MOLECULAR GENETICS OF DRUG ADDICTION VULNERABILITY

RELEASE DATE:  July 22, 2003

PA NUMBER:  PA-03-155

EXPIRATION DATE:  July 30, 2006, unless reissued.

The R01 portion of this funding opportunity has been replaced by PA-07-073,
which now uses the electronic SF424 (R&R) application for February 5, 2007 
submission dates and beyond.

National Institute on Drug Abuse (NIDA) 
 (http://www.nida.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.279

THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanisms 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

This PA seeks investigator-initiated applications for research projects that 
identify chromosomal loci and genetic variation in genes and haplotypes that 
are associated with increased vulnerability to addiction or dependence on 
stimulants (e.g., cocaine and amphetamine), narcotics (e.g., opiates), 
nicotine, benzodiazepines, barbiturates, cannabis, hallucinogens, and/or 
multiple drugs of abuse in human beings.  Much diagnostic effort has been 
focused on DSM criteria; we are additionally interested in applications that 
will examine intermediate phenotypes (endophenotypes) to better assess the 
molecular genetics of drug addiction and drug addiction vulnerability.  Thus, 
applications examining the genetics of addiction vulnerability to both 
illicit and legal drugs of abuse are relevant to this PA. 

This program announcement is a continuation of the program initiated by
RFA DA-99-003 and PA-00-115, "Genetics of Drug Addiction Vulnerability," 
http://grants.nih.gov/grants/guide/rfa-files/RFA-DA-99-003.html.  For 
additional NIDA funding opportunities in genetics, refer to the NIDA Genetics 
Workgroup homepage http://www.drugabuse.gov/about/organization/Genetics/about_genworkgroup/index.html.  

RESEARCH OBJECTIVES

Background

Evidence from adoption and twin studies, from genetic strains of rodents, and 
from induced mutations in mice, suggests that heritability may play a role in 
vulnerability to addiction.  The genetic variants underlying increased 
vulnerability to drug addiction are unknown.  However, new scientific 
opportunities may now make it possible to identify and characterize the 
genetic variants that contribute to addiction vulnerability.  This knowledge 
will increase the prospects of improved diagnosis, prevention, and treatment 
of drug addiction.  By better understanding the genetic factors involved in 
the addiction process, the environmental contributions to this disease can 
also be better understood.

Recent advances in statistical genetics, molecular biology, and genomic 
approaches have greatly accelerated the ability to identify the etiology of 
diseases that have a genetic basis.  The power of the genetic approach for 
neuroscience is evidenced by the recent positional cloning of genetic 
variations associated with many cases of Alzheimer's disease and rare forms 
of Parkinson's disease.  Animal models of these genetic disorders are now 
being created using transgenic technology.  These models provide a greater 
understanding of the underlying biology of these complex diseases.  These and 
related approaches are likely to have applicability to the brain diseases of 
addiction.

The challenge for the molecular genetics of addiction, like many other 
complex genetic disorders lacking simple patterns of Mendelian inheritance in 
humans, is addressing the complexity of polygenic disorders with substantial 
environmental influences.  Continued advances during the next 5-10 years will 
enhance the study of the molecular genetics of addiction vulnerability.

Research Scope and Goals

This PA encourages applications for research projects that identify 
chromosomal loci and variations in genes that are associated with increased 
vulnerability to addiction.  Genetic approaches may include but are not 
limited to linkage, linkage disequilibrium, and association studies.  Data 
may be collected from the general population, population isolates, 
populations with high rates of consanguinity, and/or recent admixed 
populations.  Standard and novel methods of analysis for the identification 
of genetic variation conferring vulnerability to a complex genetics disorder 
such as drug addiction are highly encouraged.  Investigators may include, as 
a component of their project, gene x gene interactions, gene x environment 
interactions, and non-human models to study the genetics of addiction 
vulnerability.

