TISSUE AND BIOLOGICAL FLUIDS BANKS OF HIV-RELATED MALIGNANCIES
 
Release Date:  April 24, 2001

RFA:  RFA-CA-02-001 (Reissued as RFA-CA-08-501)
 
National Cancer Institute
 
Letter of Intent Receipt Date:  July 13, 2001
Application Receipt Date:       August 10, 2001

This RFA is a reissue of RFA-CA-94-003, which was published in NIH Guide 
Volume 23, Number 2, January 14, 1994.

PURPOSE

The Office of the Director of the Division of Cancer Treatment and Diagnosis 
(OD-DCTD), National Cancer Institute (NCI) invites applications from consortia 
of institutions for cooperative agreements to bank tissue and biological 
fluids and to maintain associated clinical data from patients with 
HIV-associated malignancies.  The purpose of the proposed awards is to 
continue cooperative efforts to identify and improve access to tumor tissue, 
biological specimens, and associated clinical outcome data that could then be 
utilized for research, by the research community at-large, on the pathogenesis 
of HIV-associated malignancies and development of more effective therapies.

RESEARCH OBJECTIVES
 
Background

Congenital and acquired states of immunodeficiency increase the incidence of 
high-grade B cell non-Hodgkin’s lymphoma (NHL), Kaposi’s sarcoma (KS), and 
certain types of epithelial malignancies.  Individuals infected with human 
immunodeficiency virus (HIV) have a marked increase in the appearance of 
intermediate and high-grade B cell NHL and KS, and show trends for an 
increased incidence for Hodgkin’s disease and anogenital dysplasia and cancer, 
compared to age-matched controls.  The tumors in HIV-infected individuals are 
generally aggressive and insufficiently sensitive to conventional therapy.  
Trends in the epidemiology and treatment of HIV have changed.  As a result of 
behavioral changes and  highly active anti-retroviral therapy (HAART), the 
incidence of KS and primary central nervous system lymphoma has decreased.  
However, the incidence of NHL and intraepithelial neoplasias are not as 
affected by immune reconstitution.  Certain subtypes of NHL, such as T-cell 
NHL and primary effusion lymphomas, are being detected more frequently.  What 
is not yet known, and needs to be prepared for, is the effect of prolonged 
moderate immunodeficiency, incomplete or failed response to HAART, and perhaps 
HAART itself on the establishment and maintenance of cancer.   As HIV vaccine 
trials begin, new questions will arise.  Given the association of viruses with 
many AIDS-related cancers, intense investigations are needed to identify the 
pathogenic role of these viruses, especially Epstein-Barr virus, human 
herpesvirus 8/Kaposi’s Sarcoma-associated herpesvirus, and human 
papillomaviruses.

In recent years, the extramural research community has recognized the value of 
biological fluids and tissue banks in supporting translational research. They 
recognized that the most efficient method to obtain tumor specimens and bodily 
fluids would take advantage of the meticulous follow-up and monitoring of 
patients in the context of clinical trials in the institutions involved in the 
care of patients with HIV-associated malignancies.  Tumor tissue collected 
during clinical trials would permit research on the pathogenesis of 
HIV-associated malignancies and on the development of effective therapies.

Objectives and Scope

The purpose of the proposed awards is to continue the cooperative efforts of 
the Tissue and Biological Fluids Bank of HIV-associated malignancies and to 
maintain associated clinical and outcome data.  The Banks would provide 
critical resources to the research community at-large for research studies to 
gain insight into the pathogenesis of the malignancies that arise in 
HIV-infected individuals.

