INTERVENTIONS TO IMPROVE HYPERTENSION CONTROL RATES IN AFRICAN AMERICANS  
 
RELEASE DATE:  September 2, 2003 

RFA Number:  RFA-HL-04-007
 
Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATIONS:

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

COMPONENTS OF PARTICIPATING ORGANIZATIONS: 

National Heart, Lung, and Blood Institute (NHLBI)
 (http://www.nhlbi.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.837
 
LETTER OF INTENT RECEIPT DATE: December 23, 2003 

APPLICATION RECEIPT DATE: January 20, 2004
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA 

The National Heart, Lung, and Blood Institute invites applications for research 
project grants (R01) to evaluate clinically feasible interventions to effect 
changes in medical care delivery leading to an increase in the proportion of 
treated hypertensive African American patients whose blood pressure is 
controlled to levels specified by Joint National Committee on Prevention, 
Detection, Evaluation and Treatment of High Blood Pressure (JNC) guidelines.   
The ultimate goal is to prevent complications of hypertension, and thus increase 
quality and years of healthy life in African Americans - a group with highest 
prevalence and earliest onset of hypertension, and disparately high premature 
cardiovascular mortality and morbidity.  For the purpose of this initiative, 
components of medical care delivery consist of patients, clinicians, 
interactions between patients and clinicians, and physical, social and 
administrative environments in which these interactions occur.

This solicitation addresses both overarching goals of Healthy People 2010 
http://www.healthypeople.gov (increasing quality and years of healthy 
life, and eliminating health disparities) and is responsive to the first of two 
research needs recommendations of the 2002 IOM report, Unequal Treatment 
http://www.iom.edu/includes/dbfile.asp?id=4175   (Recommendation 8-1: 
Conduct further research to identify sources of racial and ethnic disparities 
and assess promising intervention strategies), and to the first of the eight 
top-tier priorities of the 2001 NHLBI Task Force Report on Research in 
Prevention of CVD http://www.nhlbi.nih.gov/resources/docs/cvdrpt.htm  (Evaluate 
approaches to enhance implementation of efficacious preventive interventions in 
medical systems at all stages of clinical practice).

RESEARCH OBJECTIVES

Background

Cardiovascular mortality rates in African Americans for ages 35-64 are more than 
twice those in Caucasians, and for men the gap has increased since 1960.  While 
some of this disparity may be explained by more frequent poverty among African 
Americans, a recent report based on a national probability sample of over 
600,000 persons identified hypertension as the single initiating cause of death 
independent of socioeconomic status that contributed the most to the racial 
disparity between African Americans and Caucasians in potential life-years lost.   
The 1999-2000 National Health and Nutrition Evaluation Survey (NHANES) data 
reveal low rates of hypertension control in treated African American men and 
women, in addition to a long-recognized high prevalence of hypertension (defined 
as BP>140/90 mm Hg or current drug treatment).  Notably, both observational 
(e.g. MRFIT screenees) and clinical trial data (e.g. HDFP) show that 
cardiovascular benefit attributable to a given decline in blood pressure is 
similar in African Americans and Caucasians.

In NHANES 1999-2000, one out of five African American men age 30-39 had 
hypertension (versus one out of eight amongst Caucasian and Mexican American 
men).  By age 50-59, nearly 60% of African American men were hypertensive 
compared to less than 40% of Caucasian and Mexican American men.  Prevalence 
rates for women aged 30-39 were relatively low for all race/ethnic groups (9% 
for African American and 6% for Caucasian and Mexican American women).  However, 
by age 40-49, nearly half of African American women had hypertension (compared 
to one fifth of Caucasian and Mexican American women).  In the age group 60-74, 
75% of African American men and 81% of African American women had hypertension – 
numbers considerably higher than for either Caucasians or Mexican Americans.

