EXPLORATORY PROGRAM GRANTS FOR FRONTIER MEDICINE RESEARCH

Release Date:  June 12, 2000

RFA:  AT-00-002

National Center for Complementary and Alternative Medicine

Letter of Intent Receipt Date:    August 7, 2000
Application Information Meeting:  September 7, 2000
Application Receipt Date:         November 14, 2000

PURPOSE

Despite the broad use of complementary and alternative medicine (CAM) 
treatments (Eisenberg et. al., 1998) there is a relative paucity of data that 
convincingly demonstrates safety, efficacy, effectiveness, and mechanisms of 
CAM practices. A similar conclusion was reached in a 1990 report on 
unconventional cancer treatments by the U.S. Office of Technology Assessment. 
This report urges a systematic analysis of the effect of alternative treatments 
on major disease, health and wellness (U.S. Office of Technology Assessment, 
OTA-H-405, 1990, p.225).  The National Center for Complementary and Alternative 
Medicine (NCCAM) has established several extramural CAM research centers and 
supports a growing portfolio of research, training, and career development 
grants.  However, the NCCAM has not succeeded in stimulating sufficient 
research activity in the area known as Frontier Medicine. 
 
Frontier Medicine can be defined, for purposes of this initiative, as those CAM 
practices for which there is no plausible biomedical explanation.  Examples 
include bioelectromagnetic therapy, biofield/energy healing, homeopathy and 
therapeutic prayer/spiritual healing.  Despite the fact that these therapies 
are used extensively by the U.S. public, there are very little high-quality 
data available to elucidate or demonstrate the safety, efficacy, effectiveness 
and/or mechanisms underlying these approaches.  Researchers and Frontier 
Medicine practitioners have very diverse backgrounds, and the latter generally 
carry out their professional activities in relative isolation from and without 
the infrastructural support provided by conventional medical and academic 
institutions.  No NIH-supported centers of excellence currently exist that 
bring together a critical mass of experienced Frontier Medicine researchers in 
the kind of supportive, yet scientifically rigorous environment that is 
necessary to conduct quality biomedical research.

This initiative will establish Exploratory Program Grants for Frontier Medicine 
Research, the purpose of which will be to create an infrastructure to nurture 
and therefore advance this field of biomedical research by providing the 
institutional support and resources necessary for rigorous scientific 
investigation.  Each of these Exploratory Program Grants will serve as a focal 
point to: (1) facilitate synergistic collaborations among 
exploratory/developmental research subprojects; (2) provide an enriched 
training and career development environment; and (3) create the opportunity for 
small pilot/feasibility research projects.  The Exploratory Program Grants will 
serve to develop the fields in ways that will increase the likelihood that 
efficacious therapeutic paradigms will emerge from the existing Frontier 
Medicine approaches, and thus increase the probability that some of these will 
become integrated with and will make a contribution to interdisciplinary 
healthcare.

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), Title 
of 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/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic 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.  Applications may include foreign components, but 
foreign organizations are not eligible to apply.  To be considered, applicant 
organizations must have:  (1) a minimum of three independent investigators who 
together represent experience in both basic and clinical research; (2) access 
to a patient care and service facility; and (3) the capacity to design, 
conduct, and evaluate three to four research projects that include at least one 
basic (mechanistic) study and one clinical study.  Phase III trials (see 
"SPECIAL REQUIREMENTS - Research Project" for definition) and surveys will not 
be considered.  

Although applications must be submitted from one institution, they may include 
subcontracted collaborative scientific and clinical arrangements with 
scientists from other institutions, including foreign institutions, as long as 
these arrangements are clearly delineated, and formally and officially 
confirmed by signed statements from the responsible officials of each 
institution.  However, a full institutional commitment must come from the 
parent institution receiving the award.

NIH staff (See INQUIRIES below) should be consulted if there are questions 
regarding any of the above requirements or exclusions.

Applicants from institutions that have a General Clinical Research Center 
(GCRC) funded by the NIH National Center for Research Resources may wish to 
identify the GCRC as a resource for conducting the proposed research.  If so, a 
letter of agreement from either the GCRC Program Director or Principal 
Investigator should be included within the application.

