PA-04-027: REDUCING PRETERM & LOW BIRTH WEIGHT IN MINORITY FAMILIES

Department of Health
and Human Services (HHS)

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REDUCING PRETERM & LOW BIRTH WEIGHT IN MINORITY FAMILIES RELEASE DATE: December 1, 2003 PA NUMBER: PA-04-027 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 Grants.gov 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. Other mechanisms relating to this announcement will continue to be accepted using paper PHS 398 applications until the stated expiration date below, or transition to electronic application submission. 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 R21 Non-AIDS Applications: March 2, 2006 EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006 EXPIRATION DATE for All R01 Applications: December 5, 2006, unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov) National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov) National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): No. 93.361, Nursing Research No. 93.865, Center for Research for Mothers and Children No. 93.121, Oral Diseases and Disorders Research 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 Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute of Nursing Research (NINR), National Institute of Child Health and Human Development (NICHD), and the National Institute of Dental and Craniofacial Research (NIDCR) invite applications to encourage collaborative multidisciplinary biobehavioral research that can elucidate the mechanisms underlying disparities in pregnancy outcomes as well as interventions to reduce such disparities. The disparity in pregnancy outcomes among minorities is largely due to preterm delivery (PTD) and low birth weight (LBW), which disproportionately affect these populations. While these problems occur across populations, and there are most likely commonalities among all groups, their greater incidence among minorities makes research with these groups particularly important. This program announcement solicits research to expand our understanding of the underlying mechanisms that contribute to the racial and ethnic variations in PTD and LBW and strategies for prevention. The goals of this program announcement are: (1) to develop innovative strategies to prevent PTD and LBW in minority populations; and, (2) to expand our understanding of how psychosocial and environmental factors affect or interact with the biologic mechanisms that influence pregnancy outcomes. This solicitation strongly encourages multidisciplinary biobehavioral approaches, defined as studies proposed by teams of scientists with the requisite expertise from diverse disciplines (e.g., nursing, medicine, social, behavioral, biological, health sciences, epidemiology) that reflect an integrated framework of social and biologic phenomena. RESEARCH OBJECTIVES Background Preterm delivery or short gestation (birth occurring before 37 weeks of pregnancy), low birth weight (less than 2,500 grams) and very low birth weight (VLBW; less than 1,500 grams), consequences of which can be profound, continue to be major public health concerns. Despite tremendous advances in medicine and a growing body of research on explanatory risk factors for adverse pregnancy outcomes, the gap between whites and nonwhites in pregnancy outcomes has widened. Black infants are more than twice as likely to die as White infants. For example, low birth weight and very low birth weight percent of live births are 13.1 and 3.1 percent, respectively, for Blacks or African Americans, compared to 6.5 and 1.1 percent, respectively, for Whites (Healthly People, 2010). Similarly, rates for American Indians and Alaska natives are approximately 50% higher than rates for White women. Rates for Hispanic women approximate or are slightly higher than rates for White women except for Puerto Ricans whose rates are 50% higher than Whites (Healthy People, 2010). Similarly, with respect to maternal mortality, Black mothers are three times more likely to die than White mothers. In a recent study on pregnancy related mortality from pre-eclampsia and eclampsia, it was reported that Black women were 3.1 times more likely to die from pre-eclampsia or eclampsia than White women. Women who had received no prenatal care had a higher risk of death from pre-eclampsia or eclampsia than women who had received any level of prenatal care. The overall pre-eclampsia/eclampsia case-fatality rate was 6.4 per 10,000 cases at delivery, and the rate was twice as high for Black women as for White women. It is well known that much of the disparity of preterm delivery and low birth weight is associated with racial and ethnic groups living under the burden of sub-optimal social, economic and health conditions. However, poverty, race and ethnicity are not the only contributing factors and, in and of themselves, do not explain the disparities in pregnancy outcomes between Whites and non-Whites. Hypotheses centering on prenatal care, health behaviors, teen births, poverty, education and genetics have not sufficiently explained the causes of PTD and LBW, nor the disparities in outcomes. The complexity of the issue is evidenced by the known variation within racial and ethnic groups. There may be a simple difference in "dose" of the experience or exposure to certain risk factors that leads to the poor outcome or it may be that a combination of common and uncommon experiences in one individual culminates in a poor outcome. There may also be an intergenerational effect of these experiences and associated risks factors and fetal exposures to these factors may trigger this risk in the next generation. There is most probably a convergence of factors but these hypotheses need to be tested. Increasingly, social stress has become the focus of much