In African Americans aged 40 and over, awareness of hypertension was high 
(71-83% across gender/age groups) and a large majority of those aware of their 
hypertension reported being treated (83-97% across gender/age groups), numbers 
similar to those in Caucasians and considerably higher than in Mexican 
Americans.  However, the proportion of treated African American patients whose 
hypertension was controlled to below 140/90 mm Hg remained low (<50%), and in 
those aged 40-59 was more than one third lower than in Caucasians (49 versus 
75% for men and 41 versus 72% for women).  Given the importance of blood 
pressure levels in determining future risk of cardiovascular events, 
intervention in this age group should lead to a decline in cardiovascular 
mortality and morbidity in African Americans, and thus decrease premature 
disability.

Efficacious strategies exist for both lifestyle and pharmacological treatment of 
hypertension.  However, these strategies are not being translated into effective 
blood pressure lowering, especially in African American hypertensive patients.  
Two important barriers to effective treatment of hypertension in African 
Americans, lack of clinical trial data in African Americans on drugs other than 
diuretics and cost of drugs, were recently addressed by the results of The 
Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial 
(ALLHAT).  This largest ever antihypertensive treatment trial, which included 
15,094 African Americans, determined that thiazide-type diuretics are the 
preferred first-step (initial or single drug) therapy for hypertension in both 
African American and non-black patients.  This evidence and the recent release 
of JNC 7 guidelines provide opportune timing to conduct intervention studies 
aimed at improving quality of treatment of hypertension in African Americans.

To date, intervention research in African Americans has primarily focused on 
bringing individuals with elevated blood pressure levels to medical attention 
and increasing patient adherence to prescribed treatment and clinic visits.  
Yet, recently published observational studies point to the importance of 
additional factors, such as patient experience with clinicians, clinicians' 
acceptance of less than optimal blood pressure levels, clinicians' experience 
with a variety of antihypertensive medications, patients' participation in 
treatment decisions, and commercial influences.  While many of these factors may 
be common across racial groups, intervention approaches may need to differ to 
address race/ethnicity-specific issues, both cultural/social and clinical.  
Many hypertensive African American patients are younger than non-African 
American due to earlier onset of hypertension.  In addition, long-standing 
hypertension and associated co-morbidities make selection of treatment regimens 
more difficult and may affect adherence due to increased potential for side 
effects.  Finally, African American patients report less satisfaction with care, 
and perceived racial bias, stereotyping, and prejudice continue to affect 
quality of care and treatment outcomes.  Researchers consistently point to the 
need for more culturally acceptable and effective methods of delivering 
hypertension care.  

Results of three NHLBI-funded randomized studies suggest that clinic-based 
programs can successfully increase the proportion of treated hypertensive 
African American patients who have adequately controlled blood pressure.  
Notably, better hypertension control (62% versus 40-48%) was obtained when the 
intervention included change in an institutional environment/culture, feedback 
to clinicians, and access to specialized care.  In addition, ALLHAT– a large, 
simple trial conducted in a variety of primary care settings – achieved blood 
pressure control to below 140/90 mm Hg in over 60% of both African American and 
non-black patients using organizational-level approaches.  While representing 
substantial improvements, these rates are far from optimal.   

Goals and Scope

This initiative will fund multiple intervention studies aimed to increase the 
proportion of treated African American hypertensive patients whose BP levels 
meet JNC 7 guidelines (primary outcome).  Studies may focus on other special 
risk populations only if local and/or national data exist documenting both poor 
blood pressure control and disparately high premature morbidity and/or 
mortality.  Interventions should be institution/clinic-based (including small 
practices) and target one or preferably more components of medical care 
delivery (patients, clinicians, interactions between patients and clinicians, 
and physical, social and administrative environments in which these interactions 
occur).  However, given prior and ongoing research, interventions targeting 
exclusively patient-level variables and/or limited to improving patient 
adherence to prescribed treatment, will not be responsive to this RFA.  

