RELEASE DATE:  May 30, 2003
RFA:  NS-04-001 

Office of Research Integrity (ORI) 
National Institute of Neurological Disorders and Stroke (NINDS) 
National Institute of Nursing Research (NINR)
National Institute on Drug Abuse (NIDA)
Agency for Healthcare Research and Quality (AHRQ)

93.853 (NINDS), 93.226 (AHRQ)


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 Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations:


The Office of Research Integrity (ORI, DHHS), the National Institute of 
Neurological Disorders and Stroke (NINDS, NIH), the National Institute 
of Nursing Research (NINR, NIH), the National Institute on Drug Abuse 
(NIDA, NIH), and the Agency for Healthcare Research and Quality (AHRQ, 
DHHS) invite applications to support research on research integrity. 

The purpose of the proposed grant program is to foster empirical 
research on societal, organizational, group, and individual factors 
that affect, both positively and negatively, integrity in research.   
Proposals must have clear relevance to biomedical, behavioral and 
health services research.  Applicants are strongly encouraged to take 
into consideration problems or issues that are relevant to the missions 
of DHHS, NIH, or specific NIH institutes and programs.

For the purposes of this RFA, "research" is interpreted broadly to 
include societal, organizational, group, and individual aspects of the 
enterprise.  "Integrity" is understood as "the use of honest and 
verifiable methods in proposing, performing, and evaluating research in 
reporting research results with particular attention to adherence to 
rules, regulations, guidelines, and commonly accepted professional 
codes or norms."  

Over the last 10-15 years, researchers have devoted increased effort to 
the empirical study of integrity in research with the encouragement of 
new journals, focused initiatives, such as the Peer Review Congresses, 
and the NIH/ORI Research Program on Research Integrity (established in 
2000).  The growing body of research on research integrity has enhanced 
understandings of integrity in research and some of the factors that 
influence the way researchers behave.  However, information is still 
lacking on the impact of specific research behaviors and of efforts to 
promote integrity in research on the research record and the overall 
practice of research.  

This RFA seeks applications for empirical research that adds to 
understandings of the ways in which research integrity and efforts to 
promote responsible conduct in research directly or indirectly impact 
the research record, research institutions, and/or the benefits derived 
from biomedical and behavioral research. Four specific areas of 
interest are outlined below. 

Areas of Interest

Integrity and the reliability of the research record.  While it is 
generally understood that some inappropriate research behaviors, such 
as deliberate misconduct, can adversely impact the research record, our 
understanding of the relationships among different aspects of integrity 
and the overall reliability of the research record are far from 
complete.  Proposals are welcomed that will:
o define and assess the prevalence of research practices that depart 
from rules, regulations, guidelines, and commonly accepted norms for 
responsible conduct in research;
o assess the importance of specific questionable practices on the 
research record—e.g. poor data management, sloppy research, unmanaged 
conflicts of interest, the use of inappropriate methods, improper 
authorship, and partial or inaccurate reporting of research methods and 
findings; and/or
o develop and test ways to assess the reliability of the research 
record, including not only final publications but grant applications 
and professional statements.

Integrity and research relationships.  Responsible research practice 
has become increasingly complicated by the growth of complex and new 
research relationships.  Proposals are welcomed that will:
o investigate how collaborative research is organized and its impact on 
research integrity, with particular interest in clinical research;
o define and assess the influence of international collaboration on 
responsible research practices and the research record; 
o investigate and assess the impact of changing financial 
relationships, such as SBIR grants, licensing agreements, and other 
financial arrangements, on research integrity and/or
o study the challenges for responsible conduct presented in high-
profile collaborative and international research, e.g. AIDS and other 
major disease/health programs.

Fostering a commitment to responsible conduct in research.  Since 1990, 
research institutions have devoted considerable attention to ways of 
fostering responsible conduct in research.  To help evaluate what has 
been accomplished and develop plans for future efforts, proposals are 
welcomed that will:
o study factors that influence research behavior;
o develop and assess the effectiveness of different ways (courses, Web 
programs, videos, mentoring, and so on) to promote responsible conduct 
in research; and/or
o provide a comprehensive assessment (content and cost) of specific 
efforts to foster responsible conduct in research.