Phenotype definition of both affected and unaffected individuals is a central 
issue in the analysis of complex traits such as addiction.  The use of 
phenotypes defined by quantity-frequency criteria and diagnostic criteria 
(such as the DSM-III-R or DSM-IV criteria) have been shown to have 
significant heritability in twin and/or adoption studies and are strongly 
encouraged.  Also encouraged are numerous structured or semi-structured 
assessment instruments with high diagnostic reliability, including the 
Structured Clinical Interview for DSM-III-R or IV (SCID), the Psychiatric 
Research Interview for Substance and Mental Disorders (PRISM), the Structure 
Clinical Assessment for Neuropsychiatry (SCAN), the Composite International 
Diagnostic Interview (CIDI), the CIDI-Substance Abuse Module (CIDI-SAM), the 
Diagnostic Interview Schedule (DIS), and the Alcohol Use Disorder and 
Associated Disabilities Interview Schedule (AUDADIS).  

However, alternative phenotype definition may better describe the genetic 
aspects of addiction.  Therefore, investigators may propose the use of other 
phenotypic information such as the presence or absence of biological markers 
or exhibition of unique individual traits, as well as combinations of these 
and/or co-morbid conditions.  Justification for the use of proposed 
alternative phenotypes should be clearly stated and evidence that it is 
heritable provided.  In addition, the use of advanced analytical methods such 
as principal-components analysis, discriminant analysis, artificial neural 
networks, spectral analysis of EEG, neuroimaging for drug activity/re-
activity, and/or pharmacokinetic/pharmacodynamic genetic profiling may help 
define groups of phenotypes with a higher heritability for complex traits.

Identifying specific genes that mediate addiction or other complex, multi-
genic diseases is complicated by the fact that analytical methods developed 
for single-gene disorders do not necessarily incorporate the effects of gene 
interactions.  Investigators are encouraged to consider using innovative 
genetic models, pedigree structure, haplotypes, and other methods of 
statistical analysis for the identification of genetic variations conferring 
vulnerability to a complex genetics disorder such as drug addiction.

Data from laboratory, field and clinical research is beginning to show gender 
differences in biological factors in drug abuse, the progression and 
initiation to drug use and abuse, the antecedents and consequences of drug 
use and abuse, and prevention and treatment. Examination of gender 
differences in the molecular genetics of addiction vulnerability is also 
encouraged.

The NIDA Genetics Consortium (NGC)

The nucleus of the NIDA Genetics Consortium (NGC) are investigators who were 
awarded grants under the RFA, "Genetics of Drug Addiction Vulnerability"
(DA-99-003) as well as those who have modified their projects to conform to
the guidelines listed in that RFA to use the resources provided by the NIDA 
Center for Genetics Studies.  The NIDA Center for Genetics Studies is funded 
by a contract awarded to Rutgers University with a subcontract to Washington 
University for the purpose of creating databases, cell lines, and DNA 
samples, and for wide distribution of the data and DNA to the scientific 
community.   After a proprietary period, the NIDA Center for Genetics Studies 
will, upon proper application and approval, distribute both the data and DNA 
samples to qualified researchers.   Members of the NGC meet two times a year 
to discuss issues related to the molecular genetics of addiction 
vulnerability.