The current Tissue and Biological Fluids Bank of HIV-associated malignancies 
is composed of five consortiums each made up of a minimum of two institutions 
with an Operations Office that provides the necessary coordination of specimen 
collection, and data management.  Collection and storage of specimens are 
performed at each institutional site that is part of each consortium.  
Formation of a consortium of institutions is encouraged to maximize specimen 
accession.  All applicants must provide evidence of availability and access to 
patient specimens, and each Consortium (made up of a minimum of two 
institutions) must have an Operations Office that is capable of providing the 
necessary coordination of specimen collection, data management, and storage of 
specimens at a central location.  Banked specimens may consist of fixed or 
frozen tumor tissue and biological fluids.  All specimens are collected and 
banked according to common procedures developed up by the Tissue and 
Biological Fluids Banks of HIV-associated malignancies.

The awardees will provide to the research community at-large tissue and 
biological fluids of high quality from patients with HIV-associated 
malignancies for high priority research studies.  This task will be 
accomplished through the workings of two committees, the Steering Committee 
and the Research Evaluation and Decision Panel (REDP).  The duties of these 
two committees are described below under SPECIAL REQUIREMENTS.

SPECIAL REQUIREMENTS

Definitions

CONSORTIUM - a consortium must include a minimum of two institutions, which 
join together under the guidance and direction of a single Principal 
Investigator.  Each consortium must have clinical laboratory and pathology 
components representing diverse scientific disciplines.

AWARDEE - the organization to which a cooperative agreement is awarded and 
which is responsible and accountable to NCI for the use of funds provided and 
for performance of the cooperative agreement-supported project.

PRINCIPAL INVESTIGATOR (PI) - the single individual at the awardee institution 
designated by the awardee in the cooperative agreement application, who is 
responsible for the scientific and technical direction of the project.

OPERATIONS OFFICE - the central office at the Applicant/Awardee Institution 
that handles all the clinical data and the tissue and biological fluids 
repository data.  The Principal Investigator serves as The Head of the 
Operations Office and is responsible for supplying specimen update information 
to the Central Operations and Data Coordinating Center at least 4 times/year.

CENTRAL OPERATIONS AND DATA COORDINATING CENTER – The administrative unit that 
coordinates all the Consortium activities. Responsibilities include 
administrative management and coordination of the workings of all awardee 
Operations Offices, developing and maintaining a central database of available 
tissue and clinical data, maintaining a database of repository samples from 
the AIDS Malignancy Consortium and other NIH-funded cooperative groups, 
responding to approved Letters of Intent, coordinating shipment and ensuring 
receipt of samples, tracking progress reports of sample recipients, developing 
a national outreach program, and ensuring adherence to the Office of Human 
Research Protection regulations.  The Central Operations and Data Coordinating 
Center will be located at the same site as a Bank Consortium.

NCI PROGRAM DIRECTOR - The OD-DCTD extramural grants Program Director, who 
interacts scientifically with the Applicant/Awardee Institutions regarding 
basic science issues.  The Program Director will also be coordinating DCTD"s 
interactions and administering and providing guidance for the overall program 
within the NCI.  He/she is available for consultation during preparation of 
applications as well as the duration of research conducted through this 
cooperative agreement.  He/she is the Executive Secretary of the Review and 
Evaluation Decision Panel.

NCI COORDINATOR - The Deputy Director, DCTD, who interacts scientifically with 
the Applicant/Awardee Institutions regarding clinical science issues.

STEERING COMMITTEE - a single Committee whose membership includes the NCI 
Coordinator, the NCI Program Director, the PI and one other investigator from 
each awarded cooperative agreement, and one research scientist with expertise 
in the field of HIV-associated malignancies who is not affiliated with any of 
the Awardee Institutions/Consortia.  This research scientist on the Steering 
Committee will be appointed by mutual agreement of the NCI Coordinator, the 
NCI Program Director and the PIs.  The Steering Committee will serve as the 
governing board of the Tissue and Biological Fluids Banks of HIV-Related 
Malignancies (see under "Terms and Conditions of Award" for function of 
Steering Committee).

