PA-03-014: RESEARCH ON MENTAL ILLNESSES IN OLDER ADULTS

Department of Health
and Human Services (HHS)

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RESEARCH ON MENTAL ILLNESSES IN OLDER ADULTS RELEASE DATE: October 22, 2002 PA NUMBER: PA-03-014 (This PA has been reissued, see PA-06-422 for R01 Submissions) 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. 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 thereafter. Applications relating to R33 and R34 activities must be in response to NIH Institute/Center (IC)-specific announcements. EXPIRATION DATE: October 2, 2005 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 Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute of Mental Health (NIMH) invites grant applications for research that will reduce the burden of mental illnesses on older adults. NIMH has a long-standing commitment to studying mental illnesses in older individuals. With a recent review of the late-life research portfolio, NIMH has identified opportunities for enhancing and strengthening its investment in late-life research. The intent of this program announcement is to intensify investigator- initiated research in this area, to attract new investigators to the field, and to enhance interdisciplinary approaches to research. RESEARCH OBJECTIVES Background The United States has the largest number of older adults than at any other time in its history, and this number is rapidly increasing. As of July 2002, U.S. Census estimates project that 35.3 million Americans are 65 years of age or older, comprising 12.6 percent of the population. In the next decade, this number is expected to grow by 18.8 percent. By 2025, the number of older adults will have increased to over 62 million -- an increase of over 77 percent. On the other hand, the nation's population will grow overall by only 20.5 percent. This rapid increase in our aging adult cohort creates an increased need to understand and reduce the public health burden of mental illnesses on older Americans. NIMH has a long-standing commitment to support research that helps reduce the burden of mental illnesses on older adults. In 2001, NIMH formed a workgroup (which formally became the "Aging Research Consortium" in January 2002) to bring together experts on all relevant NIMH areas to ensure an organized and comprehensive approach to its aging research. One of the workgroup's first tasks was to review the portfolio of grants, contracts, and intramural research targeted toward aging. One purpose of this analysis was to help provide recommendations for future aging research efforts. This program announcement builds on the findings from the workgroup report and outlines some of the major areas of interest to NIMH. Areas of Opportunity Virtually every area studied by NIMH-funded researchers has opportunities for expansion. The following section describes some of these areas and is not meant to be inclusive. a. Risk Factors and Basic Research Establishing the etiology of late-life mental illnesses and identifying risk factors and their relationship to late-life mental illnesses remain priorities. Opportunities exist in developing novel models of late-life mental illnesses and continuing efforts in biomarker validation, including the use of imaging technologies. Some research questions include: o What factors increase the risk for mental illnesses in late life? What is the significance of age at onset? What is the unique impact of long-term mental illnesses? o What are the relationships among mental illnesses, disability, and mortality in late life? o Do risk factors differ in men and women in late life? Do risk factors differ in ethnic/racial minority populations in late life? Are there identifiable environmental risk factors in late life? o What risk factors are related to recurrence or relapse in late life? o What are the risk factors for suicide in late life? In what situations does depression increase the risk of non-suicide-related mortality in late life? o What is the neurobiology of specific mental illnesses in late life? What is the natural history of those illnesses? How do co-occurring physical illnesses alter the picture? Other needs include: o Validation of biological therapeutic targets for late-life mental illnesses o Creation of animal models specific to late-life mental illnesses o Validation of surrogate markers to indicate treatment effects b. Diagnosis Older adults with psychiatric symptomatology do not typically fit the categories of diagnostic nomenclatures. They may have other co-occurring physical or mental illnesses. They may have the same symptoms at lower severity or different duration, or the symptom pattern may be different. To ultimately reduce the burden of mental illnesses on these individuals, it is necessary to have valid conceptualizations of those illnesses. Some research questions include: o Are the diagnoses of mental illnesses in late life well defined? Are the criteria for those illnesses explicit? Are there individuals with significant psychopathology who fail to meet criteria for an illness? How does the location of care affect the interpretation of these criteria? o How does co-morbidity complicate diagnosis? Do diagnostic criteria for typical disorders need to be modified in special situations (e.g., depression in Alzheimer's disease)? o Can we improve how primary care and other physicians diagnose these disorders? Other needs: o Useful, valid, and cost-effective approaches to screening in primary care and other community settings c. Treatment One goal of NIMH is to validate treatments that reduce the effects of mental illnesses on older Americans. Some research questions include: o Which treatments work best in late-life mental illnesses? Do the treatments that work best in adult-onset disorders work as well in late-life disorders? What are the special concerns regarding safety of pharmacotherapy in the elderly, particularly when other medical disorders exist? o Does early treatment affect the course of mental disorders in the elderly? How long should such treatment occur? What criteria should determine optimal length of this treatment? o When should treatment be given prophylactically? How can treatment be used to reduce the possibility of relapse or recurrence? o Which psychotherapies work in late life? Can cost-effective psychotherapeutic treatment be developed and validated? o Do treatments vary based on such identifiable factors as gender, race, ethnicity, or medical comorbidities? Can the underlying causes of the observed variance by these factors be identified? o Can treatment of mental illnesses by primary care and other physicians be improved? o What is the role of the family in treatment of mental illnesses in late life? o What rational approaches to combination treatments (e.g., pharmacologic and psychotherapeutic) should be considered? To what degree does combination therapy affect adherence/compliance? Other needs: o Development of assessment instruments