Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov)

Title: Mechanisms of Behavior Change in the Treatment of Alcohol Use Disorders (R21)

Announcement Type
New

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.

Request For Applications (RFA) Number: RFA-AA-07-005

Catalog of Federal Domestic Assistance Number(s)
93.273

Key Dates
Release/Posted Date: November 1, 2006
Opening Date: November 2, 2006 (Earliest date an application may be submitted to Grants.gov):
Letters of Intent Receipt Date(s): December 19, 2006
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Submission/Receipt Date(s):  January 19, 2007
AIDS Application Submission/Receipt Date(s):  N/A
Peer Review Date(s): February/March 
Council Review Date(s): May  2007
Earliest Anticipated Start Date(s): September 15, 2007
Additional Information to Be Available Date (Activation Date): Not Applicable
Expiration Date: January 20, 2007

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

This funding opportunity announcement (FOA) solicits Exploratory/Developmental (R21) grant applications from applicant organizations to investigate the underlying mechanisms that drive behavior change within the context of behavioral treatments for alcohol dependence.  Mechanisms of behavior change refer to the underlying psychological, social, and neurophysiological processes through which therapeutic change occurs.  These processes include, but are not limited to, factors such as client expectancies, therapeutic alliance, therapist empathy, therapeutic ritual, mastery and attributions of outcome, and social influences. Treatment is generally defined as behavioral interventions facilitated by trained professionals in face-to-face sessions, print media, or the Internet.  How pharmacotherapy might change response to behavioral interventions may be included.   Research proposals submitted under this FOA are encouraged to develop pilot projects that directly assess the causal relationship between mechanisms of behavior change and treatment outcome using the recommendations laid out by Kazdin and Nock (2003).  Non-experimental exploratory studies of mechanisms of behavior change (e.g., secondary analyses of extant data sets, naturalistic studies of behavior change) are eligible.  However, applicants must clearly demonstrate how these studies will lead to future experimental tests of the causal relationship between a potential mechanism of behavior change and treatment outcome.  Projects focusing on statistical mediation alone are not considered responsive. A further aim of this FOA is development of methods to facilitate explicit study of mechanisms of behavior change. 

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
    A. Cooperative Agreement Terms and Conditions of Award
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

Background

Research on behavioral treatments for heavy drinking and alcohol use disorders has progressed substantially in the past 20 years.  Brief behavioral interventions in primary care settings have reliably produced an approximately 25 percent reduction in heavy drinking among at-risk drinkers as compared to controls (Bien, Miller, & Tonigan, 1993).  Behavioral approaches to encourage positive change among people with alcohol use disorders in treatment have demonstrated consistently good outcomes (Miller & Wilbourne, 2002). Most importantly, the internal validity of such research has improved dramatically, through clearer specification of theoretical models of behavior change, use of treatment manuals, training and supervision of therapists, and attention to fidelity of interventions during the trial (e.g., through monitoring video or audio recordings of therapy sessions). As a result of these methodological advances, valid comparison of different therapeutic approaches such as motivational enhancement therapy or cognitive behavioral therapy became possible.  In fact, many of the behavioral treatments developed in the alcohol field are being adopted in other disease categories such as obesity, smoking, and diabetes (Hudson, 2005; Stotts, et al. 2004; Wilson, et al. 2002)).

Despite considerable progress in developing evidence-based behavioral approaches for the treatment of alcohol use disorders, there is growing evidence that a vast array of available approaches yield strikingly similar results.  A good example is the Project Match study.  Three behavioral interventions--Motivational Enhancement, Cognitive-Behavioral, and Twelve Step Facilitation—each with distinct purported mechanisms of action, were equally effective, suggesting that it is not the particular technique that is responsible for change, but other unspecified factors.  Moreover, a number of mediational analyses of behavioral interventions (e.g., 12-Step Facilitation, Cognitive-Behavioral Therapy) found little relationship between the purported theoretical mechanisms of change and observed effects (Morgenstern & Longabaugh, 2000; Morgenstern, 1996).  The failure to find significant differences in outcome from different psychotherapy models is not unique to AUD. In fact, it is characteristic of psychotherapy research more broadly (Lambert & Ogles, 2004; Wampold, 2001). If the hypothesized components of psychotherapy techniques are not primary change agents, the focus of alcohol treatment research needs to shift from one that addresses the efficacy of individual treatments to one that addresses common mechanisms or mediators of change across all behavioral treatments.

