RESEARCH ON RESEARCH INTEGRITY

Release Date:  May 9, 2002

RFA:  NS-03-001

Office of Research Integrity
National Institute of Neurological Disorders and Stroke
National Institute of Nursing Research
National Institute on Drug Abuse

Letter of Intent Receipt Date:  October 15, 2002
Application Receipt Date:  November 15, 2002 

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism 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

PURPOSE OF THIS RFA

The Office of Research Integrity (ORI, DHHS), the National Institute of 
Neurological Disorders and Stroke (NINDS, NIH), the National Institute on Drug 
Abuse (NIDA, NIH), and the National Institute of Nursing Research (NINR, NIH) 
invite applications to support research on research integrity.  "Integrity" in 
this context is understood as "adherence to rules, regulations, guidelines, 
and commonly accepted professional codes or norms."  

Research integrity is a vital component both of the reliability of the 
research record and of the trust that underlies public support for research.  
Therefore the responsible expenditure of public funds for research must 
include attention to research integrity.  The purpose of the proposed grant 
program is to foster empirical research on the institutions, processes, and 
values that affect integrity in research.  The sponsoring agencies are 
particularly interested in studies that will inform policy making at DHHS, 
NIH, and research institutions, with the goal of fostering appropriate 
attention to integrity in publicly funded research programs.

RESEARCH OBJECTIVES

Background

In the early 1980s, research integrity became a major national concern as a 
consequence of a number of well-publicized cases of research misconduct.  
Since that time, thousands of publications have in one way or another reported 
on, analyzed, and/or expressed opinions about integrity in publicly funded 
research.  However, only limited attention has been directed toward research 
on research integrity.  Little is known about the causes and significance of 
or remedies for practices that fall short of professional standards for 
conducting research. There is not enough empirical evidence to determine 
whether intentional misconduct in research is rare or widespread. The impact 
of compromises in integrity on the public and on the research record has not 
been assessed.   No systematic effort has been made to evaluate different 
approaches to transmitting high standards for integrity in research, making it 
difficult to know which ones, if any, are effective.

The lack of research on research integrity presents a significant problem for 
government, research institutions, researchers and their professional 
societies.  If integrity is defined as being truthful and living up to 
professional standards that researchers and research institutions set for 
themselves, there is ample evidence to suggest that publicly funded research 
can fall short of this standard. Some researchers have engaged in practices 
that clearly constitute research misconduct.   Research results can be 
inappropriately influenced by bias, conflicts of interest, and carelessness, 
and personal ambitions can obscure the objectivity of the research process.  
However, the lack of generalizable empirical evidence relating to research 
integrity makes it difficult to develop rational policies for these problems 
or to assess the potential harm to the public health caused when standards for 
good practice are compromised.

Areas of interest

This RFA seeks to address the need for more and better information on the 
factors that encourage and/or discourage integrity in publicly funded 
research.  For the purposes of this RFA, "research" is defined broadly to 
include societal, institutional and individual aspects of the enterprise.  
"Integrity" is understood as "adherence to rules, regulations, guidelines, and 
commonly accepted professional codes or norms."  Proposals are encouraged that 
will provide generalizable empirical knowledge about the ways in which 
researchers and research institutions meet or fail to meet their professional 
responsibilities in the conduct, evaluation, and reporting of research.  
Particular areas of interest include but are not limited to:

o Research norms and/or practices, such as:  How do researchers make decisions 
about what they should and should not do as professionals?  Do workplace 
conditions and career pressures affect their decisions?  What responsibilities 
do they accept or reject and why? How do they learn about these 
responsibilities?  How do they define and deal with conflicting 
responsibilities?  

o Institutional climate and responsibility, such as: What responsibilities do 
research institutions and scientific societies accept for maintaining the 
integrity of their research programs?  How do they meet these 
responsibilities? Do research institutions or professional societies promote 
values that effectively encourage high standards for integrity?  What impact 
does institutional climate have on the attitudes and practices of individual 
researchers?  How do professional societies establish norms for acceptable 
research practices?

o Education on the responsible conduct of research (RCR), such as:   What 
impact, if any, does RCR education have on research integrity?  Are some 
approaches (i.e., mentoring, case study, class-room lectures) to RCR education 
more effective than others?  What methods or instruments are best suited for 
assessing the effectiveness of RCR education?

o  Mentor/trainee relationships, such as:  What are the responsibilities of 
mentors and trainees in pre-doctoral and post-doctoral research programs 
(i.e., role or responsibilities of a mentor, conflicts between mentor and 
trainee, collaboration and competition, selection of a mentor, and abusing the 
mentor/trainee relationship)? 

o Data acquisition, management, sharing, and ownership.  What are the accepted 
practices for acquiring and maintaining research data?   What are the proper 
methods for record keeping and electronic data collection and storage in 
scientific research (i.e., defining what constitutes data; keeping data 
notebooks or electronic files; data privacy and confidentiality; data 
selection, retention, sharing, ownership, and analysis; data as legal 
documents and intellectual property, including copyright laws)?

o Responsible authorship, such as:  What is the level of accountability among 
authors?  How pervasive are problems associated with collaborative work and 
assigning appropriate credit, acknowledgments, appropriate citations, 
repetitive publications, fragmentary publication, sufficient description of 
methods, corrections and retractions, conventions for deciding upon authors, 
author responsibilities, and the pressure to publish?

