QUICK-TRIALS FOR NOVEL CANCER THERAPIES: EXPLORATORY GRANTS

RELEASE DATE:  August 31, 2004

PA NUMBER:   PAR-04-155

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. This announcement will stay active for 
only the May 1, 2006 AIDS and AIDS-related application submission date. The 
non-AIDS portion of this funding opportunity expires on the date indicated below. 
A replacement R21 (PAR-06-451) funding opportunity announcement has been issued 
for the submission date of June 1, 2006 and submission dates for AIDS and 
non-AIDS applications thereafter.

EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006 

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH) 
 (http://www.nih.gov)

COMPONENT OF PARTICIPATING ORGANIZATION:
National Cancer Institute (NCI) 
 (http://www.nci.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.393, 93.394, 93.395  

APPLICATION RECEIPT DATES:  December 9, 2004; April 9, 2005; August 9, 2005; 
December 9, 2005; April 9, 2006; August 9, 2006; December 9, 2006
April 9, 2007; August 9, 2007; December 9, 2007

This Program Announcement (PA) replaces PAR-03-005, which was published in 
the NIH Guide on October 7, 2002.

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA

Continuing progress in basic cancer research and drug development has led to 
discoveries of new agents or approaches for molecular targeting in novel 
cancer therapies. These new agents or approaches suppress tumor growth 
through multiple mechanisms such as cell cycle control, activation of tumor 
suppressor genes, essential signal pathway blockage, tumor vaccines, tumor 
microenvironment modification, etc. Rapid translation of these exciting 
discoveries into clinical practice requires timely support to accommodate the 
special needs of novel cancer therapy development. This Program Announcement 
(PA) is intended to provide investigators with rapid access to support for 
pilot, Phase I, and Phase II cancer clinical trials as well as support for 
patient monitoring and laboratory studies linked to a cancer clinical trial.  
Phase III trials are not excluded but such trials generally require greater 
resources and duration than available from an R21 award.  Applications that 
do not propose a cancer clinical trial or patient monitoring or laboratory 
studies linked to a cancer clinical trial may be returned to applicants 
without being reviewed.  The focus of this QUICK-TRIAL PA is on translational 
research in new agent development to ensure the timely exploitation of new 
cancer therapeutic approaches including the development of new cancer 
prevention agents. This PA is aimed at providing a new approach in the grant 
application process by offering a rapid turnaround from application 
submission to funding. Features of this initiative include a modular grant 
application and award process, inclusion of the clinical protocol within the 
grant application, and an accelerated peer review with the goal of issuing 
new awards within six months of application receipt. Inclusion of the 
complete clinical protocol within the PHS 398 grant application is intended 
to simplify the application process by eliminating the need to duplicate 
protocol details in the Research Plan section and to insure proper peer 
review of the application. In addition, QUICK-TRIAL applications do not 
require extensive preliminary data in the grant application and support 
exploratory translational and clinical research studies involving cancer 
prevention, chemotherapy and rapid development and application of novel 
clinical cancer therapies including image guided therapeutic procedures. 
Investigators may apply for a maximum of two years of funding support using 
the exploratory or developmental (R21) grant mechanism for up to $250,000 
direct costs per year.

RESEARCH OBJECTIVES

Advances in the understanding of molecular cancer genetics, basic cancer 
biology, and the development of powerful technologies such as microarray, 
proteomics and bioinformatics have led to the identification of many new 
molecular targets and pathways in cancer cells. These discoveries have 
created new frontiers for novel molecular cancer prevention and treatment 
leading to the development of molecular medicine in cancer therapy. In 
addition, these novel targets and pathways have presented excellent 
translational research opportunities for revolutionizing cancer drug 
development and bringing more effective molecular cancer therapies and cancer 
prevention strategies into clinical practice.

