IMPROVING CARE FOR DYING CHILDREN AND THEIR FAMILIES 

RELEASE DATE:  February 5, 2004

PA NUMBER: PA-04-057

January 3, 2007 - Effective with the February 5, 2007 submission date, 
all R01 applications must be submitted through Grants.gov using 
the electronic SF424 (R&R) application. Accordingly, the R01 portion 
of this funding opportunity expires on January 3, 2007.  Unsolicited 
or investigator-initiated R01 electronic SF424 (R&R) applications may 
be submitted through the Research Project Grant (Parent R01) announcement.

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 for these 
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms 
expires on the date indicated below. Other mechanisms relating to this announcement 
will continue to be accepted using paper PHS 398 applications until the stated 
expiration date below, or transition to electronic application submission. Parent 
R03 (PA-06-180) and R21 (PA-06-181) funding opportunity announcements have been 
issued for the submission date of June 1, 2006 and submission dates for AIDS and 
non-AIDS applications thereafter. Applications relating to R33 and R34 activities 
must be in response to NIH Institute/Center (IC)-specific announcements.

EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006 
EXPIRATION DATE for All R01 Applications: January 3, 2007

Department of Health and Human Services (DHHS)

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

COMPONENTS OF PARTICIPATING ORGANIZATION: 
National Institute of Nursing Research (NINR) 
 (http://www.ninr.nih.gov)
National Cancer Institute (NCI) 
 (http://www.nci.nih.gov)
National Institute of Child Health and Human Development (NICHD) 
 (http://www.nichd.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.361 (NINR), 93.865 
(NICHD), 93.395 (NCI)

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 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  

The National Institute of Nursing Research (NINR), the National Cancer 
Institute (NCI), and the National Institute of Child Health and Human 
Development (NICHD) invite applications to encourage research that will 
improve the quality of life for children who are approaching the end of life, 
the quality of the dying process, and bereavement following the death for the 
children's families, friends and other care providers.  For this PA, family 
is defined broadly in terms of traditional families and non-traditional 
families including children being cared for in foster situations, by distant 
relatives, or friends. Children are defined according to NIH as individuals 
below 21 years of age. Attention to children of all developmental stages, 
infancy through adolescence, is highly encouraged. 

RESEARCH OBJECTIVES

A recent Institute of Medicine (IOM) report, "When Children Die: Improving 
Palliative and End of Life Care for Children and Their Families," highlights 
the importance of facing the challenges of caring for dying children and 
their families (IOM, 2002). In 1997, the five leading causes of death in 
children under the age of 15 were accidents, congenital anomalies, cancer, 
homicide and diseases of the heart (National Vital Statistics Report, 1999).  
While these deaths are relatively uncommon in the United States (55,000 in 
1999), the international burden of childhood death is staggering.  For 
example, the Joint United Nations Program on HIV/AIDS (UNAIDS) estimates that 
580,000 children under the age of 15 succumbed to HIV/AIDS during 2001. 
Regardless of the number of deaths, the death of a child can be a devastating 
event for the family, friends and care providers.  Despite the importance of 
this issue, there is very little scientific knowledge to guide the care of 
dying children and their families.  What is known is primarily anecdotal.  
For example, many, if not most, care providers avoid discussing the possible 
death of a child with the families and the children themselves.  This 
reluctance leads to care that focuses so single-mindedly on cure or life-
prolongation that the possibility (or even likelihood) of death is ignored 
and the potential burdens of treatment are not adequately weighed against 
potential benefits.  Consequently, opportunities to combine curative 
therapies, such as anticancer regimens, with palliative therapies that will 
prevent or relieve a child's suffering are neglected.  

The cause of the child's death is important to consider.  When a child dies 
of a sudden and unexpected event, the parents, siblings, extended family and 
friends become the focus.  Interactions between the family and the health 
care providers in the emergency room or between the family and other 
emergency response personnel can leave a lasting, and often unpleasant memory 
with the survivors.  When a child dies of a chronic condition, such as 
cancer, it is likely that the family and the health care providers have 
established relationships that are truncated when the child dies. Loss of 
this ongoing support system can impair the family's ability to cope with the 
loss of their child, particularly if health care providers have served as the 
primary support, as can be the case with stigmatized illnesses such as 
HIV/AIDS.  The death of a child due to a genetic illness or to HIV/AIDS adds 
further complexity because parents sometimes feel guilty for passing the 
life-threatening illness to their child.  Genetic illnesses or HIV/AIDS may 
be one of the few scenarios where there can be foreknowledge of impending 
death in a child who is currently in good health or where a fatal congenital 
condition can be diagnosed prenatally.  Children dying from stigmatized 
diseases such as AIDS may face significant barriers to high-quality end-of-
life care.

