
applying for these grants.  Applications kits are available at most
institutional offices of sponsored research and may be obtained from the
Division of Extramural Outreach and Information Resources, National Institutes
of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone
301/435-0714, E-mail: grantsinfo@nih.gov.  For those applicants with internet
access, the 398 kit may be found at http://grants.nih.gov/grants/forms.htm

To ensure appropriate review and facilitate development of the Network, the
following issues should be addressed in each application.

1.  Applicants will propose a plan for implementing the Network.  In the plan,
they will describe their approach to achieving each component task included in
“Objectives and Scope”, indicate problems which might arise during the
completion of the task, and how they might be solved, and propose a timeline
for completing the critical tasks.  The timeline may differ from the timeline
suggested in “Objectives and Scope”, but must meet the milestones specified in
“Terms and Conditions of Award.”  This plan permits the applicants to provide
their own concept for developing the Network, while staying within the overall
scope and purpose of the RFA.  It should be understood that the final plan for
implementation will be developed and approved by the Coordinating Committee.

In order to abide by the Terms of Award, applicants must clearly indicate
their willingness to serve on the Coordinating Committee, to be bound by its
decisions and to participate in all activities described in "Terms and
Conditions of Award".

2.  Applicants will describe the information and specimen resources that are
available at each consortium institution.  This will include the laboratory
information system (LIS) and, if applicable, the hospital information system
(HIS).  Because the Network is being developed as a flexible model that will
accommodate a diversity of systems, each consortium will include several
different LIS or HIS systems.  Where applicable, the ability to access Cancer
Registry and/or other data should also be described.  Describe the types of
queries that are currently supported and conducted, and the extent to which
such queries can access clinical as well as pathological data.  Describe the
institutional pathological and clinical datasets, and provide the number of
surgical pathology records, the range of dates covered by the datasets, the
rate of record accrual in the data sets, and the data fields included in the
datasets.


3.  Applicants will provide a measure of the completeness and validity of
their data sets.  Completeness refers to whether a data element in a given
data record contains data.  Validity refers to whether the data element
contains sensible information.  For instance, a complete and valid date-of-
birth data element should not be empty and should contain a date consisting of
day, month and year, and the date should precede the submission date for the
surgical pathology report. Examples of data elements generally included in
surgical pathology reports are: case identifier, patient identifier, patient
date of birth, patient gender, ethnicity, date specimen received, date report
issued, type of specimen, clinical information (usually a brief clinical
history), and microscopic diagnosis.  Applicants must devise an assessment
that quantitates the percentage of their reports that are complete and valid
for each of the data elements in their institution=s surgical pathology
reports. Applicants should also justify the methodology they employed in the
assessment.

4.  Applicants must provide evidence of their expertise in pathology-related
informatics.  Where informatics support resides outside the pathology
department, applicants must demonstrate that an established cooperative
working relationship has existed.

5. Although we do not anticipate that tissues will be distributed to
researchers during the five year award period, one of the key purposes of this
Network will be to lay the groundwork for future initiatives that will
distribute tissue specimens.  Therefore, applicants will include a statement
from each consortium institution regarding its willingness to provide archived
specimens and related data to researchers within and outside the consortium
institutions.  Include, if applicable, past history of the institution in
providing specimens for research.  The statement of willingness is requested
to allow the NCI to evaluate whether Network institutions would participate in
a subsequent virtual resource to make archived tissue and data accessible to
researchers.  The NCI understands that these arrangements could be effectively
negated by circumstances beyond the control of the participating institutions.

6.  Applicants will estimate the percentage of surgical pathology records
associated with retrievable paraffin blocks, and confirm the availability of
the paraffin-archived tissues and their willingness to provide them to
researchers.

Applicants must obtain full board IRB approval for the Resource.  Applicants
must complete the “Human Subjects” section of the PHS 398 grant application,
including plans to protect patient confidentiality, and if required by their
IRB, procedures to obtain informed consent for prospective procurement of
patient data.

The travel budget should include funds for travel by two people to three
meetings of the Coordinating Committee in the first year of the grant and two
meetings of the Coordinating Committee in subsequent years.


The RFA label available in the PHS 398 (rev.4/98) application form must be
affixed to the bottom of the face page of the application.  Type the RFA
number on the label.  Failure to use this label could result in delayed
processing of the application such that it may not reach the review committee
in time for review.  In addition, the RFA title and number must be typed on
line 2 of the face page of the application form and the YES box must be
marked.

The sample RFA label available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to
allow for this change. Please note this is in pdf format.

Submit a signed, typewritten original of the application, including the
Checklist, and three signed photocopies, in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive
Room 1040 - MSC 7710
Bethesda, MD 20892-7710  (20817 for express service)

At the time of submission, two additional copies of the application must also
be sent to:

Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8062, MSC 8239
Rockville, MD 20852 (express courier)
Bethesda MD 20892-8239
Telephone: (301) 496-3428
Fax: (301) 402-0275
Email: tf12w@nih.gov

Applications must be received by July 24, 2000.  If an application is received
after that date, it will be returned to the applicant without review.  The
Center for Scientific Review (CSR) will not accept any application in response
to this announcement that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application.  The
CSR will not accept any application that is essentially the same as one
already reviewed.  This does not preclude the submission of a substantial
revision of an application already reviewed, but such an application must
follow the guidance in the PHS Form 398 application instructions for the
preparation of revised applications, including an introduction addressing the
previous critique.

