[MPWG] Program Announcement from NIH: PSYCHOPHARMACOLOGY OF WIDELY AVAILABLE PSYCHOACTIVE NATURAL PRODUCTS
Trachtenberg, Alan
Alan.Trachtenberg at ihs.gov
Thu Apr 8 11:42:52 CDT 2004
Sorry, I mislabeled the subject before.
Alan Trachtenberg, MD, MPH, Research Director,
Indian Health Service,
United States Public Health Service
Phone: 301-443-0578; fax: 301-443-1522
Program Announcement from NIH
PSYCHOPHARMACOLOGY OF WIDELY AVAILABLE PSYCHOACTIVE NATURAL PRODUCTS
RELEASE DATE: April 2, 2004
PA NUMBER: PA-04-084
EXPIRATION DATE: March 31, 2007, unless reissued.
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(<<http://www.nih.gov>>)
COMPONENTS OF PARTICIPATING ORGANIZATIONS:
National Institute on Drug Abuse (NIDA)
(<<http://www.nida.nih.gov>>)
National Institute of Mental Health (NIMH)
(<<http://www.nimh.nih.gov>>)
Office of Dietary Supplements (ODS)
(<<http://dietary-supplements.info.nih.gov/>>)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.279 (NIDA),
and 93.242 (NIMH).
THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
In September 2003, the National Institute on Drug Abuse (NIDA) and the Office
of the Director’s Office of Dietary Supplements (ODS) came together and
supported a workshop entitled “Psychoactive Botanical Products.†The
presentations and ensuing discussion illustrated how little the scientific
community currently knows about the chemistry, biology, pharmacology, and
behavioral effects of psychoactive botanical (or natural) products and thus
this workshop served to identify gaps in our knowledge outlined in this
announcement. A summary for this workshop can be found at:
<<http://www.drugabuse.gov/whatsnew/meetings/psychoactivemtgsumm.html>>.
Under this PA, NIDA, ODS, and the National Institute of Mental Health (NIMH),
invite research grant applications that characterize the chemistry,
psychopharmacology, and/or toxicology of acute and chronic exposure to
psychoactive natural products, as well as the transition in the use of these
products to licit or illicit drugs of abuse. For the purposes of this PA,
psychoactive natural products are defined as fungus- or plant-derived
products that are taken primarily for their effects on the central nervous
system (e.g., stimulant, depressant, and/or hallucinogenic effects), rather
than for treatment, medicinal or therapeutic effects.
RESEARCH OBJECTIVES
American consumers encounter a variety of plant-derived psychoactive products
in the marketplace and elsewhere. These products vary along several
dimensions and range from conventional foods (nutmeg, coffee) to garden seeds
(morning glory, devil’s trumpet) to dietary supplements (ephedra, kava) to
drugs (morphine). Some of these products have been associated with religious
rituals (e.g., peyote, Salvia divinorum) in specific cultural contexts.
Seeds of certain weedy plants (e.g. Datura stramonium) are found in the wild
and collected by individuals seeking psychoactive experiences.
The fact that a web of regulations surrounds these categories of goods does
not mean that they are unavailable. In addition, there are products
illegally in the marketplace that may claim to fall within one category, but
that may not meet regulatory standards for that category. For example,
products that claim to be dietary supplements that are to be smoked fail to
meet the requirements of DSHEA, the 1994 law that regulates dietary
supplements in the United States, as are the unapproved sale of products that
purport to be replacements for prescription drugs. These are considered to
be midbranded drugs, illegal, yet readily available.
Since these products are natural, much of the public may assume that these
products are safe. However, the recent experience with ephedra illustrates
the potential for serious health consequences from unregulated use of
psychoactive natural products. Although it was legally marketed for years,
ephedra has only recently been deemed unsafe by the U.S. Food and Drug
Administration (FDA). Moreover, the short- and long-term effects of these
psychoactive natural products on the brain and other body organ systems are
unclear. Given that many consumers are buying and using these psychoactive
products and may be unaware of the abuse potential and/or other health risks
of some ingredients, we seek to encourage the development of research
programs that investigate the psychopharmacology of psychoactive natural
products, including the chemical characterization and evaluation,
pharmacokinetics and their interaction with active or inactive ingredients,
or drugs of abuse.