No matter the cause of death, health care providers need to focus on 
promoting the quality of life of the child and family. Managing symptoms, 
such as cancer related pain or chemotherapy induced nausea and vomiting, can 
be particularly difficult in children because of dosing uncertainties, side 
effects and the reluctance of care providers to give opiate medications to 
children. Communication with the child and family that focuses on cure, 
rather than the potential for death, can also affect the quality of life at 
the end of life because the child may be unaware that he/she is dying.  Age 
appropriate communication that includes the child and family can prevent 
unwanted interventions and facilitate a peaceful death.  The siblings of 
chronically ill children are often isolated and grieve in silence or harbor 
feelings of anger and guilt as family attention and resources are focused on 
the ill child.  Ways to appropriately include and support siblings throughout 
the dying process need to be elucidated.  

Where the child dies can have a profound impact on his/her quality of life at 
the end of life and the family's experience of the dying process.  When the 
possibility of death has not been discussed until very late in the dying 
process, dying children are often admitted to intensive care units and die a 
"high tech" death.  Such deaths can isolate the family from the dying child 
and prevent a peaceful death.  Research is needed to identify and test 
approaches that care providers can implement to improve the care of dying 
children in all settings, including children dying from a stigmatized illness 
such as HIV/AIDS in areas with limited resources. This initiative fits with 
the overall NIH Roadmap activities that are underway, particularly the two 
goals of increasing the interdisciplinary research teams of the future and 
re-engineering the clinical research enterprise.

Research Scope

The chapter on research directions in the IOM report (2002) offers 
suggestions for future research directions regarding care for dying children 
and their families.  Examples of potential research topics include, but are 
not limited to the following:

o Identify age specific end-of-life issues from infancy through adolescence 
and determine how the age of the child and or the age of the parents 
influences the dying process.

o Test ways of integrating palliative care with life prolonging therapies in 
children with life threatening illnesses.

o Identify the dying trajectories of children (e.g., sudden death vs. life 
threatening condition) and determine if interventions can and should be 
structured according to the trajectories.

o Test interventions to facilitate communication among health professionals 
and the extended family in different situations such as prenatal diagnosis of 
a fatal condition, premature birth, and death of a child from traumatic 
injury or chronic illness such as cancer.

o Evaluate the role of health care providers in the lives of chronically ill 
children and their families, especially when the emphasis changes from cure 
to end-of-life care, or when families have few supports outside of the health 
care system.

o Evaluate effective bereavement interventions for siblings, parents, and 
other family members or caregivers and determine the effect the type of death 
(e.g., violence, suicide, cancer, stigmatized illness) has on the bereavement 
process. 

o Identify specific issues in vulnerable children (e.g., those who are from 
resource poor settings, handicapped,  stigmatized or who have experienced 
multiple losses, ) who are diagnosed with life threatening conditions. 

o Determine approaches appropriate to the cognitive and emotional maturity of 
the child, to assess and manage physical and psychological symptoms 
associated with conditions that are likely to be fatal.

o Test culturally sensitive communication models, appropriate to the 
cognitive and emotional maturity of the child, that involve him/her in 
decision making throughout a life threatening illness and death.

o Test interventions to determine the optimum time to initiate end-of–life 
options and the impact of early versus later initiation on the dying and the 
bereavement process (e.g., prenatal diagnosis of a fatal condition, very 
premature or very low birth weight birth, traumatic injury or chronic illness 
such as cancer).

o Evaluate the effect of a child's death on the family unit, especially 
siblings.

o Develop and test culturally sensitive individual, peer, family, community 
and structural interventions that promote a peaceful death for the child 
within the cultural context of the family.

MECHANISMS OF SUPPORT 

This PA will use the NIH R01 and R21 award mechanisms.  All participating 
Institutes have agreed to follow the NIH Guidelines for the R21 mechanism.  
As an applicant, you will be solely responsible for planning, directing, and 
executing the proposed project.  The objective of the R01 mechanism is to 
support a discrete, specified circumscribed project. The objective of the 
exploratory/developmental mechanism (R21) is to encourage applications from 
individuals who are interested in testing innovative or conceptually creative 
ideas that are scientifically sound and may advance our understanding of 
improving care for dying children and their families. Investigators are 
encouraged to explore the feasibility of an innovative research question or 
approach that will provide a basis for future research projects. 
Exploratory/developmental grants (R21) are limited to 2 years of support with 
a combined budget for direct costs of up $275,000 for the two-year period.  
For example, the applicant may request $100,000 in the first year and 
$175,000 in the second year.  The request should be tailored to the needs of 
the project. Normally, no more than $200,000 may be requested in any single 
year.  Please see the NIH-wide R21 program announcement (PA-03-107) (see 
http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html). Please see the 
"Submitting an Application" section for more details. 

This PA uses just-in-time concepts.  It also uses the modular budgeting as 
well as the non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular budget format.  Otherwise follow the instructions 
for non-modular budget research grant applications.  This program does not 
require cost sharing as defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.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.   