Mechanisms of Behavior Change Defined

What are mechanisms of behavior change?  Mechanisms of behavior change generally refer to the underlying, basic psychological processes (cognition, affect, learning, perception), social processes (persuasion, interaction, context, social control) and neurophysiologic processes (neurotransmitters/receptors, second messengers, neural networks) that drive therapeutic change.  A variety of terms have been used to describe these processes, for example, “active ingredients,” “mediators,” “nonspecific effects,” “placebo effects” (Wampold, 2001).  Examples of potential mechanisms of change include therapeutic alliance, client expectancies, therapist empathy, therapeutic ritual, confronting problems, behavioral self-regulation and social control.  In the mental health literature, Grancavage and Norcross (1990) identified 35 therapeutic factors common to psychotherapy, and grouped them into five superordinate categories: client characteristics, therapist qualities, change processes, treatment structures, and relationship elements.  More recently, Lambert and Ogles (2004) divided common factors into support, learning, and action factors. 

It is important to distinguish mechanisms of behavior change, or “mediators,” from the term “moderators” of change (Barron & Kenny, 1986).  Mediators are the processes through which change occurs (e.g., good therapeutic alliance leads to, or mediates, a reduction in heavy drinking).  In short, mediators are the catalysts that drive behavior change.  Moderators refer to characteristics (e.g., gender, affective response style, endophenotypes) that influence the degree to which behavior change occurs.   For example, level of cognitive impairment may moderate the potential for change in the context of alcohol treatment (Bates, et al., 2002).  Those with high levels of alcohol-related cognitive impairment are less likely to change in the context of treatment than those with low levels of cognitive impairment.  Finally, mediators and moderators of behavior change are related (Kazdin & Nock, 2003).  The underlying mechanisms for behavior change, or mediators, can vary with characteristics thought to moderate change. 

Benefits of Understanding Mechanisms of Behavior Change

Understanding mechanisms of behavior change will benefit the field in many ways.  First, this line of research will ultimately uncover the key features of behavioral therapy that account for improvements in patient outcomes.  Understanding what is operating inside the “black box” of complex behavioral treatment approaches is a longstanding goal in the alcohol and mental health treatment research field.  Second, the development of knowledge of mechanisms of behavior change will improve clinical practice by identifying the key aspects of therapy that must be present for maximum effect—irrespective of the specific technique being applied.  Third, delineating mechanisms of action for behavioral treatments will provide a new way to approach patient-treatment-context interactions and more individualized treatment. Finally, findings from this research will lay the groundwork for studies on the larger question of how change is affected by social and other extra-treatment factors, and how treatment approaches can begin to take these factors into consideration, even integrating them into interventions.  The treatment experience is but one element in a complex interplay of factors in an individual’s behavioral change trajectory over time.  Understanding these extratreatment factors will be essential for initiating and maintaining changes in alcohol use disorders.

Mechanisms of Behavior Change Research in the Alcohol Field

Although the focus of the alcohol treatment literature has been on establishing the efficacy of treatment, there has been a longstanding interest in understanding the active ingredients of change.  This issue was first addressed by Moos and Finney over 20 years ago (Moos & Finney, 1983) and since that time approximately 25 studies have addressed the mediators and moderators of treatment effects.  While almost exclusively tests of statistical mediation, these studies represent an initial step in identifying potential mechanisms of behavior change. These studies can be clustered into two groups:  1) those that address the statistical mediators of treatment effects within a particular treatment approach (e.g., cognitive-behavior therapy) and 2) those that look at statistical mediators of treatment effects across multiple approaches, such as those included in Project MATCH.  It is interesting to note that this line of work in the alcohol field has developed more-or-less independently of parallel work in the general psychotherapy literature (Lambert , 2004). 

