Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Drug Abuse (NIDA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Funding Opportunity Title

Women & Sex/Gender Differences in Drug and Alcohol Abuse/Dependence (R03)

Activity Code

R03 Small Grant Program

Announcement Type

Reissue of PA-11-049

Related Notices
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number

PA-14-037

Companion Funding Opportunity

PA-14-038, R01 Research Project Grant
PA-14-036, R21 Exploratory/Developmental Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.279, 93.273

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to advance research on male-females differences in drug and alcohol abuse and addiction and on factors specific to women.  Both human and animal model studies are sought.    

Key Dates
Posted Date

December 12, 2013

Open Date (Earliest Submission Date)

January 16, 2014

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Standard AIDS dates apply, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review

Standard dates apply  

Advisory Council Review

Standard dates apply  

Earliest Start Date

Standard dates apply

Expiration Date

January 8, 2017

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description

This R03 Small Grant mechanism will support small research projects that can be carried out in a short period of time with limited resources. The common characteristic of the small grant is the provision of limited funding for a short period of time. Examples of the types of projects supported under the R03 include the following: pilot or feasibility studies; small, self-contained research projects; secondary analysis of existing data for the purpose of detecting outcomes separately for males and females; and research methodology development or new research technology to enhance research on females or to detect male-female differences.   No preliminary data are required but may be included if available.


Research Objectives
On September 27, 2010, the NIH Office of Research on Women’s Health released the strategic plan, “Moving into the Future with New Dimensions and Strategies:  A Vision for 2020 for Women’s Health Research” (http://orwh.od.nih.gov ).  The plan sets forth a women’s health research agenda for NIH for the next decade and includes six goals.  The present funding opportunity announcement embraces those goals as applied to drug and alcohol abuse and contains special emphasis on the first goal which is to “increase sex differences research in basic science studies.”  That goal, along with its nine objectives, is consistent with recommendations in the 2001 Institute of Medicine report, Exploring the Biological Contributions to Human Health: Does Sex Matter? (http://lab.nap.edu/openbook.php?isbn=0309072816&page=1).  It is also consistent with recommendations in the September 23, 2010 IOM report, Women’s Health Research: Progress, Pitfalls, and Promise (http://www.iom.edu/Reports/2010/Womens-Health-Research-Progress-Pitfalls-and-Promise.aspx).  Further, it is consistent with the need to increase sex differences research in the neurosciences as identified in the March 5, 2010 IOM meeting, Sex Differences:  Implications for Translational Neuroscience Research (http://www.iom.edu/Activities/Research/NeuroForum/2010-MAR-08/Agenda%20Sex%20Difference%20Translational%20Neuroscience%20Research.aspx) and its ensuing publication, http://www.iom.edu/Reports/2010/Sex-Differences-and-Implications-for-Translational-Neuroscience-Research.aspx.  More recently, the need for sex-specific reporting of research findings was emphasized in the 2012 IOM report, Sex-Specific Reporting of Scientific Research - Workshop Summary (http://www.iom.edu/Reports/2012/Sex-Specific-Reporting-of-Scientific-Research.aspx ).

Historically, in drug and alcohol abuse research, as in other fields of public health research, participants were largely male.  Research findings that have emerged for over the past two decades, however, have clearly established the importance of studying factors specific to women and differences between males and females in all areas of drug and alcohol abuse research. From basic studies of molecular genetics and neurotransmitter systems to studies of epidemiology, etiology, consequences and prevention/treatment interventions and services, the scientific and clinical importance of analyzing data separately for males and females is becoming more and more evident.  Not only are growing numbers of studies reporting outcomes that are specifi­c to either males or females, outcomes that are opposite in males and females also are often found.  These findings reveal that failure to analyze data separately for males and females can lead to incorrect conclusions regarding males or females or both. 

Accumulating epidemiological and clinical research indicates that the predictors of drug and alcohol use, abuse, and dependence often differ in males and females.  Among them are psychiatric co-morbidities, physical and sexual abuse, trauma, prenatal drug exposure and family dysfunction.  Some predictors are gender-sensitive; that is, they are stronger for either males or females.  Others are gender-specific; that is, they apply only to males or to females.  And others are opposite in males and females.  The implications of these types of gender-based differences in risk factors remain largely unexplored; however, they raise the possibility that interventions that target gender-based risk factors and are guided by male-female differences in social, cognitive and emotional development could improve outcomes for both males and females.

Animal and human laboratory research has shown that males and females often differ in their behavioral and 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. Further, factors that affect those outcomes often do so differently in males and females.   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.  Growing numbers of brain-imagining studies are reporting male-female differences.  Despite the important progress made in laboratory sex/gender-based research, it is in an early stage and most researchers fail to analyze their data by sex/gender.  

Numerous male-female differences in cigarette smoking and nicotine dependence have been reported, including differences in 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 factors specific to females such as the menstrual cycle, pregnancy, menopause status, weight control concerns and other barriers to cessation.

Male-female differences have been identified in various aspects of drug abuse treatment and services research including barriers to treatment, treatment entry characteristics, treatment and services needs, and predictors of treatment engagement, retention, and outcomes. Research often 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 even when treatments are shown to be equally effective for males and females, outcomes could be improved by the addition of gender-based approaches that are informed by this growing body of research.