SPECIAL REQUIREMENTS 

Data and safety monitoring is required for all types of clinical trials. The 
establishment of data and safety monitoring boards (DSMBs) is required for 
clinical trials involving interventions that entail potential risk to the 
participants.
    
Starting with the October 1, 2003 receipt date, investigators submitting an 
NIH application seeking more than $500,000 or more in direct costs in any 
single year are expected to include a plan for data sharing or state why this 
is not possible. 

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:

o Direct your questions about scientific/research issues to:

Dr. Alexis D. Bakos
Office of Extramural Programs
NIH, National Institute of Nursing Research
6701 Democracy Blvd, Room 710, MSC 4870
Bethesda, MD  20892-4870
Telephone:  (301) 594-2542
Fax:  (301) 480-8260
Email:  bakosal@mail.nih.gov

Dr. Lynne M. Haverkos
Child Development and Behavior Branch
NIH, National Institute of Child Health and Human Development
6100 Executive Blvd., Room 4B05, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6881
Fax:  (301) 480-0230
Email:  haverkol@mail.nih.gov

Dr. Ann O’Mara
Division of Cancer Prevention
NIH, National Cancer Institute
6130 Executive Boulevard, Room 2011, MSC 7340
Bethesda, MD  20892-7340
Telephone:  (301) 496-8541
Fax:  (301) 496-8667
Email:  omaraa@mail.nih.gov   

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

Diane E. Drew
Office of Grants and Contracts Management
NIH, National Institute of Nursing Research
6701 Democracy Blvd, Room 710, MSC 4870
Bethesda, MD  20892-4870
Telephone:  (301) 594-2807
FAX:  (301) 451-5651 or (301) 402-4502
Email:  diane_drew@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 DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/  The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 
398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html 
in an interactive format.  For further assistance contact Grants Info, 
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 and the YES box must be checked.

SUPPLEMENTARY INSTRUCTIONS 

When submitting an R21 application, all instructions for the PHS 398 (rev. 
5/2001) must be followed, with these exceptions:

o 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.  

Appendix. Use the instructions for the appendix detailed in the PHS 398 
except that no more than 5 manuscripts, previously accepted for publication, 
may be included.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at http://grants.nih.gov/grants/dates.htm.  Application 
deadlines are also indicated in the PHS 398 application kit.

SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS:  Applications 
requesting up to $250,000 per year in direct costs must be submitted in a 
modular budget grant format.  The modular budget 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.

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

Applicants requesting more than $500,000 must carry out the following steps:
   
1) Contact the IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2) Obtain agreement from the IC staff that the IC will accept your         
application for consideration for award; and,
  
3) Identify, in a cover letter sent with the application, the staff member       
and IC who agreed to accept assignment of the application.  

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

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 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 mailed on or before the receipt 
dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  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.   Appropriate scientific review groups 
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 appropriate national advisory council 
or 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 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 the following 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:

The NIH R21 exploratory/developmental grant is a mechanism for supporting 
novel scientific ideas or new model systems, tools or technologies that have 
the potential to significantly advance our knowledge or the status of health- 
related research.  Because the research plan is limited to 15 pages, an 
exploratory/developmental grant application need not have extensive 
background material or preliminary information as one might normally expect 
in an R01 application.  Accordingly, reviewers will focus their evaluation on 
the conceptual framework, the level of innovation, and the potential to 
significantly advance our knowledge or understanding.  Reviewers will place 
less emphasis on methodological details and certain indicators traditionally 
used in evaluating the scientific merit of R01 applications including 
supportive preliminary data. Appropriate justification for the proposed work 
can be provided through literature citations, data from other sources, or, 
when available, from investigator-generated data.  Preliminary data are not 
required for R21 applications.    

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

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 

Sharing Research Data 

Applicants requesting more than $500,000 in direct costs in any year of the 
proposed research are expected to include a data sharing plan in their 
application. The reasonableness of the data sharing plan or the rationale for 
not sharing research data will be assessed by the reviewers. However, 
reviewers will not factor the proposed data sharing plan into the 
determination of scientific merit or priority score. The Final NIH Statement 
on Sharing Research data is found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html
 
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 (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.
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.  (NIH Policy for Data and Safety Monitoring, NIH Guide for 
Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

SHARING RESEARCH DATA:  Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking more than $500,000 or 
more in direct costs in any single year are expected to include a plan for 
data sharing or state why this is not possible. 
http://grants.nih.gov/grants/policy/data_sharing 
Investigators should seek guidance from their institutions, on issues related 
to institutional policies, local IRB rules, as well as local, state and 
Federal laws and regulations, including the Privacy Rule. Reviewers will 
consider the data sharing plan but will not factor the plan into the 
determination of the scientific merit or the priority score.

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. 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.  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.

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). 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.healthypeople.gov/.

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


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and Human Services (HHS)
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