Racial/ethnic minority individuals, women, and persons with disabilities are 
encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

Support of this program will be through the NIH P20 Exploratory Grants 
mechanism.  This mechanism supports the full range of research and development 
from basic to clinical and intervention studies.  NCCAM's P20 Exploratory 
Program Grants assemble critical masses of basic and/or clinical scientists to 
work together collaboratively.  The essential characteristics of this P20 
Exploratory Program Grant include:  (1) a strong, focused scientific program of 
Frontier Medicine research that will have a clear impact on human disease and 
associated quality-of-life or disability issues; (2) a strong, innovative 
program to establish and monitor pilot/feasibility studies that can respond 
quickly to new research opportunities; (3) a strong career development program 
to develop and expand the scientific cadre of investigators dedicated to 
Frontier Medicine research; and (4) a shared administrative core that can 
increase the functional capacity of the Exploratory Program Grant activities. 

Applicants will be responsible for the planning, direction, and execution of 
the proposed Exploratory Program Grant.  Awards will be administered under the 
NIH Grants Policy Statement. 

FUNDS AVAILABLE

The NCCAM anticipates making up to four awards with an estimated overall 
commitment of $2.4 million total costs for the initial year's funding.  Funding 
levels are dependent on the receipt of applications of high technical and 
scientific merit and the continued availability of funds.  Because the nature 
and scope of applications may vary, it is anticipated that the award size will 
vary.  Although this program is provided for in the financial plans of NCCAM, 
the award of grants pursuant to this RFA is contingent upon the availability of 
funds

Applicants may request up to three years of support.  Applications submitted in 
response to this RFA are limited to a maximum of $600,000 total costs (direct 
costs and Facilities and Administration costs) in the first year of the award. 
Future increases are limited to three percent per year.

RESEARCH OBJECTIVES

1.  Background

The demographics, prevalence, and patterns of use of CAM in the United States 
have been described (Eisenberg et al., 1998).  The most relevant findings are 
the following:  a) extrapolation to the population of the United States 
suggests that Americans made approximately 629 million visits to providers of 
CAM therapy during 1997; and b) expenditures associated with CAM therapies 
exceeds non-reimbursed expenses incurred for all hospitalizations in the United 
States.  These findings indicate that CAM occupies a larger role in the health 
care of U.S. citizens than previously understood.  Despite this broad use, 
there are, in general, insufficient scientific data that address safety and 
efficacy questions for CAM therapies. And the CAM therapies for which the least 
amount of research-based knowledge exists are those in the category of Frontier 
Medicine.   

2.  Goals

A.  General:

NCCAM's Exploratory Program Grants for Frontier Medicine Research will provide 
focal points for initiating and maintaining state-of-the-art research to 
improve treatment and prevention of human disease or the quality-of-life 
associated with these conditions. These Exploratory Program Grants will be 
expected to conduct a focused group of research activities, and to contribute 
significantly to the research by providing administrative core research 
resources, career development of new investigators, and an expanded base of 
collaborative research with scientists and clinicians (both CAM and 
conventional) in other institutions locally and worldwide.

The exploratory/developmental research projects should take maximum advantage 
of new research opportunities, and are expected to establish the methodological 
feasibility and strengthen the scientific rationale for proceeding to trials on 
the use of CAM.  The pilot/feasibility research program should establish a 
flexible means to respond quickly to new research opportunities.  Career 
development of new and established investigators will generate a cadre of 
scientists who could leave the Center with research experience to develop 
independent CAM research programs.

To facilitate achieving the Exploratory Program Grant goals, each application 
will propose an administrative core that will provide centralized leadership, 
coordination, and advisory activities, as well as specialized multi-user 
resources (i.e., research/clinical trial design, data management, quality 
control, and biostatistics).

B.  Specific Objectives:

Specific objectives for the Exploratory Program Grant applications include:

o Performing research related to Frontier Medicine approaches in one of the 
listed research practice areas (see RESEARCH ACTIVITIES below); 
o Investigating basic mechanisms of Frontier Medicine therapeutic and 
diagnostic interventions;
o Conducting exploratory/developmental studies or Phase I and II trials of 
sufficiently developed Frontier Medicine interventions to facilitate the design 
and eventual conduct of  randomized, masked, controlled trials; 
o Acting as an institutional focus for training in research methodology, 
bioethics, biostatistics, clinical trial design, and basic laboratory methods 
that relate to Frontier Medicine;
o Provide plans for establishing an Advisory Committee (see "SPECIAL 
REQUIREMENTS" for Advisory Committee composition) to provide program direction 
and advice to the Principal Investigator of the Exploratory Program Grant, 
including prioritization of pilot/feasibility studies, and utilization of the 
administrative core facilities;
o Developing a mechanism for scientific/technical merit review of proposed 
pilot/feasibility studies from investigators;
o Developing workshops, seminars, websites, etc. for training and dissemination 
of information about Frontier Medicine research to health care providers and 
the public; and
o Establishing a system to identify and support basic and clinical 
investigators in their career development, including promotions and tenure.