with greater sensitivity, validity, and efficiency o Development of validated methods that reduce barriers to participation for underrepresented racial/ethnic populations d. Prevention and Services Ultimately, the knowledge that is created by NIMH researchers to improve the mental health of older Americans needs to be useable by providers and individuals outside the laboratory. Of equal importance is the attempt to prevent mental illnesses before they occur. Some research questions include: o What are the social costs/economic consequences of not treating elderly persons with mental illnesses? What is the role of economic factors in the delivery and use of mental health services by elderly persons with mental illnesses? o Does reimbursement policy for mental health services for the elderly promote cost-effective care? o What is the clinical epidemiology of services provided across service settings; what methods can characterize day-to-day practice? o What are the patient, provider, and encounter factors that enhance or detract from access to and effective delivery of services? o How can the mental health and human services systems be coordinated to maximize receipt of effective services? o How can the organization and delivery of clinical services optimize outcomes for the elderly with mental illnesses? o How do preventive and support services differ in different racial/ethnic populations, if at all? o What models of rehabilitation are effective in helping the elderly with mental illnesses reintegrate into community settings? Other needs: o What are effective models for the delivery of mental health services to the elderly within the general medical care sector, including diagnosis, management, and treatment? o Development of prevention and services methods that can reduce the onset of late-life mental illnesses or reduce the duration or severity of late-life mental illnesses e. Mood Disturbance NIMH held a workshop in July 2002 organized by the Aging Research Consortium on the topic of mood disturbance in late life. The participants concluded that a significant number of older adults have mood symptomatology, which does not meet criteria for either an anxiety or mood disorder. Although these individuals have not been the focus of research, they are burdened with symptoms of mental illness. Whether they will later develop a mood disorder is unknown, but they are at risk. Areas of interest for addressing mood disorders include but are not limited to: o Establishing risk factors for mood disturbance o Better characterization of individuals with mood disturbance o Development and validation of scales for assessing mood in late life, particularly for anxiety and suicidal ideation o Improving scales of disability in late life o Following at-risk groups (e.g., those with a stressful life event) and sampling a wide range of domains (e.g., arousal, disability, affect regulation, constitutional vulnerability, setting, costs, diversity, cognition) o Developing treatment models that account for the higher placebo response rate in less severely impaired individuals o Targeting community-based samples where comorbidity, including substance abuse and disability, leads to a higher risk of mood disturbance f. Bioethics o Late-life research remains at a crossroads between the need to protect individual research participants from harm and the need to test treatments that help individuals with mental illnesses. Studies that involve following healthy individuals have to manage the risk that mental illnesses may appear. Studies that wish to determine when to stop treatment for those in remission have to weigh the risk of recurrence. Studies involving decisionally-impaired individuals have to protect these individuals. Some research questions include: o Designing ethical studies that determine rates of recurrence o Methods for ensuring informed consent from individuals whose decision-making capacity may be compromised o Methods for enhancing the informed consent process The National Institute on Aging The National Institute on Aging (NIA) also supports late-life research, including studies of the aging process, age-related diseases (including neurodegenerative diseases), and special problems of the aging population (including disability). This program announcement in particular is targeted to mental illness research in late life and not the above-mentioned areas. Applicants should consider contacting program staff at NIMH or NIA to determine the Institute most appropriate for them. MECHANISM(S) OF SUPPORT This PA will use the NIH research project grant (R01), small grant (R03), and exploratory/developmental grant (R21) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The Small Grant (R03) provides two years of funding with a maximum of $50,000 direct costs for each year. Information and application instructions for the NIMH Small Grant are available at http://grants.nih.gov/grants/guide/pa-files/PAR-99-140.html. The Exploratory/Development Grant (R21) provides up to two years of funding with up to $100,000 in total direct costs annually. The Research Plan for this R21 application (Sections a-d of the 398 application kit) is 10 pages long. Information and applications instructions for the NIMH Exploratory/Developmental Grant are available at: http://grants.nih.gov/grants/guide/pa-files/PA-00-073.html. This PA uses just-in-time concepts. It also uses the modular budgeting format (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 format. 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 or foreign (only domestic organizations are eligible for the R03 mechanism) o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institutions to develop applications 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: Jason T. Olin, Ph.D. Chair, Aging Research Consortium National Institute of Mental Health 6001 Executive Boulevard, Room 7160, MSC-9635 Bethesda, MD 20892-9635 Telephone: (301) 443-6328 FAX: (301) 594-6784 Email: jolin@nih.gov o Direct your questions about financial or grants management matters to: Joy R. Knipple Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-8811 FAX: (301) 443-6885 Email: jknipple@nih.gov 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 GrantsInfo@nih.gov. 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 the 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 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 (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 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 National Institute of Mental Health Advisory Council. 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. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm 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 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. 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. 93.242, 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.

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