and Human Services (HHS)
EXPIRED
INFORMAL CAREGIVING RESEARCH FOR CHRONIC CONDITIONS RELEASE DATE: August 26, 2002 PA NUMBER: PA-02-155 EXPIRATION DATE: August 10, 2005, unless reissued. 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 Mental Health (NIMH) (http://www.nimh.nih.gov) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanisms 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 The National Institute of Nursing Research (NINR), the National Institute of Child Health and Human Development (NICHD), and the National Institute of Mental Health (NIMH) invite applications for research grants to advance the science in informal caregiving by focusing on the caregivers of individuals with chronic illness, disability, or functional impairment requiring partial or full dependency on others. This program announcement (PA) targets studies of informal caregiving to improve caregiver health and quality of life, caregiving processes, and caregiving effectiveness and health outcomes. A key aspect of this announcement is to encourage research to advance science-based knowledge of informal caregiving, with attention to the caregiver. Clinical research areas appropriate to this PA include studies: to improve the quality of informal caregiving, to prevent or manage caregiver physical and mental health problems related to caregiving, to reduce the burden of caregiving, to test the effectiveness of advances in caregiving processes, including new technologies, and to determine the impact of formal and informal support systems on caregiving outcomes and caregiving transitions/trajectories. Applicants should consider the feasibility of translation to practice and cost effectiveness for interventions tested. Studies investigating issues related to the parenting of healthy children or studies of caregiving in institutions are not responsive to this PA. RESEARCH OBJECTIVES Background The definition of informal caregivers used by this announcement is adapted from Biegel, Sales, and Schulz (1) and includes those individuals who provide extraordinary, uncompensated care, predominantly in the home setting, involving significant amounts of time and energy for months or years, requiring the performance of tasks that may be physically, emotionally, socially, or financially demanding. The number of informal caregivers in the U.S. tripled from 1988 to 1996, according to a National Alliance for Caregiving/American Association of Retired Persons (NAC/AARP) study (2) of informal caregivers for care recipients aged 50 or older. In 1996, the U.S. had over 22 million households with English-speaking informal caregivers. The intensity of caregiving ranged from a few hours per week to constant care. The mean age of caregivers was 46 with 22% under 35 years and 36% 50+ years old. Estimates of the number of caregivers under the age of 21 are not well documented. The prevalence of informal caregiving was higher among Asian and Black households (31.7% and 29.4%) than among Hispanic (26.8%) or White (24%) households. About 73% of informal caregivers are female. The median household income of caregivers in 1996 was $35,000. About two-thirds of caregivers worked either full-time or part-time, about 20% were not employed, and 16% were retired. Almost 70% of caregivers cared for more than one person, while 23% cared for two people and 8% cared for three or more people. The main illness or problems experienced by care recipients in the study were identified, by groupings, as "aging" (15.5%), mobility problems (10.4%), dementia (9.7%), and 43.2% with various chronic diseases including heart disease, cancer, stroke, arthritis, diabetes, and pulmonary disease. Problems with smaller percentages were noted for mental or emotional illness and neurological problems. Wagner (3) compared 1988 and 1996 informal caregiving survey data and, on the basis of the comparison results, predicted that during the next decade, informal caregiving and the number of caregivers will continue to increase, as will issues in the workplace, the percentage of male caregivers, and long-distance caregiving. It is estimated that currently 4.1 million adults aged 21 to 64 need personal assistance with one or more personal or instrumental activities of daily living. Approximately 6.8 million adults over the age of 65 have daily personal assistance needs. (4,5) The cost of informal caregiving is significant and is primarily that associated with caregiving of adults and older adult populations. Informal caregiving cost estimates range from $117 to $292 billion a year for adults with a disability or chronic disease, with higher costs occurring in caregiving for Alzheimer"s disease. (6) The health issues arising from informal caregiving are significant and warrant attention. To illustrate, the NAC/AARP study (2) reports that 15% of caregivers admit to having physical or emotional health problems directly related to caregiving while other caregivers have one or more pre-existing health problems. More women than men caregivers report emotional stress and impaired physical health. The national informal caregiving surveys cited previously were targeted to older care recipients. With increasing numbers of children surviving birth defects (including genetic, neurodevelopment, and birth trauma