RESEARCH ACTIVITIES

The overall goals and objectives of the Exploratory Program Grant's research 
agenda for the requested funding period should be explicitly stated in the 
application.  This should include identification of the Exploratory Program 
Grant's research direction, as well as specific disease entities and target 
populations to be studied. For the purpose of this RFA, each application for an 
Exploratory Program Grant must include modalities from only one of the 
following broad program areas in Frontier Medicine:

o Bioelectromagnetic Therapy (e.g., diagnostic and therapeutic application of 
electromagnetic (EM) fields including pulsed EM fields, magnetic fields, Direct 
Current (DC) fields, artificial light therapy, etc.  Note:  This category does 
not include the study of electromagnetic fields as risk factors for disease);

o Biofield (e.g., energy healing, etc. Note: This category involves systems 
that use "subtle energy" fields in and around the body for medical purposes.  
Examples include Therapeutic Touch, Reiki, Huna, laying-on-of-hands, external 
Qi-Gong, etc.);

o Homeopathy; or

o Therapeutic Prayer; Spiritual Healing; Distance Healing; or other examples of 
prayer and/or spirituality as direct clinical interventions.
 
SPECIAL REQUIREMENTS

Applications must include ALL the following elements to be considered 
responsive to the RFA. 

1.  A strong institutional commitment:  

An institution receiving this award should incorporate the Exploratory Program 
Grant high within its institutional priorities.  The institution should 
demonstrate a strong commitment to the program's stability and success.  The 
application must provide a plan that addresses how the institutional commitment 
will be established and sustained, how it will maintain accountability for 
promoting scientific progress, and how the Exploratory Program Grant's research 
effort will be given a high priority within the institution relative to other 
research efforts.  The institution should demonstrate commitment to the 
scientific value of the proposed research and willingness to consider this 
research as support for tenure and promotion.  This institutional commitment 
may be in the form of commitments to recruit scientific talent, provision of 
discretionary resources to the Exploratory Program Grant director, faculty 
appointments for Exploratory Program Grant investigators, assignment of 
clinical and research space, support for training and career development, or 
other ways to be proposed by the applicant.

2.  A qualified Principal Investigator (PI):  

A leader should be selected as PI who can oversee and conduct planning 
activities and provide direction to the Exploratory Program Grant.  The PI 
should have documented experience both as a scientist and as administrator of a 
research program.  The PI is required to commit a minimum of 30% effort (15% as 
the PI plus 15% as a research project primary investigator [see # 5 below]) and 
has to be the primary investigator on one (but not more than two) research 
projects.

3.  Linkages to the CAM community:

The applicant needs to document that linkages to the relevant CAM communities 
exist and that certified or licensed CAM practitioners provide appropriate 
input to, and participate in, Exploratory Program Grant research projects.  

4.  A substantial patient population:  

The grant application must demonstrate and document access to a patient 
population that is able to participate in, and can benefit from, the innovative 
research activities of the Exploratory Program Grant.

5.  Research projects:  

Each Exploratory Program Grant application should include three to four 
exploratory/developmental research projects.  At least three projects are 
required to start in year-01 of the award.  Start of the fourth project can be 
postponed until the second year of the award.  Each of these projects must 
request at least one, but not more than three years of support in the 
application.  At least three of the submitted projects that begin in year-01 of 
the award must be judged meritorious by the peer-review panel for the 
application to meet the minimal requirements of a P20 Exploratory Program 
Grant.  Failure to meet this requirement will remove the application from 
funding consideration.  Research project primary investigators are each 
required to commit at least 15% time to these projects. Combined support for 
the 3 or 4 research projects included in the Exploratory Program Grant is 
limited to a maximum of $320,000 (direct costs) per year.