The majority of studies addressing statistical mediation have looked at individual treatment modalities—in short, specific treatment effects.  Typically, the underlying theoretical mechanisms by which the treatment approach is made explicit, then measured, and analyzed using the four-step mediational model is outlined by Morgenstern and Longabaugh (2000).   A good example would be the study of statistical mediators of change in traditional, 12-Step chemical dependency programs (Morgenstern et al., 1996).  A number of potential statistical mediators were tested: acknowledgment of powerlessness over drinking; belief in a higher power, commitment to Alcoholics Anonymous (AA), acceptance of the disease model of addiction, commitment to abstinence, and avoidance of high risk situations. The results showed that there was little relationship between the key mechanisms purported by 12-Step-oriented programs and outcomes. Other examples of statistical mediational analyses of 12-Step approaches have been conducted by Kaskutas, Bond & Humphries (2002), Kelly, Meyers & Brown (2000) and Magura et al. (2003).   Additional examples of this line of work are studies that examine potential statistical mediators in cognitive-behavioral therapy (CBT).  The hypothesized key ingredients to CBT are an increase in self-efficacy and the acquisition and use of coping skills to handle alcohol related situations. In a synthesis of ten studies that assessed the mechanisms of action of CBT, Morgenstern and Longabaugh (2000) found little evidence that the observed effects of CBT treatments were mediated by the hypothesized active ingredients.  Research on the statistical mediators of treatment specific effects has also been done on motivational interviewing (Moyers, in press), behavioral couples therapy (McCrady et al., 2002), and twelve-step facilitation (TSF) (Longabaugh et al.  2005).

A number of studies have examined mechanisms of change across psychotherapies for alcohol dependence. For example, Karno (2005) analyzed the Project Match data and found an interaction between therapist directiveness and patient reactance (extent to which someone gives up control in an interpersonal situation).  Specifically, for patients with high and medium levels of reactance, increasing levels of directiveness on the part of the therapist were associated with less positive outcomes.  This correlation was not seen in patients with low reactance. Additional potential mechanisms of change that have been addressed are therapeutic alliance (Connors et al., 1999); engagement (Dearing, 2005); and readiness-to-change (DiClemente, 2005).  

At the conceptual level, Longabaugh and Wirtz (2001) asked each investigator in Project Match to clearly delineate how they thought the matching characteristic (moderator) affected the action and outcome of the therapeutic technique (mediator).  This analysis led to the development of three general forms (termed canonical forms) of interactions between moderators and mediators and how those are related to treatment outcome (DHHS, 2001). These canonical forms represented a significant conceptual advance because prior to this, such logic models were not explicit, even though matching effects were thought to occur. 

A final indicator of the level-of-interest in the topic of mechanisms of behavior change is that for the last two years, a satellite session specifically devoted to mechanisms of behavior change has been held prior to the annual meeting of the Research Society on Alcoholism meeting.  These meetings were a collaborative effort between NIAAA and researchers from around the nation.

Next Steps

Despite the interest in the alcohol treatment research field for understanding the underlying mechanisms of change in behavioral interventions, there has been relatively little research that has directly assessed the causal relationship between a potential mechanism of change and outcome.  Strengthening causal inferences about the relationship between mechanisms of behavior change and outcomes is addressed by Kazdin and Nock (2003).  They use Hill’s criteria for distinguishing causation from mere association to examine studies of mechanisms of behavior change, and conclude that very little published work has explicitly addressed mechanisms of change. In particular, they note that statistical mediation alone is inadequate as a test of true mediation. What is needed is to move beyond studies of statistical mediation towards explicitly experimental studies that test hypothesized mechanisms prospectively.  

