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COMPLEMENTARY AND ALTERNATIVE MEDICINE (CAM) THERAPY IN THE TREATMENT 
OF HIV/AIDS 

RELEASE DATE:  August 26, 2002
 
RFA:  AT-03-001
 
National Center for Complementary and Alternative Medicine (NCCAM)
 (http://nccam.nih.gov/)
National Institute of Nursing Research (NINR) 
 (http://www.ninr.nih.gov)
 
LETTER OF INTENT RECEIPT DATE:  November 11, 2002

APPLICATION RECEIPT DATE:  December 10, 2002 

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA
This initiative will support research to identify potential roles for 
the safe and effective use of CAM in the treatment of HIV/AIDS and its 
complications, or to ameliorate medication side effects.  NCCAM and 
NINR are especially interested in supporting well-designed studies to 
characterize and investigate traditional medicine practices used in the 
treatment of HIV/AIDS.  In this context, traditional medicine practices 
are derived from systems that have evolved their own coherent bodies of 
knowledge, and are differentiated from conventional or biomedical 
systems.

RESEARCH OBJECTIVES

Background

Complementary and alternative medicine (CAM) practices are described as 
those not presently considered an integral part of conventional 
medicine. NCCAM has categorized the wide range of CAM modalities into 
five broad areas: 1) Alternative Medical Systems, 2) Mind-Body 
Interventions, 3) Biologically-based Therapies, 4) Manipulation and 
Body-based Methods, and 5) Energy Therapies.  The medical literature 
includes reports of CAM use from each of the areas in patients with 
HIV-infection. 

1) Alternative medical systems are built upon complete systems of 
theory and practice, and include Traditional Medicine systems that 
often have evolved apart from and earlier than the conventional medical 
approach used in the United States.  Examples of traditional systems, 
many of which have developed in non-Western cultures, include 
traditional Chinese medicine, Ayurveda, and Unani, as well as 
traditional Native American (American Indian) and African/African-
American systems.  Examples of alternative medical systems that largely 
have developed in Western cultures include homeopathic medicine and 
naturopathic medicine. 

2) Mind-Body interventions use a variety of techniques designed to 
enhance the mind"s capacity to affect bodily function and symptoms. 
Some techniques that were considered CAM in the past have become 
mainstream, for example, patient support groups and cognitive-
behavioral therapy.  Other mind-body techniques are still considered 
CAM, including meditation, prayer, mental healing, and therapies that 
use creative outlets such as art, music, or dance.    

3) Biologically-based therapies in CAM use foods, diets, and dietary 
supplements such as vitamins, herbs, and other natural products.  

4) Manipulation and body-based methods in CAM are based on manipulation 
and/or movement of one or more parts of the body.  Examples include 
chiropractic or osteopathic manipulation, and massage therapy.    

5) Energy therapies are of two types: 1) Biofield therapies (e.g., Qi 
gong, Reiki, and Therapeutic Touch), which are intended to affect 
energy fields that purportedly surround and penetrate the human body, 
and 2) Bioelectromagnetic-based therapies that involve the 
unconventional use of electromagnetic fields such as pulsed fields, 
magnetic fields, or alternating current or direct current fields.    

Estimates of CAM use by the general population vary, some surveys 
report prevalence as high as 40%.  Although literature supporting the 
effectiveness of CAM for the treatment of HIV infection is limited, 
HIV-infected persons reportedly use CAM at higher rates than the 
general population, estimates range from 41% to 84%.  HIV-infected 
persons reported substantial increases in CAM use after the diagnosis 
of HIV-infection.  Generally, patients with HIV infection use CAM 
modalities in association with, rather than as a substitute for, 
conventional medical care.  Although many patients perceive the use of 
CAM to be beneficial, the absence of controlled studies examining the 
outcomes of CAM use raise questions about the effectiveness of these 
interventions.  

The devastation of this epidemic increasingly focuses on racial and 
ethnic minority communities.  Many HIV-infected people of color utilize 
CAM approaches, either in association with, or instead of conventional 
medical therapy.  The scope of treatments is as varied as the cultures 
from which the people come.  Studies on the range of CAM modalities may 
contribute to understanding the differences in health behaviors 
regarding HIV among minority populations and potentially identify 
effective integrative approaches to treating HIV in minority 
communities.

