INTEGRATED PRECLINICAL/CLINICAL AIDS VACCINE DEVELOPMENT (IPCAVD) PROGRAM

RELEASE DATE:  April 3, 2003

PA NUMBER:  PAR-03-095 (See amendment, NOT-AI-05-034)

March 2, 2006 (NOT-OD-06-046)   Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using 
the electronic SF424 (R&R) application. Replacement 
U19 (PAR-06-286) funding opportunity announcement has been issued for the 
submission date of June 1, 2006 and submission dates thereafter.

EXPIRATION DATE:  November 15, 2005, unless reissued.
 
National Institute of Allergy and Infectious Diseases (NIAID)
 (http://www.niaid.nih.gov)

CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:
No. 93.855, Immunology, Allergy, and Transplantation Research
No. 93.856, Microbiology and Infectious Diseases Research

APPLICATION RECEIPT DATES:  November 13, 2003, November 15, 2004,     
November 14, 2005

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this PA
o Research Objectives
o Mechanism(s) of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations:

PURPOSE OF THIS PA

The goal of the IPCAVD Program is to support the translation of meritorious 
AIDS vaccine concepts from the bench to the clinic.  As such, the initiation 
of human studies is required during the term of the award.
 
RESEARCH OBJECTIVES

Background

The National Institute of Allergy and Infectious Diseases (NIAID) of the 
National Institutes of Health (NIH) invites applications for research aimed 
at obtaining a safe and efficacious vaccine against HIV or AIDS.  NIAID 
supports the progressive stages of AIDS vaccine research and development from 
basic research through iterative product development and clinical trials.  
NIAID supports AIDS prophylactic vaccine research and development via three 
solicited grant programs.  The Innovation Grant Program for AIDS Vaccine 
Research supports high risk/high impact early stage concept evaluation for 
projects with limited preliminary data.  The HIV Vaccine Research and Design 
(HIVRAD) Program supports a multi-project HIV vaccine design and development 
research application.  The Integrated Preclinical/Clinical AIDS Vaccine 
Development (IPCAVD) Program, also a multi-project Program, supports 
iterative product development and late stage vaccine optimization and must 
include limited human studies.

Research Objectives and Scope

The IPCAVD Program is designed to support the later, more iterative stages of 
vaccine research/development and includes limited human studies.  Studies 
responsive to this Program Announcement (PA) can include later stage 
preclinical research (vaccine optimization studies, immunogenicity/challenge 
studies, etc), GLP/GMP vaccine production, GLP preclinical toxicology and 
safety studies, pre-IND/IND preparation and submission, and clinical testing.  
Preclinical research alone, without clear feasible and realistic plans for 
progressing to human testing within the period of award is not considered 
responsive to this particular PA.  Applicants are required to delineate in 
their applications discrete goals with measurable milestones and include 
criteria that can be used in deciding when to proceed to the next phase of 
product development towards a testable vaccine in humans.  Funding of the 
final 2 years of the grant will be contingent upon the successful completion 
of negotiated milestones and the feasibility of clinical testing within the 
funding period as determined by a mid-point grant review (refer to Special 
Requirements Section below).  

MECHANISM OF SUPPORT

This PA will use the NIH Multi-project Cooperative Agreement (U19), an 
"assistance" mechanism, rather than an "acquisition" mechanism.  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.  Essential elements of 
the multi-project cooperative agreement mechanism also include: (1) a minimum 
of two interrelated individual research projects organized around a central 
theme, (2) collaborative efforts and interaction among independent projects 
and their investigators to achieve a common goal, (3) a single Principal 
Investigator who will be scientifically and administratively responsible for 
the group effort, (4) a single applicant institution that will be legally and 
financially responsible for the use and disposition of funds awarded, and (5) 
support provided, as necessary, for "Core" resources or facilities, each of 
which is expected to be utilized by at least two research projects in order 
to facilitate the research effort.  Details of the responsibilities, 
relationships and governance of a study funded under a cooperative agreement 
are discussed later in this document under the section "Terms and Conditions 
of Award."