Novel approaches or agents for inhibiting tumor growth either directly or by 
impacting the tumor microenvironment are ready to be tested in the clinic 
with new tools and laboratory analyses that allow investigators to ascertain 
how specific targets are affected by therapy. These agents include new 
classes of cytotoxic agents, agents or approaches that act via immune-
stimulatory effects, agents that stimulate apoptosis, inhibit angiogenesis 
and metastasis or alter tumor cell signaling pathways, and agents targeted 
specifically to novel cancer cell targets. New clinical therapeutic trials 
may employ drugs/agents, biologics, radiation, heat, or surgery used as 
single agents/modalities or in combination for the treatment of early and 
advanced disease. In addition, clinical trials of therapies for cancer 
treatment, including but not limited to herbal therapies, dietary 
supplements, bioactive food components, or unconventional pharmacological and 
biological interventions (e.g. antineoplastons, Coley's toxin, enzyme 
therapies, etc.) will be considered. Another relevant area of investigation 
is the use of anatomical and molecular image guidance for targeted treatment 
with ablative techniques or delivery of chemotherapeutic agents.  At present, 
there are few funding mechanisms targeted to stimulate the translation of 
promising and potentially relevant advances in new prevention or therapeutic 
agent development from the laboratory into the clinical setting. Quite 
frequently the initial stages of clinical investigation are the most 
difficult to accomplish. They are resource intensive, and, to be done well, 
they require laboratory, pharmacology, and other resource support, as well as 
substantial personnel effort, none of which is supported by traditional 
health benefit programs. Nonetheless, these early studies tend to fare poorly 
in competition for conventional grant support precisely because they are 
preliminary and cannot serve as the definitive tests of new approaches. Even 
when funding is received, the review and award cycle may introduce a year or 
more of delay. Except where there is an industrial sponsor with a particular 
commitment to development of an agent, it may take a long time for a 
promising approach to get through the initial phase of demonstrating 
feasibility and interest, or it may never be tested in more than one or two 
diseases. 

This PA will continue to support scientific, technological, clinical and 
logistical needs in novel cancer therapy development. In addition, this PA 
will complement the Rapid Access to Intervention Development (RAID) program 
http://dtp.nci.nih.gov/docs/raid/raid_index.html by providing an initiative 
with accelerated peer review and funding to support the clinical and 
laboratory costs of early clinical testing to ensure the timely development 
of new therapeutic approaches. 

MECHANISM OF SUPPORT 

This PA will use the NIH exploratory/development (R21) award mechanism.  As 
an applicant, you will be solely responsible for planning, directing, and 
executing the proposed project.  The applicant may request a project period 
of up to 2 years with direct costs limited to $250,000 per year.

This PA uses just-in-time concepts.  It also uses the modular budgeting 
format (see http://grants.nih.gov/grants/funding/modular/modular.htm).  This 
program does not require cost sharing as defined in the current NIH Grants 
Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.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 institutions/organizations
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. 

WHERE TO SEND INQUIRIES

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

Direct your questions about scientific/research issues to:

Dr. Roy Wu, 
Clinical Grants & Contracts Branch 
Cancer Therapy Evaluation Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Boulevard. EPN Room 7009
Bethesda, MD 20892-7432
Rockville, MD 20852 (for express/courier service)
Telephone: 301-496-8866
Fax: 301-480-4663
E-mail: wur@ctep.nci.nih.gov 

Direct your questions about financial or grants management matters to:

Ms. Amy Connolly
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, EPS Room 243
Bethesda, MD  20892-7150
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 496-8786
FAX:  (301) 496-8601
Email:  amyconnolly@nih.gov 

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  Applications must have a Dun and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The D&B number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/. The D&B number 
should be entered on line 11 of the face page of the PHS 398 form.  The PHS 
398 document 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.

The title and number of this program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be checked.

Because Quick-Trial applications will propose cancer clinical trials or 
patient monitoring or laboratory studies linked to a cancer clinical trial, 
applicants are reminded to properly complete item e- Humans Subjects Research 
of the Research Plan.  This is described in PHS 398.  As applicable, the 
Human Subjects Research portion of the Research Plan includes, but is not 
limited, to a Data and Safety Monitoring Plan, Women, Minority, and Children 
Inclusion sections, and a Targeted/Planned Enrollment Table.  In addition 
please note special requirements for item e- Humans Subjects Research of the 
Research Plan below.      

SUPPLEMENTARY INSTRUCTIONS

1.  Although preliminary data are not required for an R21 application, they 
may be included.  Because of the clinical nature of Quick-Trial applications, 
applicants should consider the importance of providing preliminary data to 
justify human experimentation.