Patients with HIV infection use CAM for many reasons: to reduce HIV-
related symptoms or medication side effects such as nausea, fatigue, 
and weight loss, to strengthen the immune system, maintain health, and 
slow the progression of infection, to enhance energy, increase 
productivity, promote emotional well being, and reduce stress as well 
as depression, and to increase quality of life and perceived control 
over the disease process.  In view of the potential effect of patient 
expectation on perceptions of benefit, well-designed studies are needed 
on the effectiveness of various CAM interventions used by patients with 
HIV/AIDS.

While ineffective CAM therapies cannot be advocated in place of 
demonstrably effective pharmaceutical therapy, there are circumstances 
where the use of CAM therapies merits consideration.  For example, 
recent changes in recommendations have resulted in later initiation of 
highly active antiretroviral therapy (HAART).  Studies may investigate 
ethically the use of CAM to reduce viral load earlier in the course of 
infection and potentially delay progression of HIV infection prior to 
the time conventional treatment is recommended.  Also, data indicate 
that the proportion of resistant virus is increasing.  Although more 
new medications are being developed and introduced, individuals with 
resistant virus may be candidates for complementary non-pharmaceutical 
treatment.  With the increased life expectancy afforded by HAART, 
individuals are on antiretroviral medications for longer periods of 
time, thereby increasing the risk of side effects.  While the discovery 
of potent and effective CAM antiretroviral treatments may not be highly 
likely, some agents might be sufficiently active for use by individuals 
who cannot tolerate or do not accept conventional drugs.  Moreover, 
they may be adequate to enhance antiviral responses when combined with 
conventional therapy, thereby decreasing required doses of 
pharmaceuticals, potentially lessening medication side effects and 
improving patient compliance.  Finally, the identification of useful 
CAM antiretrovirals might serve to promote the further development of 
the active chemical entity(ies) by other NIH components or by private 
sector organizations.  Additional research is needed on a wide range of 
CAM interventions, alone or in combination, to identify those CAM 
modalities that have potential roles in the treatment of HIV/AIDS.

OBJECTIVES

The objectives of this initiative are to: 
1) Identify safe and effective CAM therapies that have potential roles 
in treating HIV/AIDS and its complications, or to ameliorate medication 
side effects, 
2) Establish possible synergistic combinations of CAM and conventional 
treatments for HIV, and, 
3) Understand mechanisms of action of CAM therapies that have the 
potential for contributing to the treatment of HIV/AIDS and its 
complications, or to ameliorate medication side effects.

NCCAM and NINR are soliciting applications for research projects 
investigating the range of CAM modalities with the potential to 
contribute to the treatment of HIV/AIDS.  They may range from basic 
through clinical studies, including in vitro, animal model, phase I 
human trials, and small phase II trials.  Both preclinical and early 
clinical data, or at least substantive existing clinical study data, 
will be needed to justify phase II trials.  Studies that investigate 
interactions between botanicals and drugs used to treat HIV infection 
or the clinical outcomes of treatment for HIV infection combining 
botanical substances with antiretroviral therapy will be considered 
responsive to this solicitation.  In undertaking clinical studies, 
investigators may use surrogate markers (such as CD4 count or viral 
load) in order to remain within the budget and time limits of this 
solicitation.  NCCAM and NINR are especially interested in supporting 
well-designed studies to characterize and investigate traditional 
medicine practices used in the treatment of HIV/AIDS.  Following is a 
list of the types of studies that might be undertaken through this RFA, 
this list is exemplary, not exclusive.

