STUDIES OF ENERGY BALANCE AND CANCER IN HUMANS 

RELEASE DATE:  July 8, 2004

PA NUMBER:  PA-04-124

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. 
Replacement R21 (PA-06-405) funding opportunity announcements 
have 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
EXPIRATION DATE for All R01 Applications: January 3, 2007 
EXPIRATION DATE for All Other Applications: May 2, 2009

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, 93.399

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanisms of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Supplementary Instructions
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 Cancer Institute (NCI) invites investigator-initiated research 
applications on energy balance in humans.  These studies will focus on 
research to define factors affecting energy balance and to define mechanisms 
influencing cancer risk, prognosis, and quality of life.  These studies may 
range from new analyses of existing datasets to additional collection of data 
and biological specimens in ongoing investigations.  In order to be eligible 
for this Program Announcement (PA), an applicant must have previously 
collected measures from human subjects on two or more of the following 
exposures:  diet, physical activity, body composition, and/or related 
biomarkers (such as blood, urine, exfoliated cells, and/or tissue samples).  
It is anticipated that the knowledge gained will provide additional 
information to better understand the relationships among energy balance, 
cancer risk and prognosis.  Competitive supplements to existing NCI-funded 
grants as well as new R01s and R21s are invited. 

RESEARCH OBJECTIVES

Energy balance, defined as the integrated effects of diet, physical activity, 
and genetics on growth and body weight over the life course, has been a 
recent focus for understanding the chronology of many chronic diseases.  
Research from many sources supports the adverse effects of obesity, physical 
inactivity, and poor dietary practices on cancer risk and prognosis.  The 
recent trends in obesity rates in the U.S. population call attention to a 
potential for significant increases in cancer incidence.  With the rise in 
the prevalence of obesity in the United States, there is concern for how 
behaviors involving body weight, physical activity, and diet may affect the 
development of cancer, as well as cancer prognosis for cancer survivors.  

Research in the areas of diet, cancer risk, and prognosis typically focuses 
on a single cancer prevention-related risk factor, such as a specific 
nutrient or diet pattern.  However, less attention has been devoted to the 
combined effects of body composition, weight, physical activity, and diet on 
the key physiologic processes involved with cancer initiation and 
progression.  Many research studies have collected data on several or all of 
these parameters, but because the initial hypotheses may not have been 
related to energy balance, data analyses to determine links were not 
conducted.  Some studies have explored the clinical metabolic effect of diet, 
weight loss, and physical activity on certain parameters that could 
potentially be related to cancer, with the most extensive work on insulin 
resistance.  However, research has been more limited and is needed in the 
areas of sex steroid hormones, growth factors, lipid metabolism, and immune 
function and inflammatory factors, such as cytokines and prostaglandins.  
Adverse changes in energy balance and contributory factors are considered to 
be a major factor underlying many of the pathways involved in cancer 
initiation and progression.

Epidemiologic and intervention research within human populations can provide 
essential self-report and objective measures about diet, anthropometry, and 
physical activity important in unraveling the role of energy balance in 
cancer risk and prognosis.  These measures can be linked with analyses of 
biologic specimens such as blood, urine, exfoliated cells, and other tissues 
to study underlying metabolic and genetic etiologic mechanisms in relation to 
energy balance.  Some of the interrelationships may include shifts in steroid 
hormones, insulin-like growth factors and insulin resistance, lipid 
metabolism, immunologic parameters, inflammatory factors, and adipose tissue 
products.  In addition to understanding how these factors affect development 
of cancer, effects of differences in energy balance in cancer patients and 
survivors are included.  Under this PA, at least three types of additional 
research could be supported within existing studies to  test new hypotheses 
with existing data; to perform additional assays on existing biologic 
specimens to examine new hypotheses; and to collect and analyze additional 
self-reports or objective measures of diet, anthropometry, physical activity, 
and/or biological specimens. 

This PA complements NCI’s Transdisciplinary Research on Energetics and Cancer 
(TREC) Centers RFA (http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-05-010.html), 
which also focuses on enhancing the understanding of the 
mechanisms underlying the association between energy balance and 
carcinogenesis across the cancer continuum.  TREC utilizes the U54 mechanism 
to involve scientists from multiple disciplines to encompass projects 
spanning the biology and genetics of behavioral, socio-cultural, and 
environmental influences upon nutrition, physical activity, weight, energy 
balance, and energetics.  Studies funded under this PA are smaller in scope, 
encouraging the exploration of new hypotheses using existing data sets in a 
new way, resulting in the potential to inform and influence the development 
of research activities in TREC.  Investigators funded under this PA will be 
invited to attend TREC meetings to share expertise and identify new research 
opportunities as research results evolve. 