The total project period for applications submitted in response to this PA 
may not exceed five years.

Applicants for U19 grants must follow special application guidelines in the 
NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT 
AWARDS; this brochure is available via the WWW at: 
http://www.niaid.nih.gov/ncn/grants/multibron.htm.

ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) if your institution has any of the 
following characteristics:

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
  and laboratories 
o Units of State and local governments  
o Eligible agencies of the Federal government  
o Domestic or foreign 
o Faith-based or community-based organizations 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.   
 
SPECIAL REQUIREMENTS

Milestones  
Based on the comments from the peer reviewers, the Program Officer may wish 
to revise the milestones included in the application through negotiation with 
the applicant.  The agreed upon milestones will be included in the Terms of 
Award.  Decisions regarding funding beyond 3 years will be based on the 
completion of milestones in the first 2.5 years.

Review at 2.5 years
At the mid-point of the grant (2.5 years), based on the first two annual 
reports and any additional information that the PI elects to submit at the 
2.5 year anniversary, Program will assess the accomplishment of the 
milestones and whether the progress as reported will allow, with high 
probability, initiation of clinical study within the duration of the grant 
(up to 5 total years).  The mid-point grant review will be conducted via 
conference call or a meeting between the PI and DAIDS staff, and may include 
members of the External Steering Committee (as described in the Collaborative 
Responsibilities Section of this PA).  If DAIDS determines that that it is 
highly feasible for the grant to culminate in a human clinical study, the 
grantee will continue to be funded for years 4 and 5 of the grant.  If DAIDS 
determines that it is not likely that continued funding will lead to a 
clinical study, the grantee will receive funding for a total of 4 years.

Patent Coverage
Since applications may involve several institutions, including the private 
sector, complex patent issues may arise.  To avoid delays in the 
implementation of new vaccines for HIV as a result of intellectual property 
issues, each multi-project group is required to submit a plan, as part of the 
application that details: (1) the approach for obtaining patient coverage and 
licensing, where appropriate, (2) a statement demonstrating acceptance of the 
approach signed by all parties, and (3) the procedures to be followed for the 
resolution of legal problems that may potentially develop.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:
Applications requesting $500,000 or more in direct costs for any year must 
include a letter of intent identifying the NIAID staff member who has agreed 
to accept assignment of the application. 

Specifically, applicants requesting more than $500,000 must carry out the 
following steps:

1) Contact the NIAID program staff person listed in this PA at least 6 weeks 
before submitting the application. 

2) Obtain agreement from the NIAID contact that the IC will accept the 
application for review and potential consideration for award, and

3) Identify in the letter of intent, the NIAID staff member contacted, a 
proposed first year budget with the number of Projects, PIs and Institution 
for each project, specific aims for each project, and a projected budget for 
the proposed funding period. 

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types.  Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD

The following terms and conditions will be incorporated into the award 
statement and provided to the Principal Investigator as well as the 
institutional official at the time 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 the 
multiproject cooperative agreement (U19), 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 awardees for 
the project as a whole, although specific tasks and activities in carrying 
out the research will be shared among the awardees and the NIAID Scientific 
Coordinator.

Cooperative agreements are subject to the administrative requirements 
outlined in OMB circulars A-102 and A-110.  All pertinent HHS, PHS, and NIH 
grant regulations, policies and procedures, with particular emphasis on PHS 
regulations at 42 CFR Part 52 and HHS regulations at 45 CFR Part 74, are 
applicable. These special terms and conditions pertaining to the scope and 
nature of the interaction between the NIAID and the investigators will be 
incorporated in the Notice of Grant Award.  However, these terms will be in 
addition to, not in lieu of, the customary programmatic and financial 
negotiations that occur in the administration of cooperative agreements.

1.  Monitoring Clinical Studies

When clinical studies or trials are a component of the research proposed, 
NIAID policy requires that studies be monitored commensurate with the degree 
of potential risk to study subjects and the complexity of the study. AN 
UPDATED NIAID policy was published in the NIH Guide on July 8, 2002 and is 
available at: http://grants.nih.gov/grants/guide/notice-files/
NOT-AI-02-032.html.   The full policy, including terms and conditions of 
award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.