Listed below are examples of areas of research that are of programmatic
interest. These examples are not meant to be all-inclusive.
Classification/Mechanisms of Action:
o Both animal and human research can be used to elucidate drug classification
(e.g., stimulant, depressant, hallucinogen) and mechanisms of action of
psychoactive natural products. To this end, operant conditioning and drug
discrimination procedures in animals or humans could be used to further
investigate these areas. Other measures of subjective effects, including
effects on psychological, motivational, cognitive and emotional processes are
also of interest.
o Since current knowledge about natural product psychopharmacology may be
limited, it will be especially useful to extract, isolate, and characterize
the directly active and indirectly active metabolites of these natural
products, and then compare them to well-characterized psychoactive drugs,
such as caffeine, nicotine, cocaine, opiates, etc., in terms of their
neurobiological, behavioral and cognitive effects. Furthermore,
understanding mechanisms of action of active components through binding
assays, microdialysis, and other approaches may lead to the discovery of
novel ligands and the development of potential pharmacotherapies for treating
drug addiction and other diseases.
o Investigations into the pharmacokinetic and pharmacodynamic properties of
psychoactive natural products are also of interest. These may include, but
are not limited to, studies that investigate ligand affinity and efficacy,
receptor localization, and investigations into the neural circuitry that
underlies the psychoactive effects of these drugs.
Chemistry, Distribution, and Metabolism:
o Research studies in understanding the chemistry, toxicology,
pharmacodynamics, pharmacokinetics and the mechanisms of action of
psychoactive natural products is encouraged to better understand their
efficacy, usefulness, adverse effects and/or abuse potential, if any. Areas
of interest include, but are not limited to:
1) Development of methods to analyze and characterize active and inactive
ingredients of psychoactive natural products.
2) Studies on absorption, distribution, metabolism and excretion of active
ingredients, and interaction of active ingredients with their metabolites and
endogenous substances.
3) Research on changes in cellular metabolic profiling (metabolomics) after
administration of psychoactive natural products and their active ingredients.
4) Characterization, standardization, and comparison of efficacy and toxicity
of psychoactive natural products with their pharmaceutical formulations
(e.g., tablets, capsules, elixir).
5) Screening and identification of target receptors for active ingredients
leading to new ligand development and structure activity investigations.
6) Development of ligands by chemical synthesis for structure activity
relationship (SAR) studies.
7) Development of bioavailability studies of active ingredients.
Behavioral, Physiological, and Toxicological Effects:
o Little is known about the subjective effects of psychoactive natural
products that are marketed or used as psychedelics, stimulants,
euphoriogenics, or anxiolytics. Many drugs of abuse produce a change in
either magnitude or duration of their subjective effects with repeated
exposure. As such, it is important to investigate both the acute and chronic
subjective effects of these products.
o It is important to investigate possible physiological effects, such as
cardiovascular effects, endocrine effects, etc., following both acute and
chronic exposure to psychoactive natural products. Gender differences are
also of interest, especially as they relate to endocrine effects.
o Psychoactive natural products may affect cognitive ability. Studies
designed to understand the acute effects of psychoactive natural products on
cognition, learning and memory, and motivation (e.g., conditioned
reinforcement or incentive motivation) are needed.
o Although the acute toxicological effects associated with psychoactive
natural products have been studied, there has been little or no research into
the possible long-term neurotoxicity or psychological/functional consequences
of these agents. Such studies are needed.
o Little is known about the short- and long-term effect of using psychoactive
natural products in combination with other psychoactive natural products, or
with drugs of abuse. For example, combining sedative and hallucinogenic
natural products may result in a different set of health or abuse risks as
compared to a single psychoactive natural product taken separately.
