Department of Health and Human Services
Participating Organizations
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 on Alcohol
Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov)
Title: Women and Sex/Gender
Differences in Drug and Alcohol Abuse/Dependence (R03)
Announcement
Type
This is a reissue of PA-03-139,
which was previously released June 16, 2003.
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Program Announcement (PA) Number: PA-07-330
Due
Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive
Summary
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII.Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Historically, in drug and
alcohol abuse/dependence research, as in other fields of public health
research, participants largely have been male. Research findings emerging in
the past few years, however, clearly are establishing the importance of
studying issues specific to women and studying male-female differences in all
areas of drug abuse research. From basic studies of molecular genetics and neurotransmitters
to studies of epidemiology, etiology, and prevention/treatment interventions,
the scientific and clinical importance of analyzing data separately for males
and females is becoming more and more evident.
Accumulating epidemiological and clinical research indicates that the predictors of drug abuse and dependence are often gender-based, as are factors associated with drug abuse and dependence progression. Depression, conduct disorder, physical and sexual abuse, prenatal drug exposure and family dysfunction are among the variables differentially predictive of drug use, abuse, and dependence in males and females. In some cases, predictors are ‘gender-sensitive;’ that is, they are stronger for either males or females. In other cases, predictors are ‘gender-specific;’ that is, they apply only to males or to females. The implications of these types of gender-based differences in risk factors for prevention and treatment interventions are largely unexplored; however, these differences raise the possibility that interventions that are designed to target gender-based risk factors and that are guided by well-established sex/gender differences in psychosocial and cognitive development could improve outcomes for both males and females.
Animal and human laboratory research has shown that males and females often differ in their biological responses to drugs. Animal studies, for example, have found male-female differences in the motor-activating effects of stimulants, speed of acquisition of drug self-administration, the amount of drug self-administered, the percentage of subjects that acquire self-administration, escalation of drug self-administration, motivation for self-administration, and the tendency to relapse following drug cessation. Human and animal pharmacokinetic studies often report male and female differences, as do studies of adverse effects of abused drugs. Both human and animal studies have established that the menstrual/estrous cycle is a determinant of drug action, both pharmacokinetic and behavioral. A growing number of brain-imagining studies are reporting male-female differences. Despite the important progress made in laboratory sex/gender-based research, the work is just beginning and many questions remain unaddressed.
Numerous male-female differences in cigarette smoking and nicotine dependence have been reported, including differences in the use patterns and dependence susceptibility, cessation rates and relapse rates, effectiveness of nicotine replacement therapies and other pharmacotherapies, the role of non-nicotine factors, nicotine metabolism, and pharmacogenetics. Indeed, research on male-female differences in nicotine dependence has exceeded that of other drugs of abuse and thus may serve to guide research on other abused drugs. Nevertheless, many gaps remain in our understanding of male-female differences in the nature of nicotine addiction and its prevention and treatment, including issues specific to females such as the menstrual cycle, pregnancy, and weight control issues.
According to 2006 surveillance data from the Centers for Disease Control and Prevention, among reported HIV cases that progress to a diagnosis of AIDS, drug abuse is associated with a greater percentage of cases among women than among men. Among individuals diagnosed with AIDS, 36 percent of women are injection drug users (IDUs) whereas 21 percent of men are IDUs. An additional 14 percent of women with AIDS, compared with nine percent of men with AIDS, report having sex with IDUs. Thus, drug abuse is directly or indirectly associated with 50 percent of the reported AIDS cases in women compared to 30 percent of the cases in men. Among non-injection drug users, there are male-female differences in HIV risk behavior; for example, women who use crack cocaine are more likely to engage in sex for drugs or money than men who use crack. Recent research suggests that male-female differences exist in some fundamental aspects of the HIV/AIDS disease process; for example, an HIV-infected woman with half the amount of virus circulating in the bloodstream as an infected man will progress to a diagnosis of AIDS in about the same time as the man despite comparable immune parameters (e.g., CD4 counts). Additionally numerous male-female differences in HIV risk factors in drug abusers have been identified and there is evidence that HIV risk reduction interventions may impact men and women differently. Histories of sexual and physical abuse appear to have more consistent effects on subsequent drug use and HIV risk among women than men. Although drug abuse plays a greater role in HIV among women than men, major gaps remain in knowledge regarding male-female differences in the role of drug abuse in HIV/AIDS and the unique needs of women. In general, the conceptual links between particular types and patterns of drug use and HIV exposure are poorly documented, which makes it difficult to evaluate and intervene on motivational factors in drug use and HIV risk. More attention to gender differences in drug use, HIV risk behavior, and associated factors would enable the development of more effective HIV prevention interventions.