Influence of the research environment.  In a recent report, an 
Institute of Medicine Committee recommended that "Federal agencies and 
foundations should fund research designed to assess the relationship 
between various elements of the research environment and integrity in 
research, including similarities and differences across disciplines and 
institutions" (Integrity in Scientific Research, 2002).  Following this 
recommendation, proposals are welcomed that will:
o clarify and assess the importance of environmental elements that 
influence integrity in research; 
o provide a comprehensive assessment (cost and elements) of specific 
institutional efforts to promote integrity in research; 
o assess the impact of changes in significant environmental elements, 
such as funding patterns, major research priorities, and technology 
transfer, on research integrity; 
o define and assess ways to study the impact of policies, procedures, 
practices, and other approaches to promote responsible research at the 
institutional, departmental, or laboratory level; and/or
o develop and test assessment tools for institutions and laboratories 
to measure specific aspects of responsible research and research 

Relevant research perspectives and disciplines include, but are not 
limited to: anthropology, applied philosophy, business, economics, 
education, information studies, law, organizational studies, health 
services, political science, psychology, sociology, and survey and 
evaluation research, plus the physical, biomedical, and clinical 
sciences, including nursing.  The NINR is particularly interested in 
research done by nurses on these areas of interest.  The AHRQ is 
particularly interested in research done by health services researchers 
on these areas of interest.

This RFA will use 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 July 2004.  

This RFA uses just-in-time concepts.  It also uses the modular 
budgeting format.  (See  
Specifically, if you are submitting an application with direct costs in 
each year of $250,000 or less, use the modular format.


The ORI intends to commit approximately $1,400,000 in FY 2004 to fund 
new grants in response to this RFA.  NINDS, NINR, NIDA, and AHRQ may 
provide additional funding for projects relevant to their research 
programs.  Awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of 
meritorious applications.

An applicant may request a project period of up to 3 years and a budget 
for direct costs of up to $250,000 per year.  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 vary.  

Applicants developing new research areas or assembling new, 
interdisciplinary project teams should consider proposing limited, 
short-term projects to establish the methods for and validity of the 
work they propose to do (e.g. $75,000-100,000/ year for one or two 
years). Larger, longer-term applications should be limited to major 
data collection efforts that involve multiple institutions, phased 
surveys, detailed direct or on site analysis, or other major research 
work that cannot be accomplished in smaller studies.

In addition to new applications, amended applications for unfunded 
projects previously submitted to NIH in response to preceding RFAs from 
ORI will be accepted.  Competitive continuations of existing projects 
are not eligible under this RFA.  

You may submit an application 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 (if there are compelling reasons for carrying out 
the research in a foreign country)

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.   

Successful applicants will be asked to participate in future ORI-
sponsored conferences on research on research integrity to report 
progress, discuss problems, and share information related to the 
conduct of their grants.  It is recommended that costs associated with 
attendance of the principal investigator at one meeting per year in 
Bethesda, Maryland, be included as part of the budget proposal.

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:

Mary D. Scheetz, Ph.D.
Office of Research Integrity
1101 Wootton Parkway, Suite 750
Rockville, MD 20852
(301) 443-5302 

Mary Ellen Michel, Ph.D.
Neuroscience Center, Room 2209, MSC 9525
6001 Executive Boulevard
Bethesda, MD 20892-9525
(301) 496-1447

Martha Hare, Ph.D.
National Institute of Nursing Research
6701 Democracy Boulevard
One Democracy Plaza
Bethesda, MD 20892-4870
(301) 451-3874

Noble Jones, M.Ed.
Center for AIDS and Other Medical Consequences
NSC, Suite 5198, MSC 9593
National Institute on Drug Abuse
Bethesda, MD 20892-9593
(301) 402-0807

Sally Flanzer, Ph.D.
Agency for Health Care Research and Quality
Office of Research Review, Education, and Policy
540 Gaither Road, Room 2-2042
Rockville, Maryland 20850
(301) 427-1538

o Direct your questions about peer review issues to:

Philip F. Wiethorn, Ph.D.
Scientific Review Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Suite 3208
Rockville, Maryland 208512
Telephone: (301) 496-9223

o Direct your questions about financial or grants management matters 

Ms. Sheila Simmons
Grants Management Branch
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Room 3290
6001 Executive Boulevard
Bethesda, Maryland 20892-9231
Telephone: (301) 496-9231

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:

Mary Ellen Michel, Ph.D.
Neuroscience Center, Room 2209, MSC 9525
6001 Executive Boulevard
Bethesda, MD 20892-9525
Rockville, MD 20852 (for courier service)
FAX: (301) 480-1080


Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001).  The PHS 398 is 
available at in 
an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 710-0267, Email:
requesting up to $250,000 per year in direct costs must be submitted in 
a modular grant format.  The modular grant format simplifies the 
preparation of the budget in these applications by limiting the level 
of budgetary detail.  Applicants request direct costs in $25,000 
modules.  Section C of the research grant application instructions for 
the PHS 398 (rev. 5/2001) at includes step-
by-step guidance for preparing modular grants.  Additional information 
on modular grants is available at

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:
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 
must be sent to:

Dr. Alan Willard
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Suite 3208
Rockville, Maryland 20852 (for express/courier service)
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.  While the investigator may 
still benefit from the previous review, the RFA application is not to 
state explicitly how.

Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NINDS and ORI. Incomplete and/or non-
responsive applications will be returned to the applicant without 
further consideration.

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 NINDS in accordance with the review 
criteria stated below.  As part of the initial merit review, all 
applications will:

o Receive a written critique
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 second level review by the appropriate national advisory 
council or board. 

The purpose of the proposed grant program is to foster empirical 
research on research behaviors that adversely affect the research 
record and on the effect of efforts to change these behaviors through 
education and/or institutional reform.  Studies must have relevance to 
biomedical and behavioral research and be directly relevant to the 
missions of DHHS and NIH.

In the written comments, reviewers will be asked to discuss the 
following aspects of your application in order to judge the likelihood 
that the proposed research will have a substantial impact on the 
pursuit of these goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

The scientific review group will address and consider each of these 
criteria in assigning the application's overall score, weighting them 
as appropriate for each application.  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.

(1) SIGNIFICANCE: Does this study address an important problem?  Will 
it make a significant contribution to understandings of research 
behaviors that adversely affect the research record and on the effect 
of efforts to change these behaviors through education and/or 
institutional reform?

(2) METHOD: Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of 
the project? Will the study result in significant generalizable 
empirical information? Has the applicant conducted a thorough review of 
the existing literature?  Does the applicant acknowledge potential 
problem areas and consider alternative tactics? 

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

(4) INVESTIGATORS: Is the principal 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)? Are appropriate or necessary collaborations 
in place?  Does the research team include appropriate expertise for the 
scope of the project?

(5) ENVIRONMENT: Does the scientific environment in which the work will 
be done contribute to the probability of success? Do the proposed 
investigations take advantage of unique features of the intellectual 
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:

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).
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).

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.  


DATA SHARING:  The adequacy of the proposed plan to share data
BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.


Letter of Intent Receipt Date:  October 14, 2003
Application Receipt Date:  November 14, 2003
Peer Review Date:  March 2004
Council Review:  May 2004
Earliest Anticipated Start Date:  July 2004


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.

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. 

components involving Phase I and II clinical trials must include 
provisions for assessment of patient eligibility and status, rigorous 
data management, quality assurance, and auditing procedures.  In 
addition, it is NIH policy that all clinical trials require data and 
safety monitoring, with the method and degree of monitoring being 
commensurate with the risks (NIH Policy for Data and Safety Monitoring, 
NIH Guide for Grants and Contracts, June 12, 1998:  

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 
a complete copy of the updated Guidelines are available at http://  
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 

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

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

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of 
research on hESCs can be found at and at  
Only research using hESC lines that are registered in the NIH Human 
Embryonic Stem Cell Registry will be eligible for Federal funding (see   It is the responsibility of the applicant to 
provide the official NIH identifier(s)for the hESC line(s)to be used in 
the proposed research.  Applications that do not provide this 
information will be returned without review. 

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

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.

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 
( 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

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

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at 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  

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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