The research must be oriented toward the most critically needed areas of CAM 
research, and toward collaborative activities that address new innovative 
possibilities in CAM research.  Whenever feasible, collaborations with 
appropriate certified, licensed or otherwise qualified CAM practitioners are 
required.  Research projects should be interactive with each other whenever 
possible. Research projects can be basic (mechanistic) or clinical studies 
other than a Phase III trial (defined below).  Applications that do not meet 
this basic requirement will be ineligible for funding.  Epidemiological studies 
and health services studies and surveys WILL NOT be accepted under this RFA.  

For the purpose of this RFA, a Phase III trial is defined as a broadly based 
prospective investigation usually involving a substantial number of human 
subjects either at a single site or at multiple sites.  The primary objective 
of such trials is to evaluate an experimental intervention in comparison with a 
standard or control intervention, or to compare two or more existing 
treatments.  In Phase III trials, the primary endpoint is usually a significant 
change in some clinical outcome.  The definition includes interventions given 
for disease prevention, prophylaxis, diagnosis, or therapy. 

Research components involving phase I and II clinical trials must include 
provisions for assessment of patient eligibility and status, rigorous data 
management, quality assurance, and auditing procedures.  In addition, it is NIH 
policy that all clinical trials require data and safety monitoring, with the 
method and degree of monitoring being commensurate with the risks (NIH Policy 
for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  In 
addition, NCCAM requires that all masked clinical trials, regardless of size, 
establish an independent data and safety monitoring board.  Funds should be 
budgeted for these activities.  They should not duplicate internal review and 
monitoring systems that are already in place at the institution.  

Collaborative arrangements within the Exploratory Program Grant, within the 
parent institution and with other institutions are encouraged.  All 
collaborations with scientists outside the immediate Exploratory Program Grant 
should be documented with appropriate letters of commitment as applicable.  
Collaborations with other institutions, including foreign institutions, may 
involve subcontracting arrangements but an award will be made to one 
institution only; that institution is expected to demonstrate the full 
institutional commitment noted in item 1 above (Strong Institutional 
Commitment).

6.  An Administrative Core:  

Each Exploratory Program Grant is required to have an administrative core that 
is responsible for the day-to-day administrative details, as well as program 
coordination and ongoing evaluation of the Center.  The Career Development 
Program, the Pilot/Feasibility Research Program, and the Advisory Committee 
activities (items # 7-9 below) all fall within the responsibilities of the 
administrative core.  The administrative core must also provide expertise and 
guidance in data management, biostatistics, and clinical trial 
design/coordination (These resources should not duplicate resources already 
available to Exploratory Program Grant investigators).  The support for the 
administrative core is limited to a maximum of $120,000 (direct costs) per 
year, which includes $50,000 (direct costs) per year for the pilot/feasibility 
research program. 

7.  Career Development:  

The Program Grant application should demonstrate a consistent commitment to 
training and the career development of research project and pilot/feasibility 
project researchers.  Recruitment should encourage the participation of 
Frontier Medicine practitioners (with, or without previous research experience) 
and of qualified women and minorities where possible.  To this end, each 
applicant should include a clear policy and plans for recruiting minorities and 
women and scientists with disabilities.   

8.  Pilot/Feasibility Research Program:  

In each year of the award, the Exploratory Program Grant will allocate up to 
$50,000 (direct costs) to pilot/ feasibility projects that explore innovative 
ideas.  It is important that Exploratory Program Grants use pilot/feasibility 
funds to stimulate projects that take maximum advantage of new research 
opportunities.  These pilot/feasibility projects may be collaborative among 
scientists within the Exploratory Program Grant or with scientists outside the 
Exploratory Program Grant environment.  Pilot/feasibility research projects 
should adhere to the list of Frontier Medicine program areas appearing in this 
announcement. Rebudgeting of Exploratory Program Grant funds to, or from, the 
pilot/feasibility research program will only be permitted with prior NCCAM 
staff approval. 

Applicants are not expected or required to identify pilot/feasibility research 
projects by the time of submission.  However, the Exploratory Program Grant 
application should clearly describe the institutional review process that will 
be established to select and support pilot/feasibility research projects that 
represent the most innovative ideas and that are likely to have the greatest 
impact on Frontier Medicine research.  The funds available for the 
pilot/feasibility research program ($50,000 [direct costs] per year) are 
intended to remain flexible and to support pilot/feasibility studies (up to  
$25,000 [direct costs] each per year) of a limited duration (two years or 
less), rather than the duration of the entire Exploratory Program Grant period. 
The expectation is that successful pilot/feasibility research studies will 
become fully developed exploratory/developmental grant applications (e.g. R21). 
NCCAM staff must be notified before the start of each pilot/feasibility project 
to verify human and animal subject assurances and Advisory Committee approval.