o Integrity of publication practices and the research record, such as: Are 
research results quickly, fairly, and accurately disseminated?  Is research 
effectively self-correcting?  How effective are different approaches (e.g., 
peer review, data audits, or detailed research and publication guidelines) to 
encouraging and ensuring the integrity of the research record?

o Integrity of peer review in determining merit for research funding, such as:  
How do reviewers recognize and manage potential biases in the peer review 
process?  What are the responsibilities reviewers have to privileged 
information and confidentiality?  

o Research collaborations and issues that may arise from such collaborations, 
such as: setting ground rules early in the collaboration, avoiding authorship 
disputes, and the sharing of materials and information with internal and 
external collaborating scientists.

o Conflict of interest, such as: How do conflicting interests impact the 
conduct and results of research?  How do individuals, research institutions, 
and professional societies recognize and manage conflicts of interest?  Are 
financial conflicts of interest a growing concern in research, and if so, what 
impact do they have?  Are existing conflict of interest policies known and 
effective?  

o The meaning of research misconduct and the regulations, policies, and 
guidelines that govern research misconduct in PHS-funded institutions, such 
as:  How pervasive is fabrication, falsification, and plagiarism; error vs. 
intentional misconduct?  How effective are institutional misconduct policies?  
How effective are institutional structures in identifying misconduct?  How 
effective are the procedures for reporting misconduct; protection of 
whistleblowers; and outcomes of investigations, including institutional and 
Federal actions.

Relevant research perspectives and disciplines include, but are not limited 
to: anthropology, applied philosophy, business, economics, education, 
information studies, law, organizational studies, 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 topics.  Proposals 
that address research integrity issues that are relevant to specific NIH 
institutes, including the NIDA and NINDS, are 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 July 2003.

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

FUNDS AVAILABLE 

The ORI intends to commit approximately $750,000 in FY 2003 to fund new grants 
in response to this RFA. (In addition to new applications, amended 
applications for unfunded projects previously submitted to NIH will be 
accepted.)  Competitive continuations of existing projects are not eligible 
under this RFA. An applicant may request a project period of up to 2 years and 
a budget for direct costs of up to $100,000 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 also vary. 
Although the financial plans of ORI 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 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

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

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.

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:

Mary D. Scheetz, Ph.D.
Office of Research Integrity
Division of Education & Integrity
5515 Security Lane, Suite 700
Rockville, MD 20852 
(301) 443-5302  
Email: MScheetz@osophs.dhhs.gov

Mary Ellen Michel, Ph.D.
NINDS/NIH
Neuroscience Center, Room 2209, MSC 9525
6001 Executive Boulevard
Bethesda, MD 20892-9525
(301) 496-1447
Email: mm108w@nih.gov

Karin Helmers, Ph.D.
Office of Extramural Programs
National Institute of Nursing Research
Building 45, Room Number 3AN12, MSC 6300
Bethesda, MD  20892-6300
Telephone:  (301) 594-2177
FAX:  (301) 480-8260
Email: Karin_helmers@nih.gov

Joseph Frascella, Ph.D.
Clinical Neurobiology Branch
Division of Treatment Research and Development
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4123, MSC 9559
Bethesda, MD  20892-9559
Telephone:  301-443-4877
Email:  jfrascel@mail.nih.gov

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
Email: pw73q@nih.gov

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

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
Email: ss433y@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:

Mary Ellen Michel, Ph.D.
NINDS/NIH
Neuroscience Center, Room 2209, MSC 9525
6001 Executive Boulevard
Bethesda, MD 20892-9525
Rockville, MD 20852 (for courier service)
FAX: (301) 480-1080
Email: mm108w@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  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.
 
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  Applications 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 
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.

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 must be 
sent to:

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 by 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.
 
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.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed. This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must include 
an Introduction addressing the previous critique.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NINDS.  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. 

REVIEW CRITERIA

The goal of this grant program is to foster empirical research on the 
institutions, processes, and values that positively and/or negatively shape 
integrity in research.  The sponsoring agencies are particularly interested in 
studies that will inform policy making at DHHS, NIH, and research 
institutions, with the goal of fostering appropriate attention to integrity in 
their research programs.  

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 your application's overall score, weighting them as appropriate 
for each application.  Your 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, you 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? If the aims 
of the application are achieved, how will the understanding of research 
integrity be advanced?  What will be the effect of these studies on the 
concepts or methods that drive RRI and policy making more broadly?

(2) APPROACH:  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?  Does the applicant acknowledge potential problem areas and 
consider alternative tactics?

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

(4) 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)?

(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, your 
application will also be reviewed with respect to the following:

o PROTECTIONS:  The adequacy of the proposed protection for humans, animals, 
or the environment, to the extent they may be adversely affected by the 
project proposed in the application.

o INCLUSION:  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 included in the 
section on Federal Citations, below)

o 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: October 15, 2002
Application Receipt Date: November 15, 2002
Peer Review Date: March 2003
Council Review: May 2003
Earliest Anticipated Start Date: July 2003

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
o Program balance among similarly meritorious applications.

REQUIRED FEDERAL CITATIONS 

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 AMENDMENT "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 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.

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.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal 
Domestic Assistance No. 93.853, 93.279, and 93.361 and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92.

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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