Data Sharing Plan: Dissemination of Data and Biological Materials

Investigators belonging to the NGC have developed detailed plans for the 
dissemination and distribution of all clinical, diagnostic, and pedigree 
information, as well as the generation of cell lines and the distribution of 
DNA, 18 months after the funding period.  As part of the sharing plan, the 
investigators belonging to the NGC agree to send blood samples from study 
subjects and specific diagnostic and descriptive data to a repository (NIDA 
Center for Genetics Studies).  These specific diagnostic and descriptive data 
include 1) subject ID #; 2) family ID #; 3) site ID #; 4) parental ID #s; 5) 
sex; 6) death status; 7) ethnicity or geographic origin of ancestry; 8) age 
and/or year of birth; 9) twin status; 10) DSM-III-R diagnoses; 11) DSM-IV 
diagnoses; 12) instrument used to establish diagnoses; 13) answers to all of 
the questions in the structured interview or, minimally, the answers to those 
questions from which the addiction diagnoses were established; 14) age of 
onset of drug dependence and quantity-frequency of peak lifetime use of all 
addictive substances; and 15) Proband.  Applicants responding to this 
announcement are strongly encouraged to join the NGC.  Applicants wishing to 
join the NGC are expected to follow the stipulations under special 
requirements in the RFA "Genetics of Drug Addiction Vulnerability" 
http://grants.nih.gov/grants/guide/rfa-files/RFA-DA-99-003.html and to seek 
the advice of program staff.  By joining the NIDA Genetics Consortium the 
applicant will:  

o  Increase statistical power of the samples being collected;

o  Enhance quality control of the data collected;

o  Facilitate and enhance opportunities for collaboration;

o  Have access to a data management facility to create extensively documented 
files at no cost;

o  Have high quality cell lines produced upon receipt of blood samples; 

o  Have aliquots of high quality DNA extracted from the cell lines and 
returned at no cost;
  
o  Have an unlimited supply of DNA; and

o  Be able to devote more resources to data collection and data analysis.

Investigators with a currently funded NIH grant with specific aims related to 
the genetics of addiction who would like to join the NIDA Genetics Consortium 
should also contact the program official listed at the end of the 
announcement.  For further information on the NGC, please see 
http://www.drugabuse.gov/about/organization/Genetics/consortium/index.html. 

The sharing of biological materials, interview and other assessment data, and 
genotype information (including software) in a timely manner has been an 
essential element in the rapid progress that has been made in the genetic 
analysis of human diseases.  PHS policy is that investigators must make 
unique research resources readily available for research purposes to 
qualified individuals within the scientific community when first results 
based on these resources have been published (PRINCIPLES AND GUIDELINES FOR 
RECIPIENTS OF NIH RESEARCH GRANTS AND CONTRACTS ON OBTAINING AND 
DISSEMINATING BIOMEDICAL RESEARCH RESOURCES; published on December 23, 1999 
in the Federal Register http://www.ott.nih.gov/policy/rt_guide_final.html).  
Accordingly, to address the interests of the research community and 
government in promoting the science of the genetic basis of drug addiction 
vulnerability, NIDA expects applicants who respond to this PA to develop and 
propose detailed plans for sharing the data and materials generated through 
the grant.  See NIDA Human Molecular Genetics Research: Frequently Asked 
Questions (FAQs) 
http://www.drugabuse.gov/about/organization/Genetics/about_genworkgroup/index.html and 
Frequently asked questions about the NIDA Center for Genetic Studies 
http://www.nida.nih.gov/about/organization/genetics/FAQ_GeneticStudies.html

It is expected that the Data Sharing Plan will specify the following 
elements: 1) creation of comprehensive and verified databases that contain 
all clinical, diagnostic, pedigree structure, and genotypic information 
collected and produced by the grant, 2) establishment of cell lines (from 
which DNA will be extracted and stored) from all protocol subjects from whom 
blood samples have been obtained, 3) a mechanism or protocol by which all 
databases and biological materials (DNA samples, cell lines) can be widely 
searched or distributed to qualified investigators in the scientific 
community, and 4) a timetable specifying when various elements of the 
database (e.g., diagnostic, assessment, or genetic data) will be available 
for distribution.

