NOVEL HIV THERAPIES: INTEGRATED PRECLINICAL/CLINICAL PROGRAM

RELEASE DATE:  June 12, 2003

PA NUMBER:  PAR-03-138 (This PA has been reissued with modifications, 
                        see RFA-AI-06-009)
                       (Change in status, see NOT-AI-05-046)
                       (See amendment, NOT-AI-05-035)

EXPIRATION DATE:  November 18, 2005, unless reissued.

National Institute of Allergy and Infectious Diseases (NIAID)
 (http://www.niaid.nih.gov)
National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov)

CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:
No. 93.855, Immunology, Allergy, and Transplantation Research
No. 93.856, Microbiology and Infectious Diseases Research
No. 93.242, Mental Health Research Grants

APPLICATION RECEIPT DATES: November 17, 2003; November 17, 2004; November 17, 
2005

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
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 National Institute of Allergy and Infectious Diseases (NIAID) and the 
National Institute of Mental Health (NIMH), National Institutes of Health 
(NIH), invite applications for the discovery, development, and evaluation of 
innovative therapies for HIV infection.  

Research advances in recent years have yielded a wealth of information on HIV 
molecular biology, the pathogenesis of HIV disease, and the impact of disease 
progression on immune function.  Concomitantly, pivotal methodological 
advances have been made.  Together this scientific and technological progress 
has made possible the exploration of a wide range of non traditional 
therapeutic concepts as well as traditional drug-based therapies exploiting 
novel viral and cellular targets.  This program announcement (PA) is designed 
to assist researchers interested in HIV therapeutics development to assemble 
the diverse scientific expertise and ancillary resources needed to translate 
basic laboratory discoveries to applied entities.  In the preclinical area, 
the PA seeks research on:  (1) the development/validation of new therapeutic 
targets; and (2) the discovery, development, and evaluation of small molecule 
inhibitors of viral or cellular proteins or pathways critical to HIV 
replication and/or persistence.  The inclusion of animal model studies is 
encouraged.  In the clinical area, the focus is on iterative bench to bedside 
research to optimize new therapeutic approaches.  Pilot clinical studies (10-
20 subjects) will provide the means for demonstrating proof-of-concept.

Applications may propose:  (1) preclinical research exclusively; (2) 
preclinical research that transitions to clinical research during the award 
period; or (3) clinical research in the first year of award.  Responsive 
applications will involve creative and original therapeutics research that 
has as its goal to move new treatment concepts to the clinic.  To facilitate 
the latter, applications are required to include at least one component (a 
research project or core) headed by and derived from the private sector, e.g. 
a pharmaceutical or biotechnology company.  Excluded from this PA is research 
on targets and approaches already under extensive investigation, topical 
microbicides to block HIV transmission, non-targeted random screening of 
potential inhibitors, and research on AIDS-associated opportunistic pathogens 
and malignancies. 

RESEARCH OBJECTIVES

For more than 15 years, drug discovery efforts have concentrated on a 
relatively small number of HIV targets:  the reverse transcriptase (RT) and 
protease (PR).  While viral load can be reduced dramatically by combining RT 
and PR inhibitors in regimens referred to as highly active anti-retroviral 
therapy (HAART), recent studies suggest that many treatment failures occur 
due to the development of drug resistance and/or lack of adherence to 
complicated and often toxic regimens.  Recently, new classes of agents 
directed at the virus binding and entry process have entered the development 
pipeline, with one such agent now approved for use in patients with HIV 
infection.  Early data suggest, however, that the development of resistance 
will continue to be a problem as new agents are introduced into HAART 
regimens.  Moreover, extensive research has shown that HAART cannot totally 
eliminate HIV-1 and only partially reverses virus-related damage to the 
immune system.  Thus, there remains an urgent need for the identification of 
new host and viral targets, novel drugs and delivery systems, and approaches 
to boost/restore the immune system.  