Male-female differences are emerging in various aspects of drug abuse treatment research including barriers to treatment, treatment entry characteristics, treatment and services needs, and predictors of treatment engagement, retention, and outcomes. Additionally, research sometimes finds that treatments are not equally efficacious in males and females. These male-female differences in treatment research, along with research showing male-female differences in the determinants and predictors of drug abuse, raise the possibility that treatments shown to be equally effective for males and females could be improved by the addition of gender-based approaches that are informed by this growing body of research.
The extant literature on male-female differences in drug abuse strongly suggests that males and females are likely to differ in many aspects of drug abuse yet to be explored and that in the long run, identifying and understanding such differences can improve our understanding of the nature and etiology of drug abuse and have implications for tailoring prevention and treatment interventions to maximize outcomes for both males and females. Although progress has been made in knowledge of male-female differences in drug abuse and issues unique to women, noteworthy gaps remain. Often, studies fail to include sex/gender analyses, and only a small proportion of animal research includes female subjects thus providing no opportunity to analyze data for sex differences. Thus, in all areas of drug abuse, research is needed that examines male-female differences and issues specific to females.
TERMINOLOGY. In scientific literature on differences between males and females, the terms ‘sex’ and ‘gender’ are sometimes used interchangeably. Typically, however, distinctions are made as in the 2001 Institute of Medicine report, Exploring the Biological Contributions to Human Health: Does Sex Matter? (http://lab.nap.edu/openbook/0309072816/html/1.html , page 1), wherein sex is defined as “the classification of living things, generally as male or female according to their reproductive organs and functions assigned by their chromosomal complement, and gender as a person’s self-representation as male or female, or how that person is responded to by social institutions on the basis of the individual’s gender presentation. Gender is shaped by environment and experience.” Thus, sex is a biological construct whereas gender is a psychosocial construct. This distinction notwithstanding, epigenetic research reveals that biological factors often unfold in ways that are influenced by the environment, and thus can obviate this distinction between sex and gender. Therefore, because it is often not known a priori whether a male-female difference is sex-based or gender-based or both, in this program announcement ‘sex/gender difference’ will be used generically to refer to male-female differences regardless the origins of the differences, although a search for those origins is a major focus of this announcement. In non-human animal research, however, the term ‘sex difference’ is the preferred term. Additionally, researchers are encouraged to recognize that a sex/gender difference is sometimes only a proxy for an unidentified independent variable(s). Thus, finding a sex/gender difference typically should be regarded as a first step in a search for such variables as their identification will shed light on the phenomenon under study.
NIDA’s Areas of Research Interest:
Areas of research interest include, but are not limited to, the following:
I. MECHANISMS AND ORIGINS: Sex/gender differences in the basic behavioral, biological, and genetic mechanisms underlying drug abuse and dependence; and laboratory, epidemiological, and clinical studies of sex/gender differences in the determinants of initiation, progression, and maintenance of drug use and dependence.
II. CONSEQUENCES AND IMPACT: Laboratory (both human and animal), field, and clinical research aimed at (1) identifying male-female differences in the consequences of drug use, abuse, and addiction following acute use, chronic use, as well as residual effects following prolonged abstinence, and (2) examining drug-related consequences that are unique to females.