Available Genotyping Resources

Investigators should note that an existing resource available to 
investigators for genotyping is the Center for Inherited Disease Research 
(CIDR), which is supported by a contract to Johns Hopkins University by eight 
NIH institutes including NIDA.  CIDR was established in 1996 to provide high-
throughput genotyping and statistical services for complex genetic diseases 
to the scientific community at large.  Introductory no cost access to CIDR 
resources is available to investigators who have been approved by the CIDR 
Access Committee (CAC) and who are supported by one of the eight supporting 
NIH institutes (including NIDA).  Thus, projects supported by this PA are 
eligible for no cost access to CIDR resources following CAC approval.  
Investigators should request access to CIDR resources, if needed, and obtain 
CIDR approval before the requested start date of the grant.  The deadlines 
for submission of applications requesting CIDR access are November 1, 
February 1, and June 1.  For more information about CIDR, see the CIDR Web 
site at http://www.cidr.jhmi.edu or contact Dr. Jerry Roberts at 301-402-0838 
or at jerry_roberts@nhgri.nih.gov.

Alternatively, investigators may wish to use the Mammalian Genotyping Service 
(http://research.marshfieldclinic.org/genetics/) at the Marshfield Medical Research 
Foundation in Marshfield, Wisconsin.  This facility is sponsored by the 
National Heart, Lung, and Blood Institute (NHLBI) at NIH and is provided at 
no cost to investigators whose projects are approved for genotyping by the 
Scientific Advisory Panel of the Mammalian Genotyping Service.  For 
submission dates, investigators should contact the Mammalian Genotyping 
Service at (715) 387-9150.

MECHANISMS OF SUPPORT 

This PA will use the NIH research project grant (R01) and the program project 
(P01) award mechanisms.  As an applicant, you will be solely responsible for 
planning, directing, and executing the proposed project.  

This PA uses just-in-time concepts.  It also uses the modular budgeting 
format (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 format.  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.  

The P01 consists of a minimum of three interrelated individual research 
projects that contribute to the overall program objective.  To achieve 
sufficient statistical power or needed expertise these projects may be 
located at more than one institution.  This type of award can also provide 
support for certain shared resources ("cores") that provide funds for tasks 
common to two or more projects within the award.  

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
o Faith-based or community-based organizations

Foreign institutions are not eligible for program project (P01) grants.

The collection of clinically well-characterized samples of sufficient size 
for linkage analyses and for linkage disequilibrium mapping studies in 
genetically isolated populations may be facilitated by the establishment of 
international consortia.  Collaborations among U.S. scientists and scientists 
at foreign institutions are encouraged, when scientifically appropriate.  In 
these cases, awards may be made to foreign institutions or to domestic 
applications that include foreign components.  

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 two 
areas:  scientific/research, and financial or grants management issues:

o Direct your questions about scientific/research issues to:

Joni L. Rutter, Ph.D.
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse, NIH, DHHS
6001 Executive Blvd., Rm 4282, MSC 9555
Bethesda, MD  20892-9555
Telephone:  (301) 435-0298
Fax:  (301) 443-594-6093
Email:  jrutter@nida.nih.gov

o Direct inquiries regarding fiscal or grants management matters to:

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6847
Email:  gf6s@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

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:
   
Contact NIDA 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 NIDA staff that the NIDA will accept your 
application for consideration for award; and,
  
3) Identify, in a cover letter sent with the application, the staff member 
and NIDA 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 Receive a written critique
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 second level review by the National Advisory Council on Drug 
Abuse.

REVIEW CRITERIA

The information in this section pertains to R01 applications; those 
interested in a P01 submission should refer to NIDA's "Program Projects 
Guidelines found at http://www.drugabuse.gov/Funding/P01.html.

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

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these criteria 
in assigning the application's overall score, weighting them as appropriate 
for each application.  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 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?

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?

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?

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 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 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 

DATA SHARING:  The adequacy of the proposed plan to share data. Please also 
see http://www.nida.nih.gov/about/organization/genetics/FAQ_DataSharing.html 
and the previous section on The NIDA Genetics Consortium (NGC).

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 

MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data and Safety 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 "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.

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 www.nida.nih.gov under the Funding, or may be obtained by 
calling (301) 443-2755.

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 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.

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.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


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