MEDICATIONS DEVELOPMENT FOR CANNABIS-RELATED DISORDER
RELEASE DATE: December 1, 2003
RFA NUMBER: RFA-DA-04-014 - (Reissued as RFA-DA-09-001)
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.279
LETTER OF INTENT RECEIPT DATE: February 20, 2004
APPLICATION RECEIPT DATE: March 23, 2004
THIS REQUEST FOR APPLICATIONS (RFA) CONTAINS THE FOLLOWING INFORMATION:
o Purpose of this RFA
o Research Objectives
o Mechanisms of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
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
The National Institute on Drug Abuse (NIDA) is seeking grant
applications focusing on the identification, evaluation and development
of safe and effective pharmacological treatments for cannabis-related
disorders (CRDs), such as cannabis abuse or dependence, and cannabis-
induced disorders (e.g., intoxication, delirium, psychotic disorder,
and anxiety disorder), and their comorbidity with other medical and
psychiatric disorders (e.g., depression), with special interest in the
treatment of children and adolescents. Cannabis use includes marijuana,
hashish, and other tetrahydrocannabinol (THC) containing substances.
This RFA will support clinical trials to test potential medications in
humans, and the preclinical development of new chemical entities (NCEs)
for advancement to the clinical development stage. Applications may
focus on the pharmacotherapy of cannabis abuse and they may target one
or various CRDs or clinical manifestations of the disorders. For
example, research may focus on marijuana dependence or specifically on
marijuana withdrawal. Clinical applications may include human
laboratory studies to develop models for testing medications targeting
single or multiple manifestations of the CRDs, and the interaction of
cannabinoids with other medications, pharmacokinetic and/or
pharmacodynamic studies of potentially therapeutic compounds.
Preclinical applications may include pharmacological studies on NCEs
leading to the identification of candidates for advanced preclinical or
phase I/II IND covered clinical evaluation as potential
pharmacotherapies for CRDs.
RESEARCH OBJECTIVES
Background
The treatment of CRDs is an issue of great public health concern.
Currently, marijuana is the most commonly used illicit drug in the
United States with recent estimates from SAMSHA of 14.6 million users
in the past month, with particularly heavy use occurring in adolescent
populations (over 20% of all high school seniors). Approximately 2.4
million people use marijuana for the first time every year and two
thirds of them are between 12 and 17 years of age. In addition, of the
3.5 million people who met criteria for past-year cannabis abuse or
dependence in 2001, more than two thirds were between the ages of 12
and 25 years. An estimated 852,000 individuals reported marijuana as
the specific substance for which they received their last or current
treatment among persons who received treatments in the past year and
approximately one half of those individuals were 25 years old or
younger.
Sufficient research has been carried out to confirm that the use of
cannabis can produce serious physical and psychological consequences.
The consequences of cannabis use may be due to the acute effects of the
drug or due to the chronic exposure that may ultimately produce abuse
or dependence. The use of a large amount in a short period of time may
induce hallucinations, delirium, and other perceptual manifestations
compatible with a psychotic episode. Chronic users of cannabis may
experience difficulty in stopping or controlling drug use, develop
tolerance to the subjective and cardiovascular effects, and eventually
present withdrawal symptoms after sudden discontinuation of use.
Long-term heavy use may also produce cognitive changes that affect
memory and learning and, in predisposed individuals, induce psychosis
and other perceptual phenomena, anxiety, depression and suicidal
ideation. In young people, cannabis use additionally seems to affect
the normal development of adolescence, and is associated with poor
school performance, early problems with the law, and the use of other
drugs and alcohol.
Among the medical problems, cannabis use has been associated with
cardio-respiratory problems, such as aggravation of asthma, bronchitis,
emphysema, hypertension and arrhythmias, and increased risk of sexually
transmitted diseases.
Given the extent of the use of cannabis in the general population and
the medical and psychological consequences of its use, particularly the
clinically significant psychosocial impairment, there is a great public
health need to develop safe and effective therapeutic interventions.
The need to develop treatments targeting adolescents and young adults
is particularly relevant in view of their disproportionate use
patterns.
Unfortunately, there is currently no effective pharmacological
treatment for CRDs and there is very limited research focused on the
identification and development of medications to treat these disorders.
Drug abuse treatment research as a whole has rarely focused on the
treatment of CRDs. One indicator is the fact that there are no
published randomized controlled clinical trials to evaluate
pharmacotherapies for CRD as the primary outcome.