This PA invites new R01 and R21 research applications as well as competitive 
supplements to existing NCI-funded grants that explore relationships between 
energy balance and cancer risk and prognosis by proposing new hypotheses 
within existing studies.  The approach is also to encourage collaborations 
among scientists working in the areas of nutrition, physical activity, 
genetics, and other disciplines (such as chemistry or biochemistry) to 
utilize data from existing studies to study the impacts of diet, physical 
activity, and weight on the genetic, epigenetic, genomic, proteomic, and 
metabolic influences of cancer biology and prevention. Because primary 
measures related to cancer and energy balance are diet, physical activity, 
body composition (especially obesity), and related biomarkers, in order to be 
eligible to apply for this PA, the applicant must already have access to 
measures on two or more of these exposures.  Examples of the types of 
research topics and approaches that would be responsive to this PA include 
but are not limited to:

1) Hypothesis-based analyses of stored blood samples from members of existing 
cohorts for assessment of biologic markers of cancer risk and prognosis, such 
as sex hormone-binding globulin (SHBG), insulin-like growth factors (IGF), 
lipids, and cytokines linked with repeated measures of diet, physical 
activity, and anthropometrics; 

2) Collection and hypothesis-based analyses of biological specimens, such as 
blood, urine, or exfoliated cells, from cohort or case-control subjects for 
study as metabolic markers of diet and for genetic and hormonal analysis that 
can be related to energy balance measures and cancer risk and prognosis; 

3) Analyses of fat aspirates from subjects enrolled in studies to evaluate 
the environmental and genetic determinants of cancer that may be 
etiologically associated with body fat distribution patterns and diet and 
physical activity measures; 

4) Collection and hypothesis-based analyses of biological specimens, such as 
blood, urine, or exfoliated cells, from cancer survivors for linkage with 
questionnaire data on environmental factors that could be related to energy 
balance; 

5) Analyses of data to examine the relationships among blood hormones and 
markers of energy balance in prevention studies to explore the association 
with cancer risk and prognosis;

6) Hypothesis-based analyses of stored blood samples from subjects in 
prevention studies to explore whether there is a differential effect on 
carcinogenesis according to hormonal status and weight gain; 

7) Collection and hypothesis-based analyses of additional information related 
to energy balance, such as diet and physical activity, in ongoing cancer 
therapy trials of adults, children, and/or adolescents to determine if there 
is a relationship between obesity and long-term survival; 

8) Collection and hypothesis-based analyses of biological samples from 
subjects in prevention studies to examine differences in racial and ethnic 
groups related to energy balance and cancer risk and prognosis;

9) Collection and hypothesis-based analyses of biological specimens, such as 
blood, urine, or exfoliated cells, from cohort or case-control subjects for 
linkage with questionnaire data on psychosocial, cognitive, or basic-
biobehavioral factors that could be related to energy balance and cancer risk 
and prognosis; and

10) Collection and hypothesis-based analyses of biological specimens, such as 
blood, urine, or exfoliated cells, from cohort or case-control subjects, for 
linkage with questionnaire data on medication use, especially those known to 
be associated with weight gain that could be related to energy balance and 
cancer risk and prognosis.

MECHANISMS OF SUPPORT

This PA will use the NIH Investigator-Initiated Research Project Grants 
(R01), NIH Exploratory/Developmental Grants (R21), and Competitive 
Supplements to existing NCI-funded grants.  As an applicant, you will be 
solely responsible for planning, directing, and executing the proposed 
project. 

An R21 applicant may request a project period of up to 2 years with a 
combined budget for direct costs of up to $275,000 for the 2-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 note that facilities and administrative (F&A) costs requested 
by any consortium participants are excluded from the direct cost limit per 
NIH Guide Notice NOT-OD-04-040; 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html )

Applications for a competitive supplement may be submitted based on existing 
NCI-funded research RO1, P01, P30, and U01 grants.  Applicants may apply for a 
supplement to a related R01, P01, P30, or U01 research award, as long as the 
following conditions are met: 
 
1) The title of the awarded grant is same as that of the proposed supplement,  
2) There must be an active parent grant during the entire funding 
period of this supplement.  
3) The Principal Investigator for the supplement must be the Principal 
Investigator of the parent grant.