III. PREVENTION AND PREVENTION SERVICES: Using input and involvement of both researchers and practitioners, design, develop and test the efficacy/effectiveness of sex/gender-based prevention strategies that are informed by sex/gender-based theories (e.g., psychosocial, biological, developmental) and empirical findings on the risk and protective factors related to drug abuse initiation, progression, transition, and maintenance.
IV. TREATMENT AND TREATMENT SERVICES: Using input and involvement of both researchers and practitioners, develop and test the efficacy/effectiveness of sex/gender-based treatment strategies (including behavioral treatment and pharmacotherapies) that are informed by relevant sex/gender-based theories (e.g., biological, psychosocial, developmental) as well as empirical findings on gender differences in drug abuse including, e.g., sex/gender differences in risk factors, psychopathology and factors affecting treatment entry, completion, and outcomes. Examine gender-based issues related to the effective and efficient delivery of drug abuse treatment services.
V. HIV/AIDS and RELATED INFECTIOUS DISEASES: Based on the input and involvement of both researchers and practitioners, develop and evaluate sex/gender-based interventions directed at preventing and treating HIV/AIDS and related infectious diseases among drug using populations and those at risk for drug use at every age level.
CROSS-CUTTING ISSUES
In addition to the above areas of research on male-female differences and issues unique to women, several research considerations and topic areas apply to many areas of research. They include, but are not limited to, the following:
Secondary Data Analyses
Under this announcement, investigators may request funds to perform secondary data analyses of either their own data sets or other data sets that are publicly available.
Revision (formerly “competing supplemental”) Applications
NIDA welcomes applications that request a revision (formerly competitive supplement) to their active NIDA grant in order to pursue research on women and sex/gender differences that is relevant to the parent grant, but which reflects a significant expansion of the scope or research protocol of the parent grant. The duration of the supplement may not exceed the end date of the active parent grant. For other requirements and instructions, see Section 2.8 on page 27 at http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.pdf
NIAAA’s Areas of Research Interest:
Alcohol-related problems including alcohol use disorders (abuse and dependence) represent a significant public health problem that is associated with considerable harm to the individual and society. Epidemiological surveys indicate that, among women, alcohol dependence has not declined, while alcohol abuse has increased. Despite the fact that alcohol use is more prevalent among men than women, whether there are genetic and biological mechanisms for these differences in drinking patterns is unknown. Women become intoxicated faster than men, achieve higher concentrations of alcohol in the blood after drinking equivalent amounts of alcohol, and appear to eliminate alcohol from the blood faster than men. These findings may be due to various physiological processes and fluctuations in gonadal hormonal levels that affect the rate of alcohol metabolism making women more susceptible to alcohol’s effects. Consequently, women’s health may be more adversely affected than men’s with the experience of adverse effects that include but are not limited to intentional/unintentional injuries (e.g., suicide, traffic-related injuries, falls), acute or chronic health effects (e.g., fetal alcohol syndrome, increased risk for certain cancers, liver disease, brain damage, alcohol-induced organ damage), social and/or interpersonal problems (e.g., sexual assault, physical abuse, violence), and mental health problems (e.g., mood and anxiety disorders).
Research findings suggest that there are certain high risk groups (e.g., racial/ethnic) and vulnerable populations (e.g., underage and younger drinkers) for which more research is needed that examines etiological issues, complexities of drinking pattern trajectories, genetic risks, neurobehavioral processes, environmental influences, other drug and/or psychiatric comorbidity, strategies for early identification, and the development of effective prevention interventions.