9.  Advisory Committee:

Scientific and administrative Exploratory Program Grant oversight is charged to 
a multidisciplinary Advisory Committee (AC) to be appointed on a rotating basis 
by the Principal Investigator. The AC shall not be chaired by the Principal 
Investigator who will serve in an ex officio capacity only. The AC should meet 
at least twice a year and minutes of the meeting should be kept.  These minutes 
shall be made available to NCCAM staff within 6 weeks of the meeting.  The AC 
should consist of at least nine individuals familiar with the Exploratory 
Program Grant's research activities.  The AC shall include at least one person 
with expertise in biostatistics and clinical trial design to assist with the 
review of projects and the optimal approaches for subsequent data analysis.  
The AC must have representation from the scientific, practitioner and lay 
communities in both CAM and conventional medicine.  Members SHOULD NOT be 
identified until after an award is made.  However, the process by which members 
will be chosen should be specified.

Besides being intimately involved in prioritizing and selecting 
pilot/feasibility research projects submitted by Exploratory Program Grant or, 
if applicable, consortium investigators, the AC should periodically review 
Exploratory Program Grant operations to ensure that resources are used for the 
most scientifically worthy projects.  The AC should take an active role in 
encouraging faculty members to perform research and assisting them to apply 
appropriate research concepts and methods.  The AC should also be involved in 
the selection and mentoring of candidates for the career development program.  
Support for the AC should be explicitly budgeted and justified.

10.  Investigational New Drug (or Device) applications (INDs):

It is the sole responsibility of the applicant to obtain all necessary 
clearances from the Food and Drug Administration as required.  It is expected 
that applicants will have started the IND process, if required, well before 
submission of the P20 application.  In addition, applicants are strongly 
encouraged to consult their local Institutional Review Boards (IRBs) concerning 
IND status and the IRB approval process.

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 have been 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 the following URL address:  
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.

LETTER OF INTENT

Prospective applicants are asked to submit, by August 7, 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 
NCCAM staff to estimate the potential review workload and plan the review.

Mail/Fax letters of intent to:

Dr. Neal B. West
Program Officer
National Center for Complementary and Alternative Medicine
Building 31/ Room 5B58
Bethesda, MD  20892-2182
Telephone:  (301) 402-5867
FAX:  (301) 402-4741
Email:  westn@od.nih.gov

APPLICATION INFORMATION MEETING

In order to give potential applicants the opportunity to clarify any issues or 
questions concerning the RFA, an Application Information Meeting (AIM) will be 
held.  At the AIM, potential applicants will have the opportunity to discuss 
application concepts and outlines of proposed applications with NIH staff.  The 
AIM will be held at, or in close proximity to NIH on (Thursday, September 7, 
2000). Although a registration fee is not associated with this meeting, pre-
registration is encouraged.  NCCAM has not allocated funds to pay for attendee 
travel to the AIM; all travel costs are the responsibility of the attendee.  
Additional information on the meeting, as well as registration materials can be 
obtained from the NCCAM Program Officer listed under "INQUIRIES".  A summary of 
the presentations and issues discussed at the meeting will be made available 
through the NCCAM Web-site about one week after the AIM.  Hard copies will be 
made available for those applicants without Web access.

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.  The application is also available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

The total page limitation of the application, as specified in the instructions 
of the Form PHS 398, does not apply to this RFA.  Instead, the following 
stipulations apply:  

Table of Contents:

Disregard the Table of Contents page from PHS 398 and, instead, write a Table 
of Contents appropriate for this Exploratory Program Grant application.  The 
Table of Contents should list all items for which funding is sought, in 
addition to each specific activity required of the Exploratory Program Grant as 
outlined under "Special Requirements."  Specifically list the locations of the 
checklist and the various supporting documents, including bibliographic 
sketches and other support pages.  Each page of the application should be 
numbered consecutively.  This numbering should be reflected in the Table of 
Contents.