research and, at the same time, it has become apparent that it is important to understand the context, especially the neighborhood context, in which women at risk for poor pregnancy outcomes live their lives. Maternal psychosocial stress, including the stress of infection, and racially based discrimination, can be linked to biological mechanisms that are associated with PTD. Maternal stress may affect PTD via neuroendocrine, immune/inflammatory and vascular pathways. Stress appears to decrease immunity thereby leaving the host susceptible to infection. Stress-induced changes may be caused, at least in part, via physiological mechanisms involving the autonomic nervous system and the hypothalamic-pituitary-adrenal (HPA) axis. If the stress activation is chronic it can then result in allostatic load or the inability to achieve stability in the face of stress. Elements of weathering such as poverty, racism and family functioning can lead to vulnerability prior to conception via alterations in HPA reactivity and degradation of the immune response and to risk factors for PTD such as elevations in corticotrophin-releasing hormone (CRH), hypertension, pre-eclampsia, and inflammatory responses that are associated with PTD/LBW. Clearly more research is needed on PTD and LBW as the outcomes of chronic exposure to stressors prior to pregnancy. Stresses in the environment vary by ethnic background and the degree of acculturation. Potential buffers like hardiness, resilience and social support systems may mitigate some of the effects of stress. In order to develop effective interventions the mutability of risk factors needs to be understood. Interventions such as increased social support and other means of increasing the resistance of the host to the insult are important and may require collaboration with basic scientists to understand what is immutable. Additionally, when measuring stress, it is necessary to differentiate between stressors and stress responses. Another area of maternal-fetal interaction receiving much attention is inflammation. One hypothesis is that immune hyper-responsiveness in pregnancy can lead to inflammation and contribute to adverse pregnancy outcomes. In the presence of a hyper-inflammatory response the mother may avoid death via sepsis by delivering the baby early. There may be a genetic susceptibility to maternal hyper-responsiveness carried by the mother. Additionally, women with Syndrome X (also termed "metabolic syndrome" and defined as a clustering of heart disease risk factors in some people including central obesity, glucose intolerance, hyperlipidemia and high blood pressure), molar pregnancy or HIV positive women not taking anti-viral medications may be more at risk for pre- eclampsia. It is interesting to note that in perinatal and neonatal mortality cases there is a higher rate of infection seen among minority populations. Infection appears to trigger premature rupture of membrane and morbidity, however, PTD may occur at various levels of bacterial burden and may be influenced by cytokine polymorphisms. Infection is only part of the problem, however, and requires further study as evidenced by the finding that when placentas are examined post delivery, a relatively high proportion of the cases have pathologies that are vascular in origin, not the result of infections. PTD and LBW contribute substantially to both infant mortality and to childhood physical impairment. Recent evidence suggests that these impairments persist well into adulthood. Although infant mortality in the United States has declined steadily over the past several decades and is at a record low of 7.2 per 1,000 live births, the United States still ranks 25th in infant mortality compared with other industrialized nations, largely due to its high PTD and LBW rates. The strong association between LBW and preterm delivery places LBW children at risk for neurosensory, developmental, physical, and psychological problems. Cerebral palsy is a major neurologic abnormality in LBW occurring much more commonly in LBW infants than their normal weight peers. Additionally, LBW children are at risk for lower scores on intelligence tests and developmental delay. As a group, LBW children experience more health problems, such as asthma, upper and lower respiratory infections and ear infections. A decade ago, the costs associated with LBW were estimated at more than $5.4 billion, with 75% of these costs due to infant care. Approximately 10% of annual health care expenditures for children result from LBW-related problems. As the rate of low birth weight rate increases among minority families, associated costs will increase as well. Although the exact causes of PTD and LBW are not known, associations with modifiable causes have been demonstrated in the literature but the underlying biologic mechanisms are poorly understood. These include genital tract and oral microbial infections and inflammation, poverty, social support, stress and its correlates, housing (i.e., physical environment such as lead paint, safety, crowding, pollution), community resources, toxic habits including smoking, alcohol use during pregnancy and risky behaviors and exposure to violence. To date, interventions directed toward these risk factors have not been effective in reducing disparities associated with PTD and LBW. More research is needed on health behaviors including smoking, nutrition, eating patterns and exercise. Some women report that smoking helps reduce stress but smoking exposes them to cadmium and benzopyrene, which can have toxic effects. Similarly, the effects of fasting on CRH levels are not known and further research is needed on the role of micronutrients and vitamins. Minority women are more likely to have high fat, low protein diets and little