REVIEW AND EVALUATION DECISION PANEL (REDP) - A panel composed of the NCI 
Program Director and six to eight scientists with clinical/basic research 
expertise in the field of HIV-associated malignancies.  The members of the 
panel will evaluate all research (those of the awardees as well as proposals 
from the research community at-large) proposing to utilize the specimen and 
data Banks according to the evaluation and review criteria provided by the 
Steering Committee.  The panel will provide a recommendation to the Steering 
Committee regarding the priority of the proposed research.  The membership of 
the REDP may vary, depending on the scientific areas of the proposed research 
to be reviewed and evaluated.  Except for the NCI Program Director, all 
members will be selected by the Steering Committee (see under "Terms and 
Conditions of Award" for function of REDP).

Study Organization and Function

The current overall structure of the Tissue and Biological Fluids Banks of 
HIV-Related Malignancies consists of five funded Consortia that are governed 
and coordinated through the Steering Committee.  Each Bank or funded 
Consortium is composed as follows: two or more member institutions of the 
Consortium who are responsible for contributing specimens, biological fluids 
and clinical data, an Operations Office at the awardee institution, and one PI 
who is responsible for providing the scientific and administrative leadership 
for the Consortium and serves as the Head of the Operations Office. A 
separately funded Central Operations and Data Coordination Center will provide 
administrative oversight to the consortia as described under Definitions.

The overall function of the Tissue and Biological Fluids Banks of HIV-Related 
Malignancies is to continue to serve as a national resource to the research 
community at-large.  The Tissue and Biological Fluids Banks of HIV-Related 
Malignancies will provide tissue specimens and clinical outcome data after the 
requests for such specimens and data have been reviewed and prioritized by the 
REDP and approved by the Steering Committee.  Requests for specimens and data 
from the awardees and their collaborators will be reviewed, prioritized by the 
REDP and approved by the Steering Committee along with all other requests from 
investigators in the research community at-large.

The following terms and conditions will be incorporated into the award 
statement and provided to the Principal Investigator(s) as well as the 
institutional official at the time of award.

Terms and Conditions of Award

These special Terms of Award are in addition to, and not in lieu of, otherwise 
applicable OMB administrative guidelines, HHS Grant Administration Regulations 
at 45 CFR part 74 and 92, and other HHS, PHS, and NIH Grant Administration 
policy statements.

The administrative and funding instrument used for this program is a 
cooperative agreement (U01), an assistance mechanism in which substantial NCI 
scientific and/or programmatic involvement with the awardee is anticipated 
during performance of the activity.  Under the cooperative agreement, the NCI 
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, the NCI Program Director and the NCI 
Coordinator.

1.  Awardee Rights and Responsibilities
 
The Awardee will have primary and lead responsibilities for the project as a 
whole, including the following:

The Awardee will establish a bank, collect specimens and clinical data.

The Awardee Principal Investigator, and one other investigator from the 
Consortium, will serve on the Steering Committee.

The Awardee Principal Investigator will ensure that a database of specimen 
information is kept current, using software compatible with the Central 
Operations and Data Coordinating Center database software.  The Awardee 
Principal Investigator will provide updated database information on a 
quarterly basis as defined by the Steering Committee.

The Awardee will work together with the other Awardees and the Central 
Operations and Data Coordinating Center through the Steering Committee to 
establish uniform collection methods and policies, and to assure quality 
control of specimens and data.  The Awardee will be required to accept and 
implement the common policies and procedures approved by the Steering 
Committee.

The Awardee agrees to provide access to specimens and data to investigators 
both within and outside of the awardees" institutions based on the 
prioritization of research proposals set by the REDP and final approval by the 
Steering Committee.  The Awardee will abide by the decisions of the Steering 
Committee based on recommendations from the REDP.

The Awardee 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.

The Awardee will ensure that all cooperating institutions must have an 
approved assurance of compliance for the protection of human subjects on file 
with the Office of Human Research Protection and that necessary IRB reviews 
are conducted by the IRBs of the appropriate institutions in accordance with 
45 CFR part 46 prior to the involvement of human subjects.