o  In vitro studies examining antiretroviral properties of herbs or 
other supplements.
o  Studies investigating interactions between botanical substances and 
drugs used to treat HIV infection.
o  Projects that combine botanical substances with antiretroviral 
therapy to investigate clinical outcomes in treating HIV infection.  
o  Studies of CAM interventions in treating HIV using animal models.
o  The use of CAM interventions to decrease symptoms of HIV infection 
or medication side effects. 
o  Studies of the effects of herbs or other CAM interventions, alone or 
in combination with antiretroviral therapy, on progression of HIV 
infection or on patient adherence.
o  Projects to characterize and investigate the safety and efficacy of 
traditional medicine treatments in widespread use.
o  Clinical studies of herbs shown to have anti-HIV activity in vitro.  
o  Studies of the potential benefits to persons with HIV infection of 
dietary supplements such as vitamins A, C, E, selenium, and natural 
substances.
o  Studies of the impact of massage therapy and other manual therapies 
on objective and subjective measures of symptoms and HIV infection. 
o  The use of CAM interventions to improve the well being or enhance 
quality of life for patients with HIV infection.
o  Studies of the benefits of using homeopathic remedies in HIV-
infected patients 
o   Studies on the potential role for energy therapies including 
Therapeutic Touch, Qi gong, or magnets in treating symptoms or slowing 
the progression of HIV infection. 
o  Studies to assess the impact, using objective or subjective 
measures, of using meditation and other mind-body interventions on 
patients with HIV infection. 
o  Outcomes research investigating the use of a single CAM modality, a 
combination of CAM modalities, or traditional medicine approaches, 
alone or in association with conventional treatment for HIV/AIDS.
o  Studies to illuminate the differences in health behaviors regarding 
HIV among minority populations, and potentially identify effective 
integrative approaches to treating HIV in minority communities.

MECHANISMS OF SUPPORT

This RFA will use the National Institutes of Health (NIH) R01 and 
NCCAM"s R21 award mechanisms.  As an applicant, you will be solely 
responsible for planning, directing, and executing the proposed 
project.  This RFA is a one-time solicitation.  Future unsolicited, 
competing-continuation applications based on this project will compete 
with all investigator-initiated applications and will be reviewed 
according to the customary peer review procedures.  The anticipated 
award date is June 2003.  

R01 Applications.  R01 awards will vary in size and duration reflecting 
the nature and scope of the research proposed.  Future unsolicited 
competing-continuation applications will compete with all investigator-
initiated applications and be reviewed according to customary peer 
review. 

R21 Applications.  The purpose of the R21 mechanism is to provide 
investigators, at all career levels, with a funding opportunity for 
exploring the feasibility, as well as the development, of projects 
investigating CAM and for generation of preliminary data.  The R21 
mechanism is specifically intended to support research where 
preliminary data as evidence of feasibility are sparse or do not exist. 
These grants are not intended for large-scale undertakings or to 
support or supplement ongoing research.  Because the requirements for 
NCCAM R21 applications differ from those for the R01 applications, 
investigators intending to use the R21 mechanism are advised to consult 
the URL (http://nccam.nih.gov/research/instructions/r21/index.htm) for 
specific requirements, e.g. the 15 page limit for Items a-d in the 
Research Plan and restrictions on appendices, as well as additional 
information. 

This RFA uses just-in-time concepts.  It also uses the modular as well 
as the non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  
Specifically, if you are submitting an R01 application with direct 
costs in each year of $250,000 or less, use the modular format.  
Otherwise follow the instructions for non-modular research grant 
applications.

FUNDS AVAILABLE

The NCCAM intends to commit approximately $750,000 total funding in FY 
2003 to fund two to four new and/or competitive continuation grants in 
response to this RFA.  The NINR intends to commit up to $750,000 total 
funding in FY 2003 to fund two to four new or competitive continuation 
grants in response to this RFA, as well. For an R01 application, an 
applicant may request a project period of up to five years and a budget 
for direct costs of up to $375,000 per year.  Because the nature and 
scope of the proposed research will vary from application to 
application, it is anticipated that the size and duration of each award 
will also vary.  For an R21 application, an applicant may request a 
project period of up to two years and a budget for direct costs of up 
to $125,000 per year.  Although the financial plans of NCCAM and NINR 
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. At this time, it is not 
known if this RFA will be reissued.
 