2.  RESOURCES: A description of both the clinical and laboratory facilities 
and resources should be included in the grant application. This includes 
detailed information on plans for data management, quality control of patient 
and laboratory data, and computer resources and plans for handling both 
laboratory and clinical data. If Cancer Center cores will be used for these 
tasks, letters of support from the appropriate individual with authority to 
commit the needed resources should be included in the application. Provide 
information on resources provided by the drug sponsor if not in your 
institution.

3.  RESEARCH PLAN: Items a - d of the Research Plan (Specific Aims, 
Background and Significance, Preliminary Studies, and Research Design and 
Methods) may not exceed a total of 15 pages.  No preliminary data is required 
but may be included if it is available.  Please note that a Progress Report 
is not needed; competing-continuation applications for an 
exploratory/developmental grant will not be accepted.

Item a - Specific Aims - In one page or less, list in priority order, the 
broad, long-range objectives.  Describe concisely and realistically the 
hypothesis to be tested and what the specific research described in this 
application is intended to accomplish.

Item b - Background and Significance - In two pages or less, use this section 
to describe (a) how the proposed research will contribute to meeting the 
goals and objectives of the PA; and, (b) explain the rationale for the 
selection of the general methods and approaches proposed to accomplish your 
specific aims.  Describe the significance of the planned studies and consider 
how the pilot study, if encouraging, could transition into an eventual 
definitive test of the therapeutic approach.  Describe the innovative aspects 
of the studies including novel concepts, approaches, or methodologies.  Do 
not include background material provided in the clinical protocol document 
but you may refer to the appropriate sections/pages of the protocol.

Items c-d - Progress Report/Preliminary Studies, Research Design and Methods 
- In twelve pages or less, complete as instructed in the PHS 398 booklet.  TO 
THE EXTENT THAT MATERIAL INCLUDED IN THE CLINICAL PROTOCOL IS ADEQUATE FOR 
REVIEW, IT NEED NOT BE REPEATED IN THESE SECTIONS c-d.  (The clinical 
protocol and informed consent form(s) must be included in the Human Subjects 
section even if support is only requested for related laboratory or patient 
monitoring studies.) The investigator may use these sections (c-d) to address 
the following:

o Preliminary studies pertinent to the application;
o Rationale and hypothesis for the clinical trial and laboratory studies;
o General methods that will be utilized (clinical, laboratory, or both, as 
appropriate); reason(s) for selecting these approaches; provide specific 
details for those techniques which are unique or where a significant 
departure from a generally accepted technique is important for reviewers to 
know;
o Outcome measures that will be used to assess the success or failure of each 
set of experiments (include statistical analyses for laboratory and clinical 
studies); clinical endpoints should be discussed with particular emphasis on 
those aspects that may be especially complicated in clinical trials (e.g., 
lack of conventionally measurable disease; patients whose only evidence of 
disease is biochemical);
o A statistical section should be included discussing the choice of the 
clinical trial design and laboratory analyses with power calculations. The 
statistician involved with the study should be identified and a letter of 
support included if no effort is requested on the grant application.  Plans 
for data management and verification of research data should also be 
included;
o Potential pitfalls in the experimental design and alternative studies that 
will be done if the proposed experiments fail. 

4.  HUMAN SUBJECTS: IN ADDITION TO THE INFORMATION REQUESTED IN THE PHS 398 
FORM, INCLUDE THE COMPLETE CLINICAL PROTOCOL AND INFORMED CONSENT FORM(S) IN 
THIS SECTION. Include the complete clinical protocol and informed consent 
forms(s) even if support is only requested for related laboratory or patient 
monitoring studies.  NIH will treat as confidential any scientific, 
preclinical, clinical, or formulation data and information that the sponsor 
deems to be proprietary and confidential.  

5.  IN ADDITION, applicants must insure that the first page of the human 
subjects section includes the following drug availability/IND information:

1a)  If NCI-provided agent(s) will be used, indicate the CTEP-assigned 
LOI/Protocol number and date of the CTEP LOI/Protocol response letter 
confirming potential availability.