Applications are accepted on regular receipt dates and are reviewed in the 
same way as any other competing application. Because the nature and scope of 
the research proposed in response to this PA may vary, it is anticipated that 
the size of supplements will vary.  

This PA uses just-in-time concepts.  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_2003/index.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 

Multi-Disciplinary Collaboration
The approach is also to encourage collaboration among scientists working in 
the areas of nutrition, physical activity, genetics, and other disciplines 
(such as chemistry or biochemistry) to utilize data from existing studies to 
study the impact of diet, physical activity, and weight on the genetic, 
epigenetic, genomic, proteomic, and metabolic influences of cancer biology 
and prevention.

Statistical Issues 
Applicants funded under this PA should thoroughly address sample size and 
power issues to ensure the statistical validity of results. 

Travel
Investigators are strongly encouraged to participate in meetings of NCI-
funded investigators supported by this PA and other energy balance 
initiatives.  Investigators are specifically encouraged to attend the semi-
annual meetings of grantees funded under the Transdisciplinary Research on 
Energetics and Cancer (TREC) Centers RFA. The semi-annual meetings of the 
TREC Centers’ investigators and other invited participants (e.g., recipients 
of awards for this initiative) will enable investigators working in relevant 
fields of research to better exchange scientific knowledge, share expertise, 
develop standards for studying the mechanisms involved in energy balance and 
cancer risk and prognosis, and identify new research opportunities.  
Applicants should provide budgets that include costs for two 2-day trips per 
year to attend meetings that are likely to occur on the East Coast [i.e., 
closer to the NCI]. 

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:

Virginia W. Hartmuller, Ph.D., R.D.
Epidemiology and Genetics Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd., EPN Room 5102, MSC 7324
Bethesda, MD 20892-7324
Rockville, MD 20852 (for express/courier service) 
Telephone:  (301) 594-3402
FAX:  (301) 402-4279
E-mail: hartmulv@mail.nih.gov

Noreen M. Aziz, M.D., Ph.D., M.P.H.
Office of Cancer Survivorship
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd., EPN Room 4090, MSC 7397
Bethesda, MD 20892-7397
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 496-0598 
Fax:  (301) 594-5070 
e-mail: na45f@nih.gov

Jackie Whitted, Ph.D., M.P.H.
Nutritional Science Research Group
Division of Cancer Prevention
National Cancer Institute
6130 Executive Blvd., EPN Room 3154, MSC 7328
Bethesda, MD 20892-7328
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 496-0129 
Fax:  (301) 480-3925 
e-mail: whittedj@mail.nih.gov

Direct your questions about financial or grants management matters to:

Crystal Wolfrey
Division of Extramural Activities
National Cancer Institute
6120 Executive Blvd., EPS Room 234, MSC 7150
Bethesda, MD 20892-7150
Telephone: (301) 496-8634
FAX: (301) 496-8601
Email: wolfreyc@mail.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 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.

SUPPLEMENTARY INSTRUCTIONS 

All instructions for the PHS 398 (rev. 5/2001) must be followed, with these 
exceptions for R21 applications:
 
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 are required but may be included if 
available.  Please note that a Progress Report is not needed; competing 
continuation applications for an Exploratory/Developmental Grant (R21) will 
not be accepted.
 
o 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.

For the NIH Exploratory/Development Grant (R21), applicants may request 
direct costs in $25,000 modules, up to a total direct cost of $275,000 for 
the combined 2-year award period.

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;
  
3. Identify, in a cover letter sent with the application, the National Cancer 
Institute and the staff member 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 an appropriate national advisory council 
or board.
 
REVIEW CRITERIA

 Update: Enhanced review criteria have been issued for the 
evaluation of research applications received for potential FY2010 
funding and thereafter - see 
NOT-OD-09-025)

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 applications 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:

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 below on Federal Citations.)  

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 
below on Federal Citations.)

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.  Details are 
available at http://grants.nih.gov/grants/policy/data_sharing.
 
BUDGET:   The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

STATISTICAL ISSUES:  Applicants funded under this PA should thoroughly 
address sample size and power issues to ensure the statistical validity of 
results.  The reasonableness of statistical issues will be assessed by the 
reviewers.

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

SHARING RESEARCH DATA:  Investigators submitting an NIH application seeking 
$500,000 or more in direct costs in any single year are expected to include a 
plan for data sharing (http://grants.nih.gov/grants/policy/data_sharing) or 
state why this is not possible.  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.  

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 plan 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.


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H H S Department of Health
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