ELIGIBLE INSTITUTIONS
 
You may submit an application if your institution has any of the 
following characteristics: 

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, 
hospitals, and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign
o Faith-based or community based organizations 
 
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

Any individual with the skills, knowledge, and resources necessary to 
carry out the proposed research is invited to work with their 
institution to develop an application for support.  Individuals from 
underrepresented racial and ethnic groups as well as individuals with 
disabilities are always encouraged to apply for NIH programs.   

SPECIAL REQUIREMENTS 

The following special requirements apply to all applications concerning 
research with natural substances. 

Practitioners of CAM believe that the polypharmacy of complex natural 
products has advantages over single-ingredient drugs by providing 
greater therapeutic benefit and less overall toxicity.  In pursuit of 
its mission, the National Center for Complementary and Alternative 
Medicine (NCCAM) supports research to determine safety, efficacy, and 
mechanisms of action of complex natural products.  NCCAM will support 
research characterizing single constituents extracted from complex 
natural products if the purpose is to identify and standardize whole 
products, compare the actions of single constituents with the complex 
product, or identify mechanisms of action for the whole product.  NCCAM 
will not accept applications to isolate the active constituents of 
complex natural products for the express purpose of developing these 
constituents as discrete drugs.  Funding support for applications to 
develop active constituents as drugs may be available from other 
Institutes and Centers at NIH.
 
Investigators seeking funding from NCCAM for research that involves 
natural products must consider several issues when designing their 
studies and preparing their applications.  Overall, the applicant is 
responsible for convincing the NCCAM and the NIH peer review committee   
that the natural products chosen are of sufficient quality to merit 
study as proposed.  

For these products, the levels of characterization, standardization, 
stability, purity, and optimization of the presumed active 
ingredient(s) will vary, and for some, the active ingredient(s) may be 
unknown.  However, natural products should be chemically characterized 
as thoroughly as the state of the science allows, and the methods used 
must be described.  When the active compound is unknown, "marker" 
compounds may be identified and measured.  Natural products should be 
tested for contaminants such as microorganisms, pesticide residues, 
toxic elements, mycotoxins, and drugs.  For in vitro studies of 
extracts or isolated chemical constituents of natural products that are 
normally ingested, the concentrations and chemical constituents should 
be physiologically and pharmacologically relevant.

The experts who serve on the NIH peer review committee must be 
convinced that the natural products to be used in any study are 
described in sufficient detail that the results can be understood and 
independently reproduced.  Studies that do not use a well-
characterized, commercial product must provide evidence that the test 
material has been reliably identified. For botanical natural products, 
this evidence includes, but is not limited to, the correct plant name 
(Latin binomial with authority, cultivar where appropriate), geographic 
source of the material, time of harvest, plant part, and credentials of 
the person who collected and/or identified the material.  A voucher 
specimen should be collected and placed into an identified repository. 

For some natural products, acceptable commercial sources may be 
available.  When using commercial products, investigators must provide 
information from the product label.  When possible, additional details 
available from the manufacturer should also be included in the 
application. 

Applicants also should consider having natural products, including 
those obtained from commercial sources, tested by an independent 
laboratory.  Depending on the study design, independent verification of 
the samples before the start and at the end of the study may be 
necessary to ensure product stability.  Testing of reserved product is 
especially important for large-scale clinical trials.
 
WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity 
to answer questions from potential applicants.  Inquiries may fall into 
three areas:  scientific/research, peer review, and financial or grants 
management issues:

o Direct your questions about scientific/research issues to:

Morgan N. Jackson, M.D., M.P.H.
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD  20892-5475
Telephone:  301-402-1278
FAX:  301-480-3621
Email:  mj145m@nih.gov

Martha L. Hare, Ph.D., R.N.
National Institute of Nursing Research
6701 Democracy Blvd., Suite 710
Bethesda, MD 20892-4870
Telephone: 301-451-3874
FAX: 301-480-8260
Email: harem@mail.nih.gov

o Direct your questions about peer review issues to:

Dr. Martin Goldrosen 
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD  20892-5475
Telephone:  301-594-2014
FAX:  301-480-2419
Email: mg85x@nih.gov

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

Mr. Brian Campbell
Grants Management Branch
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD  20892-5475
Telephone:  301- 594-8738
Email: campbeb@mail.nih.gov
 
Ms. Diane Drew
Grants Management Branch
National Institute of Nursing Research
6701 Democracy Blvd., Suite 710
Bethesda, MD 20892-4870
Telephone: 301-594-2807
Email: diane_drew@nih.gov

LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that 
includes the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

Although a letter of intent is not required, is not binding, and does 
not enter into the review of a subsequent application, the information 
that it contains allows NCCAM staff to estimate the potential review 
workload and plan the review.
 