The Awardee must provide an annual progress report in its continuing 
application to OD-DCTD, NCI, and a copy to the chairperson of the Steering 
Committee, in a format that is standardized and compatible with the annual 
progress reports from the other Awardees.  Information on the operations of 
the bank, specimen accrual and dispersement, are to be included.

The Awardee must cooperate with the following groups by serving as a resource 
for either repository or donation functions: the AIDS-Malignancies Consortium, 
a national clinical trials cooperative group funded by the NCI under separate 
granting mechanism, the NCI-sponsored Clinical Trials Cooperative Groups, and 
with the NCI-sponsored Epidemiology Cohort studies, the latter two also funded 
by the NCI under separate granting mechanisms.
 
2.  National Cancer Institute Staff Responsibilities

The NCI Coordinator and the NCI Program Director will have substantial 
scientific-programmatic involvement during conduct of this activity through 
participation in the Steering Committee and the REDP, respectively.  They will 
provide technical assistance, advice and coordination, assure that the 
Steering Committee and the REDP follow the NIH guidelines on conflict of 
interest issues and play critical roles in promoting the availability and use 
of the Banks.  The roles of the NCI Coordinator and the NCI Program Director 
are to assist and facilitate, but not to direct activities of the Tissue and 
Fluids Banks of HIV-related Malignancies.

The NCI Coordinator and Program Director will serve as a voting member on the 
Steering Committee, may attend meetings of the REDP as an observer and will 
serve as an information resource on the relevant NCI extramural awardees 
likely to require the resources of the proposed banks.  The NCI Program 
Director will serve as the non-voting executive secretary of the REDP.  He/she 
will advise the ad hoc REDP members on the Steering Committee"s algorithm for 
reviewing the proposals requesting biological specimens and clinical data and 
will provide information on other relevant on-going NCI activities and help 
answer any programmatic issues.  Both NCI staff will serve on subcommittees of 
the Steering Committee and the REDP as required.

The National Cancer Institute reserves the right to reduce the budget, to 
withhold support, and to suspend, terminate or curtail a study or an award in 
the event of substantial shortfall in specimen accrual, data reporting, 
inadequate quality control in specimens or clinical data collection, 
non-adherence to biohazard precautions, refusal to carry out the 
recommendations of the REDP and Steering Committee, or substantial failure to 
comply with the terms of award.

3.  Collaborative Responsibilities

a.  Steering Committee

The Steering Committee will serve as the governing board of the Tissue and 
Biological Fluids Banks of HIV-Related Malignancies.  The Steering Committee 
is composed of the NCI Coordinator and Program Director, the PI and one other 
investigator from each awarded Consortium, and one research scientist with 
expertise in the field of HIV-associated malignancies who is not affiliated 
with any of the Awardee Institutions/Consortia.  This research scientist on 
the Steering Committee will be appointed by mutual agreement of the Steering 
Committee.

The Steering Committee has primary responsibility for developing and 
evaluating policies for quality control of the specimens, and uniformity of 
procedures across institutions, for promoting the availability and the uses of 
the specimen bank, and for developing an algorithm for review and 
prioritization of research proposals, to be used by the REDP, utilizing the 
banked specimens and clinical data (e.g., based on scientific merit with high 
priority awarded to investigators with funded grants).  The NCI Coordinator 
and Program Director will assist the other members of the Steering Committee 
in all these tasks.  Furthermore, the NCI Coordinator and Program Director 
will serve as the scientific liaisons between the awardees and other program 
staff of NCI who have previous experience in the establishment of tumor banks.  
Each member of the Steering Committee will have one vote.  One Chairperson 
will be selected by the Steering Committee, and be someone other than the NCI 
Coordinator or Program Director.  The Chairperson, together with the Central 
Operations and Data Coordinating Center, is responsible for coordinating the 
Steering Committee"s activities, for preparing meeting agendas, for scheduling 
and chairing meetings, and preparing an annual progress report, which will 
include individual reports from each Awardee.  Each Awardee is responsible for 
timely preparation of this report, which will be submitted to the Central 
Operations and Data Coordinating Center.  The Central Operations and Data 
Coordinating Center (CODCC) is responsible for providing documentation as to 
the availability and accessibility of specimens and data for scientific 
investigations (e.g., the PI of the CODCC will send the principal investigator 
of an REDP reviewed high priority proposal a letter as to the availability of 
the specimens, with a final letter to be sent stating that specimens and/or 
data will be made available as requested when funding for the REDP reviewed 
high priority proposal is documented.  If the proposal is already funded at 
the time it is submitted to the REDP and reviewed as high priority, then the 
PI will send the final letter at that time).  The only occurrence in which the 
Steering Committee can overturn the recommendations of the REDP is when 
specimens and/or data are not available.

