and Human Services (HHS)
EXPIRED
MENTAL RETARDATION AND DEVELOPMENTAL DISABILITIES RESEARCH CENTERS RELEASE DATE: September 3, 2004 RFA NUMBER: RFA-HD-04-024 (This RFA has been reissued, see RFA-HD-05-030) EXPIRATION DATE: December 22, 2004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.865 LETTER OF INTENT RECEIPT DATE: November 21, 2004 APPLICATION RECEIPT DATE: December 21, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute of Child Health and Human Development (NICHD), through the Mental Retardation and Developmental Disabilities (MRDD) Branch, Center for Developmental Biology and Perinatal Medicine (CDBPM), invites Center Core Grant (P30) applications to advance diagnosis, prevention, treatment, and amelioration of mental retardation and developmental disabilities. This Request for Applications (RFA) seeks applications from institutions that meet the qualifications for a program of MRDD research. The primary objective of the NICHD Mental Retardation and Developmental Disabilities Research Centers (MRDDRC) Program is to provide core support and facilities for cohesive, interdisciplinary research and research training. Funds for the research projects using these core facilities come from independent sources including Federal, State, and private organizations. RESEARCH OBJECTIVES Background For more than 35 years, NICHD has provided support for MRDDRCs through Center Core grants (P30) that facilitate program coordination and support central research facilities, administration, and development of a limited number of new research programs. A major goal of the NICHD MRDDRC Program is to support research that leads to prevention and/or amelioration of MRDD. The degree of impairment associated with MRDD varies with the cause. Moderate and more severe MRDD often results from problems that produce profound alterations in brain development and/or function. Diminished intellectual and adaptive capacity often can be traced to defective genes, teratogenic agents, toxic substances, infections, nutritional deficits, accidents, maternal conditions, and other factors causing brain damage. A larger proportion of cases of MRDD is related to environmental or social conditions and disorders of unknown etiology. Several MRDD syndromes have been identified and new ones are being discovered. Each requires fundamental research into the underlying processes, as well as studies designed to meet the unique needs of the affected children. Therefore, one of the missions of the MRDD Branch is to support research on the etiology, pathophysiology, epidemiology, diagnosis and evaluation, prevention, and treatment or amelioration of MRDD. Research conducted in the MRDDRCs will cover a broad spectrum of scientific approaches ranging from laboratory research on fundamental processes of normal and abnormal development to clinical and behavioral research in which persons with MRDD are studied. It is thought that major solutions to the problems of MRDD may emerge from multidisciplinary, collaborative, and integrated approaches involving biomedical, behavioral, and biobehavioral sciences in the MRDDRCs. Thus, NICHD encourages cooperation among the Centers, including their integration into a network. Administrative and scientific organization within a Center and across the network of MRDDRCs should enhance opportunities for breakthroughs. Research Scope The intent of MRDDRC Center Core Grants is to bring together scientists from a variety of disciplines to work within a Center on the common problems of MRDD. NICHD strongly encourages translation of basic research observations into patient-oriented protocols whose ultimate aims are to validate the mechanistic basis of MRDD in humans and to develop new approaches for the prevention, diagnosis, and treatment of MRDD. Consequently, applications for MRDDRC Center Core Grants (P30) should include investigators studying a range of topics in basic and clinical or applied research. NICHD encourages, but does not require, applicants to include both biomedical and behavioral components among the topics addressed within their Center. Center grant applications must include among these topics at least five of the following, focused specifically on MRDD. This list of topics is not comprehensive, nor are the examples exhaustive. 1. Developmental and neurobiological studies to define the molecular and cellular bases of MRDD and to facilitate development of specific hypotheses about basic abnormalities that underlie these conditions. 2. Studies of cellular and molecular aspects of brain development: differentiation, synapse formation and modification, plasticity, trophic factors, and neurotransmitter function and modulation. 3. Applied clinical and experimental studies of inborn errors of metabolism relevant to MRDD that involve pathophysiology of cellular and subcellular organelles. 4. Development of novel and innovative technologies for pre- and post-natal diagnosis of common and rare causes of MRDD; investigation and therapy of conditions associated with MRDD. 5. Studies of the genetic and epigenetic basis of MRDD by molecular genetic, genomic, and proteomic approaches. 6. Studies of the pathways by which genotype affects the development, function, and dysfunction of the nervous system, particularly with respect to cognition and behavior. 7. Creation and characterization of animals that, through genetic alteration, model specific important aspects of MRDD by clear neurodevelopmental, pathophysiological, genetic, and/or functional homology and their use to test existing and develop new medications that are safe and effective for individuals with MRDD. 8. Prenatal therapy of genetic and structural defects using nutritional, pharmacological, surgical, and other techniques. 9. Genetic, molecular, behavioral, and biobehavioral research and therapeutic approaches to the MR syndromes, such as Down, Fragile X, and Rett. 10. Studies of physical environmental factors in the etiology, treatment, and prevention of MRDD, such as heavy metals (e.g., lead and mercury) and toxic wastes (e.g., hydrocarbons and polycarbonates or PCBs) and their effects on morphogenesis and function that contribute to MRDD. Areas of interest include developmental and behavioral teratology, neuroimmunological toxicology, and conditions such as fetal alcohol syndrome. 