Additionally, multiple psychoactive natural products may be marketed (and
thus taken) as a single product. It is therefore important to investigate
the short- and long-term effects of psychoactive natural products alone and
in combination with other psychoactive drugs or products.
Prenatal or Developmental Effects:
o Since psychoactive natural products are widely available and may be used by
pregnant women, animal models investigating the physiological, behavioral,
and toxicological effects of these products on both pregnant mother and
offspring are needed.
o Little is known of how stage of development interacts with the effects of
psychoactive natural products. These products may produce different
subjective, physiological, and cognitive effects occurring in children,
adolescents and adults. Issues related to vulnerability of children and
adolescents to both the reinforcing and adverse consequences of psychoactive
natural product use are of interest. The effects of dose should also be
investigated, as it is not known how dosages intended for adults will affect
younger users. It is expected that these studies will employ epidemiological
methods, survey data, animal models, or other approaches that do not involve
administering these products to children or adolescents.
o Investigations focused on the maternal-fetal pharmacokinetics and
pharmacodynamics, and how placental formation and function may be altered by
use of psychoactive natural products, including placental transport of these
agents, are encouraged. These types of studies would shed light on how the
growth and development of the fetus and offspring are affected by these
psychoactive natural products. Research in this area could focus on studies
of transfer of drug to fetus through placenta, biochemical and
pharmacokinetic effects on placenta and fetus such as receptor binding,
interaction with transporters, and enzymes, drug absorption, distribution,
metabolism and elimination. It is expected that these studies will employ
epidemiological methods, survey data, animal models, or other approaches that
do not involve administering these products to pregnant mothers.
o Development of methodologies for analyzing drug concentration in fetal
fluids, meconium and fetal hairs, as well as placental transfer of drugs,
concentration of drugs and their metabolites in fetal circulation, and their
possible effects on fetuses and offspring are needed. Appropriate animal
model studies on fetal exposure to psychoactive natural products are also
encouraged.
MECHANISMS OF SUPPORT
This PA will use the National Institutes of Health (NIH) R03 (small research
grant, see <<http://grants.nih.gov/grants/guide/pa-files/PA-02-170.html>>)
mechanism, and R01 (research project grant) mechanisms. As an applicant, you
will be solely responsible for planning, directing, and executing the
proposed project. The total project period for an application submitted in
response to this PA may not exceed five years for an RO1 and two years for
the R03.
This PA 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>>.
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 your inquiries concerning this PA 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:
Allison Chausmer, Ph.D.
Translational Research Branch
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD 20892-9555
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 402-5088
FAX: (301) 594-6043
Email: achausme at nida.nih.gov <<mailto:achausme at nida.nih.gov>>
Matthew Rudorfer, M.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7160, MSC 9635
Bethesda, MD 20892-9635
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-1185
FAX: (301) 594-6784
Email: mrudorphe at nida.nih.gov <<mailto:mrudorphe at nida.nih.gov>>
o Direct your questions about financial or grants management matters to:
Gary Fleming, J.D.
National Institute on Drug Abuse
6101 Executive Boulevard, Room 250, MSC 8403
Bethesda, MD 20892-9605
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: gfleming at nida.nih.gov <<mailto:gfleming at nida.nih.gov>>
Joy Knipple
National Institute of Mental Health
6001 Executive Boulevard, Room 6131, MSC 9605
Bethesda, MD 20892-9605
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-8811
FAX: (301) 443-6885
Email: knipple at mail.nih.gov <<mailto:knipple at mail.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 is available at <<http://grants.nih.gov/grants/funding/phs398/phs398.html>>
in an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 435-0714, Email: GrantsInfo at nih.gov <<mailto:GrantsInfo at nih.gov>>.
The title and number of this program announcement must be typed on line 2 of
the face page of the application form and the YES box must be checked.