conditions), developing chronic diseases, and the continuing numbers of automobile and other accidents resulting in traumatic injuries to adolescents and young adults, informal caregiving needs are, and will continue to be, present across the lifespan. The percentage of children ages 5 to 17 with any limitation in activity from chronic conditions is 8%, as reported by the CDC National Center for Health Statistics in 1997. Furthermore, there are 1.5 million children and adolescents who have serous health conditions that impair daily functioning. (5,6) Chronic diseases that are severe require extraordinary caregiving. One example is the growing number of health outcomes of very low birth weight infants. Low birth weight infants have higher rates of mental retardation, cerebral palsy, blindness, deafness, and psychomotor problems than do normal weight infants. (7) Many of these health problems require a lifetime of committed informal caregiving by parents and family members and may have a deleterious impact on family dynamics, quality of life, and financial status. Informal Caregiving Recipient Populations Examples of care recipient populations and caregiving problems are briefly discussed. It is not possible, in this context, to specify all possible caregiving situations or care recipient groups. The following examples illustrate the breadth and depth of informal caregiving problems experienced by caregivers. Chronic Illnesses. The Centers for Disease Control and Prevention (CDC) reports that nearly three quarters of adults age 65 years and older have one or more chronic illnesses, and nearly half report two or more. Many chronic diseases are debilitating and may have a deleterious affect on self-care functions, requiring informal caregiving from family or friends. The moderate to severe forms of stroke, for example, often require sudden intense and frequent caregiving interventions, with caregiving needs changing over time. A review (8) of caregiving for stroke patients found several caregiver well- being issues including depression, concern for future care, and caregiver burden. Burden was related, in various studies, to level of patient disability, and psychological distress. Caregiver depression was related to the relationship with the patient (spouse), more concern for future care, fewer social contacts, more physical symptoms in the caregiver, and stroke patient symptoms. Caregiver fatigue and sleep difficulties were found to be significantly greater for spousal caregivers of individuals with Alzheimer"s Disease, Parkinson"s disease, or cancer when compared with a control group of little or no caregiving requirements. (9) In a longitudinal cohort study (10) of almost 400 older spousal caregivers, caregivers who experienced mental or emotional strain related to caregiving had mortality risks 63% higher than non-caregiving controls. The findings suggest that having caregiver strain is an independent risk factor for mortality among older spousal caregivers. Alzheimer"s Disease. At least 5 million Americans provide care for someone with Alzheimer"s disease (AD). (11) These informal caregivers are twice as likely to be providing constant care and 38% have been providing care for more than five years. The caregiving required is intense and includes assistance with activities of daily living, incontinence, feeding, and transfer or use of a wheelchair or walker. The majority (73%) of AD caregivers age 65 and over provide the highest levels of care. These caregivers are twice as likely to report physical strain and high levels of emotional stress as a direct result of caregiving responsibilities. They are more likely to report family conflict, to spend less time with other family members, and to give up vacations, hobbies, and other personal activities. A high level of financial strain is present for AD caregivers as well. Technology-Dependent. Technological caregiving in the home is becoming more prevalent. Examples of technology use for care recipients of all ages include kidney dialysis, intravenous lines, electronic monitoring, nutritional tube feedings, and ventilators. Care recipients who are technology dependent may need constant vigilance and monitoring. The need for long-term technology re- education, support, and caregiving guidance has not been adequately addressed. Informal technology caregiving success is related to caregiver and care recipient abilities to share responsibilities, to understand tasks, and to coordinate efforts with multiple health professionals. (12) The use of technology in informal caregiving remains a major problem for caregivers and care recipients as technological advances become more common and more sophisticated. This announcement is based on growing scientific opportunities that reflect the increased current and future need for informal caregiving. These opportunities were summarized at an NINR-sponsored Research In Informal Caregiving: State of the Science Workgroup Meeting in July 2001 at which a group of science experts in informal caregiving, including lay representatives, reviewed the current state of the science in the field. A summary of the workgroup meeting and research questions raised can be found at: http://www.ninr.nih.gov/research/dea/workgroup_chronic_conditions.html Research