There are multiple reasons why it is timely to develop medications to
treat CRDs. First, there are newly marketed medications available
whose mechanisms of actions may have potential therapeutic effects on
the clinical manifestations of CRD. Second, the recent discovery of an
endogenous cannabinoid system with specific receptors and endogenous
ligands, the availability of genetically engineered knockout mice that
lack functional cannabinoid receptors to study genetic predispositions
to the effects of cannabinoids, and the subsequent development of
reliable preclinical models to study the rewarding and dependence-
producing effects of THC, all provide understanding of the basic
therapeutic mechanisms. Lastly, there is the discovery and development
of new chemical entities, some of them already being investigated at
the clinical level, which target the cannabinoid system and have the
potential for therapeutic benefit. All these factors are setting the
stage for the development of medications to treat CRDs.
Objectives and Scope
The goal of this RFA is to develop safe and effective medications for
the treatment of CRDs. Studies may focus on the treatment of
marijuana, hashish or other cannabis derivatives. Medications studied
under this RFA may aim to treat cannabis-use disorders, such as abuse
and dependence, or cannabis-induced disorders, such as intoxication,
delirium, psychosis, and anxiety. They may also focus on the specific
symptoms of the disorder such as withdrawal, craving or relapse,
complications such as cognitive impairment, sleep disorders/disruption
of normal rhythms or the clinical surrogates of their use such as
depression and other mood disorders.
Research topics of interest include but are not limited to:
o Development and testing of human laboratory models to evaluate the
effects of medications on cannabinoid drug discrimination, conditioned
place preference or aversion, self-administration, reward, tolerance,
sensitization, craving, withdrawal, and physiological dependence.
o Human laboratory evaluation of medications that may affect the
pathophysiological correlates of cannabis-use disorders such as self-
administration, reward, tolerance, withdrawal, craving, and
physiological dependence.
o Design and implementation of FDA defined Phase I clinical trials to
assess the medical safety and tolerability of medications when
treating patients with CRDs.
o Interaction studies focused on the effects of medications to treat
CRDs and the concurrent use of cannabis derivatives, including
pharmacokinetic and/or pharmacodynamic studies.
o Testing medications that may affect the interaction between
cannabinoid, opioid and dopamine systems, and which may have
therapeutic effect not only for CRDs but also for other medical
conditions such as pain and other drug dependencies.
o Exploratory/developmental pilot studies to evaluate the preliminary
efficacy of medications to treat single or multiple clinical
manifestations of CRDs.
o Randomized clinical trials, defined by FDA as Phase II, to evaluate
the efficacy of new or already marketed medication for the treatment
of single or multiple CRDs, or any of their clinical manifestations.
For example, studies may focus on the treatment of marijuana
dependence or marijuana withdrawal.
o Development of medications to block withdrawal symptoms.
o Studies focusing on the treatment of comorbid psychiatric conditions
that may negatively affect the outcome of the disorders or their
treatment. For example, studies may focus on treating the clinical
depression associated with the use of cannabis.
o Studies focusing on interactions of medications developed for CRDs
with those treating comorbid mental disorders.
o Brain imaging studies to determine the effects of treatments on brain
processes and to determine surrogate markers of treatment efficacy.
o Clinical studies aimed at preventing or reducing the medical
consequences of cannabis use, including HIV and other infections.
o Pharmacological testing of potential medications which would act as
full agonists, partial agonists, or antagonists (or prodrugs whose
metabolism would result in such desired activity).
o Identification and testing of potential medications which would
produce one or more of the following effects in pharmacological
studies: a relatively long duration of action; mild reinforcement when
compared to cannabinoids; and/or blockade of cannabinoid’s effects in
behavioral assays and on cognitive, spatial/motor and/or
learning/memory functions.
o Design and synthesis of novel radioligands targeting the cannabinoid
receptors for use as tools to study both the neurobiology of ligand-
receptor interaction as well as targets for treatments.
The rationale for choosing the medication(s) to be investigated can be
based on a top-down approach, a bottom-up approach, or both approaches
combined. The top-down approach would be the testing of marketed
medications that are available for other indications and which may be
promising candidates for the treatment of CRDs. For example, an FDA
approved antidepressant may be chosen as a target medication. The
bottom-up approach involves the identification and testing of new
chemical entities that, because of their chemical characteristics and
mechanism of action, could be candidates to be developed specifically
for CRDs.