Subcommittees will be established by the Steering Committee, as it deems 
appropriate.  The NCI Coordinator and Program Director will serve on 
subcommittees as appropriate.

The Steering Committee will meet at a minimum of twice per year in conjunction 
with the NCI Coordinator and the Program Director, to map strategies to 
fulfill the objectives of their function, to develop operating procedures and 
to evaluate progress.  The initial meeting will occur immediately after 
funding.  The Steering Committee will also meet with the REDP once per year.  
The NCI Program Director will attend the joint meeting of the Steering 
Committee and REDP as a non-voting member.

The Steering Committee will select members of the REDP.  The Steering 
Committee in the conduct of all business matters will pay particular attention 
to conflict of interest issues, especially in actions regarding recommended 
prioritizations of the REDP.

b.  Research Evaluation and Decision Panel

The REDP will serve the Steering Committee by reviewing and evaluating all 
research submitted by the research community at-large as well as by the 
awardees proposing to utilize the specimen and clinical data Banks   A 
recommendation in terms of priority of the proposed research will be provided 
to the Steering Committee.  The only occurrence in which the Steering 
Committee can overturn the recommendations of the REDP is the unavailability 
of the requested specimens and/or clinical data.  The REDP will meet with the 
Steering Committee at least once yearly, at one of the two scheduled Steering 
Committee meetings.

The REDP will be composed of the NCI Program Director and six to eight 
scientists with clinical/basic research expertise in the field of 
HIV-associated malignancies.  The members of the panel will evaluate all 
research (those of the awardees as well as proposals from the research 
community at-large) proposing to utilize the specimen and data Banks according 
to the evaluation and review criteria provided by the Steering Committee.  The 
panel will provide a recommendation to the Steering Committee as to the 
priority of the proposed research. The membership of the REDP may vary, 
depending on the scientific areas of the proposed research to be reviewed and 
evaluated.  All members will be selected by the Steering Committee.  The 
Chairperson of the REDP will always be someone other than the NCI Program 
Director.

The review of proposals can be conducted either in person, by conference call 
or by mail at a minimum of twice per year.  All reviews will be conducted 
according to rules pertaining to conduct of reviewers for NIH grants, 
contracts, and cooperative agreements, paying special attention to issues of 
conflict of interest, whether real or apparent.  The NCI Program Director will 
serve as the executive secretary (non-voting role) for the review and will 
forward the final recommendation to the Central Operations and Data 
Coordinating Center for distribution to the Steering Committee.  The NCI 
Program Director in the role of executive secretary of review will inform and 
advise the ad hoc REDP members on the Steering Committee"s algorithm for 
review and prioritization of proposals, will provide information to the ad hoc 
REDP members on the studies that have already been approved and on other 
relevant on-going NCI activities so that redundant studies are not performed, 
and will help answer any programmatic issues.  The NCI Program Director also 
plays an important role in the whole review process by lending a degree of 
continuity with the Steering Committee, as the ad hoc REDP composition may 
change depending on the expertise required to review the submitted research 
proposals.

