RESEARCH ON RESEARCH INTEGRITY

Release Date:  May 7, 2001

RFA:  RFA-NS-02-005

Office of Research Integrity
National Institute of Neurological Disorders and Stroke
National Institute of Nursing Research

Letter of Intent Receipt Date:  October 15, 2001
Application Receipt Date:       November 19, 2001

THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  IT 
INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS 
THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA.

PURPOSE

The Office of Research Integrity (ORI, DHHS), the National Institute of 
Neurological Disorders and Stroke (NINDS, 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?  

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 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.

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.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) individual 
research project grant (R01) award mechanism.  Specific application 
instructions have been modified to reflect "MODULAR GRANT" and "JUST-
IN-TIME" streamlining efforts being examined by the NIH.  Complete and 
detailed instructions and information on Modular Grant applications can 
be found at http://grants.nih.gov/grants/funding/modular/modular.htm.  

Responsibility for the planning, direction, and execution of the 
proposed project will be solely that of the applicant.  The total 
project period for an application submitted in response to this RFA may 
not exceed two years.  Future unsolicited competing continuation 
applications will compete with all investigator-initiated applications 
and be reviewed according to the customary peer review procedures.  The 
anticipated award date is July 2002.

FUNDS AVAILABLE 

The ORI intends to commit approximately $500,000 in FY 2002 grants in 
response to this RFA.  In addition to new applications, amended 
applications for projects previously submitted to NIH will be accepted.  
An applicant may request a project period of up to two years and a 
budget for direct costs of up to $100,000 per year.  Because the nature 
and scope of the research proposed may vary, it is anticipated that the 
size of each award will also vary.  Although the financial plans of the 
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. 

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and 
non-profit organizations, public and private, such as universities, 
colleges, hospitals, laboratories, units of State and local 
governments, and eligible agencies of the Federal government. 
Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply as Principal Investigators.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to 
clarify any issues or answer questions from potential applicants is 
welcome.

Direct inquiries regarding programmatic 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 Cheung, 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

Direct inquiries regarding review issues to:

Lillian M. Pubols, Ph.D.
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Suite 3208
Rockville, Maryland 208512
Telephone: (301) 496-9223
Email: lp28e@nih.gov

Direct inquiries regarding fiscal 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) 496-8084
Email: ss433y@nih.gov
 
LETTER OF INTENT

Prospective applicants are asked to submit by October 15, 2001, a 
letter of intent that includes a descriptive title of the proposed 
research, the name, address, and telephone number of the Principal 
Investigator, the identities of other key personnel and participating 
institutions, and the number and title of the RFA in response to which 
the application may be submitted.  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 NINDS 
staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent to:

Mary Ellen Cheung, 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

SCHEDULE SUMMARY

Letter of Intent Receipt Date:    October 15, 2001
Application Receipt Date:         November 19, 2001
Peer Review Date:                 March 2002
Council Review:                   May 2002
Earliest Anticipated Start Date:  July 2002

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used 
in applying for these grants.  These forms are available at most 
institutional offices of sponsored research and from the Division of 
Extramural Outreach and Information Resources, National Institutes of 
Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, 
telephone 301/435-0714, email: GrantsInfo@nih.gov.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

The modular grant concept establishes specific modules in which direct 
costs may be requested as well as a maximum level for requested 
budgets. Only limited budgetary information is required under this 
approach.  The just-in-time concept allows applicants to submit certain 
information only when there is a possibility for an award. It is 
anticipated that these changes will reduce the administrative burden 
for the applicants, reviewers and Institute staff.  The research grant 
application form PHS 398 is to be used in applying for these grants, 
with the modifications noted below.