The testing of combinations of medications is within the scope of this
RFA. Medications may target one or more neurochemical mechanisms
implicated in the physiopathology of CRDs by direct or indirect
modulation of the systems, or by producing synergistic or antagonist
effects.
The treatment of CRDs usually requires a multidisciplinary approach,
including behavioral treatment strategies. Therefore, it is expected
that the medication treatment studies proposed under this RFA should
have a behavioral intervention platform or propose the concurrent
evaluation of medications and behavioral interventions in a 2X2 design.
MECHANISM OF SUPPORT
This RFA will use the NIH research project (R01), the small grant (R03)
and the exploratory/development (R21)
(http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html) 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 September 30,
2004. Applications that are not funded in the competition described in
this RFA may be resubmitted as NEW investigator-initiated applications
using the standard receipt dates for NEW applications described in the
instructions to the PHS 398 application.
This RFA uses just-in-time concepts. It also uses the modular
budgeting as well as the non-modular budgeting formats (see
http://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are submitting an application with direct costs in
each year of $250,000 or less, use the modular budget format.
Otherwise follow the instructions for non-modular budget research grant
applications. This program does not require cost sharing as defined in
the current NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
FUNDS AVAILABLE
NIDA intends to commit approximately $3 million in FY 2004 to fund 4-7
new and/or competitive continuation grants in response to this RFA. An
applicant may request for the R01 a project period of up to 5 years and
up to $400,000 in direct costs per year. For the R03, the project
period is 2 years and direct costs up to $50,000 for each of those
years. For the R21, the project period is 2 years and up to $275,000
in direct costs for the two-year period. 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.
Although the financial plans of NIDA 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.
The size of individual awards will vary as a function of the nature and
scope of the research proposed. It is anticipated that the upper limit
of each award will be $400,000 in direct costs, and applications over
this amount will not be accepted for review. Budget requests should be
carefully justified and commensurate with the complexity of the
project.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) 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 institutions/organizations
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.
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 categories: Scientific/research, peer review, and financial or
grant management issues:
o Direct your questions about scientific/research issues to:
Iv n D. Montoya, M.D., M.P.H.
Division of Treatment Research and Development
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4143, MSC 9551
Bethesda, MD 20892-9551
Phone: (301) 443-8639
Fax: (301) 443-2599
Email: imontoya@mail.nih.gov
o Direct your questions about peer review issues to:
Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 220, MSC 8401
Bethesda, MD 20892-8401
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tl25u@nih.gov
o Direct your questions about financial or grants management matters
to:
Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 242, MSC 8403
Bethesda, MD 20892-8403
Telephone: (301) 443-6710
FAX: (301) 594-6847
Email: gf6s@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 Name 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 NIDA 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 should be sent to:
Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 220, MSC 8401
Bethesda, MD 20892-8401
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tl25u@nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). Applications must
have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS)
number as the Universal Identifier when applying for Federal grants or
cooperative agreements. The DUNS number can be obtained by calling
(866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS number should be entered on
line 11 of the face page of the PHS 398 form. The PHS 398 document 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: Applications
requesting up to $250,000 per year in direct costs must be submitted in
a 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/DHHS
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 and
all copies of the appendix material must be sent to:
Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Rockville, MD 20852 (for express/courier service)
APPLICATION PROCESSING: Applications must be received on or before 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.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and
funding assignments within 8 weeks.
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. However, when a previously unfounded application,
originally submitted as an investigator-initiated application, is to be
submitted in response to an RFA, it is to be prepared as a NEW
application. That is, the application for the RFA must not include an
Introduction describing the changes and improvements made, and the text
must not be marked to indicate the changes from the previous unfunded
version of the application.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by NIDA. Incomplete and/or nonresponsive
applications will not be reviewed. 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 NIDA in
accordance with the review criteria stated below. As part of the
initial merit review, all applications will:
o 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 written critique
o Receive a second level review by the National Advisory Council on
Drug Abuse
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 evaluate the
application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. For the
regular project applications (R01) the scientific review group will
address and consider each of the following criteria in assigning the
application's overall score, weighting them as appropriate for each
application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The application does not need to be strong in all categories to be
judged likely to have major scientific impact and thus deserve a high
priority score. For example, an investigator may propose to carry out
important work that by its nature is not innovative but is essential to
move a field forward.