Budget:

For preparation of the budget, the applicant should present a composite budget 
for all years of support.  This composite budget should include the direct 
costs for each required Exploratory Program Grant activity (e.g., Advisory 
Committee, Developmental Research Program, etc.), as well as each research 
project and the administrative core facility.  This composite budget should be 
in tabular format, with each budget year being listed in a separate column and 
each Exploratory Program Grant activity, core or subproject being listed in a 
separate row. Budget Form pages 4 and 5 of PHS Form 398 should be completed for 
each Exploratory Program Grant activity, i.e., administrative core or project 
listed in the composite budget.  These pages should be clearly labeled as to 
which Exploratory Program Grant activity they address.
 
Bibliographic Sketches:
Bibliographic sketches and other support pages are required for all proposed 
Exploratory Program Grant personnel and for all investigators associated with 
the mandatory research projects and the administrative core.  These pages 
should be in alphabetical order following the budget pages and should not be 
duplicated in the descriptions of individual component projects and the core.  

Research Projects and Administrative Core:
Each research project is allowed 15 pages, excluding bibliographies.  

NOTE:  The section on the Administrative Core is to include descriptions and 
justifications of the Advisory Committee, the Developmental Research Program, 
and the Exploratory Program Grant's overall goals and objectives; this combined 
section is limited to 25 pages.

Descriptions of the research projects and the administrative core should follow 
the PHS 398 format, section 9 (Research Plan) with the addition that each 
project should have its own title page and abstract.  The research project 
title page should list all investigators and their associated institutions, as 
well as the direct and total costs for the project for each year of the award. 
In addition, each research project must document its relationships to other 
projects and to the Exploratory Program Grant.  Each of the six points listed 
under Human Subjects in the PHS 398 application must be addressed for those 
studies involving human subjects.  Although not required at the time of the 
application, Institutional Animal Care and Use Committee approval must be 
obtained for each research project listed, if appropriate, within 60 days of 
submission.  Institutional Review Board approval(s) are needed before an award 
can be made.

The RFA label available in the PHS 398 application package must be affixed to 
the bottom of the face page of the application.  The affixed label should 
clearly display the RFA number:  AT-00-002.  Failure to use this label could 
result in delayed processing of the application.  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 typewritten, signed original of the application, four signed 
photocopies, and the completed checklist 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)

Applicants who prefer to use express mail or courier service should change the 
zip code above to 20817.

At the time of submission, mail one additional complete copy of the application 
to the following RFA program administrator:

Dr. Richard L. Nahin
Director, DERTR
National Center for Complementary and Alternative Medicine
9000 Rockville Pike
Building 31, Room 5B58
Bethesda, MD  20892-2182
Telephone: (301) 496-4792
FAX: (301) 402-4741
Email: nahinr@od.noh.gov 

Applications must be received by November 14, 2000.  If an application is 
received after the date, it will be returned to the applicant without review.  
The CSR will not accept any application that is essentially the same as one 
previously reviewed.  This does not preclude the submission of a substantial 
revision of an application already reviewed, but such an application must 
follow the guidance in the PHS Form 398 application instructions for 
preparation of revised applications, including an introduction addressing the 
previous critique.

REVIEW CONSIDERATIONS

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 NCCAM in accordance with the NIH peer review procedures.  As part of the 
initial merit review, all applications will receive a written critique and 
undergo a process, streamlined review, in which only those applications deemed 
to have the highest scientific merit, generally the top half of applications 
under review, will be discussed, assigned a priority score, and receive a 
second level review by the NCCAM Advisory Council.

Review Criteria

All applications submitted in response to this RFA will be reviewed according 
to the following review criteria.  Reviewers will consider these criteria when 
assigning a single overall score to each application.  This single score should 
reflect their judgement that the proposed Exploratory Program Grant will have a 
substantial impact on the pursuit of its goals.

Major factors to be considered in evaluation of applications will include:

1.  How the proposed Exploratory Program Grant combines basic and clinical 
research with the research theme and CAM program areas.

2. Incorporation of appropriate CAM expertise, including certified or licensed 
CAM practitioners.


3.  The integration of appropriate CAM and conventional medical expertise.  

4.  Scientific merit of each proposed research project.  Each research project 
will be reviewed according to the explicitly-stated set of five review criteria 
recently adapted by the NIH:

(a)  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?

(b)  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?

(c)  Innovation:  Does the project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new methodologies or technologies?
 
(d)  Investigator:  Is the research project primary investigator appropriately 
trained and well suited to carry out this work?  Is the work proposed 
appropriate to the experience level of the research project primary 
investigator and other researchers (if any)?