Objectives and Scope

The principal aim of this Exploratory/Developmental (R21) funding opportunity announcement (FOA) is to develop new knowledge on the underlying mechanisms that drive behavior change within the context of evidence-based behavioral treatments for alcohol use disorders.  Mechanisms of behavior change refer to the underlying psychological, social, and neurophysiological processes through which therapeutic change occurs.  These processes include, but are not limited to, factors such as client expectancies, therapeutic alliance, therapist empathy, therapeutic ritual, and mastery and attributions of outcome. Treatment is defined to include established behavioral interventions delivered by trained professionals in traditional face-to-face sessions or by way of print media or the Internet.  Research proposals submitted under this FOA are encouraged to develop pilot projects that directly assess the causal relationship between mechanisms of behavior change and treatment outcome using the recommendations laid out by Kazdin and Nock (2003). 

Another key aim of this FOA is to move beyond mechanism of behavior change studies that focus on statistical mediation alone.  Non-experimental studies of mechanisms of behavior change (e.g., secondary analyses of extant data sets, naturalistic studies of behavior change) are eligible.  However, applicants must clearly demonstrate how these studies will lead to future explicit tests of the causal relationship between a potential mechanism of behavior change and treatment outcome.  Studies using statistical mediation alone are not considered responsive to this FOA.

An additional aim of this FOA is methods development in the study of mechanisms of behavior change.  In particular, feasibility studies of new and innovative measurement tools for assessing ongoing changes in the context of treatment are encouraged.  A final aim of this FOA is to encourage collaborations between experts in the treatment of alcohol use disorders and the larger psychotherapy research community.

The following topics are relevant examples for the development of R21 grant applications in response to this FOA.  These examples are not meant to be all-inclusive.  Innovative ideas and concepts are highly encouraged. 

•           Identify potential mechanisms of behavior change using secondary analyses of existing data sets (including audio and video tapes of therapy sessions) and/or naturalistic studies of the process of change in the context of treatment for alcohol use disorders, in order to design more explanatory research projects.

•           Test the causal relationship between mechanisms of behavior change and treatment outcome.  These experiments can be carried out in the context of a clinical trial or in human laboratory settings.  Research designs developed to conduct these experiments should follow the recommendations of Kazdin and Nock (2003).

•               Investigate the social and environmental context of behavior change before, during, and after treatment for alcohol use disorders.

•           Describe and test the psychological, social, and neurobiological processes that lead to a decision to change behavior and to seek professional as well as informal sources of help for alcohol use disorders.

•           Develop innovative methods for capturing and testing mechanisms of behavior change.  One promising avenue of research is the use of Ecological Momentary Assessment.  This method, which uses personal data assistants to collect data, could assess changes in cognitive processes (e.g., decision making tasks or implicit memory tasks related to cognitions about drugs) on a moment to moment basis as an individual progresses through treatment.  Life vests containing an apparatus to measure physiological responses could also be used to monitor emotional changes during the treatment process. 

References

Baron RM, Kenny DA (1986) The moderator-mediator distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol 51:1173-1182.

Bates ME, Bowden SC, Barry D (2002) Neurocognitive impairment associated with alcohol use disorders: implications for treatment. Exp Clin Psychopharmacol 10:193-212.

Bien TH, Miller WR, Tonigan JS (1993) Brief interventions for alcohol problems: a review. Addiction 88:315-335.

Connors GJ, DiClemente CC, Dermen KH, Kadden R, Carroll KM, Frone MR (1999) Predicting the therapeutic alliance in alcoholism treatment. J Stud Alcohol 61:139-149.

Dearing RL, Barrick C, Dermen KH, Walitzer KS (2005) Indicators of client engagement: influences on alcohol treatment satisfaction and outcomes. Psychol Addict Behav 19:71-78.

DiClemente CC (2005) Addiction & change: how addictions develop and addicted people recover. Guilford Press substance abuse series, New York, NY, 317 pp.

Grencavage L, Norcross J (1990) Where are the commonalities among the therapeutic common factors? Prof Psychol Res Pr 21:372-378.

Hill AB (1965) The environment and disease: association or causation? Proc R Soc Med 58:295-300.