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted at the standard application deadlines, which
are available at <<http://grants.nih.gov/grants/dates.htm>>. Application
deadlines are also indicated in the PHS 398 application kit.
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>>.
SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:
Applications requesting $500,000 or more in direct costs for any year must
include a cover letter identifying the NIH staff member within one of NIH
institutes or centers who has agreed to accept assignment of the application.
Applicants requesting more than $500,000 must carry out the following steps:
1) Contact the IC program staff at least 6 weeks before submitting the
application, i.e., as you are developing plans for the study;
2) Obtain agreement from the IC staff that the IC will accept your
application for consideration for award; and,
3) Identify, in a cover letter sent with the application, the staff member at
the IC who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1), competing
continuation (type 2), competing supplement, or any amended or revised
version of these grant application types. Additional information on this
policy is available in the NIH Guide for Grants and Contracts, October 19,
2001 at <<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html>>.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the checklist, and five 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)
APPLICATION PROCESSING: Applications must be mailed on or before the receipt
dates described at
<<http://grants.nih.gov/grants/funding/submissionschedule.htm>>. The CSR will not
accept any application in response to this PA 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 a substantial revision of an application already reviewed, but
such application must include an Introduction addressing the previous
critique.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned on the basis of
established PHS referral guidelines. An appropriate scientific review group
convened in accordance with the standard NIH peer review procedures
(<<http://www.csr.nih.gov/refrev.htm>>) will evaluate applications for scientific
and technical merit.
As part of the initial merit review, all applications will:
o Undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the appropriate national advisory council
or board
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 application in
order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals. 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.
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?
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?
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?
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)?
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, 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). <<http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm>>
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 will be assessed. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the sections on
Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL CONSIDERATIONS
Sharing Research Data
Applicants requesting more than $500,000 in direct costs in any year of the
proposed research are expected to include a data sharing plan in their
application. The reasonableness of the data sharing plan or the rationale for
not sharing research data will be assessed by the reviewers. However,
reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or priority score.
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
AWARD CRITERIA
Applications submitted in response to a PA will compete for available funds
with all other recommended applications. The following will be considered in
making funding decisions:
o Scientific merit of the proposed project as determined by peer review o Availability of funds
o Relevance to program 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://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm>>
DATA AND SAFETY 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 and Safety Monitoring, NIH Guide for
Grants and Contracts, June 12, 1998:
<<http://grants.nih.gov/grants/guide/notice-files/not98-084.html>>).
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
investigators submitting an NIH application seeking $500,000 or more in
direct costs in any single year are expected to include a plan for data
sharing or state why this is not possible.
<<http://grants.nih.gov/grants/policy/data_sharing>>.
Investigators should seek guidance from their institutions, on issues related
to institutional policies, local IRB rules, as well as local, state and
Federal laws and regulations, including the Privacy Rule. Reviewers will
consider the data sharing plan but will not factor the plan into the
determination of the scientific merit or the priority score.
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 "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.
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.
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 Informationâ€,
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 entitiesâ€) 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>>.
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 PA
is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at <<http://www.healthypeople.gov/>>.
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 Office of Dietary Supplements (ODS) was mandated by Congress in 1994 and
established within the Office of the Director, National Institutes of Health
(NIH). The Dietary Supplement Health and Education Act (DSHEA) [Public Law
103-417, Section 3.a] amended the Federal Food, Drug, and Cosmetic Act "to
establish standards with respect to dietary supplements." This law authorized
the establishment of the ODS.
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.
Return to Volume Index </grants/guide/2004/04.04.02/index.html>
Return to NIH Guide Main Index </grants/guide/index.html>
<<http://www.os.dhhs.gov/>> << OLE Object: Picture (Metafile) >> <<http://www.os.dhhs.gov/>> Department of Health and Human Services <<http://www.nih.gov>> << OLE Object: Picture (Metafile) >> <<http://www.nih.gov>> National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892
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