This award provides support for one or more NIH-defined Phase III clinical 
trials.  The NIH Policy for research supported as an NIH Phase III Clinical 
Trial has been updated in Section III.B. of the "NIH Guidelines on the 
Inclusion of Women and Minorities as Subjects in Clinical Research", updated 
October 9, 2001  (URL listed below under REQUIRED FEDERAL CITATIONS).  A 
description of plans to conduct analyses, as appropriate, by sex/gender 
and/or racial/ethnic groups must be included in clinical trial protocols and 
the results of the subset analyses must be reported to NIH in Progress 
Reports, Competitive Renewal Applications, and in the required Final Progress 
Report, as stated in Section III.B. of the Guidelines.

2.  Awardee Rights and Responsibilities

Awardees will have primary responsibility for defining the research 
objectives, approaches and details of the projects within the guidelines of 
the PA and for performing the scientific activity. Specifically, awardees 
have primary responsibility as described below.  All awardees are required to 
host for the Program Officer and NIAID Program Staff an annual site visit 
review.  The PI, all co-PIs, and the External Steering Committee (see below 
under Collaborative responsibilities) members shall attend this meeting.  An 
update and summary of results generated on each project shall be presented by 
the PI, co-PI and/or all pertinent staff.  These presentations shall include 
summaries of all goals or milestones (refer to Special Requirement Section of 
PA) and a description of all problems encountered that may have an impact on 
the achievement of future goals and milestones.  In addition to the annual 
site visits hosted by the PI, the PI will be afforded the opportunity to 
submit in writing a mid-point progress report delineating progress on each of 
the stated milestones and a clear plan for the initiation of a clinical 
study.  Any such supplemental information must be provided to the PO no later 
than 1 month before the 2.5 year anniversary of the grant award.

3. NIAID Staff Responsibilities

NIAID staff assistance will be provided by the Program Officer who will serve 
as NIAID's Scientific Coordinator.  The NIAID Scientific Coordinator will 
have substantial scientific/programmatic involvement during the conduct of 
this activity through technical assistance, advice and coordination above and 
beyond normal program stewardship for grants, as described below:

a. Interacting with the PI on a regular basis to monitor study progress, 
compliance, adherence to protocol, and quality assurance in order to ensure 
the production of high-quality, unbiased results.  Monitoring may include: 
(a) regular communication with the PI and staff, (b) periodic site visits for 
discussions with awardee research teams, (c) observation of field data 
collection and management techniques, quality control, fiscal review, and 
other relevant matters, as well as (d) attendance at and participation in 
annual site visit meetings and/or External Steering Committee (refer to 
Collaborative Responsibilities section below) meetings.  The NIAID retains, 
as an option, periodic external review of progress.  NIAID reserves the right 
to independently monitor any clinical trial to ensure adherence to regulatory 
requirements.  Such review and monitoring may be conducted by organizations 
contracted by and acting on behalf of NIAID.
a.  Serving as a resource with respect to ongoing NIAID activities that may 
be relevant to the research, to facilitate compatibility, avoid unnecessary 
duplication, and potentially forge collaborations that may enhance the 
quality and breadth of the study.
b.  Providing substantial assistance in design and coordination of research 
activities for awardees including:
i.   advice on the planning, management, and technical performance of the 
investigators
ii.  access to and use of, when appropriate, reagents and assays, and other 
resources available
through NIAID contractors and awardees
iii.  technical advice and assistance for meeting FDA requirements for 
investigational drugs
iv.  review and approval of protocols to ensure that they are within the 
scope of the original proposal, and that they follow peer review comments and 
suggestions; and for adequacy of safety, protection of human subjects, and 
representation of women and minorities as required by Federal regulations.  
The NIAID PO will monitor protocol progress, and DAIDS may require that a 
protocol be closed to accrual for reasons including: (a) accrual rate 
insufficient to complete the study in a timely fashion, (b) accrual goals met 
early, (c) poor protocol performance, (d) patient safety, human subjects, and 
women/minority recruitment concerns, (e) study results that are already 
conclusive, and (f) emergence of new information that diminishes the 
scientific importance of the study.  The NIAID will not permit further 
expenditure of NIAID funds for a study after requesting closure 
(except for patients/subjects on-study and final data analysis and reporting).
v. review and advice regarding the establishment of mechanisms for quality 
control and study monitoring
d. Recommending continued funding based on: (a) overall study progress, 
including study subject and/or data accrual, (b) cooperation in carrying out 
the research, and/or (c) maintenance of high quality research that will allow 
pooling of data and comparison across multiple grant/cooperative agreement 
awards for common data elements.