11. Studies of the effects of malnutrition (protein, caloric, micronutrient) on intellectual, behavioral, social, and physical development; intergenerational effects of malnutrition. 12. Studies of psychopharmacology, including medication use and development; cellular and molecular mechanisms, pharmacokinetics, behavioral effects; rational drug development (e.g., combinatorial chemistry, pharmacogenomics); medication use and treatment efficacy in different subpopulations of MRDD; dual diagnoses. 13. Clinical trials for the treatment, amelioration, and/or prevention of MRDD. 14. Studies of infectious diseases in the etiology, treatment, and prevention of MRDD; neuropathological, neurological, behavioral, and intellectual consequences of AIDS in children. 15. Studies that develop and test novel methods and measures for screening and diagnosis, and/or identify children and infants at risk; validation of emerging technologies (e.g., microarrays, proteomics, microanalysis of analyates, biomolecule sensing, mass spectrometry, functional imaging) for screening and diagnosis. 16. Studies that develop methods to better define clinical phenotypes in MRDD, including sources of variability, with particular focus on characteristic components of behavior and cognition; measurement tools to assess cognitive and behavioral development; tests that highlight abilities and disabilities, including tests for specific subpopulations (e.g., specific inborn errors of metabolism and syndromes such as Down, Fragile X, Prader-Willi, and Williams). 17. Studies involving early interventions (biological, behavioral, educational, environmental) for infants born at risk for MRDD; research into the strategies for early intervention; follow-up of high-risk infants and children whose risk is due to biomedical conditions such as low birth weight and/or conditions of environmental deprivation; studies of intergenerational effects and outcomes for children whose parents have conditions associated with MRDD; effects of teen pregnancy on at-risk infant outcome. 18. Predictive and developmental studies of perinatal problems associated with MRDD; developmental studies of low birth weight, including infants who are small for gestational age, preterm, medically fragile, and neonatally sick (such as those who experience hypoxic or ischemic insults). 19. Neurodevelopmental and longitudinal studies that characterize the neuropathogenesis and inherent variability in MRDD to develop specific hypotheses about the initial (primary) abnormality, and to address the degree to which phenotypic variation impacts upon postnatal brain development. 20. Studies to follow the developmental trajectories of different brain functions and their influence on developing cognitive and motor skills; such studies might use techniques of imaging, electrophysiology, pharmacology, molecular biology, and behavioral science. 21. Studies of psychological processes in MRDD, including attention, cognition, information processing, perception, motor development, neuropsychology, and affective, social, motivational, and personality factors. 22. Studies of autism and autism spectrum disorders: screening and diagnosis, etiology, neurobiology, genetics, pathophysiology, developmental course, using medical, biological, and pharmacological approaches; behavioral and pharmacological interventions. 23. Studies involving manipulations of interaction between behavior and environment of individuals with MRDD throughout the life-span to reduce behavior problems or to facilitate vocational training, social and self-help skills, and learning; use of social support networks; parent-child, sibling, peer, and family interactions over the life-span. 24. Studies that examine and evaluate residential, educational, and vocational settings of individuals with MRDD throughout the life-span. 25. Studies of learning disabilities, dyslexia, and attention deficit hyperactivity disorder. 26. Studies of language and communication in MRDD populations. 27. Studies of socio-ecological processes: individuals with MRDD from various cultural and ethnic groups in multiple settings (naturalistic observation); ethnographic research, life history reporting, and systematic observation of specific activities. 28. Studies of hyperaggressive, destructive, and self-injurious behavior in humans and animal models, including pharmacological and behavioral treatments; stereotypic behaviors; lack of adherence of mentally retarded individuals in family and educational settings. 29. Studies of the epidemiology of MRDD: analytic and case-control studies of etiology; incidence and prevalence; follow-up over the life span for outcomes. 30. Studies that examine and evaluate behavior, life styles, health needs, and health disparities of affected individuals that could affect mortality and morbidity throughout the life-span. 31. Studies that develop and utilize assistive devices (e.g., computer software, hand-held devices, and touch screen computers) to help individuals with MRDD to learn and to communicate. MECHANISM OF SUPPORT This RFA will use the NIH Center Core Grant (P30) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. Applications must be prepared in a manner consistent with the guidelines presented in the "NICHD P30 CENTER CORE GRANT GUIDELINES" (by http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm). The anticipated award date is July 1, 2005. At this time, it is not known if this RFA will be reissued. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm. FUNDS AVAILABLE The NICHD intends to commit approximately $4.3 million in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2005 to support up to four new and/or competing continuation grants in response to this RFA. An applicant for a new grant may request a project period of five years and budget for direct cost of up to $750,000 per year. An applicant for a competing continuation may request a project period of five years and a budget for initial year direct costs of $750,000 or the amount representing an increase of 10 percent above the direct costs awarded in the final non- competing (Type 5) year, whichever is greater. Budget increments for subsequent years will be limited to three percent. Budgets for new and renewal applications will be stringently reviewed within these guidelines. Applications with budget requests exceeding these guidelines will be administratively withdrawn by NICHD and returned to the applicant without review. The cost of a proposed Center will be a material consideration in the selection of applications for funding. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. Although the financial plans of the NICHD provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit an application 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 institutions/organizations o Foreign institutions are not eligible to apply. For the purpose of this RFA, the NICHD will support no more than one MRDDRC grant (P30) per institution. To be eligible for an award, the proposed Center must provide core support for a minimum of 10 projects funded from non- university sources. Additional eligibility criteria for the P30 are listed in the NICHD P30 CENTER CORE GRANT GUIDELINES at: http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm. 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 his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. The MRDDRC Director should be a scientist or science administrator who can provide effective scientific and administrative leadership. The Director will be responsible for the organization and operation of the MRDDRC and for communication with the NICHD on scientific and operational matters. She/he should be able to integrate and synthesize the proposed research and, thereby, serve as an example to other investigators. SPECIAL REQUIREMENTS o Scientific personnel and institutional resources must be available to provide a strong research base in the specified fields. In addition, the institution and pertinent departments must show a strong commitment to the Center's support. Dedicated space and/or equipment, staff recruitment, investigators' salaries or other financial support for the proposed Center exemplify such commitment. o Applications for P30 MRDDRC grants must propose a program consisting of cores to be accessed by grants that propose research addressing at least five of the topics relevant to the mission of the MRDD Branch outlined above. The program should consist of at least 10 externally funded research projects grouped according to relevant topics. These projects must be of high quality and provide a multidisciplinary approach to the problem(s) under investigation. Each project is to be summarized in accordance with the NICHD P30 CENTER CORE GRANT GUIDELINES (http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm). Projects funded under initiatives unrelated to this RFA (such as Fragile X Research Centers, Centers for Programs of Excellence in Autism, Rare Disease Research Centers, and traditional P01s) may be counted among the 10 externally funded research projects. o An MRDDRC must contain an Administrative Core and a minimum of two additional core units. A minimum of three federally funded research projects, at least one of which is NIH-funded, must utilize each core unit. These projects must be related to MRDD and at least one must be funded by NICHD, exclusive of research contracts, training grants, interagency agreements, and NIH-supplemental projects funded by other agencies. o Subprojects within a Program Project (P01) will be considered as individual projects comparable to an R01. Those projects located at institutions that do not already have an MRDDRC must receive NICHD prior approval to access core facilities. o The applicant must provide a detailed description of each Core unit proposed as part of the Center, with detailed budget and budget justification. o Budgetary items allowable for Administrative Core Units include salaries and support for a limited number of administrative and clerical personnel; administrative support services, when not covered by institutional Facilities and Administrative (F & A) charges; travel to one Center Directors' meeting to discuss scientific advancements of the Centers annually; and travel to one Center Directors' and administrators' meeting annually to confer with other NICHD Center Directors. o Budgetary items allowable for other Cores include salaries and support for core staff; supplies (including animals); scientific equipment; computer facilities and services; travel for technical or administrative staff for technical training or to maintain operation of the core unit; and consultant services. o The applicant must name a scientist to be responsible for each Core unit proposed. The description of each Core unit should include a rationale, indicating how the Core will support the research effort in an efficient and cost-effective manner. Cores should integrate with or buy in to existing institutional resources rather than duplicate them. Core support to individual investigators should not overlap with support already available to them from other sources. o The applicant institution must provide facilities for the primary needs of the MRDDRC Program. These facilities should require no more than modest alteration and/or renovation. No funds for new construction will be provided. o As a major goal, the MRDDRC Program promotes 1) interdisciplinary collaboration among scientists, 2) data/information sharing and integration, 3) synthesis of knowledge about MRDD, and 4) translational research that will lead to amelioration and prevention. Each Center application should present a specific plan for achieving this goal. o Another goal of the MRDDRC Program is to attract scientists to MRDD research. Where appropriate, the