CLINICAL TRIALS: COLLABORATIONS FOR NURSING RESEARCH

Release Date:  February 1, 2000

RFA:  NR-00-003

National Institute of Nursing Research (http://www.ninr.nih.gov/)

Letter of Intent Receipt Date:  April 30, 2000
Application Receipt Date:  May 19, 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/PA.

PURPOSE

The National Institute of Nursing Research (NINR) invites nurse 
investigators to participate in an initiative that capitalizes on the 
substantial National Institutes of Health (NIH) resource of available 
study populations in clinical trials from the unique perspective of 
nursing research and special expertise of nurse researchers. The 
purpose of this Request for Applications (RFA) is to link substudies 
posed by nurse researchers to currently funded clinical research 
studies, or to link substudies by non-nurse researchers with ongoing 
clinical studies where nurse researchers are the Principal 
Investigators (PI).  Collaborations and consortia promoting the cross-
fertilization of ideas are encouraged.  The rationale for this RFA is 
that substudies are cost effective ways to stimulate ongoing research 
while capitalizing on resources expended on a parent clinical trial.  

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2000," a 
PHS-led national activity for setting priority areas.  This Request for 
Applications (RFA), Clinical Trials:  Collaborations for Nursing 
Research, is related to the areas of heart disease and stroke, lung 
conditions, women’s health, trauma, cancer, diabetes, Alzheimer’s 
disease, chronic disabling conditions, and HIV infection. Potential 
applicants may obtain a copy of "Healthy People 2000" at 
http://odphp.osophs.dhhs.gov/pubs/hp2000.

ELIGIBILITY REQUIREMENTS

The applicant responding to this RFA should be a registered nurse with 
doctoral preparation who poses a research question from her/his ongoing 
program of research which can be answered by accessing a currently 
funded clinical trial, or, a nonnurse doctorally prepared scientist who 
seeks to answer a clinical question or solve a nursing problem using 
the clinical study resources where the PI is a nurse researcher.   

Nurse researchers are to collaborate with non-nurse PIs and/or the 
steering committees on currently funded clinical trials where resources 
can be accessed  (i.e., study population for screening, recruitment or 
follow-up visits; data for secondary analyses; fluid samples; genetic 
data banks) in order to answer a clinical question or solve a nursing 
problem. Likewise, non-nurse researchers in various fields are 
encouraged to collaborate with an NIH funded nurse researcher to access 
a study population in a scientific field of their choice.

For the purpose of this RFA, collaboration on a clinical research study 
is required.  A clinical research study is defined as a clinical trial 
where large numbers of subjects are being recruited, hypotheses are 
being tested, and subjects are randomized to a control and experimental 
groups.  Epidemiological study populations are acceptable, but not 
preferred, and may only be used when large cohorts of patients are 
recruited.

The PI or the steering committee for the clinical trial identified as 
the collaborator for the applicant’s RFA R01 must provide written 
assurances in the application that the proposed study is technically 
and administratively feasible as a complementary study, is compatible 
with the parent study protocol, and will not add substantial burden to 
the participants of the currently funded parent grant.  If 
collaborative expertise or research resources (i.e., tissue samples, 
data sets, or access to cohorts) are required to implement the 
applicant’s RFA R01 successfully, documentation of the characteristics, 
quality, and availability of these resources must be fully addressed in 
the application. 

Examples of potential PIs for nurse researchers to collaborate with 
include ethicists, physicians, anthropologists, bioengineers, 
psychologists and other social scientists, epidemiologists, 
geneticists, and molecular biologists.  The following list will assist 
nurse researcher applicants in locating the names of PIs currently 
funded on NIH clinical trials: 
http://cancertrials.nci.nih.gov/
http://www.nei.nih.gov/neitrials/index.htm
http://apps.nhlbi.nih.gov/clinicaltrials/
http://www.niaid.nih.gov/clintrials/
http://www.nih.gov/niams/clinical/
http://www.nichd.nih.gov/ct/ct.htm
http://www.nidcd.nih.gov/research/clinicaltrials/index.asp
http://www.niddk.nih.gov/patient/patient.htm
http://www.nida.nih.gov/ClinicalTrials.html
http://www.nimh.nih.gov/studies/index.cfm
http://rarediseases.info.nih.gov
http://www1.od.nih.gov/obssr/mbpage.htm

Applicants will find grant information for NIH institutes and centers 
that do not maintain Clinical Trial databases at these websites:
http://www.ninr.nih.gov/1998NINRgrants.html
http://www.nhgri.nih.gov/Grant_info/Grant_search/query.cgi
http://www.nih.gov/nia/about/
http://silk.nih.gov/silk/niaaa1/grants/ResCtrs1198.htm
http://silk.nih.gov/public/hba1mqw.@www.active.html
http://www.ninds.nih.gov/clinicians/default.htm

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 or local governments, 
and eligible agencies of the Federal Government.  Foreign organizations 
that have current NIH-supported grants are eligible to apply, and 
domestic applications may include international components.  The NINR 
encourages applications that include investigators who are 
racial/ethnic minority individuals, women, and persons with 
disabilities.