The letter of intent is to be sent by the date listed at the beginning 
of this document.  The letter of intent should be sent to:

Morgan N. Jackson, M.D., M.P.H.
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD  20892-5475
Telephone:  301-402-1278
FAX:  301-480-3621
Email:  mj145m@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001).  The PHS 398 is 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in 
an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  R01 applications 
requesting up to $250,000 per year in direct costs must be submitted in 
a modular grant format.  R01 applications requesting in excess of 
$250,000 in direct costs must be submitted in a non-modular grant 
format.  R21 applications must be submitted in the modular grant 
format.  The modular grant format simplifies the preparation of the 
budget in these applications by limiting the level of budgetary detail.  
Applicants request direct costs in $25,000 modules.  Section C of the 
research grant application instructions for the PHS 398 (rev. 5/2001) 
at http://grants.nih.gov/grants/funding/phs398/phs398.html includes 
step-by-step guidance for preparing modular grants.  Additional 
information on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 
5/2001) application form must be affixed to the bottom of the face page 
of the application.  Type the RFA number on the label.  Failure to use 
this label could result in delayed processing of the application such 
that it may not reach the review committee in time for review.  In 
addition, the RFA title and number must be typed on line 2 of the face 
page of the application form and the YES box must be marked. The RFA 
label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 
original of the application, including the Checklist, and three signed, 
photocopies, in one package to:
 
Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application 
must be sent to:
 
Dr. Martin Goldrosen 
National Center for Complementary and Alternative Medicine
6707 Democracy Blvd., Suite 401
Bethesda, MD  20892-5475
Telephone:  301-594-2014
FAX:  301-480-2419
Email: mg85x@nih.gov
 
APPLICATION PROCESSING: Applications must be received by the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the 
applicant without review.
 
The Center for Scientific Review (CSR) will not accept any application 
in response to this RFA that is essentially the same as one currently 
pending initial review, unless the applicant withdraws the pending 
application.  The CSR will not accept any application that is 
essentially the same as one already reviewed. This does not preclude 
the submission of substantial revisions of applications already 
reviewed, but such applications must include an Introduction addressing 
the previous critique.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by NCCAM.  Incomplete applications will be returned 
to the applicant without further consideration.  If the application is 
not responsive to the RFA, CSR staff may contact the applicant to 
determine whether to return the application to the applicant or submit 
it for review in competition with unsolicited applications at the next 
appropriate NIH review cycle.

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 NCCAM in accordance with the review criteria 
stated below.  As part of the initial merit review, all applications 
will:

o Receive a written critique
o May undergo a process in which only those applications deemed to have 
the highest scientific merit, generally the top half of the 
applications under review, will be discussed and assigned a priority 
score
o Receive a second level review by the NCCAM National Advisory Council.
 
REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
In the written comments, reviewers will be asked to discuss the 
following aspects of your application in order to judge the likelihood 
that the proposed research will have a substantial impact on the 
pursuit of these goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

The scientific review group will address and consider each of these 
criteria in assigning your application"s overall score, weighting them 
as appropriate for each application.  Your application does not need to 
be strong in all categories to be judged likely to have major 
scientific impact and thus deserve a high priority score. 

(1) SIGNIFICANCE:  Does your study address an important problem? If the 
aims of your application are achieved, how do they advance scientific 
knowledge?  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?  Do you acknowledge potential problem areas and 
consider alternative tactics?