The objectives of the IPCP are to:  (1) maintain a strong and diverse base in 
preclinical discovery and development of new therapeutics, and (2) support 
the translation of innovative treatment concepts from preclinical studies to 
pilot clinical proof-of-concept studies.  Successful programs will develop a 
new treatment concept that can be reduced to clinical practice and/or open a 
new research direction.

Examples of research of interest to the IPCP under the current PA include, 
but are not limited to:

o  Development/validation of new therapeutic targets
o  Discovery, development, and evaluation of small molecule inhibitors of 
viral or cellular proteins or pathways critical to HIV 
replication/persistence
o  Development of strategies or entities to eliminate viral reservoirs 
o  Strategies to boost HIV-specific immune responses and/or improve immune 
function, e.g. therapeutic vaccines, adjuvants, cytokine therapies
o  Gene transfer strategies to interfere with the replication or spread of 
HIV-1
o  Identification of the molecular and cellular mechanisms and the genetic 
factors contributing to HIV-related CNS dysfunction as well as the 
development of CNS targeted therapeutics.

A list of projects supported under previous issuances of the PA (PAR97-080 & 
00-098) can be found at: http://www.niaid.nih.gov/daids/pdatguide/ipcp.htm.

MECHANISM(S) OF SUPPORT

This PA will use the NIH program project grant (P01) award mechanism.  The 
applicant will be solely responsible for planning, directing, and executing 
the proposed project.  Program project grants support broadly based, 
multidisciplinary research programs that have a well-defined, central 
research focus or objective.  An important feature is that the 
interrelationships of the individual scientifically meritorious projects will 
result in a greater contribution to the overall program goals than if each 
project were pursued individually.  The program project grant consists of a 
minimum of three interrelated individual research projects that contribute to 
the program objective.  The P01 type of award can also provide support for 
certain common resources termed cores.  Such resources should be utilized by 
two or more projects within the award.  To facilitate the development of new 
therapeutic concepts and entities under this program, each program project is 
required to include a research project or core headed by and derived from the 
private sector, e.g. a pharmaceutical or biotechnology company.  The total 
project period for this PA is 4 years.

Since the clinical research to be carried out under this program may pose 
more than minimal risk to study subjects, the P01 will be converted to a 
cooperative agreement (U01 or U19) if the project transitions to the clinical 
mode.  Terms of agreement will be negotiated with the PI and the applicant 
institution at the time of the transition. 

The suggested budget for a Group engaged exclusively in preclinical research 
is $650,000 direct) costs for the first year.  Applicants proposing the use 
of large animals (e.g. monkeys) may increase this amount to $775,000 direct 
costs, upon pre-approval by the Program Official listed under "INQUIRIES".  
The maximum budget for a Group actively engaged in clinical studies is $1.3 
million direct costs for the first year.  Groups proposing to transition from 
preclinical to clinical studies during the award period should submit a 
budget for each phase that reflects the limits given above.

The level of support available for clinical research under this PA may be 
insufficient to provide all the funds necessary to conduct the proposed 
clinical study.  Prospective Groups are therefore encouraged to develop plans 
to use existing infrastructure and organizational support to complement the 
award [including NIH-sponsored General Clinical Research Centers (GCRC) and 
Centers for AIDS Research (CFAR)].  These plans should be included in the 
application.

Applicants for P01 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 

The applicant may submit (an) application(s) if their 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 (i.e. located within the USA and territories thereof)

The applicant institution may include, as components of the P01, research 
projects or cores originating from collaborators at foreign institutions.  

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 

Intellectual property (IP)

Since an application may include several institutions, including the private 
sector, complex IP situations may arise.  To avoid delays in implementing new 
therapies for HIV, each multi-project group is required to provide a plan as 
part of the application, detailing (1) the approach to be used for obtaining 
patent coverage and for licensing, where appropriate; (2) a statement 
demonstrating acceptance of the approach, signed by all parties; (3) a 
description of procedures to be followed for the resolution of legal problems 
that potentially may develop; and (4) a list of existing patents/licenses 
related to the proposed research.

