PSYCHOPHARMACOLOGY OF WIDELY AVAILABLE PSYCHOACTIVE NATURAL PRODUCTS 

RELEASE DATE:  April 2, 2004  

PA NUMBER: PA-04-084

The R01 portion of this funding opportunity has been replaced by PA-07-108,
which now uses the electronic SF424 (R&R) application for February 5, 2007 
submission dates and beyond.

March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using 
the electronic SF424 (R&R) application. This announcement will stay active for 
only the May 1, 2006 AIDS and AIDS-related application submission date for these 
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms 
expires on the date indicated below. Other mechanisms relating to this announcement 
will continue to be accepted using paper PHS 398 applications until the stated 
expiration date below, or transition to electronic application submission. 
A replacement R03 (PAS-06-323) funding opportunity announcement has been issued 
for the submission date of June 1, 2006 and submission dates for AIDS and 
non-AIDS applications thereafter.

Expiration DATE for R03 Non-AIDS Applications: March 2, 2006
Expiration DATE for R03 AIDS and AIDS-Related Applications: May 2, 2006 
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007

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/archive/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@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@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@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@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@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://www.hhs.gov/ohrp/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://www.hhs.gov/ohrp/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 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.

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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Research (OER)
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and Human Services (HHS)
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