and Human Services (HHS)
EXPIRED
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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) 710-0267,
Email: [email protected].
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
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