Hudson JL (2005) Mechanisms of change in cognitive behavioral therapy for anxious youth. Clin Psychol 12:161-165.

Karno MP, Longabaugh R (2005) An examination of how therapist directiveness interacts with patient anger and reactance to predict alcohol use. J Stud Alcohol 66:825-832.

Kaskutas LA, Bond J, Humphreys K (2002) Social networks as mediators on the effect of Alcoholics Anonymous. Addiction 97:891-900.

Kazdin AE, Nock MK (2003) Delineating mechanisms of change in child and adolescent therapy: methodological issues and research recommendations. J Child Psychol Psychiatry 44:1116-1129.

Kelly JF, Myers MG, Brown SA (2000) A multivariate process model of adolescent 12-step attendance and substance use outcome following inpatient treatment. Psychol Addict Behav 14:376-389.

Lambert MJ (2004) Bergin and Garfield’s Handbook of Psychotherapy and Behavior Change, Fifth edition. New York, NY: John Wiley & Sons.

Lambert MJ, Ogles BM (2004) The efficacy and effectiveness of psychotherapy. In Handbook of Psychotherapy and Behavior Change, ed. Lambert MJ, 139-193. New York, NY: John Wiley and Sons.

Longabaugh R, Wirtz P (2001) Causal chain analysis. In Project MATCH Hypotheses: Results and Causal Chain Analyses, eds. Longabaugh R, Wirtz P, 18-29. Bethesda, MD: US Department of Health and Human Services.

Longabaugh R, Donovan DM, Karno MP, McCrady BS, Morgenstern J, Tonigan JS (2005) Active ingredients: how and why evidence-based alcohol behavioral treatment interventions work. Alcohol Clin Exp Res 29:235-247.

Luborsky L (1975) Comparative studies of psychotherapies. Is it true that "everywon has one and all must have prizes"? Arch Gen Psychiatry 32:995-1008.

Magura S, Knight EL, Vogel HS, Mahmood D, Laudet AB, Rosenblum A (2003) Mediators of effectiveness in dual-focus self-help groups. Am J Drug Alcohol Abuse 29:301-322.

McCrady BS, Hayaki J, Epstein EE, Hirsch LS (2002) Testing hypothesized predictors for change in conjoint behavioral alcohol treatment for men. Alcohol Clin Exp Res 26:463-470.

Miller WR, Wilbourne PL (2002) Mesa Grande: a methodological analysis of clinical trials of treatments for alcohol use disorders. Addiction 97:265-277.

Moos RH, Finney JW (1983) The expanding scope of alcoholism treatment evaluation. Am Psychol 38:1036-44.

Morgenstern J, Frey RM, McCrady BS, Lavouvie E, Neighbors CJ (1996) Examining mediators of change in traditional chemical dependency treatment. J Stud Alcohol 57:53-64.

Morgenstern J, Longabaugh R (2000) Cognitive-behavioral treatment for alcohol dependence: a review of evidence for its hypothesized mechanisms of action. Addiction 95:1475-1490.

Moyers TB, Miller WR, Hendrickson ML (in press 2005) How does motivational interviewing work?

Stotts AL, DeLaune KA, Schmitz JM, Grabowski J (2004) Impact of a motivational intervention on mechanisms of change in low-income pregnant smokers. Addict Behav 29:1649-1657.

The Project Match Research Group (1997) Matching alcoholism treatments to client heterogeneity: project MATCH posttreatment drinking outcomes. J Stud Alcohol 58:7-29.

U.S. Department of Health and Human Services, National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism (2001)  Project Match Monograph Series:  Volume 8-Project MATCH Hypotheses: Results and Causal Chain Analyses, 330 pp. NIH Pub No. 01-4238.

Wampold BE (2001) The great psychotherapy debate: models, methods, and findings. Mahwah, NJ: Lawrence Erlbaum Associates.

Wilson GT, Fairburn CC, Agras WS, Walsh BT, Kraemer H (2002) Cognitive-behavioral therapy for bulimia nervosa: time course and mechanisms of change. J Consult Clin Psychol 70:267-274.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the Exploratory/Developmental (R21) grant  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.