In general, a randomized design should be used.  A quasi-experimental design may 
be used if scientifically appropriate and justified.  A concurrent control group 
is required, and two or more interventions may be compared.  If "usual care" is 
used as a control group, participants should at minimum receive a copy of JNC 7 
treatment guidelines (clinicians) and related patient education materials 
(patients).  Research plans should take into consideration differences in 
practice settings.  NOTE: Proposed programs should be feasible and practical for 
implementation beyond research settings.  Applications should include an 
institutionalization phase with evaluation.  Also to be included are cost-
effectiveness evaluation and plans for dissemination of study results and 
intervention, if successful.  If appropriate and representing substantial 
opportunity, the investigators are encouraged to include plans for collection 
and storage of blood samples, including consent, to be used for genetic, 
pharmacogenetic, or other ancillary studies to be conducted in the future and 
funded separately.  Consideration should be given to collection of other 
information that may be needed to make these samples useful in the future.  
NOTE: This RFA is not budgeted for any ancillary studies; only collection and 
storage of blood specimens (through the end of the study) will be an allowable 
expense.  

It is estimated that for a patient-randomized trial, a total of about 300 
patients would be required to achieve 90% power to detect a difference in blood 
pressure control rates between 45% (usual care) and 65% (intervention).  For a 
clinic-randomized trial (i.e. cluster randomized trial), it is estimated that 
about 30 clinics with 30 patients each would be required to detect with 90% 
power a difference in blood pressure control rates between 45% (usual care) and 
65% (intervention).  Clinic-randomized trials must use appropriate statistical 
methodology to deal with the hierarchical nature of the data.

Interventions to be tested may include but are not limited to the following 
examples:
o one-on-one or small group onsite education (academic detailing) and advice by 
opinion leaders 
o Use of hypertension treatment guidelines in a patient-oriented context 
o Facilitation of patient-clinician interactions
o Specialized teams, academic partnerships
o Continuous quality improvement process
o Access to free or reduced price drugs
o Decision support and reminder systems using information technology
o Multi-component combinations

Program Organization

While the Program will consist of independent research projects, grantees will 
meet annually to discuss progress, share experiences and discuss overall 
progress of relevant scientific areas.  Collaboration amongst investigators will
be encouraged and facilitated, if appropriate. 

MECHANISM OF SUPPORT
 
This RFA will use the NIH R01 award mechanism.  As an applicant you will be 
solely responsible for planning, directing, and executing the proposed project.  
This RFA is a one-time solicitation.  Future unsolicited, competing-continuation 
applications based on this project will compete with all investigator-initiated 
applications and will be reviewed according to the customary peer review 
procedures. The anticipated award date is September 30, 2004.  Applications that 
are not funded in the competition described in this RFA may be resubmitted as 
NEW investigator-initiated applications using the standard receipt dates for NEW 
applications described in the instructions to the PHS 398 application.

This RFA uses just-in-time concepts.  It also uses the modular 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.  

FUNDS AVAILABLE 
 
The NHLBI intends to commit approximately $3 million in FY 04 and a total of 
$17.5 million over five years to fund three to six new grants in response to 
this RFA. An applicant may request a project period of up to five years.  
Because the nature and scope of the proposed research will vary from application 
to application, it is anticipated that the size and duration of each award will 
also vary. Although the financial plans of the NHLBI provide support for this 
program, awards pursuant to this RFA are contingent upon the availability of 
funds and the receipt of a sufficient number of meritorious applications.
 
ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) if your institution is domestic and 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 Faith-based or community-based organizations 
o Foreign institutions are not eligible to apply
 
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 

THE FOLLOWING CRITERIA WILL GUIDE THE NHLBI STAFF IN DETERMINING RESPONSIVENESS 
OF THE APPLICATIONS TO THIS RFA:  

o Primary endpoint:  Proportion of patients in the organization that achieve 
blood pressure levels meeting JNC 7 recommendations.  

o Patient Population:  The primary endpoint should be measured in treated 
hypertensive African American patients or, as specified under Goals and Scope 
above, another group of treated hypertensive patients if local and/or national 
data exist documenting both poor blood pressure control and disparately high 
premature morbidity and/or mortality.  Data on other patients may be evaluated 
in secondary analyses and for comparative purposes.

