BASIC AND TRANSLATIONAL RESEARCH IN EMOTION RELEASE DATE: September 4, 2003 PA NUMBER: PA-03-169 March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through using the electronic SF424 (R&R) application. This announcement will stay active for only the May 1, 2006 AIDS and AIDS-related application submission date for these mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms expires on the date indicated below. The R01 portion of this announcement has been replaced by PA-06-380. Parent R03 (PA-06-180) and R21 (PA-06-181) funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates for AIDS and non-AIDS applications thereafter. Applications relating to R33 and R34 activities must be in response to NIH Institute/Center (IC)-specific announcements. EXPIRATION DATE for R03 Non-AIDS Applications: March 2, 2006 EXPIRATION DATE for R03 AIDS and AIDS-Related Applications: May 2, 2006 EXPIRATION DATE for All R01 Applications: May 2, 2006 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS National Institutes of Health (NIH) ( COMPONENTS OF PARTICIPATING ORGANIZATIONS National Institute of Mental Health (NIMH) ( National Institute on Aging (NIA) ( National Institute on Alcohol Abuse and Alcoholism (NIAAA) ( National Cancer Institute (NCI) ( National Institute of Child Health and Human Development (NICHD) ( National Institute on Drug Abuse (NIDA) ( National Institute of Neurological Disorders and Stroke (NINDS) ( CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.242 (NIMH), 93.866 (NIA), 93.273 (NIAAA), 93.399(NCI), 93.865 (NICHD), 93.279 (NIDA), and 93.853 (NINDS) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This Program Announcement (PA) replaces PA-00-105 and PA-00-106. Under this PA, the National Institute of Mental Health, National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Cancer Institute, National Institute of Child Health and Human Development, National Institute on Drug Abuse, and the National Institute of Neurological Disorders and Stroke invite research grant applications to expand basic and translational research on the processes and mechanisms involved in the experience and expression of emotion. RESEARCH OBJECTIVES The study of emotion encompasses a wide range of psychological, social, cognitive, developmental, and biological phenomena. Central and peripheral nervous system (CNS, PNS) activity in the origins, expression, regulation and modulation of emotion are important objects of study, as is the contribution of emotional and motivational systems to cognitive faculties such as perception, attention, learning, memory, and motor control. The study of emotion includes investigations of overt behaviors (such as aggression or withdrawal), interpersonal relationships, communication and decision making, and the environmental circumstances and experiences that shape and elicit emotions. Emotion research can also include the study of licit and illicit psychoactive substances that alter mood states, and conversely, the study of how emotional and mood states can predispose to, or modulate the effects of, pain or alcohol and psychoactive substances. This PA also encourages research on emotional reactions in the context of the diagnosis and treatment of cancer, and the study of emotion as it relates to this disease or increased risk of this disease, including outcomes such as social relationships, health care provider relationships, adherence and others. These investigations may use human or other animals. Recent years have shown the rapid expansion of concepts and methods for studying emotion in all of its aspects. Outlined in this program announcement are current needs that stem from these advances and that constitute critical components of a comprehensive basic research strategy, with the ultimate aim of fostering mental and physical health and the understanding of human development and aging. Sample research questions are provided for illustration; they are not intended to be exhaustive. Basic Mechanisms of Emotion The study of emotion may involve measurements in a number of different response systems (e.g., neural, physiological, behavioral). To foster the rapid and orderly accumulation of knowledge, it is important that multiple system measurements be conducted whenever possible. Interactions of emotion with cognition also constitute an important area of study. For example, a more detailed understanding is needed of the interplay between emotion and cognition that can inform conceptualizations of disorders in which impairments of both emotion and cognition are apparent (e.g., schizophrenia, depression, alcohol and drug dependence, Alzheimer's Disease, autism), as well as provide data important for promoting good cognitive functioning and emotional self- regulation. In addition, the interplay between emotion and cognition may be studied in the context of risk perception and decision-making, for example, as this interplay applies to treatment and screening among cancer patients or individuals at increased risk of cancer, drug abuse and other health risking behaviors (e.g., violence or sexual risk-taking), and in the context of financial and medical decision-making by older adults. Sample research questions include the following: o What are the relationships among behavioral, physiological, and neural aspects of emotion? What are the circumstances under which these various systems act in concert, and what is the significance of various patterns of desynchrony? What is the developmental time course of these components? What are the biological or psychological consequences of the inhibition of one or more components? o A number of different emotion theories posit some number of discrete emotions. Other theories approach the domain as two, three or more dimensions of emotional response. How are these two approaches related, and can they be reconciled in a comprehensive theory of emotion? o What are the basic mechanisms by which emotions are acquired or otherwise shaped by the physiological and social contexts in which they occur? What are the roles of parents, peers, siblings, teachers, care providers, and the media in socializing emotion? How do these socialization processes interact with physiological and neural aspects of emotion? o What are the continuities