Specifically, if you are a U.S. organization and 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). 

U.S. applicants requesting more than $250,000 in annual direct costs and 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.

The R21 will not allow a renewal (competing continuation). 

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 Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project. Direct costs are limited to $275,000 over a two-year period, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period.

The participating organization(s) National Institute on Alcohol Abuse and Alcoholism (NIAAA) intends to commit approximately $3,000,000 dollars in FY2007 to fund 13-15 applications.

NIH grants policies as described in the 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 institution/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 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.

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 a SF424 (R&R) 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 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

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

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 organization/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 301-451-5936.

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 for this FOA through Grants.gov/APPLY.

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 Modular Budget
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/archive/grants/policy/nihgps_2003/index.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) or Section I of the Research Plan in the PHS 398), 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 note 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:  November 2, 2006 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s):December 19, 2006
Application Submission/Receipt Date(s):  January 19, 2007
Peer Review Date(s): February/March 
Council Review Date(s): May  2007
Earliest Anticipated Start Date(s): September 15, 2007
Expiration Date: January 20, 2007

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Abraham Bautista, Ph.D.
Chief, Extramural Project Review Branch, Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
Room 3039
5635 Fishers Lane
Bethesda, MD 20892-9304

Telephone: (301) 443-9737
Fax: (301) 443-6077
Email: bautista@mail.nih.gov

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. 

In order to expedite the review, applicants are requested to notify the NIAAA Referral Office by email (baugista@mail.nih.gov) when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.

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 funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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.”

Research Plan Component Sections

While each section of the 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 better monitor 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.   

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts and with the following requirements for R21 applications:

Appendix Materials

The following materials may be included in the Appendix:

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the relevant policies and procedures may be delayed in the review process.

Appendix materials will not be accepted after the Submission/Receipt Date.

Foreign Applications (Non-domestic (non-U.S.) Entity)

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy expects that grant awardee 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/archive/grants/policy/nihgps_2003/index.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.

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIAAA in accordance with the review criteria stated below.

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 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 critiques, 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. Each of these criteria will be addressed and considered in assigning the 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? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?

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
PD/PIs and other key personnel 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: Do(es) the scientific environment(s) 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(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

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 the “Human Subjects Sections” of the PHS398 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 the “Human Subjects Sections” of the PHS398 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 adequacy of the plans for their care and use will be assessed. See the “Other Research Plan Sections” of the PHS398 Research Plan component of the SF424 (R&R).

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.

Applications from Foreign Organizations: Does 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.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: Does 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

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy expects that grant awardee 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/archive/grants/policy/nihgps_2003/index.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 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.”
 
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

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

An Annual Report is due two months prior to the grant anniversary date. For the awards of this program, there is no specific page limit or format requirement on the progress report at this time; the parameters of the project report will be determined at the 6 month meeting so that certain common elements can be incorporated and so that the information presented across sites will be comparable. The progress reports will include at least the following information: an overview of the major achievements made in the previous year including status on meeting the milestones, and accomplishing the research objectives, outreach development goals, training activities and data collection objectives of the project.

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

Section VII. Agency Contacts


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:

Robert B. Huebner, Ph.D.
Division of Treatment and Recovery Research
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2049
Bethesda, MD 20892-9304
Telephone: (301) 443-1206
Fax: (301) 443-8774
Email: bhuebner@niaaa.nih.gov

2. Peer Review Contacts:

Abraham Bautista, Ph.D.
Chief, Extramural Project Review Branch, Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
Room 3039
5635 Fishers Lane
Bethesda, MD 20892-9304

Telephone: (301) 443-9737
Fax: (301) 443-6077
Email: bautista@mail.nih.gov

3. Financial or Grants Management Contacts:

Judy Fox, Chief
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
Fishers Place, Room 3023
5635 Fishers Lane
Bethesda, MD 20892-9304

Telephone: (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 (45 CFR 46) 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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 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


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