According to 2010 HIV/AIDS surveillance data from the Centers for Disease Control and Prevention

among persons living in the U.S with a diagnosis of HIV infection at the end of 2010, injection drug use (IDU) was associated with a greater percentage of cases among women than among men (http://www.cdc.gov/hiv/surveillance/resources/reports/2010report/pdf/2010_HIV_Surveillance_Report_vol_22.pdf).  The HIV/AIDS disease process has been found to differ between males and females; 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, there is evidence that neurocognitive measures may differ between HIV+ drug using males and females and that they may be differentially impacted by HIV risk reduction interventions. 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, including the unique needs of women and how to address them in prevention and treatment efforts.

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 our knowledge of male-female differences in drug abuse and issues unique to women, many gaps remain. Often studies fail to include sex/gender analyses, and only a very small proportion of animal studies includes female subjects thus providing no opportunity to analyze data for sex differences and therefore running the risk that knowledge gained from animal models of drug abuse is limited to males.  Thus, in all areas of drug abuse, research is needed that examines male-female differences and factors specific to females.

Terminology: In scientific literature on differences between males and females, the terms sex and gender are sometimes used interchangeably. However, they have very different meaning as described in the 2001 IOM report, Exploring the Biological Contributions to Human Health: Does Sex Matter? (http://lab.nap.edu/openbook.php?isbn=0309072816&page=1, 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 individuals 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. Because it is often not known a priori whether a male-female difference is sex-based or gender-based or both, in this funding opportunity announcement sex/gender difference will sometimes be used generically to refer to male-female differences especially when the biological and social origins of the differences are unknown or likely involve both.  Of course, the 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 urged to recognize that a sex/gender difference is often a proxy for an unidentified independent variable(s) and therefore can serve as a research tool. 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. ETIOLOGY AND MECHANISMS OF DRUG ABUSE: In both animal and human research, study sex/gender differences in the basic behavioral and biological mechanisms underlying drug abuse and dependence across the lifespan; and conduct laboratory, epidemiological, and clinical studies of male-female differences in the determinants of initiation, progression, and maintenance of drug use and dependence.  Examples include:

II. CONSEQUENCES AND IMPACT: Laboratory (both human and animal), field, and clinical research aimed at (a) identifying sex/gender differences across the lifespan in the consequences of drug use, abuse, and addiction following acute use, chronic use, as well as residual effects following prolonged abstinence, or (b) examining drug-related consequences that are unique to females.  Examples include:

III. PREVENTION AND PREVENTION SERVICES: 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.  Examples include:

IV. TREATMENT AND TREATMENT SERVICES: Develop and test the efficacy/effectiveness of sex/gender-based treatment approaches (both behavioral and pharmacologic) 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 and treatment services.  Examples include:

V. HIV/AIDS and RELATED INFECTIOUS DISEASES: 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 sex/gender 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:

Drug Abuse in Pregnancy and the Post-Partum and Mental Health Comorbidity

See PA-09-174 “Women's Mental Health in Pregnancy and the Postpartum Period (R01)” for additional description of NIDA’s interest in basic and clinical research and prevention and treatment interventions on this topic.

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.  For example, NIDA's Clinical Trials Network Data Share website (http://www.ctndatashare.org) currently includes HIPAA-de-identified raw data from 23 studies completed by NIDA's Clinical Trials Network, 20 of which are randomized multi-site clinical trials.  No approval is needed to download the data.

Revision (formerly competing supplement) 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 http://grants.nih.gov/grants/funding/424/index.htm .  

NIAAAs 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, the genetic and biological mechanisms for these differences in drinking patterns are not fully known. For example, 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 alcohols 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 or 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 FOA exemplified in I. Etiology and Mechanisms, 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:

I. EPIDEMIOLOGY AND PREVENTION:

II. NEUROSCIENCE:

III. 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:

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 supplement) 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 http://grants.nih.gov/grants/funding/424/index.htm .  

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://grants.nih.gov/grants/guide/notice-files/NOT-DA-07-013.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.drugabuse.gov/funding/clinical-research/nacda-guidelines-administration-drugs-to-human-subjects

Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community.  Please see http://www.drugabuse.gov/about-nida/advisory-boards-groups/national-advisory-council-drug-abuse-nacda/council-statements/points-to-consider-regarding- for details.

Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit:  NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org).  Please see NOT-DA-12-008 (http://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Resubmission
Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

The combined budget for direct costs for the two year project period may not exceed $100,000. No more than $50,000 in direct costs may be requested in any single year.

Award Project Period

The maximum project period is 2 years.  

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are  eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are  eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are  allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility


Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed. 

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.  

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix:  Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

No publications or other printed material, with the exception of pre-printed questionnaires or surveys, may be included in the Appendix.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

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 only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

The R03 small grant supports discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research project usually is limited, an R03 grant application may not contain extensive detail or discussion. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem. 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.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?   

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the Center for Scientific Review (CSR) in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information


1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Samia Dawud Noursi, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-594-5622
Email: snoursi@mail.nih.gov

Ellen D. Witt, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443- 6545
Email: ewitt@mail.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Ms. Heidi Young
National Institution on Drug Abuse (NIDA)
Telephone: 703-243-8267
Email: youngh@nida.nih.gov

Ms. Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301- 443-4704
Email: jfox@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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.


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