NIAAA is interested in the research areas in this PA exemplified in sections I. Mechanisms and Origins, II. Consequences and Impact, III. Prevention and Prevention Services, and V. HIV/AIDS and Related Infectious Diseases as they relate specifically to alcohol consumption. The research areas of particular interest to NIAAA include, but are not limited to, the following:
EPIDEMIOLOGY AND PREVENTION:
NEUROSCIENCE:
PUBERTAL AND HORMONAL PROCESSES:
NIAAA has a special interest in sex/gender differences in drinking patterns that become apparent during puberty, and the mechanisms underlying these differences. Specifically, we are interested in research that will increase our understanding of 1) the degree to which hormonal changes at puberty interact with neurodevelopmental processes to promote sex effects in alcohol use and misuse, and 2) the effects of adolescent alcohol exposure on these interactive processes. Research areas of include the following:
Revision (formerly “competing supplemental”) Applications
NIAAA welcomes applications that request a revision (formerly competitive supplement) to their active NIAAA grant in order to pursue research on women and sex/gender differences that is relevant to the parent grant, but which reflects a significant expansion of the scope or research protocol of the parent grant. The duration of the supplement may not exceed the end date of the active parent grant. For other requirements and instructions, see Section 2.8 on page 27 at http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.pdf.
Special Considerations
HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: In light of recent significant advances in rapid testing for HIV and in effective treatments for HIV, NIDA has revised its 2001 policy on HIV counseling and testing. NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV. This policy applies to all NIDA funded research conducted domestically or internationally. For more information see http://www.nida.nih.gov/about/organization/nacda/CouncilStatement.html.
National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects: The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects. 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 Web site at http://www.nida.nih.gov/about/organization/nacda/CouncilStatement.html.
National Advisory Council on Alcohol Abuse and Alcoholism Recommended Guidelines on Ethyl Alcohol Administration in Human Experimentation: The National Advisory Council on Alcohol Abuse and Alcoholism recognizes that research involving the administration of alcohol to human subjects is a critical experimental approach that is essential to address fundamental questions on the etiology, treatment and prevention of alcohol abuse and alcoholism. However, ethical principles exist that must be adhered to in the conduct of such research. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer alcohol to human subjects. The guidelines are available on NIAAA’s Home Page at http://www.niaaa.nih.gov/Resources/ResearchResources/job22.htm
See Section VIII, Other
Information - Required Federal Citations, for policies related to this
announcement.
Section II. Award Information
1. Mechanism(s) of Support
This Funding Opportunity Announcement (FOA) will use the NIH Small Research
Grant (R03) award mechanism. The applicant will be solely responsible for
planning, directing, and executing the proposed project.
This FOA uses “Just-in-Time” information concepts. It also uses the modular as well as the non-modular budget formats (see the “Modular Applications and Awards” section of the NIH Grants Policy Statement. All applications submitted in response to this FOA must use the modular budget format. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, “Modular Budget Component,” of the Application Guide).
All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.
Competing renewal (formerly “competing continuation”) applications will not be accepted for the R03 grant mechanism. Small grant support may not be used for thesis or dissertation research. Up to two resubmissions (formerly “revisions/amendments") of a previously reviewed small grant application may be submitted. See NOT-OD-05-046, April 29, 2005.
For specific information about the R03 programs, see: http://grants.nih.gov/grants/funding/r03.htm.
2. Funds Available
Because the nature and scope of the proposed
research will vary from application to application, it is anticipated that the
size and duration of each award will also vary. Although the financial plans of
the NIH Institutes and Centers (ICs) provide support for this program, awards
pursuant to this funding opportunity are contingent upon the availability of
funds and the receipt of a sufficient number of meritorious applications.
A project period of up to two years and a budget for direct costs of up to two $25,000 modules, or $50,000 per year, may be requested (i.e., a maximum of $100,000 over two years in four modules of $25,000 each). Commensurate Facilities and Administrative (F&A) costs are allowed.
F&A costs requested by consortium participants are not included in
the direct cost limitation. See NOT-OD-05-004, November 2, 2004.
Section III. Eligibility Information
1.
Eligible Applicants
1.A. Eligible
Institutions
You may submit an application(s) if your organization
has any of the following characteristics:
1.B. Eligible Individuals
Any individual with
the skills, knowledge, and resources necessary to carry out the proposed
research as the Project Director/Principal Investigator (PD/PI) is invited to
work with his/her 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 support.