The agreement among the institutions comprising the Group, signed and dated 
by the organizational officials authorized to enter into such arrangements 
for each Group member and member institution, must be submitted with the 
application, and a copy submitted to the NIAID program official specified 
under INQUIRIES.  If the Group wishes to place all inventions and discoveries 
resulting from these studies within the public domain, a letter to that 
effect must be submitted in lieu of the agreement.  The letter must be co-
signed by the Principal Investigator, each of the Project Leaders, and each 
of the business officials representing the respective institutions.

Meetings and Travel

Funds should be budgeted to cover the costs associated with 1 IPCP group 
meeting per year for the PI, the Project and Core Leaders, and the Scientific 
Advisory Board members.  No travel funds will be provided for investigators 
to attend other domestic or foreign scientific meetings.

Scientific Advisory Panel

The PI will constitute a Scientific Advisory Panel of 2-3 investigators not 
affiliated with any of the institutions comprising the Group, if an award is 
made.  Selecting Panel members in advance of the review, and naming them in 
the application, narrows the field of potential reviewers.  This is a post 
award activity.

The Panel will attend one or more IPCP group meetings each year, review the 
Group's activities, and evaluate progress, adherence to the original time 
frame of activities, and the continued relevance of each project to the 
Group's overall goals.  The Panel will recommend new directions as 
appropriate and will provide the PI with a comprehensive written evaluation 
of the Group's activities and recommendations after each meeting.  A copy of 
the report will be sent to the DAIDS Scientific Coordinator within 30 days of 
the meeting.  [The Scientific Coordinator for each group will be the Program 
Officer assigned to the group on the basis of his/her scientific research 
expertise.]

Terms and Conditions

o  Groups proposing human studies during the term of the award must include a 
development plan in the application.  The plan must articulate a set of goals 
and milestones to be completed prior to the transition from preclinical to 
clinical studies and a time table for achieving them.  The goals and 
milestones will be used to judge the completion of the preclinical 
development phase and the readiness of the Group to proceed to the clinical 
phase.  This decision will be made by the NIAID and may involve the 
Scientific Advisory Panel and/or outside expertise.  For purposes of the 
initial peer review, the application must include a clinical protocol based 
on research findings available at the time of submission, including the 
designation of a clinical site and investigators to be involved. 

o  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.  

o  Release of funds for the clinical study will depend on compliance with the 
NIAID Clinical Terms of Award, including the applicable institutional and 
regulatory requirements (IRB, IBC, FDA, RAC, other).  NIH policy regarding 
compliance with NIH guidelines on recombinant DNA research is found at: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-052.html.

o  If the research transitions from the preclinical to the clinical mode, the 
P01 will be converted to a cooperative agreement (U01 or U19).  Additional 
terms and conditions will be negotiated at that time.

WHERE TO SEND INQUIRIES

The NIAID encourages inquiries about this PA and welcomes 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 questions about NIAID scientific/research issues to:

Sandra Bridges, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 4128, MSC-7626
6700-B Rockledge Drive
Bethesda, MD 20892-7626
Telephone:  (301) 496-8198
FAX:  (301) 402-3211 
Email:  sb33j@nih.gov 

o  Direct questions about NIMH scientific/research issues to:

Kathy Kopnisky, Ph.D.
Division of Mental Disorders, Behavioral Research & AIDS
National Institute of Mental Health
Room 6199, MSC-9619
6001 Executive Blvd.
Bethesda, MD 20892-9619
Telephone:  (301) 443-7726
FAX:  (301) 443-9719
Email:  kk150q@nih.gov 

o  Direct questions about peer review issues to:

Dianne Tingley, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2148, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Telephone:  (301) 496-0818
FAX:  (301) 402-2638
Email:  dt15g@nih.gov 

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

Patricia Felner
Division of Extramural Activities 
National Institute of Allergy and Infectious Diseases
Room 3224, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone:  (301) 402-6450
FAX:  (301) 493-0597
Email:  pf14h@nih.gov 

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

Brian Albertini
Division of Mental Disorders, Behavioral Research & AIDS
National Institute of Mental Health 
Room 6135
6001 Executive Blvd. 
Bethesda, MD 20892
Phone:  (301) 443-0004
Fax:  (301) 443-6885
Email:  ba18b@nih.gov

SUBMITTING AN APPLICATION

Applicants for P01 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) 435-0714, 
Email:  GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES: Applications submitted in response to this Program 
Announcement will be accepted at the receipt dates specified on the front 
page of this PA.