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 composed of three members -- one 
selected by the Steering Committee (with the NCI member not voting) or by the 
individual awardee in the event of an individual disagreement, a second member 
selected by the NCI, and the third member selected by the two prior 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.

MECHANISM OF SUPPORT

The administrative and funding instrument to be used for this program will 
remain a cooperative agreement (U01), an assistance mechanism, in which 
substantial NCI scientific and/or programmatic involvement with the awardee is 
anticipated during performance of the activity.  Under the cooperative 
agreement, the NCI 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 this cooperative agreement are discussed later in this RFA under the 
section "Terms and Conditions of Award."

Awards and level of support depend on receipt of a sufficient number of 
applications of high scientific merit.  Because of the variation in numbers of 
patients to be accrued, and specimens to be accessed, it is anticipated that 
the size of awards will vary also.  The total project period for applications 
submitted in response to the RFA may not exceed five years.  The anticipated 
award date is June 1, 2002.  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.

This RFA is a one-time solicitation.  At this time the NCI has not determined 
whether or how this solicitation will be continued beyond the present RFA.  If 
it is determined that there is a sufficient continuing program need, the NCI 
will either invite recipients of awards under this RFA to submit competitive 
continuation cooperative agreement applications for review or re-issue the RFA 
for re-competition.  If the NCI does not continue the program, awardees may 
submit grant applications through the usual investigator-initiated grants 
program.

FUNDS AVAILABLE

Approximately $3.5 million in total costs per year for five years will be 
committed to fund applications submitted in response to this RFA.  It is 
anticipated that 6 awards for the Tissue and Biological Fluids Banks of 
HIV-Related Malignancies will be made, including one for the Central 
Operations and Data Coordinating Center, and 5 for Bank Consortia.   It is 
anticipated that the award for the Central Operations and Data Coordinating 
Center will be made for approximately $500,000 (including direct and 
Facilities and Administrative costs) per year.

ELIGIBILITY REQUIREMENTS

This is a recompetition of a previously issued RFA.  Domestic and Canadian 
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 are eligible to 
apply.  Foreign institutions other than Canadian are not eligible to apply or 
be a collaborating institution.  Canadian institutions are included because 
many of them are members of the NCI-Sponsored Clinical Trials Cooperative 
Groups and the NIAID-sponsored AIDS Clinical Treatment Units.  Applications 
must be from a consortium of no less than two institutions, which can include, 
but are not limited to, the NCI-Sponsored Clinical Trials Cooperative Groups, 
the NIAID-Sponsored AIDS Clinical Treatment Units, or a coalition of Cancer 
Centers.  New and experienced investigators are encouraged to apply.  
Applications from minority individuals, women, and persons with disabilities, 
are encouraged to apply as principal investigators.

INQUIRIES
 
Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.
 
Direct inquiries regarding clinical scientific issues to:

Ellen G. Feigal, M.D.
Deputy Director
Division of Cancer Treatment and Diagnosis
National Cancer Institute
Building 31, Room 3A44
Bethesda, MD  20892
Telephone:  (301) 496-6711
Fax:  (301) 496-0828
Email:  ef30d@nih.gov

Direct inquiries regarding basic science or programmatic issues to:

Jodi B. Black, Ph.D.
Program Director
Office of the Director, Division of Cancer Treatment and Diagnosis
National Cancer Institute
Building 31, Room 3A44
Bethesda, MD  20892
Telephone:  (301) 402-6293
Fax:  (301) 496-0828
Email:  blackj@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 8109, MSC-8326
Rockville, MD  20852 (express courier)
Bethesda MD  20892-8326
Telephone:  (301) 496-3428
Fax:  (301) 402-0275
Email:  tf12w@nih.gov

Direct inquiries regarding fiscal matters to:

Kelli Oster
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard
Executive Plaza South, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-8627
FAX:  (301) 496-8601
Email:  osterk@GAB.NCI.NIH.GOV

LETTER OF INTENT

Prospective applicants are asked to submit by July 13, 2001, 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 the 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 the 
NCI staff to estimate the potential review workload and to plan the review.