More than one PD/PI, or multiple PDs/PIs, may be
designated on the application for projects that require a “team science”
approach that clearly does not fit the single-PD/PI model. Additional
information on the implementation plans and policies and procedures to formally
allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
2. Cost Sharing or Matching
This program does not require cost sharing as defined in the current NIH Grants Policy Statement.
3.
Other-Special Eligibility Criteria
Applicants may submit more than one application,
provided each application is scientifically distinct.
Section IV. Application and Submission Information
To download an
Application Package and SF424 (R&R) Application Guide for completing the
SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
Grants.gov
Customer Support
Contact Center Phone: 800-518-4726
Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
Email support@grants.gov
2) Organizational/Institutional Registration in the eRA Commons
eRA
Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours M-F 7:00 a.m. – 8:00 p.m. Eastern Time
Email commons@od.nih.gov
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the “Attachment” files may be useable for more than one FOA.
For further assistance contact GrantsInfo, Telephone 301-435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY 301-451-0088.
2.
Content and Form of Application Submission
Prepare all applications using the SF424
(R&R) application forms and in accordance with the SF424 (R&R)
Application Guide.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required
Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site
Locations
Research
& Related Other Project Information
Research
& Related Senior/Key Person
PHS398 Cover
Page Supplement
PHS398
Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget, as appropriate (See Section
IV.6., “Special
Instructions,” regarding appropriate
required budget component.)
Research & Related Budget
(required for foreign applications)
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
Foreign Organizations (Non-domestic
(non-U.S.) Entity)
NIH policies concerning grants to foreign (non-U.S.)
organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact” PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PD/PI.” Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” (Section 14 of the Research Plan Component in the SF424 (R&R)), must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.
3. Submission Dates and Times
See Section IV.3.A. for
details.
3.A. Submission, Review, and
Anticipated Start Dates
Opening Date: March
15, 2007(Earliest date an application may be submitted to Grants.gov
Letters of Intent Receipt Date(s): Not applicable.
Application
Submission/Receipt Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application
Submission/Receipt Date(s): Standard dates apply, please
see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review
Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council
Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest
Anticipated Start Date(s): Standard dates apply,
please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
3.A.1.
Letter of Intent
A letter of intent is not required for the funding
opportunity.
3.B.
Submitting an Application Electronically to the NIH
To submit an application in response to this FOA, applicants should
access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C. Application Processing
Applications may be submitted on or
after the opening date and must be successfully received by Grants.gov
no later than 5:00 p.m. local time (of the
applicant institution/organization) on the
application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt
date(s) and time, the application may be delayed in the review process or not
reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
Upon receipt, applications will be evaluated for completeness by the
Center for Scientific Review, NIH. Incomplete applications will not be
reviewed.
There
will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the
assignment of an application to a Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an “Introduction” addressing the previous critique. Note that such an application is considered a "resubmission" for the SF424 (R&R).
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are subject to the terms and
conditions, cost principles, and other considerations described in the NIH Grants
Policy Statement.
Pre-award costs are allowable. A grantee may, at its
own risk and without NIH prior approval, incur obligations and expenditures to
cover costs up to 90 days before the beginning date of the initial budget
period of a new award if such costs: are necessary to conduct the project and
would be allowable under the grant, if awarded, without NIH prior approval. If
specific expenditures would otherwise require prior approval, the grantee must
obtain NIH approval before incurring the cost. NIH prior approval is required
for any costs to be incurred more than 90 days before the beginning date of the
initial budget period of a new award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See the NIH
Grants Policy Statement.
6.
Other Submission Requirements
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.”
Organizational DUNS
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”
Renewal (formerly “competing continuation” or “Type 2”) applications are not permitted.
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, with the following requirements for R03 applications:
APPENDIX MATERIALS
IMPORTANT NOTE: NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Foreign Applications (Non-domestic (non-U.S.) Entity)
Plan for Sharing Research Data
Not
Applicable.