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. 

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 at the address listed under INQUIRIES.

APPLICATION PROCESSING: Applications must be received by the receipt dates 
listed on the front page of the PA.  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 an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines. An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit. 

P01 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 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 written critique
o Receive a second level review by an appropriate national advisory council 
or board.

REVIEW CRITERIA

The general review criteria for P01 grant 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: 

o  The likelihood that the research will open new directions in the treatment 
of HIV disease or containment of HIV infection, demonstrate a capacity to be 
translated to clinical practice, and merit evaluation in IND-directed 
clinical trials for safety and proof-of-concept. 

o  The suitability of the proposed private sector partner to the overall 
scientific objectives of the Group; scientific capabilities of the private 
sector partner; commitment to the Group's objectives and to the development 
of the proposed therapeutic entity or modality; adequacy of the development 
plan to achieve the scientific goals of the proposed research and to move the 
proposed therapeutic toward clinical application.

o  The commitment of the Principal Investigator (PI) and Project Leaders 
(PLs) to devote substantial time and effort to the program.  [Due to the 
complexity and time required to maintain a well coordinated and productive 
research effort, a minimum 20% effort by the PI and PLs is strongly 
suggested.]

o  The multidisciplinary nature of the P01.  The Group should be composed of 
independent investigators from diverse research settings, e.g. from different 
academic departments (if from the same institution or company), from 
different institutions, from the private sector.

o  The soundness of the administrative and organizational structure of the 
program.  The description of the Administrative Core should detail short and 
long term management components of the Program, such as:  communication, 
group meetings, sharing and transmission of information and reagents, 
problems and how will they be addressed, engagement of the Scientific 
Advisory Panel and NIAID, as appropriate, in the Group's research 
activities/meetings, consideration and integration of scientific 
input/recommendations from the Scientific Advisory Panel and NIAID, as 
appropriate, into scientific direction and decision-making, timely reporting 
as required in the NIAID Clinical Terms of Award, and other aspects relevant 
to the cohesiveness and interactive nature of group activities.

For Groups focusing on preclinical research:

o  the likelihood that the target/strategy will be developed and moved toward 
clinical evaluation during the award period.

For groups proposing clinical research:

o  Adequacy and validity of the proposed milestones for determining the 
readiness of the Group to transition to clinical research; iterative research 
plan to develop and optimize the proposed strategy; protocol design; short 
and long term development plans; contingency plans; plans to ensure the 
safety of research subjects; plans to evaluate outcome even if unanticipated; 
and provisions to obtain the required institutional and regulatory approvals 
(IRB, IBC, FDA, RAC, if applicable) to conduct the clinical study.

o  Experience of the PI and PLs in the planning, design, and conduct of small 
clinical studies in HIV-infected subjects; availability of a GCRC, CFAR, or 
other additional source of institutional support and/or statistical support; 
the infrastructure required for the conduct of safe and efficient clinical 
research; and short and long range plans that will result in the successful 
implementation of clinical studies during the award period.

If application is a competitive renewal:  

o  The novelty and importance of the proposed concept.  The concept must be 
new, substantially improved, or represent a new opportunity/direction 
originating in the previously funded program.

Each of these review 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. 

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 included in the 
section on Federal Citations, below.)

CARE AND USE OF VETERBRATE 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

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions: 

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION:  Federal regulations (45 CFR 46) 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.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

MONITORING PLAN AND DATA AND SAFETY AND 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://stemcells.nih.gov/index.asp 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, No. 93.856, Microbiology and 
Infectious Diseases Research, and No. 93.242, Mental Health Research Grants.  
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 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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
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Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
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