The Letter of Intent is to be sent to Dr. Jodi Black, listed above 
under INQUIRIES.

SCHEDULE
 
Letter of Intent Receipt:         July 13, 2001
Application Receipt Date:         August 10, 2001
Review by NCAB Advisory Board:    February 22, 2002
Earliest Anticipated Start Date:  June 1, 2002

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/funding/phs398/phs398.html.

Additional Materials to Include in the Application
 
It is critical that applicants clearly describe plans to accommodate stated 
criteria and staff involvement as listed in the Terms and Conditions of Award, 
and in the Review Criteria section.

Re-Competing Applicants

One Applicant should present the overview of the entire Consortium in its 
current form.  Individual applicants should state how their formed Consortium 
composed of no less than two institutions will maintain and enhance their 
specimen bank. This should be divided into two parts: 1) The investigators 
should demonstrate their productivity during the previous 4 years of funding.  
This should include documenting the types, quantities, and quality of 
specimens and clinical/demographic data that have been obtained. Also, state 
the numbers, types, and progress of proposals that have utilized their 
resources.  The investigators should list the projects proposed, and the 
projects that are actually provided specimens, as well as the number of 
specimens that are provided for the projects.  The investigators should list 
the publications (abstracts and papers) from such projects that have utilized 
the specimens.  The investigators should list their cost per specimen.  The 
investigators should detail how they have set up a common database for the 
Banks.  2) The investigators should state how they will enhance their specimen 
bank, e.g., in the operations center, the database, plans to incorporate new 
research opportunities, as well as describe future contributions of specimens 
in the upcoming years of funding.  This should include documenting the types, 
quantities, and quality of specimens and clinical/demographic data that will 
be obtained, how they have utilized the feedback from the proposals that are 
currently utilizing specimens and data on future specimens and data that 
should be made available.  The investigators should state and describe how 
they intend to enhance their operations and database to incorporate new 
research endeavors (e.g., AIDS Malignancy Consortium, NCI sponsored Clinical 
Trials Cooperative Groups, NCI sponsored Epidemiology Cohorts, the NIH 
sponsored VA Aging Cohort Study), and their anticipated cost per specimen.

The applicant for the Central Operations and Data Coordination Center should 
budget for all administrative duties listed under Definitions and Terms of 
Award, for computer needs and software upgrades, and for REDP and Bank 
Advisors travel expenses.

New Applicants

The applicant should form a Consortium composed of no less than two 
institutions to design and develop a specimen bank and document their access 
to and numbers of HIV infected oncology patients in clinical trials.  Details 
on the mechanism for tissue accession and storage and procedures for clinical 
data collection and storage need to be provided.  The application should also 
address quality control issues for the specimens and clinical data collected.  
The application needs to address the types of specimens (frozen and fixed tumor 
tissue, biological fluids) planned for inclusion in the bank. Tissues and fluids 
to be collected should come from groups of patients that are treated uniformly 
on standard therapeutic regimens or clinical trials where clinical and outcome 
data are available. Examples of pathology and clinical data forms that will be 
used should be provided in the appendix of the application.  The application 
should propose an approach to setting up a common database for the consortium.

Applicants should clearly describe the Operations Office, the facilities for 
banking and data collection, the investigators" experience and expertise in 
banking and the applicants" ability to obtain tumor tissue and biological 
specimens from HIV-infected patients with malignancies.  The application must 
provide details on the appropriate facilities and biohazard precautions and 
comply with all applicable Federal, State and Local regulations, laws and 
ordinances in the operation of the Banks.  Applicants must maintain a database 
compatible with the existing Bank database and budget funding for necessary 
computers and software.

The applicants must state a willingness to cooperate with other awardees in 
developing policies for quality control and to share data with other awardees.