(e)  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

Each research project will receive a priority score.  The score reflects not 
only the feasibility of the project and the adequacy of the experimental 
design, but also its relevance to the overall goals of the Exploratory Program 
Grant, the appropriate utilization of administrative core resources (e.g., 
experimental design, biostatistics), and the integration of CAM practitioners. 
 
Each research project also will be reviewed for the adequacy of plans to 
include both genders, minorities, children and their subgroups as appropriate 
for the scientific goals of the research.  Plans for the recruitment and 
retention of subjects also will be evaluated. 

In addition, the adequacy of the proposed protection for humans, animals or the 
environment will be evaluated to the extent they may be adversely affected by 
the project proposed in the application.

5.  Scientific merit of combining the component parts into an Exploratory  
Program Grant (e.g., the whole must be greater than the sum of its parts);

6.  Technical merit and justification of the administrative core;

7.  Adequacy of facilities to perform the proposed research, including 
laboratory and clinical facilities, instrumentation, and data management 
systems, when needed;

8.  Adequacy of plans for interaction among investigators, and the integration 
of the various research projects with the administrative core;

9.  Qualifications, experience and commitment of the PI and his/her ability to 
devote time and effort to provide effective leadership;

10.  Scientific and administrative structure, including internal and external 
procedures for monitoring and evaluating the proposed research and for 
providing ongoing quality control and scientific review;

11.  Institutional commitment to the program, and the appropriateness of 
resources and policies for the administration of an Exploratory Program Grant;

12.  The proposed organization and activities of the Advisory Committee will be 
evaluated, including the process to choose Committee members after an award is 
made;

13.  Career Development Program including adequacy of the process for selecting 
candidates for career development and plans for recruiting minority and women 
candidates; and adequacy of the individuals available to serve as possible 
mentors of career development candidates;

14.  Pilot/Feasibility Research Program including adequacy of the proposed 
process for continuously reviewing and funding projects for their quality, 
innovativeness and potential impact; and potential of the program to generate 
innovative, high-quality projects on a consistent basis.

15.  Demonstration of an effective relationship among Consortium institutions, 
if any, including documentation of current relationships, as well as the 
functions, commitments and contributions each Consortium member will bring to 
the proposed Exploratory Program Grant;

16.  The appropriateness of the budget for the proposed program and its 
individual components will be considered independently of the factors indicated 
above.

A single numerical priority score will be assigned to the Exploratory Program 
Grant application as a whole.  Although primary emphasis will be placed on 
scientific merit, innovativeness, and past progress (where applicable), 
significant consideration will be given to administrative structure, 
multidisciplinary interactions including those with CAM practitioners, 
potential for impacting on the disease/condition in question, and institutional 
commitment.

AWARD AND REPORTING REQUIREMENTS

Applications recommended by the NIH Initial Review Group and by the NCCAM 
Advisory Council will be considered for award based on: 1) scientific and 
technical merit as determined by peer review; 2) program relevance and balance; 
3) availability of funds; and 4) responsiveness to the goals and objectives of 
the RFA. 

Letter of Intent Due:        August 7, 2000 
Application Receipt Date:    November 14, 2000
Review by Advisory Council:  May 2001
Anticipated Award Date:      July 2001

INQUIRIES

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

Inquiries regarding programmatic issues should be directed to:

Dr. Neal B. West
Program Officer
National Center for Complementary and Alternative Medicine

Building 31, Room 5B58
Bethesda, MD  20892-2182
Telephone:  (301) 402-5867
FAX:  (301) 402-4741
Email:  westn@od.nih.gov

Inquiries regarding review issues should be directed to:

Dr. Richard L. Nahin
Director, DERTR
National Center for Complementary and Alternative Medicine
9000 Rockville Pike
Building 31, Room 5B58
Bethesda, MD 20892-2182
Telephone: (301) 496-4792
FAX: (301) 402-4741
Email: nahinr@od.nih.gov 

Inquiries regarding budget issues should be directed to:
Suzanne White*
Grants Operations Branch
National Heart, Lung and Blood Institute
National Institutes of Health
Two Rockledge Center, Suite 7154, MSC 7926
6701 Rockledge Drive
Bethesda, MD 20892-7952
Phone:  301-435-0170
Fax:  301-480-3310
Email: WhiteS@gwgate.nhlbi.nih.gov

* Note: NHLBI is the Grants Management Service
Center for the NCCAM

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.213. 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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