Sharing Research Resources
NIH policy expects that grant recipients
make unique research resources readily available for research purposes to
qualified individuals within the scientific community after publication (See
the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., “Reporting.”
Section V. Application Review Information
1.
Criteria
Only the review criteria described below will be
considered in the review process.
2.
Review and Selection Process
Applications submitted for this funding opportunity
will be assigned to the ICs on the basis of established Public Health Service
(PHS) referral guidelines.
Appropriate scientific review groups convened in
accordance with the standard NIH peer review procedures (http://cms.csr.nih.gov/ResourcesforApplicants/)
will evaluate applications for scientific and technical merit.
As part of the initial merit review, all applications
will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The NIH R03 small grant is a mechanism for supporting discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the Research Plan component is restricted to 10 pages, a small grant application will not have the same level of detail or extensive discussion found in an R01 application. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem, placing less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.
The goals of NIH-supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written comments, reviewers will be asked to comment on each of the following criteria 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 these criteria in assigning the application's overall score, weighting them as appropriate for each application.
Note that an 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 or clinical practice be advanced? What will be the effect
of these studies on the concepts, methods, technologies, treatments, services,
or preventative interventions that drive this field?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators 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? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?
Environment: Does the scientific
environment in which the work will be done contribute to the probability of
success? Do the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support?
2.A.
Additional Review Criteria
In addition
to the above criteria, the following items will continue to be considered in
the determination of scientific merit and the priority score:
Resubmission
Applications (formerly “revised/amended” applications): Are the responses
to comments from the previous scientific review group adequate? Are the
improvements in the resubmission application appropriate?
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 item 6 of the
Research Plan component of the SF424 (R&R).
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 item 7 of the Research Plan component of the SF424
(R&R).
Care and Use of Vertebrate Animals in Research: If vertebrate animals
are to be used in the project, the five items described under item 11 of the
Research Plan component of the SF424 (R&R) will be assessed.
Biohazards: If materials or procedures are proposed that are potentially
hazardous to research personnel and/or the environment, determine if the
proposed protection is adequate.
2.B. Additional Review
Considerations
Budget: The reasonableness of the proposed budget and the requested period of
support in relation to the proposed research. The priority score should not be
affected by the evaluation of the budget.
Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.
2.C. Sharing Research Data
Not Applicable.
2.D.
Sharing Research Resources
NIH policy expects that grant recipients make unique
research resources readily available for research purposes to qualified
individuals within the scientific community after publication (See the NIH
Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be responsible for the
administrative review of the plan for sharing research resources.
The adequacy of the resources sharing plan will be
considered by Program staff of the funding organization when making
recommendations about funding applications. Program staff may negotiate
modifications of the data and resource sharing plans with the awardee before
recommending funding of an application. The final version of the data and
resource sharing plans negotiated by both will become a condition of the award
of the grant. The effectiveness of the resource sharing will be evaluated as
part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3., “Reporting.”
Model Organism Sharing Plan: Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations. For the R03 mechanism, the presence or adequacy of a plan should not enter into the scoring of the application.
3. Anticipated Announcement and Award Dates
Not
Applicable.
Section VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed,
the PD/PI will be able to access his/her Summary Statement (written critique)
via the NIH eRA Commons.
If the application is under consideration for funding, NIH will request
"just-in-time" information from the applicant. For details, applicants
may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A formal notification in the form of a Notice
of Award (NoA) will be provided to the applicant organization. The NoA
signed by the grants management officer is the authorizing document. Once all
administrative and programmatic issues have been resolved, the NoA will be
generated via email notification from the awarding component to the grantee
business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Section IV.5.,
“Funding Restrictions.”
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include
the NIH Grants Policy Statement as part of the NoA. For these terms of award,
see the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General and Part
II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities.
3. Reporting
When multiple years are involved, awardees will be required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required in
the NIH
Grants Policy Statement
We encourage your inquiries concerning this funding
opportunity 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:
1.