Scope Informal Caregiving Populations. All caregiving populations are of interest to this PA, including understudied populations such as caregivers of children or adolescents. Also of interest are ethnic/racial minority, gay/lesbian, and highly stressed/overwhelmed caregivers. Age groups across the lifespan, including young or older caregivers, and both genders should be considered. Applications for all informal caregiving populations will be considered and include various conditions of care recipient illness, disability or functional impairment as well as different levels of severity of recipient health. Various levels of intensity of informal caregiving are of interest, ranging from a few hours per week to constant and vigilant caregiving. Studies of diverse populations are encouraged, including urban, inner city, rural, and other understudied groups. The following research topics are provided as examples that would extend research currently funded by DHHS. They are not listed in any priority order and are not intended to be inclusive or restrictive. All responsive applications, regardless of design or target group, must display awareness of and sensitivity to cultural or race/ethnic issues in appropriate components of the study. Informal Caregiving Populations Applicants may propose studies among an unlimited number of caregiving populations, including those previously studied. Understudied populations of interest include, but are not limited to: o Both genders, all sexual orientations, and all age groups, including young caregivers. o Caregivers of ethnic minorities, children or adolescent care recipients o Highly stressed or overwhelmed caregivers. o Caregiving populations by care recipient illness or disability, including but not limited to persons with cancer, cardiovascular disease, diabetes, arthritis, stroke, serious mental illness, Alzheimer"s disease and other dementias, or physical disability (through trauma, birth defects, or debilitating conditions). Caregiver Abilities, Problem Solving, and Care Decisions o Test interventions that improve the knowledge and abilities of caregivers for symptom management, caregiving procedures/activities, accessing appropriate health care/social services assistance, health care visits, symptom and medication management, prevention of complications, preventive care, changes in care needs when conditions improve or worsen, recipient health crises, troublesome behaviors, and physical and emotional dependency. o Test interventions to improve caregivers" ability to problem solve and make care decisions. Examples include but are not limited to: knowing who and when to call for health care/social services assistance, health care visits, symptom and medication management, changes in care needs for improving or worsening of condition, health crises, troublesome physical or psychological behaviors, physical and emotional dependency, and assessing necessity to institutionalize. o Examine interventions for caregivers at different transitions in the trajectory of caregiving, for example, when the recipient"s condition either improves or worsens, or the recipient is institutionalized or dies. Examples include the support needed, adaptation mechanisms, and skills to manage the transition for the caregiver and care recipient. o Test interventions that improve the quality of caregiving behaviors and knowledge, and that consider the cost of informal caregiving and outcomes. Determine the health care resources that are critical for all caregivers, regardless of type of care recipient. o Test strategies to instill the critical knowledge and skills needed by caregivers for their effectiveness in guidance, psychoemotional support, and partnering with the care recipient. o Examine in-home assistive information and communication-based technologies, including computers and health care equipment for its enhancement of informal caregiving effectiveness and easing of the stress or intensity of caregiving effort. o Assess methods for education, safety and technology skill maintenance, and care decisions in technology-dependent caregiving. o Examine interventions that improve the quality of interactions between formal and informal care providers and that improve both caregiver and care recipient health outcomes. o Examine best methods to provide health information about the health condition of the care recipient and the intervention strategies the caregiver must carry out, incorporating culturally competent approaches. o Develop and test measurements for caregiving attitudes, skills, knowledge and outcomes across and within different geographic regions and ethnic groups as well as recipient health conditions. Impact on Caregiver o Evaluate interventions that help to maintain and improve the caregiver"s physical and mental health across and within different geographic regions, racial/ethnic groups, and by recipient health conditions. o Test interventions to assist caregivers to cope with or alleviate unanticipated demands of caregiving such as time required, loss of social interactions with others, other personal lifestyle sacrifices, insufficient family assistance, financial impact, and work issues. o Assess methods to intervene for caregivers with dysfunctional family dynamics, including aggressive