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

(4) INVESTIGATOR: Are you appropriately trained and well suited to 
carry out this work?  Is the work proposed appropriate to your 
experience level as the principal investigator and to that of other 
researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your 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?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

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

o INCLUSION:  The adequacy of plans to include subjects from both 
genders, all racial and ethnic groups (and subgroups), and children as 
appropriate for the scientific goals of the research.  Plans for the 
recruitment and retention of subjects will also be evaluated. (See 
Inclusion Criteria included in the section on Federal Citations, below)

o DATA SHARING:  The adequacy of the proposed plan to share data. 

o BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: November 11, 2002
Application Receipt Date:  December 10, 2002
Peer Review Date:  February/March 2003
Council Review:  May/June 2003
Earliest Anticipated Start Date:   June 2003

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
 
REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: 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).  

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH:  It is the 
policy of the NIH that women and members of minority groups and their 
sub-populations must be included in all NIH-supported clinical research 
projects unless a clear and compelling justification is provided 
indicating that inclusion is inappropriate with respect to the health 
of the subjects or the purpose of the research. This policy results 
from the NIH Revitalization Act of 1993 (Section 492B of Public Law 
103-43).

All investigators proposing clinical research should read the AMENDMENT 
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research - Amended, October, 2001," published in the NIH Guide 
for Grants and Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a 
complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition 
of clinical research, updated racial and ethnic categories in 
compliance with the new OMB standards, clarification of language 
governing NIH-defined Phase III clinical trials consistent with the new 
PHS Form 398, and updated roles and responsibilities of NIH staff and 
the extramural community.  The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or 
proposals and/or protocols must provide a description of plans to 
conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable, and b) 
investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS:  The NIH maintains a policy that children (i.e., individuals 
under the age of 21) must be included in all human subjects research, 
conducted or supported by the NIH, unless there are scientific and 
ethical reasons not to include them. This policy applies to all initial 
(Type 1) applications submitted for receipt dates after October 1, 
1998.

All investigators proposing research involving human subjects should 
read the "NIH Policy and Guidelines" on the inclusion of children as 
participants in research involving human subjects that is available at  
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:  
NIH policy requires education on the protection of human subject 
participants for all investigators submitting NIH proposals for 
research involving human subjects.  You will find this policy 
announcement in the NIH Guide for Grants and Contracts Announcement, 
dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: 
The Office of Management and Budget (OMB) Circular A-110 has been 
revised to provide public access to research data through the Freedom 
of Information Act (FOIA) under some circumstances.  Data that are (1) 
first produced in a project that is supported in whole or in part with 
Federal funds and (2) cited publicly and officially by a Federal agency 
in support of an action that has the force and effect of law (i.e., a 
regulation) may be accessed through FOIA.  It is important for 
applicants to understand the basic scope of this amendment.  NIH has 
provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application 
should include a description of the archiving plan in the study design 
and include information about this in the budget justification section 
of the application. In addition, applicants should think about how to 
structure informed consent statements and other human subjects 
procedures given the potential for wider use of data collected under 
this award.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and 
proposals for NIH funding must be self-contained within specified page 
limitations. Unless otherwise specified in an NIH solicitation, 
Internet addresses (URLs) should not be used to provide information 
necessary to the review because reviewers are under no obligation to 
view the Internet sites.  Furthermore, we caution reviewers that their 
anonymity may be compromised when they directly access an Internet 
site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of 
"Healthy People 2010," a PHS-led national activity for setting priority 
areas.  This RFA is related to one or more of the priority areas. 
Potential applicants may obtain a copy of "Healthy People 2010" at  
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.213 and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or 
Health Systems Agency review.  Awards are made under authorization of 
Sections 301 and 405 of the Public Health Service Act as amended (42 
USC 241 and 284) and administered under NIH grants policies described 
at http://grants.nih.gov/grants/policy/policy.htm and under Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 

The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the use of all tobacco products.  In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits 
smoking in certain facilities (or in some cases, any portion of a 
facility) in which regular or routine education, library, day care, 
health care, or early childhood development services are provided to 
children.  This is consistent with the PHS mission to protect and 
advance the physical and mental health of the American people.





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