MECHANISM OF SUPPORT

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

The mechanism of support for the RFA will be the traditional research 
project grant (R01). Responsibility for planning the proposed project 
will be solely that of the applicant. R01 awards will vary in size and 
duration reflecting the nature and scope of the research proposed on 
the currently funded parent grant. R01 applications proposing secondary 
analyses of existing data, pilot studies, small clinical studies or any 
projects with budgets less than $250,000 (direct costs) will follow the 
modular grant streamlining mechanism. 

Future unsolicited competing continuation applications will compete 
with all investigator-initiated applications and be received according 
to customary peer review.  Although multidisciplinary approaches and 
collaboration are required for successful competition of applications, 
it is not the intent of the announcement to solicit applications for 
large clinical trials or large epidemiologic studies.  In general, 
funds will not be provided for the purchase and installation of 
expensive, new equipment.  To evaluate the effectiveness of this RFA 
initiative, there will be a yearly meeting of funded investigators and 
NINR staff at the National Institutes of Health.  Applicants should 
request travel funds for this purpose in all fiscal years of their 
budget for this purpose.  Applicants should also include a statement in 
their applications indicating their willingness to participate in these 
meetings. This RFA is a one-time solicitation.  The anticipated award 
date is September 29, 2000.

FUNDS AVAILABLE

The NINR intends to commit $1.5 million in FY 2000 to fund 
approximately 5 new grants in response to this RFA, pending the 
availability of funds.  Additional projects will be considered on a 
case by case basis. Because the nature and scope of the research 
proposed may vary, it is anticipated that the size of awards will also 
vary. Although the financial plans of  NINR are to 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 
applications of outstanding scientific and technical merit. At this 
time, it is not known if competing renewal applications will be 
accepted and/or if this RFA will be reissued.

RESEARCH OBJECTIVES

Background

Critical gaps in knowledge about symptom management of acute and 
chronic illness, prevention of disease and promotion of healthy 
lifestyles exist.  NINR research has attempted to close these gaps by 
promoting research in the following science areas:  neurofunction and 
sensory conditions (i.e., Alzheimer’s disease, multiple sclerosis, 
pain, sleep/biorhythms); reproductive and infant health (i.e., low 
birthweight, teen pregnancy); immune responses and oncology (i.e., HIV, 
infectious disease, end-of-life); cardiopulmonary and critical care 
(i.e., asthma, hypertension, pressure ulcers, transplantation, trauma, 
genetics); chronic illness (i.e., arthritis, diabetes, urinary 
incontinence) the aging population and long term care, and health 
promotion and risk behaviors (i.e., women’s health, children’s health, 
nutrition, obesity, drug abuse).  Currently, the NIH has a wealth of 
resources and information in currently funded clinical trials that 
remains untapped by nurse researchers.  Adding nursing studies to these 
clinical trials will capitalize on current NIH–wide investments in 
research by building upon resources already available (e.g., tissue 
samples, gene data banks, cohorts of subjects with well-delineated 
medical and health data, pediatric or adult clinical trials testing 
drugs or drug combinations). In addition, currently funded nurse 
investigators have large cohorts of patients where biological and 
genetic questions could easily be asked by nonnurse researchers as 
companion studies.  This RFA is expected to enrich scientifically and 
to extend the scope of relevant NIH-funded research grants supporting 
biological, biomedical, or behavioral clinical trials, or nursing 
clinical studies, by asking additional clinical questions. 

Research Objectives and Scope

The overall objective of this RFA is to take full advantage of the 
research process by solving additional health care problems on 
currently funded clinical trials or studies. 

The following research topics are provided as examples that would 
extend research currently funded by NIH.  They are not listed in any 
priority order and are not intended to be inclusive or restrictive.

o  Examine the role that social behavior plays in potentiating 
infection with HIV.

o  Determine the efficacy of dietary and/or exercise protocols for 
patients with AIDS who have elevated lipid levels while on highly 
active antiretroviral therapy.

o  Assess physiological/immunological/genetic parameters in ethnically 
diverse groups with and without chronic conditions, such as diabetes, 
to characterize unique and common responses to medical treatments or 
pharmacological regimens.

o  Assess the occurrence of apolipoprotein subtype alleles found in 
head injured patients and relate them to other disorders such as 
hypertension or stroke.