4.  Collaborative Responsibilities

In addition to the interactions defined above, awardees and NIAID staff shall 
share responsibility for the organization of an External Steering Committee 
(ESC).  The composition of the ESC membership shall be determined by 
consensus between the PI and the NIAID PO.  The ESC will consist of a minimum 
of 3 members not directly affiliated with the research scope of the award.  
The ESC in combination with the PI will be responsible for determining 
progress of the PI/co-PI during the annual site visit reviews.  

5.  Arbitration

Any disagreement that may arise on scientific or programmatic matters (within 
the scope of the award) between award recipients and the NIAID may be brought 
to arbitration.  An arbitration panel will be will be formed to review any 
scientific or programmatic issue that is significantly restricting progress, 
and will be composed of three members -- one selected by the Steering 
Committee or by the individual awardee in the event of an individual 
disagreement, a second member selected by the NIAID, and a third member with 
expertise in the relevant area who is selected by the two other members.  
While the decisions of the Arbitration Panel are binding, these special 
arbitration procedures will in no way affect the awardee's right to appeal an 
adverse action in accordance with PHS regulations at 42 CFR Part 50, subpart 
D, and HHS regulations at 45 CFR Part 16.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into three 
areas:  scientific/research, peer review, and financial or grants management 
issues:

o Direct your questions about scientific/research issues to:

Dr. Michael Pensiero
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 4109, MSC-7628
6700-B Rockledge Drive
Bethesda, MD  20892-7628
Telephone:  (301) 435-3749)
FAX:  (301) 402-3684
E-Mail:  [email protected] 

o Direct your questions about peer review issues; address the letter of intent;
mail two copies of the application and all five sets of appendices to:

Dr. Dianne Tingley
Division of Extramural Affairs 
National Institute of Allergy and Infectious Diseases 
Room Number 2148A, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: (301) 496-2550
FAX: (301) 402-2638 
Email: [email protected]

o Direct your questions about financial or grants management matters to:

Victoria P. Connors 
Division of Extramural Affairs
National Institute of Allergy and Infectious Diseases 
Room Number 2121, MSC-7614 
6700-B Rockledge Drive
Bethesda, MD 20892-7614 
Telephone: (301) 402-6579  
FAX: (301) 480-3780 
Email:  [email protected] 

SUBMITTING AN APPLICATION

Applicants for U19 grants must follow special application guidelines in the 
NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT 
AWARDS; this brochure is available via the WWW at: 
http://www.niaid.nih.gov/ncn/grants/multibron.htm

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 
Email: [email protected].

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the receipt dates noted at the heading of 
the Program Announcement.  

SENDING AN APPLICATION TO THE NIH: 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
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional exact copies of the grant 
application and all five sets of any appendix material must be sent to:

Dr. Dianne Tingley
Division of Extramural Affairs 
National Institute of Allergy and Infectious Diseases 
Room Number 2148A, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 496-2550
FAX: (301) 402-2638 
Email: [email protected]

Applications that are not received as a single package on the receipt date or 
that do not conform to the instructions contained in PHS 398 (rev. 5/01) 
Application Kit (as modified in, and superseded by, the NIAID BROCHURE 
ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS"), will be 
judged non-responsive and will be returned to the applicant. 

SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS PA:

Applicants for U19 cooperative agreements must follow special application 
guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR 
MULTI-PROJECT AWARDS; this brochure is available from NIAID listed under 
INQUIRIES via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm.

This brochure presents specific instructions for sections of the PHS 398 
(rev. 5/01) application form that should be completed differently than usual.  
For all other items in the application, follow the usual instructions in the 
PHS 398.

APPLICATION PROCESSING: Applications must be received by the application 
receipt date listed in the heading of this PA.  If an application is received 
after that date, it will be returned to the applicant without review.

The CSR will not accept any application in response to this PA 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 application must include an Introduction 
addressing the previous critique.
 
Concurrent submission of an R01 and a Component Project of a Multi-project 
Application:  Current NIH policy permits a component research project of a 
multi-project grant application to be concurrently submitted as a traditional 
individual research project (R01) application.  If, following review, both 
the multi-project application and the R01 application are found to be in the 
fundable range, the investigator must relinquish the R01 and will not have 
the option to withdraw from the multi-project grant.  This is an NIH policy 
intended to preserve the scientific integrity of a multi-project grant, which 
may be seriously compromised if a strong component project(s) is removed from 
the program.  Investigators wishing to participate in a multi-project grant 
must be aware of this policy before making a commitment to the Principal 
Investigator and awarding institution.

Although there is no immediate acknowledgement of the receipt of a 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

PEER REVIEW PROCESS  

Applications submitted to this PA will be assigned on the basis of 
established PHS referral guidelines.  

U19 applications that are complete and responsive to this PA will be 
evaluated for scientific and technical merit by an appropriate peer review 
group convened by the NIAID.

As part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Allergy and 
Infectious Diseases Council

REVIEW CRITERIA

The general review criteria for U19 multi-project cooperative agreement 
applications are presented in the NIAID brochure entitled "INSTRUCTIONS FOR 
APPLICATIONS FOR MULTI-PROJECT AWARDS" at  
http://www.niaid.nih.gov/ncn/grants/multibron.htm.

ADDITIONAL REVIEW CRITERIA:  In addition, the following review criteria items 
will be considered in the determination of scientific merit and the priority 
score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation 
in the proposed research will be assessed. (See criteria included in the 
section on Federal Citations, below).
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of 
plans to include subjects from both genders, all racial and ethnic groups 
(and subgroups), and children as appropriate for the scientific goals of the 
research will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.  

ADDITIONAL CONSIDERATIONS 

DATA SHARING:  The adequacy of the proposed plan to share data. 
BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit of the proposed project as determined by peer review 
o Availability of funds
o Programmatic priorities

The NIAID gives special consideration for funding, including award of grants 
beyond the established NIAID percentile and priority score paylines, to 
scientifically meritorious applications in response to Program Announcements.

REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.

MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a 
clear and compelling 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 clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at http://
grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy 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 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 is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  This policy announcement is in the NIH Guide for Grants and 
Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to 
the "Standards for Privacy of Individually Identifiable Health Information", 
the "Privacy Rule," on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as "covered entities") must do so by April 14, 2003  (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on "Am I a covered 
entity?"  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.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.   Furthermore, 
we caution reviewers 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 PA 
is related to one or more of the priority areas. 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 Catalogue of Federal Domestic Assistance at 
http://www.cfda.gov/ in the following citations: No. 93.855, Immunology, 
Allergy, and Transplantation Research and No. 93.856, Microbiology and 
Infectious Diseases Research. Awards are made under authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 
284and 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 NIH Grants Policy Statement is available at 
http://grants.nih.gov/grants/policy/policy.htm. This document includes 
general information about the grant application and review process; 
information on the terms and conditions that apply to NIH Grants and 
cooperative agreements; and a listing of pertinent offices and officials at 
the NIH.  All awards are subject to the terms and conditions, cost 
principles, and other considerations described in the NIH Grants Policy 
Statement. 

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the 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.

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