BUDGET INSTRUCTIONS
Modular Grant applications will request direct costs in $25,000 
modules, up to a total direct cost request of $100,000 per year.  The 
total direct costs must be requested in accordance with the  program 
guidelines and  the modifications made to the standard PHS 398 
application instructions described below:

PHS 398

o FACE PAGE: Items 7a and 7b should be completed, indicating Direct 
Costs (in $25,000 increments up to a maximum of $100,000) and Total 
Costs [Modular Total Direct plus Facilities and Administrative  (F&A) 
costs] for the initial budget period.  Items 8a and 8b should be 
completed indicating the Direct and Total Costs for the entire proposed 
period of support.

o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form 
Page 4 of the PHS 398. It is not required and will not be accepted with 
the application.

o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete 
the categorical budget table on Form Page 5 of the PHS 398.  It is not 
required and will not be accepted with the application.

o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget 
Narrative page. (See 
http://grants.nih.gov/grants/funding/modular/modular.htm for sample 
pages.) At the top of the page, enter the total direct costs requested 
for each year.  This is not a Form page.

o Under Personnel, list all project personnel, including their names, 
percent of effort, and roles on the project. No individual salary 
information should be provided. However, the applicant should use the 
NIH appropriation language salary cap and the NIH policy for graduate 
student compensation in developing the budget request.

For Consortium/Contractual costs, provide an estimate of total costs 
(direct plus facilities and administrative) for each year, each rounded 
to the nearest $1,000. List the individuals/organizations with whom 
consortium or contractual arrangements have been made, the percent 
effort of all personnel, and the role on the project. Indicate whether 
the collaborating institution is foreign or domestic. The total cost 
for a consortium/contractual arrangement is included in the overall 
requested modular direct cost amount.  Include the Letter of Intent to 
establish a consortium.

Provide an additional narrative budget justification for any variation 
in the number of modules requested.

o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information 
used by  reviewers in the assessment of each individual's 
qualifications for a specific role in the proposed project, as well as 
to evaluate the overall qualifications of the research team. A 
biographical sketch is required for all key personnel, following the 
instructions below. No more than three pages may be used for each 
person. A sample biographical sketch may be viewed at:  

- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations;

o CHECKLIST - This page should be completed and submitted with the 
application. If the F&A rate agreement has been established, indicate 
the type of agreement and the date. All appropriate exclusions must be 
applied in the calculation of the F&A costs for the initial budget 
period and all future budget years.  (Note: Grants to unaffiliated 
individuals are not eligible for facilities and administrative cost 
reimbursement.)

o The applicant should provide the name and phone number of the 
individual to contact concerning fiscal and administrative issues if 
additional information is necessary following the initial review.

The RFA label available in the PHS 398 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.

There is a sample RFA label available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.  Please note 
this is in pdf format.

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. Lillian Pubols
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Suite 3208
Rockville, Maryland 20852 (for express/courier service)

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.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the ORI and NINDS staff.  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 NINDS in accordance with the review criteria 
stated below.  As part of the initial merit review, all applications 
will receive a written critique and 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, assigned a priority score, and receive a second level review 
by the NINDS National Advisory Council and the NINR National Advisory 
Council. 

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 the 
application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of this goal.  Each of 
these criteria will be addressed and considered in assigning the 
overall score, weighting them as appropriate for each application.  
Note that the application does not need to be strong in all categories 
to be judged likely to have major scientific impact and thus deserve a 
meritorious 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? 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?

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will 
also be evaluated.

o  The reasonableness of the proposed budget and duration in relation 
to the proposed research.

o  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  The adequacy of the proposed plan to share data, if appropriate.

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.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

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 
biomedical and behavioral research projects involving human subjects, 
unless a clear and compelling rationale and justification are 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 research involving human subjects should 
read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities 
as Subjects in Clinical Research," published in the NIH Guide for 
Grants and Contracts on August 2, 2000 (); a complete copy of the 
updated Guidelines are available at . The revisions relate to NIH 
defined Phase III clinical trials and require: a) all applications or 
proposals and/or protocols to 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) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS

It is the policy of NIH 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 was published in 
the NIH Guide for Grants and Contracts, March 6, 1998, and is available 
at the following URL address: 
http://grants.nih.gov/grants/guide/notice-files/not98-024.html

Investigators also may obtain copies of these policies from the program 
staff listed under INQUIRIES.  Program staff may also provide 
additional relevant information concerning the policy.

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.  Reviewers are cautioned 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 Request for 
Applications (RFA), "Research on Research Integrity", 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  and No. 93.361.  Awards are made under authorization of 
Sections 301 and 405 of the Public Health Service Act as amended (42 
USC 241 and 284) and administered under NIH grants policies and Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  This program is not 
subject to the intergovernmental review requirements of Executive Order 
12372 or Health Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and promote the non-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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