exercise. They may have less social support, including childcare, to enable them to take time from parenting to exercise. A group oriented, community supported form of exercise might be a solution. Women of color are more likely to experience unwanted pregnancies that lead to not taking proper care of their health. As such, there is still much to be gleaned from studies investigating the impact of behavioral influences on maternal health as it relates to disparities in pregnancy outcomes. Finally, the impact of cultural beliefs and practices on disparities in pregnancy outcome is poorly understood. Although information on the nature of these practices exists, knowledge of the mechanisms of action on pregnancy outcome is sparse. Disentangling the underlying psychosocial and biologic mechanisms responsible for racial and ethnic variations in LBW and preterm delivery and eliminating or significantly reducing this variation is an ongoing challenge to research in this area. While race and ethnicity are clearly implicated, caution has been urged in defining and using race as a variable, rather than as a process. There may be a case for a relationship between health outcomes and genes with no strong evidence to link the outcome to race. A unifying paradigm to study minority women at risk of PTD or LBW takes into account the environment, socio-cultural experiences or exposures, lifestyle, maternal- fetal interactions, physiologic responses and weathering. Research Scope The National Institute of Nursing Research (NINR), National Institutes of Health (NIH), convened the workgroup Optimizing Pregnancy Outcomes in Minority Populations on March 3-4, 2003 in Bethesda, Maryland. This workgroup brought together researchers in the fields of nursing, epidemiology, psychology, and clinical and basic sciences in a collaborative, multi-disciplinary approach to address this issue and formulate future research strategies. In addition, each of the sponsors of this PA has a strategic plan, which addresses research related to minority health and health disparities. This is located on their websites. For purposes of this initiative, the definitions of health disparities and minority populations are those outlined in the NINR’s Strategic Plan on Reducing Health Disparities located at http://www.ninr.nih.gov. Health disparities are defined as differences in the incidence, prevalence, mortality, and burden of diseases and other adverse health conditions that exist among specific population groups in the US. Specific population groups are identified as African American, Asian and Asian Pacific Islander, Hispanic and Latino, American Indian and Alaska Native. These groups are the target populations for this announcement. Clinical and basic research applications that address questions pertaining to the goals of this PA are appropriate. The following are offered as illustrations of topics that would be appropriate for this PA. Applications need not, however, be limited to these specific topics: o Interventions targeting underlying health problems among minorities, e.g., anemia, hypertension, diabetes, infections and their relationship to disparities in birth outcomes. o Investigations to further identify specific stressors and associated mechanisms related to the weathering hypothesis (e.g., poverty, racism, family functioning), including quantifying weathering and its link to pregnancy outcomes. o Interventions targeting specific physiologic pathways and biochemical markers known to be associated with poor pregnancy outcomes, including serial measurements to ascertain critical time periods. o Studies focused on the relationship of stressors and stress response, pre- eclampsia, CRH, and cytokine polymorphisms in PTD and LBW. o Investigations representing collaborations among diverse disciplines (e.g., basic, clinical and social scientists) focused on delineating risk and protective factors and biological pathways utilizing interdisciplinary theoretical and methodological approaches (e.g., What risk factors for poor pregnancy outcomes are mutable? How are biologic phenomena impacted? What are the biologic markers of risk?) o Studies focused on acute and chronic stress, with special attention to measures of stressors and stress responses including the role of antecedent and concurrent environmental exposures as risk factors for pregnancy outcomes (e.g., Are there familial patterns or patterns of acquired risk? Are all stressors associated with some biologic phenomena? How are additive and interactive effects linked with PTD and LBW?) o Investigations to explore the relationship between metabolic syndrome and allostatic load, in response to the stress of internalized racism, and its impact on PTD and LBW. o Studies to identify biomarkers in the fetus, mother, cord, and placenta associated with disparities in pregnancy outcomes. o Studies focused on gene/environment interactions (e.g., studies to isolate the genetic components of hardiness/resilience in subgroups within specific ethnic groups). o Investigations to examine the role of nutrition and its impact on disparities in pregnancy outcomes (e.g., fasting and its impact on CRH levels; the role of micronutrients; the effects of culture on diet patterns and physical activity.) o Development and testing of interventions, including the effectiveness of social supports, home visitation, and other approaches that mediate adverse psychological, social, and environmental effects, and improve or prevent microbial infections and inflammation. o Interventions to test the impact of culturally competent preconception and prenatal care, access to care and linkages with public health and social services, on pregnancy outcomes. o Investigation of the role of environmental and occupational factors (i.e., exposure to