Scientific/Research Contacts:
Cora Lee Wetherington, Ph.D.
Women &
Gender Research Coordinator
National
Institute on Drug Abuse
6001 Executive
Blvd., Rm 4282, MSC 9555
Bethesda, MD 20892-9555 (For overnight mail:
Rockville, MD 20857)
Phone:
(301) 435-1319
Fax:
(301) 594-6043
E-mail: wetherington@nih.gov
Mariela C. Shirley, Ph.D.
Health Scientist
Administrator
Division of
Epidemiology and Prevention Research
National
Institute on Alcohol Abuse and Alcoholism
5635 Fishers
Lane
Room 2086 MSC
9304
Bethesda, MD 20892-9304
Federal Express:
Rockville, MD 20852-1705
Phone:
301-443-9787
Fax:
301-443-8614
Email: shirleym@mail.nih.gov
2. Peer
Review Contacts:
Not Applicable
3. Financial or Grants
Management Contacts:
Yinka
Abu
Grants
Management Branch
National
Institution on Drug Abuse
6101
Executive Blvd., Suite 270
Bethesda, MD 20892-8403
Telephone:
(301) 443-6710
Fax:
301-594-6847
Email: abuy@nida.nih.gov
Ms. Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol
Abuse and Alcoholism
5635 Fishers Lane
Room 3023 MSC 9304
Bethesda, MD 20892-9304
Phone: 301-443-4704
Fax: 301-443-3891
Email: jfox@mail.nih.gov
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals
must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
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).
Monitoring should be commensurate with risk. The establishment of data and
safety monitoring boards (DSMBs) is required for multi-site clinical trials
involving interventions that entail potential risks to the participants (NIH
Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research
Data:
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 and 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.
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 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 funding opportunity 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.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important
research resources including the sharing of model organisms for biomedical
research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH
Grants Policy Statement).
Beginning October 1, 2004, all investigators submitting an NIH application or
contract proposal are expected to include in the application/proposal a
description of a specific plan for sharing and distributing unique model
organism research resources generated using NIH funding or state why such
sharing is restricted or not possible. This will permit other researchers to
benefit from the resources developed with public funding. The inclusion of a
model organism sharing plan is not subject to a cost threshold in any year and
is expected to be included in all applications where the development of model
organisms is anticipated.
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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is 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 SF424 (R&R) application; 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 Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all clinical research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them.
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 (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 applications for research involving human
subjects and individuals designated as key personnel. The policy is available
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 (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.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript
submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts resulting from 1) currently
funded NIH research projects or 2) previously supported NIH research projects
if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award
mechanisms, cooperative agreements, contracts, Institutional and Individual
Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural
research studies. The Policy applies to peer-reviewed, original research
publications that have been supported in whole or in part with direct costs
from NIH, but it does not apply to book chapters, editorials, reviews, or
conference proceedings. Publications resulting from non-NIH-supported research
projects should not be submitted.
For more information about the Policy or the
submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.
Standards
for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) 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 HHS
Office for Civil Rights (OCR).
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. For publications listed in the appendix and/or Progress report,
internet addresses (URLs) must be used for publicly accessible
on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for 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 FOA 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 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 Part 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 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.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified
health professionals who have made a commitment to pursue a research career
involving clinical, pediatric, contraception, infertility, and health
disparities related areas. The LRP is an important component of NIH's efforts
to recruit and retain the next generation of researchers by providing the means
for developing a research career unfettered by the burden of student loan debt.
Note that an NIH grant is not required for eligibility and concurrent career
award and LRP applications are encouraged. The periods of career award and LRP
award may overlap providing the LRP recipient with the required commitment of
time and effort, as LRP awardees must commit at least 50% of their time (at
least 20 hours per week based on a 40 hour week) for two years to the research.
For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
![]() |
Office of Extramural Research (OER) |
![]() |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
![]() |
Department of Health and Human Services (HHS) |
![]() |
||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, RealPlayer, Video or Flash files, see Help Downloading Files. |