REVIEW CONSIDERATIONS


Upon receipt, applications will be reviewed for completeness by CSR and for
responsiveness by the National Cancer Institute.  Incomplete and/or non-
responsive applications will be returned to the applicant without further
consideration.

Applications that are complete and responsive to the RFA will be evaluated for
scientific and technical merit by an appropriate peer review group convened by
the NCI in accordance with the review criteria stated below.  As part of the
initial merit review, all applications will receive a written critique and
undergo a process in which only those applications deemed to have the highest
scientific merit, generally the top half of the applications under review,
will be discussed, assigned a priority score, and receive a second level
review by the National Cancer Advisory Board.

Review Criteria

The goal of NIH-supported resources is to facilitate research that advances
the understanding of biological systems, improves the control of disease, and
enhances health.  In the written comments reviewers will be asked to discuss
the following aspects of the application in order to judge the likelihood that
the proposed Network would have a substantial impact on the pursuit of these
goals.  Each of the criteria will be addressed and considered in assigning the
overall score, weighting them as appropriate for each application.  Note that
an application does not need to be strong in all categories to be judged
likely to have major scientific impact and thus deserve a competitive priority
score.  For example, an investigator may propose to carry out important work
that by its nature is not innovative but is essential to move a field forward.

(1) Significance: Will the proposed approach advance the ability of the
research community to access clinical information linked to archived tissue
specimens?  Will the approach facilitate progress in the field of specimen-
related informatics?

(2) Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and propose
alternative tactics?

(3) Innovation: Does the project employ creative approaches and methods for
the development and implementation of the Shared Pathology Informatics
Network?

(4) Investigator: Is the investigator appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to the experience level
of the principal investigator and other consortium participants?

(5) Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Does the proposed Network take
advantage of unique features of the institutional environment or employ useful
collaborative arrangements? Is there evidence of institutional and
departmental support for the effort?

In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:

o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research.  In addition does the population represent an appropriate age
distribution?
o The reasonableness of the proposed budget and duration in relation to the
proposed research.
o The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the project
proposed in the application.

Additional scientific/technical merit criteria:

The quality of the pre-existing hospital information system (HIS) and
laboratory information system (LIS) of the institutions within each applicant
consortia.  This would include the completeness, quality, extensiveness,
quantity and accessibility of clinical and pathological reports included in
HIS and/or LIS datasets and of associated archived specimens.

The ability to access clinical information in addition to that contained in
pathology reports, particularly clinical data contained in Cancer Registries
or some other institutional dataset that includes clinical data and outcome
information.

The accessibility of archived paraffin-embedded specimens referenced in the
surgical pathology report dataset.

AWARD CRITERIA

Applications recommended by the National Cancer Advisory Board will be
considered for award based upon (a) scientific and technical merit; (b)
program balance, including in this instance, sufficient compatibility of
features to make a successful collaborative program a reasonable likelihood;
and (c) availability of funds.

SCHEDULE

Letter of Intent Receipt Date:    June 19, 2000
Application Receipt Date:         July 24, 2000
Peer Review Date:                 October or November 2000
NCAB Review Date:                 February, 2001
Earliest Anticipated Start Date:  April 1, 2001

INQUIRIES

Written and telephone inquiries concerning this RFA are strongly encouraged.
The opportunity to clarify any issues or questions from potential applicants
is welcome.

Direct inquiries regarding programmatic issues to:

Jules J. Berman, Ph.D., M.D.
Resources Development Branch, Cancer Diagnosis Program
National Cancer Institute

Executive Plaza North, Room 700
6130 Executive Boulevard, MSC-7420
Bethesda MD 20892-7240 (Rockville, MD 20850 for express/courier service)
Telephone: (301) 496-7147
FAX: (301) 402-7819
Email: bermanj@mail.nih.gov

Direct inquiries regarding review issues to:

Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116, Executive Blvd., Room 8062, MSC-8239
Bethesda MD 20892-7399 (Rockville, MD 20852 for express/courier service)
Telephone (301) 496-3428
Fax: (301) 402-0275
Email: tf12w@nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Barbara A. Fisher
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
6120 Executive Boulevard, MSC 7150
Bethesda, MD 20892-7150 (Rockville, MD 20850 for express/courier service)
Telephone: (301) 496-8626
FAX:  (301) 496-8601
Email: stones@gab.nci.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.394 Cancer Detection and Diagnosis.  Awards are made under authorization of
Sections 301 and 405 of the Public Health Service Act as amended, (42 USC 241
and 284) and administered under NIH grants policies and Federal Regulations 42
CFR Parts 52 and 45 CFR Parts 74 and 92.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.


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smoke-free workplace and promote the non-use of all tobacco products.  In
addition, Public Law 103-227, the Pro- Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care or early
childhood development services are provided to children.  This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.