behaviors or abuse. o Determine what factors facilitate and inhibit the successful maintenance of healthy partnerships between the informal caregiver and their care- recipients, other family members, and formal health care providers, while maintaining the caregiver"s own health. o Study issues related to or interventions aimed at the termination dynamics experienced by caregivers when the care recipient dies or is placed in an institutional facility. o Explore the ethical dilemmas faced by family-member caregivers and how the caregiver"s response to these dilemmas influence the outcomes of caregiving for the caregivers and recipients. o Test strategies that reduce the burden experienced by non-caregiving children or other family members and that enhance the level of their participation in caregiving. o Determine the impact on the caregiving relationship when the caregiver and care recipient have the same or similar illness states or when the caregiver has a serious health problem. o Determine the physiological, mental health, and psychosocial effects on the caregiver when the caregiver is a child, young adult, adult, or elderly. o Explore various caregiver effectiveness and satisfaction issues such as mental health and depression, respite or compensation, family conflict, health needs of the caregiver, evaluation of caregiving effectiveness, social isolation, distress, and emotional strain. Formal Health Care and Community Resources for Effective Caregiving o Test interventions or collaboration strategies between caregivers and formal health care systems that improve caregiving effectiveness and satisfaction. o Test the impact of formal (health care providers) and informal community resources (social services including social/financial, community organizations) on effectiveness in supporting the caregiver and caregiving processes and outcomes, including access to and utilization of formal, informal, and community sources of caregiving assistance. o Investigate the role of telehealth or technology in improving informal caregiving and strategies that enable effective caregiving with new or advanced technologies. This announcement is sponsored by several Institutes, however, NICHD is interested in research on the caregivers of children and adults with chronic physical disabilities such as spinal cord injury, spina bifida, head injury or stroke. The NIMH is interested in supporting research that will provide the basis for the development, validation, and implementation of strategies and interventions to identify, treat, prevent and/or rehabilitate depression, anxiety, and other mental disorders among caregivers of individuals with chronic care needs. The NIMH has special interest in research that examines the influence of social and cultural factors on caregiving, and caregiver burden and mental health needs, and in the development of interventions that are transportable to rural and frontier populations. In addition, studies on the organization and delivery of relevant services across mental health, general health, and other community care settings in order to improve mental health outcomes for caregivers are also of interest. References 1. Biegel, D., Sales, E., and Schulz, R. (1991). Family caregiving in chronic illness: Heart disease, cancer, stroke, Alzheimer"s disease, and chronic mental illness. Newbury Park, CA: Sage Publications. 2. National Alliance for Caregiving & American Association of Retired Persons (1997). Family caregiving in the U.S.: Findings from a national survey. Sponsored by the National Alliance for Caregiving, Bethesda MD, and the American Association of Retired Persons, Washington DC. 3. Wagner, DL (1997). Comparative analysis of caregiver data for caregivers to the elderly 1987 and 1997. National Alliance for Caregiving: Bethesda MD. 4. Schulz, R, & Quittner, AL (1998). Caregiving through the life-span: Overview and future directions. Health Psychology, 17(2), 107-111. 5. Quittner, AL, Opipari, LC, Regoli, MJ, Jacobsen, J, & Eigen, H (1992). The impact of caregiving and role strain on family life: Comparisons between mothers of children with CF and matched controls. Rehabilitation Psychology, 37, 289-304. 6. Arno, PS, Levine C, Memmott, MM (1999). The economic value of informal caregiving. Health Affairs, 18(2):182-188. 7 Hack, M, Klein, NK, & Taylor, HG (1995). Long-term developmental outcomes of low birth weight infants. In RE Behrman (Ed.), The Future of Children, 5(1):176-196. Published by the Center for the Future of Children, The David and Lucile Packard Foundation. 8. Han, B, & Haley, WE (1999). Family caregiving for patients with stroke: review and analysis. Stroke, July, 1478-1485. 9. Teel CS, & Press AN (1999). Fatigue among elders in caregiving & non- caregiving roles. West J Nurs Res, Aug,21(4):498-514. 10. Schulz R, & Beach SR (1999). Caregiving as a risk factor for mortality: The caregiver health effects study. JAMA, 282:2215-2219. 11. Alzheimer"s Association and the National Alliance for Caregiving. (1999). Who cares? Families caring for persons with Alzheimer"s disease. A report of the Alzheimer"s Association, Washington DC, and the National Alliance for Caregiving, Bethesda MD. 12. Smith, C. (1996). Quality of life and caregiving in technological home care. In J Fitzpatrick & J Norbeck (Eds.), Annual review of nursing research (Vol. 14, pp. 95-118). New York: Springer Publishing. 