o Interventions:  Interventions should be delivered at the organization/clinic 
level and be feasible (including cost) for implementation outside research 
settings.  NOTE: Interventions targeting exclusively patient-level variables 
and/or limited to improving patient adherence to prescribed treatment will not 
be responsive to this RFA.  

o Study design:  The study design should be concurrently controlled. A 
randomized design is preferred – quasi-experimental designs are allowed if 
strongly justified.  Providers/clinics/organizations or patients may be 
randomized.  Detailed sample size calculations with assumptions should be 
provided.

o Dissemination Plan:  The purpose of this RFA is to improve translation of 
knowledge into everyday clinical practice.  Applicants must include in their 
application a plan for dissemination of research results and of the 
intervention.  The latter will be implemented if the intervention is successful 
and should aim to enhance utilization of the study intervention in clinical 
practice.  Such plan should include: identification and description of target 
audience for the dissemination plan; description of methods to be used to reach 
the audience; appropriate benchmarks for success; appropriate additional 
personnel for developing and implementing the dissemination activities; an 
appropriate budget for the proposed dissemination activities for the last year 
of requested funding; a statement that the investigators agree to discuss and 
finalize the dissemination plan with Institute staff prior to its 
implementation. NOTE: Applications that do not include a dissemination plan will 
be considered non-responsive and not eligible for review.  Funds budgeted for 
dissemination activities will be held in reserve until the final year of the 
study and released only with the approval of the Institute. The dissemination 
plan implementation can continue up to one year beyond the award period as a 
no-cost extension. 

THE FOLLOWING ARE SPECIAL REQUIREMENTS OF THIS RFA:  

o Timelines:  Funding will be provided for up to 5 years.  Projects should 
include an institutionalization phase with evaluation and a dissemination plan.  
An initial planning phase may be included to refine interventions.

o Cost-effectiveness analysis:  Must be included and budgeted for in the 
application.

o Blood sample collection:  Applicants who are planning to collect blood samples 
for genetic, pharmacogenetic or other ancillary studies must describe blood 
sample collection and storage for the duration of the trial, and budget for 
these activities.   

o Informed Consent: Applications should describe how informed consent will be 
obtained and include a sample consent form (does not have to be approved by the 
IRB).  If the application includes plans for future genetic or other ancillary 
studies, such plans should be included in the consent form, which may be tiered 
to allow participation in the main study for individuals who refuse 
participation in the blood sample collection.  

o Monitoring Plan: Applications should include a data and safety monitoring 
plan.  A Data and Safety Monitoring Board (DSMB) appointed by the participating 
Institution is required and should be budgeted for.  Please see "Establishing 
Data and Safety Monitoring Boards and Observational Study Monitoring Boards" 
and "Responsibilities of DSMBs Appointed by Participating Institutions" under 
"NHLBI Clinical Research" at http://www.nhlbi.nih.gov/funding/policies/index.htm.

o Recruitment:  Recruitment plans should be described and documented to the 
extent possible.

o Meetings:  Investigators from each research project will be required to attend 
annual meetings in the Washington, DC metropolitan area.  The travel budget 
should therefore reflect appropriate allocation for this activity. 

o Data sharing: Applicants seeking $500K or more in direct costs in any year of 
the project period are expected to include a data sharing-plan in their 
applications stating how they will share the data or, if they cannot share the 
data, why not.  Reviewers will assess the adequacy of the proposed plan.  More 
information on data sharing can be found at 
http://grants.nih.gov/grants/policy/data_sharing/.
 
WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to answer 
questions from potential applicants.  Inquiries may fall into three areas:  
scientific/research, peer review, and financial or grants management issues:

o Direct your questions about scientific/research issues to:

Paula T. Einhorn, M.D., M.S.
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 8111 
Bethesda, MD  20892-7936
Telephone:  (301) 435-0563
FAX:  (301)480-1669
Email: einhornp@nhlbi.nih.gov

o Direct your questions about peer review issues to:

Anne Clark, Ph.D.
Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214 
Bethesda, MD  20892 – 7924
Bethesda, MD 20817 (for express/courier service)
Telephone:  (301) 435-0270
FAX:  (301) 480-0730
Email: clarka@nhlbi.nih.gov

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

Mr. Kieran Kelley
Senior Grants Management Specialist
Division of Extramural Affairs
National Heart, Lung, and Blood Institute/NIH
6701 Rockledge Drive, Room 7170
Bethesda, Maryland  20892-7926  
Telephone:  (301) 435-0154 
FAX:  (301)-480-3310 (fax
Email: email:  kelleyk@nhlbi.nih.gov

LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that includes the 
following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

Although a letter of intent is not required, is not binding, and does not enter 
into the review of a subsequent application, the information that it contains 
allows IC staff to estimate the potential review workload and plan the review.
 
The letter of intent is to be sent by the date listed at the beginning of this 
document.  The letter of intent should be sent to Anne Clark, Ph.D. at the 
address listed under WHERE TO SEND INQUIRIES.

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 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.

SPECIFIC INSTRUCTIONS FOR MODULAR 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 budget grants.  Additional 
information on modular budget grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label could 
result in delayed processing of the application such that it may not reach the 
review committee in time for review.  In addition, the RFA title and number must 
be typed on line 2 of the face page of the application form and the YES box must 
be marked. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the 
application, including the Checklist, and three signed, photocopies, in one 
package to:
 
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application plus all 
five collated sets of appendix material must be sent to Anne Clark, Ph.D. at the 
address listed under WHERE TO SEND INQUIRIES.

APPLICATION PROCESSING: Applications must be received on or before the 
application receipt date listed in the heading of this RFA.  If an application 
is received after that date, it will be returned to the applicant without 
review. 

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.
 
The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  
However, when a previously unfunded application, originally submitted as an 
investigator-initiated application, is to be submitted in response to an RFA, it 
is to be prepared as a NEW application.  That is, the application for the RFA 
must not include an Introduction describing the changes and improvements made, 
and the text must not be marked to indicate the changes from the previous 
unfunded version of the application.  

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NHLBI. Incomplete applications will not be reviewed. 

If the application is not responsive to the RFA, NIH staff may contact the 
applicant to determine whether to return the application to the applicant or 
submit it for review in competition with unsolicited applications at the next 
appropriate NIH review cycle.

Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by an appropriate peer review group convened by 
the National Heart, Lung, and Blood Institute in accordance with the review 
criteria stated below.  As part of the initial merit review, all applications 
will:

o Undergo a process in which only those applications deemed to have the highest 
scientific merit, generally the top half of the 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 Heart, Lung, and Blood Institute 
Advisory Council. 

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 and the specific goals of this RFA. 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? Is the 
proposed intervention appropriate for the proposed clinical setting and 
culturally sensitive to the patient population? Does the applicant acknowledge 
potential problem areas and consider alternative tactics?  Are the 
institutionalization and dissemination plans (including evaluation) appropriate 
for the proposed settings?  Is cost-effectiveness analysis appropriate for the 
intended utilization of the program?

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.  Plans for the recruitment and retention of subjects will also be 
evaluated. (See Inclusion Criteria in the sections on Federal Citations, below).

ADDITIONAL REVIEW CONSIDERATIONS 

SHARING RESEARCH DATA:  Applicants requesting more than $500,000 in direct costs 
in any year of the proposed research must 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. See 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html for guidance. 

BUDGET:  The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  December 23, 2003
Application Receipt Date:  January 20, 2004
Peer Review Date:  June, 3004          
Council Review:  September 2, 2004
Earliest Anticipated Start Date:  September 30, 2004

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic 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.

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 RFA 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 RFA 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) CFDA 
93.837 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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