across, and distinctions among, the phenomena of emotion, mood, temperament, emotional trait, and emotional disorder? What social, psychological, environmental, and biological factors mediate or modulate their interrelationships? How do these interrelationships change with age? How do these phenomena interact in order to contribute to psychological adjustment, normal psychological and biological development, treatment and screening adherence, and quality of life among individuals with physical or mental illness or those at risk for illness? o What are the potential mechanisms by which sensation and perception interact with emotion; and how do these interactions result in behavior? In turn, how are interactions between sensation, perception, and emotion modulated in the experience of pain, in learning and memory, and in cognitive and social development? o How do attention, memory and perceived threat act to sustain or interrupt emotional states? In turn, how do emotions serve to modulate or drive mechanisms of attention, memory, and threat perception? Emotional Processes in Mental Health, Substance Abuse, Developmental Disorders, and Physical Disease The study of emotional processes in disorders is similar in some aspects to research on basic mechanisms of emotion, and different in other aspects. Impairments of emotion found in psychopathology and developmental disorders may differ in either qualitative or quantitative ways from normal emotional processes. Emotional reactions may interact with the course of disease processes to alter the course of disorder and these influences may be subject to modification by alcohol or drugs of abuse. Examples of relevant issues include the following: o What are the continuities and discontinuities between normative emotional processes (e.g., emotional development, expression, understanding, awareness, communication, resilience) and emotional processes seen in psychopathology, developmental disorders, health risk behaviors including alcohol or drug abuse, or other developmental problems (e.g., insecure attachment, aggressive behaviors, extreme shyness, or difficulties in social relationships)? o To what extent can behavioral, physiological, and neural measures of emotion identify individuals at risk for suicidal, violent, or self-injurious behavior, or alcohol/drug abuse, within the context of preventive interventions? o Do individual differences in emotional reactivity and regulation, including responses to stress or trauma, produce differential vulnerabilities to mental or developmental disorders, including alcohol and/or drug dependence? Conversely, does alcohol/drug use or dependence produce changes in emotional reactivity? How do stimuli associated with alcohol or drug use become triggers of emotional and subjective states that may lead to relapse? o Among cancer patients or people at increased risk for cancer, how do individual differences in emotional processes relate to fatigue, resumption of activities of daily living, adherence to treatment, cancer screening behaviors, family relationships, and patient-health care provider relationships? What is the role of emotional processes in decision making related to cancer prevention, detection or treatment? Do individual differences in emotional reactivity associated with neural, immunological, or other biological pathways influence cancer? o How can individuals be trained to best identify and regulate emotions and mood states that may represent a possible risk for relapse of physical or mental illness? Does focusing on such emotions/moods help prevent relapse, or actually increase risk for relapse? o How do cognitive changes associated with late aging modify the expression of emotion and its underlying processes in older individuals? Individual Differences Research is suggesting that individual differences in emotional responsivity may mark specific vulnerabilities to mental disorder, including alcohol or drug dependence. A detailed examination of these individual differences is critical for understanding the etiology of various disorders and for designing prevention efforts. In-depth study is needed of the determinants, consequences, and sequelae of infant temperament. Research in adult personality variation also is beginning to examine individual differences in emotional responsivity, with some indications of connections to physiology. Sample research questions include the following: o What are the biological (including genetic) and experiential sources of individual differences in emotional reactivity and regulation throughout development? How do biological and experiential influences combine and interact in influencing outcomes? How do these change with age? o How do individual differences in emotionality relate to phenomena such as activity level, attention, and cognitive processes? What are the neural substrates of the relationships among such phenomena, and how do these relationships maintain or change over time? o Among children with developmental and learning problems or disabilities or childhood illness, how are individual differences in emotional processes related to functioning over time? What developmental and/or learning disabilities or other pediatric problems interact with the development of emotional regulation and reactivity over time? New approaches that integrate quantitative and qualitative methods are needed to investigate the study of emotion and learning/ learning disabilities in order to study these interactions. o What are the specific emotional and behavioral differences in individuals with mental retardation and how do these differ from the general population? New techniques are needed to assess the impact of psychosocial stressors in the lives of people with mental retardation and developmental disabilities and to integrate this knowledge with diagnostic protocols, treatment strategies and service systems. o What biological, developmental, social, personality, and cognitive factors interact with emotion-based individual differences to contribute to psychopathology, health risk behaviors, drug use, and other developmental problems or disorders? o How do emotions get attached to attitudes, stereotypes, and identity? How do these influence health, illness, adherence to