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 exploratory/developmental mechanism (R21) is to encourage applications from individuals who are interested in testing innovative or conceptually creative ideas that are scientifically sound and may advance our understanding of informal caregiving. Investigators are encouraged to explore the feasibility of an innovative research question or approach that will provide a basis for future research project applications. The NINR and NICHD limit exploratory/developmental grants (R21) to 2 years of support and up to $150,000 per year in direct costs. The NIMH limits R21 grants to 3 years of support and up to $125,000 per year in direct costs. For further guidance on the NIMH R21 mechanism, please see: http://grants.nih.gov/grants/guide/pa-files/PA-99-134.html. Please contact the appropriate IC for specific guidance on the direct costs allowed or other questions. Application page limits differ according to mechanism. Please see the "Submitting an Application" section for more details. This PA uses just-in-time concepts. It also uses the modular and 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, you must use the modular format. Otherwise, use the standard PHS 398 instructions for detailed budgets. 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 o Faith based and 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: Dr. Nell Armstrong Office of Extramural Programs National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-5973 FAX: (301) 480-8260 Email: [email protected] Dr. Louis Quatrano Behavioral Sciences and Rehabilitation Engineering National Institute of Child Health and Human Development 6100 Executive Boulevard, 2A03, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 402-4221 FAX: (301) 496-0832 Email: [email protected] Dr. Emeline Otey Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6186, MSC 9625 Bethesda, MD 20892-9625 Telephone: (301) 443-1636 FAX: (301) 443-4611 Email: [email protected] o Direct your questions about financial or grants management matters to: Ms. Diane Drew Office of Grants and Contracts Management National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-2807 FAX: (301) 451-5651 Email: [email protected] Mr. Christopher Myers Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, 8A17, MSC 7510 Telephone: 301-435-6996 FAX: 301-402-0915 Email: [email protected] Mr. Brian Albertini Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-0004 FAX: (301) 443-6885 Email: [email protected] SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 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]. Please note, when completing an application for the R21 mechanism, Items a-d in the Research Plan must not exceed a total of 15 pages. Tables and figures are included in the page limitations. Applications that exceed the page limitation or NIH requirements for type size and margins (refer to PHS 398 application for details) will be returned to the applicant without further consideration. The 15-page limitation does not include Items e-i (Human Subjects, Vertebrate Animals, Literature Cited, Consortia and Consultants/Collaborators). 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 GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular 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 $500,000 or more must carry out the following steps: 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 received by or 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 application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group 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 Receive a written critique 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 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 discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment 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. 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. (1) 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? (2) 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? (3) 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? (4) 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)? (5) 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, your application will also be reviewed with respect to the following: PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. INCLUSION: 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. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) DATA SHARING: The adequacy of the proposed plan to share data. 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 MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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 AMENDMENT "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. 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. 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.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.361 (NINR), 93.929 (NICHD) and 93.242 (NIMH), and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284 and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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
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