The applicants must state a willingness and should discuss their approach to 
cooperate with the Steering Committee and the REDP in evaluating research 
proposals utilizing specimens obtained in their bank(s) and to abide by the 
decisions of the REDP in prioritizing such proposals, after final approval by 
the Steering Committee based on specimen availability.

All Applicants

Each applicant must provide the name and qualifications for the second 
investigator from the consortium on the Steering Committee. Each applicant 
must also provide the name and qualifications of one scientist not affiliated 
with its institution/consortium as a potential member of the Steering 
Committee.  In addition, each applicant must provide the names and 
qualifications of two scientists not affiliated with its 
institution/consortium as potential members of the REDP.  Travel funds for two 
investigators to attend two Steering Committee meetings per year should be 
included in the budget.

All costs required for the proposed Banks must be included in the application 
and must be fully justified.  These costs include the collection and storage 
of specimens, quality assurance, data management and analysis, and travel.  An 
estimate and explanation based on cost per specimen is required.

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 8109, MSC-8326
Rockville, MD  20852 (express courier)
Bethesda, MD  20892-8326

Applications must be received by August 10, 2001.  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 include an introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR and 
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 Division of Extramural Activities of the National Cancer Institute 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 criteria to be used in the evaluation of grant applications are listed below.
 
The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  The 
reviewers will comment on the following aspects of the application in their 
written critiques in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals.  Each of these 
criteria will be addressed and considered by the reviewers in assigning the 
overall score weighting them as appropriate for each application.  Note that 
the application does not need to be strong in all categories to be judged 
likely to have a major scientific impact and thus deserve a high 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.
 
Extent to which the application address the goals and objectives of the RFA,

Adequacy of applicant"s plans for addressing the special scientific and 
technical program requirements presented in the RFA,

Merit of the proposed activities and organizational plans for implementing the 
proposed Tissue and Biological Fluids Banks of HIV-Related Malignancies,

Qualifications and experience of the Principal Investigator and staff, 
particularly, but not exclusively, in the area of the banking facilities and 
procedures and clinical data collection,

Adequacy of existing physical facilities and resources of the organization,
Demonstration of the numbers of patients with HIV-associated malignancies 
accessible to the investigators for clinical data and specimen collection,

Adequacy of plans for effective cooperation and coordination among 
participating awardees, the NCI Program Director and the NCI Coordinator, as 
per Special Requirements of the RFA,

Past contributions of specimens to the Tissue and Biological Fluids Banks of 
HIV-Related Malignancies if applicable,

The initial review group will also examine: the appropriateness of proposed 
project budget and duration, the adequacy of plans to include both genders and 
minorities and their subgroups as appropriate for the scientific goals of the 
research and plans for the recruitment and retention of subjects, the adequacy 
of plans for including children as appropriate for the scientific goals of the 
research, or justification for exclusion, the provisions for the protection of 
human and animal subjects, and the safety of the research environment.
 
AWARD CRITERIA
 
Applications recommended by the National Cancer Advisory Board will be 
considered for award based upon (a) scientific and technical merit of the 
application based on priority score, (b) availability of resources, and study 
populations, and  (c) availability of funds.   Furthermore, the applicant 
organization must indicate a commitment to accept provisions outlined under 
the SPECIAL REQUIREMENTS section, terms and Conditions of Award. The 
anticipated date of award is June 1, 2002.

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 indicating 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 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), 
a complete copy of the updated Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups, if applicable, and b) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

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 these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

All investigators proposing research involving human subjects should read the 
policy published in the NIH Guide for Grants and Contracts, June 5, 2000 
(Revised August 25, 2000), available at the following URL address 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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.

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, Tissue and Biological Fluids 
Bank of HIV-Related Malignancies, is related to priority area of AIDS and 
cancer.  Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople/.
 
AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.395, Cancer Treatment Research. 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 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.

The PHS strongly encourages all grant recipients to provide a 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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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