(1) SIGNIFICANCE: Please assess the extent to which the study aims are
consistent with the goals of the RFA. Does this study address an
important problem? If the aims of the application are achieved, how
will scientific knowledge be advanced? What will be the effect of
these studies on the concepts or methods that drive this field?
(2) APPROACH: Are the conceptual framework, design, methods, and
analyses adequately developed, well-integrated, and appropriate to the
aims of the project? Does the applicant acknowledge potential problem
areas and consider alternative tactics?
(3) INNOVATION: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
(4) INVESTIGATOR: Is the investigator appropriately trained and well-
suited to carry out this work? Is the work proposed appropriate to the
experience level of the principal investigator and other researchers
(if any)?
(5) ENVIRONMENT: Does the scientific environment in which the work will
be done contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Is there
evidence of institutional support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the
following items will be considered in the determination of scientific
merit and the priority score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of
human subjects and protections from research risk relating to their
participation in the proposed research will be assessed. (See criteria
included in the section on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 in the
sections on Federal Citations, below).
ADDITIONAL REVIEW CONSIDERATIONS
BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
The R03 and R21 applications will be evaluated based on the review
criteria specified in the respective R03 and R21 announcement. The
applicants should read the appropriate announcement before preparing
the application. They can be found at the following web addresses:
http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html and
http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html,
respectively.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: February 20, 2004
Application Receipt Date: March 23, 2004
Peer Review Date: June/July 2004
Council Review: September 2004
Earliest Anticipated Start Date: September 30, 2004
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
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated
with reference to the risks to the subjects, the adequacy of protection
against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to
be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.
DATA SAFETY AND MONITORING PLAN: Data and safety monitoring is required
for all types of clinical trials, including physiologic, toxicity, and
dose-finding studies (phase I); efficacy studies (phase II); efficacy,
effectiveness and comparative trials (phase III). The establishment of
data and safety monitoring boards (DSMBs) is required for multi-site
clinical trials involving interventions that entail potential risk to
the participants. (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.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of
research on hESCs can be found at
http://stemcells.nih.gov/index.asp and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human
Embryonic Stem Cell Registry will be eligible for Federal funding (see
http://escr.nih.gov). It is the responsibility of the applicant to
provide, in the project description and elsewhere in the application as
appropriate, the official NIH identifier(s) for the hESC line(s)to be
used in the proposed research. Applications that do not provide this
information will be returned without review.
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 PA 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.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:
The Department of Health and Human Services (DHHS) issued final
modification to the Standards for Privacy of Individually Identifiable
Health Information , the Privacy Rule, on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the
protection of individually identifiable health information, and is
administered and enforced by the DHHS Office for Civil Rights (OCR).
Those who must comply with the Privacy Rule (classified under the Rule
as covered entities ) must do so by April 14, 2003 (with the exception
of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule
reside with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule,
including a complete Regulation Text and a set of decision tools on Am
I a covered entity? Information on the impact of the HIPAA Privacy
Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts
can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON
DRUG ABUSE: Researchers funded by NIDA who are conducting research in
community outreach settings, clinical, hospital settings, or clinical
laboratories and have ongoing contact with clients at risk for HIV
infection, are strongly encouraged to provide HIV risk reduction
education and counseling. HIV counseling should include offering HIV
testing available on-site or by referral to other HIV testing service
for persons at risk for HIV infection including injecting drug users,
crack cocaine users, and sexually active drug users and their sexual
partners. For more information see
http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.
NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE
ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS: The National Advisory
Council on Drug Abuse recognizes the importance of research involving
the administration of drugs to human subjects and has developed
guidelines relevant to such research. Potential applicants are
encouraged to obtain and review these recommendations of Council before
submitting an application that will administer compounds to human
subjects. The guidelines are available on NIDA's Home Page at
http://www.nida.nih.gov under the Funding, or may be obtained by calling
(301) 443-2755.
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 at http://www.cfda.gov/ and is not subject
to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act
as amended (42 USC 241 and 284 and under Federal Regulations 42 CFR 52
and 45 CFR Parts 74 and 92. All awards are subject to the terms and
conditions, cost principles, and other considerations described in the
NIH Grants Policy Statement. The NIH Grants Policy Statement can be
found at http://grants.nih.gov/grants/policy/policy.htm.
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
|
|
|
|
Department of Health and Human Services (HHS)
|
|
|
|
NIH... Turning Discovery Into Health®
|