RESEARCH ON RESEARCH INTEGRITY

Release Date:  August 14, 2000

RFA:  NS-01-008

Office of Research Integrity
National Institute of Neurological Disorders and Stroke

Letter of Intent Receipt Date:  November 17, 2000
Application Receipt Date:       December 15, 2000 

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) and the National Institute of 
Neurological Disorders and Stroke (NINDS, NIH) invite applications (R01) 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 of both the trustworthiness 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 positively and/or negatively influence 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 (e.g., 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 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 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 Research policies, such as:   How well are current federal and institutional 
policies known and understood by researchers?  How effective are those 
policies in promoting responsible research conduct or in pursuing allegations 
of research misconduct?  Are humans and animals adequately protected when 
serving as participants in research projects? 

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.

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 2001.

FUNDS AVAILABLE 

The ORI intends to commit approximately $500,000 in FY 2001 to fund three to 
five new grants in response to this RFA. 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.  Pending approval, ORI is 
planning to commit approximately $1,000,000 in FY 2002 to continue support for 
the first-year proposals, plus to fund an additional three to five new 
proposals.

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

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 3254
6001 Executive Boulevard
Bethesda, Maryland 20892-9537
Telephone: (301) 496-8084
Email: ss433y@nih.gov
 

LETTER OF INTENT

Prospective applicants are asked to submit by November 17, 2000, 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) 

SCHEDULE SUMMARY

Letter of Intent Receipt Date:    November 17, 2000
Application Receipt Date:         December 15, 2000 
Peer Review Date:                 March 2001
Council Review:                   May 2001
Earliest Anticipated Start Date:  July 2001

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 (rev. 4/98) 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 key 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:  
http://grants.nih.gov/grants/funding/modular/modular.htm

- 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 re-imbursement.)

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 (rev. 4/98) 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.

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 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? 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 subpopulations 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 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 
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research," which was published in the Federal Register of March 28, 1994 (FR 
59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 
11, March 18, 1994, and is available on the web at: 
http://grants.nih.gov/grants/guide/notice-files/not94-100.html. 

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.  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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