applicant may request up to five years' support for "New Program Development" for direct research support of one or more projects. This support should not exceed a total of $100,000 direct costs per year, or 10 percent of total direct costs, whichever is less. Applicants may use such funds to attract new investigators to the Center, to develop a new area or program of research, to facilitate the development of new research programs of newly trained investigators or investigators new to MRDD research, or to facilitate use of a Core at one Center by investigators affiliated with another Center that lacks that kind of Core. Description of New Program Development projects should compare to R01 research grant applications in detail and development. Each such project may provide support for no more than two years to any one investigator. o A major goal of the NICHD is to promote active collaboration among MRDDRCs. To accomplish this goal, successful applicants will participate in the collaborative efforts of established Centers' programs. In planning the program, applicants should consider potential collaborative studies and projects that they may propose for the MRDDRC network. The Administrative Core should budget for interactive functioning including meetings to develop common protocols, databases, and communications and informatics technologies. o 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 sharing is not possible. For more information on data sharing, please see website http://grants.nih.gov/grants/policy/data_sharing/. The reviewers will assess the reasonableness of the data sharing plan or the rationale for not sharing research data. However, reviewers will not factor the proposed data-sharing plan into the determination of scientific merit or priority score. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA 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: o Direct your questions about scientific/research issues to: Ljubisa Vitkovic, Ph.D. Mental Retardation and Developmental Disabilities Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, 4B09E, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 402-1822 FAX: (301) 496-3791 Email: [email protected] o Direct your questions about peer review issues to: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, 5B01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1485 FAX: (301) 402-4104 Email: [email protected] o Direct your questions about financial or grants management matters to: Chris Robey Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6996 FAX: (301) 480-4783 Email: [email protected] LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA 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 NICHD staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Ljubisa Vitkovic, Ph.D. Mental Retardation and Developmental Disabilities Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, 4B09E, MSC 7510 Rockville, MD 20852 (for express/courier service) Bethesda, MD 20892-7510 Telephone: (301) 402-1822 FAX: (301) 496-3791 Email: [email protected] 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 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected]. SUPPLEMENTARY INSTRUCTIONS: Instructions for application preparation can be found in the NICHD P30 CENTER CORE GRANT GUIDELINES (http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm). USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three 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) At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, 5B01, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA 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 an RFA, it is to be prepared as a NEW application. That is, the application for the RFA 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NICHD. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NICHD in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Advisory Child Health and Human Development Council. REVIEW CRITERIA All applications responding to this RFA will be evaluated according to the review criteria for Core units, New Program Development projects, and the overall center as outlined in the NICHD P30 CENTER CORE GRANT GUIDELINES (http://www.nichd.nih.gov/funding/mechanism/p30_guide.cfm). In addition to the review criteria applied to new applications, review of competing continuation (renewal) applications (type 2) will evaluate the progress made by a Center in the previous funding period. The reviewers will evaluate productivity of investigators affiliated with a Center by the number and impact of their publications that acknowledge support by the Center grant. 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 CONSIDERATIONS SHARING RESEARCH DATA: Applicants requesting $500,000 or more in direct costs in any year of the proposed research must 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. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: November 21, 2004 Application Receipt Date: December 21, 2004 Peer Review Date: March/April 2005 Council Review: June 2005 Earliest Anticipated Start Date: July 01, 2005 AWARD CRITERIA Criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities o Cost-effectiveness of the core facilities o Cost of the Center REQUIRED FEDERAL CITATIONS ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable. HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III). 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: 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, 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 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 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. 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 RFA 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). 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 RFA 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 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
|
| ||||||
|
|
|
Department of Health and Human Services (HHS) |
|
|||
|
NIH... Turning Discovery Into Health® |
||||||