medical regimens, and recovery? Developmental Aspects Data are accumulating rapidly in areas such as children's understanding and experience of emotions, and in emotional communications occurring between parents and children beginning in the earliest weeks of life. The import of findings related to the development of emotions would be well served by an overarching theoretical framework specifying the ontogeny of emotion. Also, the primary concentration to date on the early years of life needs to be broadened to include focused attention on early and middle childhood, adolescence, adulthood, and old age. Sample research questions include the following: o Are connections among the various components of emotions present at birth? Do these change with age, particularly during periods of transition (e.g., the transition to school, adolescence)? How do changes in bodily systems with age affect the nature and intensity of emotional responses and the interrelationships among these response systems? Do some changes predispose toward psychopathology or drug abuse in older individuals? o What are the determinants, age-specific characteristics, and consequences of emotional attachments across the lifespan? What are the parallels among attachment patterns in infancy, in childhood, in adolescence, in adulthood, in old age? o How do cognitive factors (e.g., intelligence, learning disabilities) influence the development of emotional processes over the lifespan? o What affective processes are particularly germane to coping with events in the family life cycle (e.g., marriage, divorce, birth, transition to parenthood, aging, retirement, grandparenting, dealing with death and bereavement, coping with substance use of family members)? o What are the developmental psychobiological contributions of stress and other environmental influences (e.g., trauma, violence) on emotional development and expression? o What is the role of emotion in brain development over the life course and what are the relevant mechanisms? How might emotions affect the endocrine, immune and neural systems that change over the course of development and aging? Does prenatal exposure to alcohol or abused drugs or use of abused drugs in adolescence affect emotional development? Conversely, are children with disorders of emotional regulation more vulnerable to becoming drug dependent? Does sleep deprivation affect emotion regulation, and if so, how? Social Aspects The quality of interpersonal relationships can be a significant source of both positive and negative emotions. Further, social relationships play a substantial role in the modulation of emotional responses, however generated. Social factors thus make a critical contribution to an understanding of the risks for mental disorders, alcohol/drug dependence, and other developmental problems. In addition to the need for further research on these interpersonal aspects of emotion, it is very important to examine the macro-environmental processes (e.g., culture, social structure, the media) that help to shape emotional development and adjustment. Sample research questions include the following: o How do cultural and socialization processes influence the experience and expression of emotion? How do salient social factors and contexts (e.g., child care and school settings, media, exposure to violence) in particular developmental stages shape affective development and expression? o What are the dynamics of emotional communications occurring within families and other intimate groups and how do they relate to the development, maintenance, or erosion of emotional bonds? How do variations in social sharing of emotions lead to differences in psychopathology, therapeutic approaches, and potential health outcomes? How can these variables be best modeled preclincally? How are these patterns altered by drug dependence? Among cancer patients and their significant others, what are the short- and long-term consequences of patterns of emotional communication on social relationships and psychological adjustment? o How do variations in parenting style and behaviors (e.g., teaching, limit- setting) influence the development of affect regulation in children? How does child abuse or neglect (resulting from psychopathology, alcohol or drug addiction or other causes) influence emotional development in children? o How does caregiver behavior influence affect regulation in persons with mental disorders or drug abuse in late life, including Alzheimer's Disease? o How do the emotions involved with social relationships affect life in the community for severely disordered or disabled individuals, and how do these emotions interact with the characteristics of the disorder to affect its course? o What role does the process of social comparison play in the emotional response to cancer and to aging, what are some potential mechanisms explaining the direction of the social comparison process across individuals, and how might these processes be influenced by other social or non-social mechanisms? Biological Aspects The study of emotion provides a valuable opportunity for examination of the interplay between psychological, physiological, and neural processes, and methods are increasingly becoming available for examining the neural substrates of emotion. Sample research questions include the following: o What are the bi-directional influences between emotional states or emotional traits (e.g., temperament) and neurobiological, endocrine and immune systems? Among cancer patients, how might these influences on biology influence health status or treatment (side effects, ability to tolerate treatment)? o What are the neuroanatomical circuits and neurochemical processes involved in emotional states and emotion-based individual differences? How do these systems evolve over the lifespan and how are they influenced by drugs of abuse? To what extent do these neural processes overlap with those associated with psychopathology and substance use disorders such as alcohol or drug addiction? o How can neuroimaging and large-array electrophysiological techniques best be used to study brain areas that are active during different emotional states and in pain perception? What is the relationship of observed CNS or PNS activity to other responses