chemicals in the home and work environment, indoor and outdoor air pollution, contaminants in the food supply) on disparities in pregnancy outcomes. o Investigation into the diagnosis, mechanisms and treatment of intrauterine growth restriction. o Studies focused on new or novel methodologies, conceptual models, data analytic approaches, or the development and testing of culturally sensitive instruments to capture psychosocial and biologic influences resulting in disparities in PTD and LBW (e.g., lifestyle exposure, sociocultural factors, risk factors associated with weathering, data mining techniques). MECHANISMS OF SUPPORT This PA will use the NIH R01 and R21 award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The objective of the R01 mechanism is to support a discrete, specified circumscribed project. Investigators are encouraged to explore the feasibility of an innovative research question or approach that will provide a basis for future research projects. Exploratory/developmental grants (R21) are limited to 2 years of support with a combined budget for direct costs of up $275,000 for the two-year period. For example, the applicant may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of the project. Normally, no more than $200,000 may be requested in any single year. Please see the NIH-wide R21 program announcement (PA-03-107) (see http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html). Please see the "Submitting an Application" section for more details. This PA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format. Otherwise follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. 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. SPECIAL REQUIREMENTS Data and safety monitoring is required for all types of clinical trials. The establishment of data and safety monitoring boards (DSMBs) is required for clinical trials involving interventions that entail potential risk to the participants. Starting with the October 1, 2003 receipt date, 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. 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: Yvonne Bryan, PhD Program Director National Institutes of Health Office of Extramural Programs National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-6908 Fax: (301) 480-8260 Email: bryany@mail.nih.gov John V. Ilekis, PhD Health Scientist Administrator National Institutes of Health National Institute of Child Health and Human Development Center for Developmental Biology and Perinatal Medicine Pregnancy and Perinatology Branch 6100 Executive Blvd, Room 4B03C, MCS 7510 Bethesda, MD 20892-7510 Telephone: 301-435-6895 Fax: 301-496-3790 Email: ilekisj@mail.nih.gov Richard L. Mowery, Ph.D. Chief, Clinical, Epidemiology and Behavioral Research Branch Division of Population and Health Promotion Sciences National Institute of Dental and Craniofacial Research Building 45, Room 4AS-43F 45 Center Drive, MSC 6401 Bethesda, MD 20892-6401 Telephone: (301) 594-4848 Fax: (301) 480-8322 Email: Richard.Mowery@nih.gov o Direct your questions about financial or grants management matters to: Lawrence Haller Office of Grants and Contracts Management NIH, National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 402-1878 FAX: (301) 451-5652 Email: HALLERL@mail.nih.gov 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 http://www.dunandbradstreet.com/ The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact Grants Info, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. The title and number of this PA must be typed on line 2 of the application form and the YES box must be checked. SUPPLEMENTARY INSTRUCTIONS When submitting an R21 application, all instructions for the PHS 398 (rev. 5/2001) must be followed, with these exceptions: o Research Plan Items a - d of the Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed a total of 15 pages. No preliminary data is required but may be included if it is available. Please note that a Progress Report is not needed; competing continuation applications for an exploratory/developmental grant will not be accepted. Appendix. Use the instructions for the appendix detailed in the PHS 398 except that no more than 5 manuscripts, previously accepted for publication, may be included. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR 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 http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an 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 (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o 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 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 the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: The NIH R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools or technologies that have the potential to significantly advance our knowledge or the status of health- related research. Because the research plan is limited to 15 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications. 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). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 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 $500,000 or more 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. The Final NIH Statement on Sharing Research data is found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 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: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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. http://grants.nih.gov/grants/policy/data_sharing 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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, 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. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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