1b) If agent(s) will be provided by a company, indicate that a letter is 
provided confirming plans to provide agents and the date of availability.

1c)  If this protocol is an initial IND-filing study, indicate the date the 
IND was submitted to the FDA and the status of the application.  An IND is 
not required to submit a Quick-Trials application, but for trials in which an 
IND is necessary, it is required before a Quick-Trials award can be made.

1d)  If none of the above (1a, 1b, or 1c) applies indicate this on the first 
page of the human subjects section.

NCI/CTEP or drug company correspondence addressing agent availability should 
be included in the human subjects section, 
as applicable.    

6.  APPENDIX: Include a maximum of 5 publications, manuscripts (accepted for 
publication), abstracts, patents, or other printed material relevant to this 
project. 

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: All investigator 
initiated R21 applications must be submitted in a modular grant format.  The 
modular grant format simplifies the preparation of the budget in these 
applications by limiting the level of budgetary detail.  Applicants request 
direct costs in $25,000 modules.  Section C of the research grant application 
instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

SENDING AN APPLICATION TO THE NIH: Submit a signed, type written original of 
the application, including the checklist, and five 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)

APPLICATION PROCESSING:  Applications must be received on or before the 
receipt dates listed on the first page of this 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 unfunded version of an application already 
reviewed, but such application must include an Introduction addressing the 
previous critique.

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.  

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 the National Cancer Advisory Board. 
 
REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to evaluate the application in 
order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals.  The scientific review 
group will address and consider each of these criteria in assigning the 
application’s overall score, weighting them as appropriate for each 
application.  

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The application does not need to be strong in all categories to be judged 
likely to have 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.

SIGNIFICANCE: Does this study address an important problem? If the aims of 
the application are achieved, how will scientific knowledge be advanced? What 
will be the effect of these studies on the concepts or methods that drive 
this field?

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

INNOVATION: Does the project employ novel concepts, approaches or methods? 
Are the aims original and innovative? Does the project challenge existing 
paradigms or develop new methodologies or technologies?

INVESTIGATOR: Is the investigator appropriately trained and well suited to 
carry out this work? Is the work proposed appropriate to the experience level 
of the principal investigator and other researchers (if any)?

ENVIRONMENT: Does the scientific environment in which the work will be done 
contribute to the probability of success? Do the proposed experiments take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements? Is there evidence of institutional support?  

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
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 REVIEW CONSIDERATIONS

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 

ANIMAL WELFARE PROTECTION:  Recipients of PHS support for activities 
involving live, vertebrate animals must comply with PHS Policy on Humane Care 
and Use of Laboratory Animals 
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as 
mandated by the Health Research Extension Act of 1985 
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA 
Animal Welfare Regulations 
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.

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. See 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy, 
effectiveness and comparative trials (phase III). The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the 
participants.  (See NIH Policy for Data and Safety Monitoring, NIH Guide for 
Grants and Contracts, June 12, 1998 at 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html.)  

Clinical trials supported or performed by NCI require special considerations.  
The method and degree of monitoring should be commensurate with the degree of 
risk involved in participation and the size and complexity of the clinical 
trial.  Monitoring exists on a continuum from monitoring by the principal 
investigator/project manager or NCI program staff or a Data and Safety 
Monitoring Board (DSMB).  These monitoring activities are distinct from the 
requirement for study review and approval by an Institutional review Board 
(IRB).  For details about the Policy for the NCI for Data and Safety 
Monitoring of Clinical trials see: 
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.  For Phase I and II 
clinical trials, investigators must submit a general description of the data 
and safety monitoring plan as part of the research application.  For 
additional information, see NIH Guide Notice on “Further Guidance on a Data 
and Safety Monitoring for Phase I and II Trials” at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.  
Information concerning essential elements of data safety monitoring plans for 
clinical trials funded by the NCI is available at 
http://www.cancer.gov/clinical_trials/.

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 "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. 

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.  You will find this policy announcement 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.  A 
continuing education program in the protection of human participants in 
research is available online at http://cme.nci.nih.gov/.

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, in the project 
description and elsewhere in the application as appropriate, 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).  

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 Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92  All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm.

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)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


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