in emotion, including alcohol/drug-induced or alcohol/drug withdrawal- or craving-induced changes in emotion? o How does the aging process, either in association with age-associated neurogenerative disease processes or without disease, affect the emotion-based networks within the brain and those that interact with the endocrine system? Methodological Needs Methods related to the study of emotion run the full range, from self-report and interview procedures, to behavioral observations and more direct assessments of behavior, and to measures of PNS and CNS structure and function. Improvements are needed in ways that enhance the validity and efficiency of measurement without sacrificing richness and detail. In research on physical illness such as cancer, methodology also is needed that takes into account the reports of others in the patient's social and medical environment, and reports that are sensitive to the changes in emotional responsiveness over time. Sample needs include the following: o Most research on emotional expression concentrates on the face. Methods also are needed to assess vocal, postural, and gestural components of emotional expression. Further, measures of emotion need to be developed that can be applied across settings, cultures, cohorts, and species. o Techniques of computer science, neural networks, and image processing need to be applied to the task of producing valid and reliable judgments of facial and other behavioral expressions of emotion. o Computational models and other quantitative expressions of theories of emotions need to be developed. o Expanded and improved neuroimaging techniques are needed to examine CNS activity in emotional responding. Further research is needed on the methodological and conceptual relationships among techniques with different spatial and temporal resolution. o Animal models need to be used to their fullest potential to examine social, cognitive, and biological determinants and consequences of emotion. o Advanced and ethically-guided human laboratory procedures for inducing positive and negative emotional states are needed. MECHANISM(S) OF SUPPORT This PA will use the NIH Research Project Grant (R01) and Small Grant Program (R03) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total project period for an R01 application submitted in response to this PA may not exceed five years. The Small Grant (R03) provides two years of funding with a maximum of $50,000 direct costs for each year. Instructions for the R03 application can be found at This PA uses just-in-time concepts. It also uses the modular budgeting format. (see Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format. Otherwise follow the instructions for non-modular budget grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign institutions/organizations o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Susan E. Brandon, Ph.D. Affect and Biobehavioral Regulation Research Program National Institute of Mental Health 6001 Executive Boulevard, Room 7218, MSC 9651 Bethesda, MD 20892-9651 Telephone: (301) 443 4863 FAX: (301) 443 9876 Email: Jeffrey W. Elias, Ph.D. National Institute on Aging 7201 Wisconsin Avenue, Room 533 Bethesda, MD 20892 Telephone: (301) 496-3136 FAX: (301) 402-0051 Email: Ellen Witt, Ph.D. Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-6545 FAX: (301) 594-0673 Email: Wendy Nelson, Ph.D. Behavioral Research Program National Cancer Institute 6130 Executive Boulevard, Room 211, MSC 7326 Bethesda, MD 20892-7326 Telephone: (301) 435-4590 FAX: (301) 435-7547 Email: Margaret Feerick, Ph.D. Child Development and Behavior Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, 4B05, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6882 FAX: (301) 480-0230 Email: Allison Chausmer, Ph.D. National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 301-402-5088 FAX: (301) 594-6849 Email: Emmeline Edwards, Ph.D. National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Room 2109, MSC 9521 Bethesda, MD 20892-9521 Telephone: (301) 496-9964 FAX: (301_ 402-2060 Email: o Direct your questions about financial or grants management matters to: Carol J. Robinson Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6118, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-3858 FAX: (301) 443-6885 Email: Traci Lafferty Grants Management Specialist National Institute on Aging 7201 Wisconsin Avenue, Room 2N-212 Bethesda, MD 20892 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: Judy Fox Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 504, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4704 FAX: (301) 443-3891 Email: Crystal Wolfrey Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243, MSC 7150 Bethesda, MD 20892-7150 Telephone: (301) 496-8634 FAX: (301) 496-8601 Email: Dianna Bailey Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A07E, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6978 FAX: (301) 402-0915 Email: Gary Fleming Grants Management National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6849 Email: Aaron Kinchen Grants Management Specialist National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Room 3271 Bethesda, MD 20892-9537 Telephone: (301)496-7386 FAX: (301) 402-0219 Email: SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget grant format. The modular budget grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures ( will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the appropriate national advisory council or board REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment Your 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, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. BUDGET: The reasonableness of the proposed budget and the requested period of Support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking more than $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 ( Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (; a complete copy of the updated Guidelines are available at The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website ( 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 URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at 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.

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