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
https://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 https://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 https://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
https://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:
https://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:
https://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
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a
complete copy of the updated Guidelines are available at
https://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
https://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
https://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
https://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 https://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.