o  Perform secondary data analyses techniques to ask questions that are 
not part of the original study, i.e., describe ways to prevent 
contributing factors responsible for health disparities; list ways to 
improve management of discomfort for persons at the end of life; assess 
why menopausal women decide to initiate estrogen replacement therapy; 
identify the influence of maternal diet, exercise habits or 
micronutrients on body mass, insulin levels, cholesterol levels or 
blood pressure of their offspring.

o  Determine the efficacy of home monitoring and other self-management 
skills to prevent hospital readmission of patients with chronic 
diseases such as congestive heart failure.

o  Develop tools for parents and care providers to be used in the 
prevention and treatment of asthma attacks in children and adolescents.

o  Characterize the roles of socioeconomic status, age, gender, 
behaviors, or dietary patterns in transplantation patients who are 
noncompliant with medical regimens.

o  Qualitatively measure the decision-making processes for declining 
and chosing therapies in families with a child diagnosed with cancer.

o  Identify factors associated with a reduction in the burden of 
caregiving of family members with a chronic illness such as Alzheimer’s 
disease.

o  Measure endocrine and psychoneuroimmune levels in subjects recruited 
in ongoing clinical intervention studies and relate to optimum vaccine 
inoculation in children and adolescents.

o  Develop symptom management tools for caregivers to use for persons 
at the end of life.

o  Identify specific nursing care measures to improve the outcomes of 
critically ill children diagnosed with traumatic brain injury while in 
intensive care units.

o  Test unique interventions utilizing modern technology (i.e., the 
Internet) in various settings to reach rural populations, the elderly, 
or children and adolescents to maintain healthy lifestyles. 

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 is 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, available on the 
web at:
http://grants.nih.gov/grants/guide/notice-files/not94-100.html.  
AHCPR follows these guidelines as applicable.

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. 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.

LETTER OF INTENT

Prospective applicants are asked to submit 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 NINR staff to 
estimate the potential review workload and avoid conflict of interest 
in the review.

The letter of intent is to be sent to the program staff listed under 
INQUIRIES by the letter of intent receipt date listed in the heading of 
this RFA.

APPLICATION PROCEDURES

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 $250,000 per year. 
(Applications that request more than $250,000 direct costs in any year 
must follow the traditional PHS398 application instructions.) 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 $250,000) 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 key 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.

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.

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.  
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 sample RFA label available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to 
allow for this change.  Please note this is in pdf format.

Submit a signed, typewritten original of the application, including the
Checklist, and four 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, also send one additional copy of the 
application to:

Robin L. Gruber, MPS
Program Analyst
National Institute of Nursing Research
Building 45, Room Number 3AN-12, MSC 6300
Bethesda, MD  20892-6300

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 for responsiveness by NINR.  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 NINR in accordance with 
the review criteria stated below.  As part of the initial merit review, 
a process will be used by the initial review group in which 
applications 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 may receive a second level 
review by the National Advisory Council for Nursing Research.

Review Criteria

The goals of the supported research are to advance our understanding of
biological systems, improve the control of disease, improve health care 
services, and enhance health.  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 these goals.  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 scientific knowledge be 
advanced?  What will be the effect of these studies on the concepts or 
methods that drive this field?

(2) Approach:  Are the conceptual framework, design, methods, and 
analyses adequately developed, well-integrated, and appropriate to the 
aims of the project?  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 
experiments take advantage of unique features of the scientific 
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.

The initial review group will also examine the provisions for the 
protection of human subjects and the safety of the research 
environment.

Schedule 

Letter of Intent Receipt Date: April 30, 2000
Application Receipt Date:  May 19, 2000
Peer Review Date: July 2000
Council Review: September 2000
Earliest Anticipated Start Date: September 29, 2000

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.

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Dr. Hilary D. Sigmon
Program Director
Division of Extramural Activities
National Institute of Nursing Research
Building 45, Room Number 3AN-12, MSC 6300
Bethesda, MD  20892-6300
Telephone:  (301) 594-5970
FAX:  (301) 480-8260
Email: Hilary_Sigmon@nih.gov

Direct inquiries regarding fiscal matters to:

Jeff Carow
Grants and Contracts Management Office
National Institute of Nursing Research
Building 45, 3AN-12, MSC 6300
Bethesda, MD  20892-6300
Telephone: (301) 594-6869
FAX:  (301) 480-8260
Email:  jeff_carow@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance 
No. 93.361 (Nursing Research). Awards are made under authorization of 
the Public Health Service Act, Title IV, Part A (Public Law 78-410, as 
amended by Public Law 99-158, 42 USC 241 and 285) and Title IX (42 USC 
299-299c-6).  Awards are administered under PHS grants policies and 
Federal Regulations 42 CFR 52 and 67, subpart A, and 45 CFR Part 74.  
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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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