QUALITY OF LIFE FOR INDIVIDUALS AT THE END-OF-LIFE Release Date: August 2, 2000 PA NUMBER: PA-00-127 National Institute of Nursing Research National Cancer Institute National Center for Complementary and Alternative Medicine National Institute of Allergy and Infectious Diseases National Institute of Dental and Craniofacial Research National Institute of Mental Health National Institute on Aging This program announcement replaces PA-98-019, which was published in the NIH Guide, Vol. 26, No. 40, December 19, 1997. THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. PURPOSE The National Institute of Nursing Research (NINR) and 6 other ICs seek research grant applications that will generate scientific knowledge to improve the quality of life for individuals who are facing end-of-life issues and for their families. Research applications may include basic, clinical or care delivery studies focused on management of physical and psychological symptoms, patient-provider and patient-family communication, ethics and clinical decision-making, caregiver support, or the context of care delivery for those facing life-limiting illnesses. In a broad sense the purpose of this program announcement is to enhance the quality of life remaining for individuals who are nearing the end of their lives. 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 Program Announcement (PA), Quality of Life for Individuals at the End-of-Life, 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/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) Research Project Grant (R01) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed 5 years. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm RESEARCH OBJECTIVES Background The life expectancy of the American people has reached an all time high, but along with the increased life expectancy is an increase in the number of people living with, and dying from, chronic debilitating diseases such as heart disease, cancer, stroke and chronic obstructive pulmonary disease (National Center for Health Statistics, 1999). While the elderly with chronic illnesses comprise a group one might associate with end-of-life issues, there are other groups for whom these concerns are important. Examples extend across the life span including neonates in intensive care units, children with AIDS, teens with cancer, and young adults with degenerative diseases. Coupled with this spectrum of individuals is the increased availability of technologies and treatments that can be used to prolong life and, in some cases, death. Defining when these technologies and treatments shift from life saving interventions to burdensome and futile procedures that negatively impact quality of life has proved elusive. When these technologies and treatments become futile, the individuals families and significant others may be involved in a difficult period of decision-making about how much aggressive treatment to try and when to stop. Conversely there is widespread fear that the only alternative to aggressive treatment is abandonment and suffering. For many Americans, end-of-life care is fragmented, painful, and emotionally distressing, with unnecessary transitions between health care institutions, community-based organizations and home care settings. There are opportunities for health care providers to learn more about how to deliver optimal end-of- life care. Results of two separate surveys found on average only 2% of the content of nursing (Oncology Nursing Forum, 1999) and medical (JAMA, 2000) text books was relevant to end-of-life care. There are many national initiatives underway to improve care of the dying. Significant efforts are being made to better train health professionals and to encourage public awareness of the issues. Yet important gaps in knowledge limit our ability to help individuals who are dying achieve the highest possible quality of life. From the cellular to the social level, much remains to be learned about how people die and how reliably excellent and compassionate care can be achieved (IOM, 1997). Research is needed to better define what is meant by end-of-life, to identify aspects of an optimal death experience within the cultural and ethnic context of the individual so better palliative care can be provided, to facilitate communication and ethical decision-making among those involved in end-of-life decisions, and to support the development of a well integrated health care system that includes the family and the multidisciplinary team. A research workshop convened by the National Institutes of Health in September, 1997, focused on Symptoms in Terminal Illness . The report from that workshop is available at http://www.ninr.nih.gov/end-of-life.htm. Subsequently, a Program Announcement Management of Symptoms at the End-of- Life and a Request For Applications Research on the Care at End-of-Life were published. This program announcement builds on those two initiatives. More needs to be understood about the physical, emotional, social, cultural and spiritual experiences of people who are dying and about the environmental context which influences the quality of the life remaining. Issues related to research methods are important to consider with inquiry into dying. There are pressing needs to better define key concepts, identify and test appropriate measures, develop strategies to minimize subject burden, and devise methods for complex data analysis. Advances in understanding how to help individuals who are dying to attain the highest quality of life possible can be advanced with innovative, science-based research. Objectives: Topics of interest include, but are not limited to: Clinical management to promote the quality of life of individuals across the life span who are at the end-of-life o pathogenesis of symptoms that result from common end-of-life conditions such as AIDS, emphysema, heart disease, stroke and cancer o more effective techniques to prevent and manage symptoms including better targeted drugs and delivery techniques and alternative and complementary approaches o prevention and reduction of secondary side effects of medications used to treat common end-of-life conditions such as antiretrovirals, steroids, and chemotherapy o better understanding of the cultural and ethnic context surrounding the death event to enhance clinical management and sensitivity to patient and family choices o multidisciplinary interventions to enhance the psychological, social or spiritual well-being of persons facing life-limiting illness such as children with AIDS or cancer o the explicit role that mental disorders, symptoms, and related disabilities play in the quality of life at the end-of-life, specifically, studies on modifiable risk and protective processes including developing and testing new interventions Communication o interventions relating to patterns and processes of communication between patients and caregivers which facilitate open discussion, discernment of patient and family wishes and concerns, and respect for cultural and ethnic diversity o strategies to foster high quality care at the end-of-life Ethics and clinical decision making o processes that assist providers, patients and families to assess the situation-specific value of healthcare interventions so they can make informed decisions about treatments that affect quality of life o ethical issues for dying persons who are vulnerable such as children and people who are cognitively impaired o strategies to better incorporate patients culture, values and preferences into decisions such as advance care planning Caregiver support o strategies used by clinicians to maintain the integrity of the family through the dying process o interventions which provide social support for those caring for dying persons o efficacy of interventions to support grieving survivors Care delivery o identification of the clinical contextual factors that foster an optimal death experience in persons across the life span o international studies of the approaches to using life-sustaining devices such as ventilators and the impact of such devices on quality of life remaining o investigations that include evaluation of the economic aspects of providing culturally-sensitive care at the end-of-life o organizational and economic determinants of hospice use, including transitions from acute and nursing home settings and length of stay in hospices INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided 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 research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994 and is available on the web at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. NOTE FOR APPLICATIONS FOCUSED ON AGING RESEARCH Applications received in response to this program announcement are expected to focus on scientific issues related to aging and to aging-related aspects of disease. In describing the plan to recruit human subjects, investigators may cite a focus on aging or on aging-related aspects of disease as the justification for why children will be excluded. In this regard, applicants may use Justification 1, the research topic to be studied is irrelevant to children, from the policy announcement. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: GrantsInfo@nih.gov. Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute or Center (IC) program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the IC staff that the IC will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute or Center who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-030.html The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o Under Personnel, List key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations, o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. 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) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Council for Nursing Research. 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 the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o 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. Additional scientific/technical merit criteria specific to the objectives of the PA and the mechanism used must be included if they are to be used in the review. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Ann Knebel Division of Extramural Activities National Institute of Nursing Research Building 45, Room 3AN12, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5966 FAX: (301) 480-8260 Email: aknebel@nih.gov Dr. Claudette Varricchio Division of Cancer Prevention National Cancer Institute 6130 Executive Boulevard, EPN 300 Bethesda, MD 20892 Telephone: (301) 496-8541 FAX: (301) 496-8667 Email: varriccc@mail.nih.gov Dr. Mary Ann Richardson National Center for Complementary and Alternative Medicine 31 Center Drive, Building 31, Room 5B58 Bethesda, MD 20892-2182 Telephone: (301) 402-1272 FAX: (301) 402-4741 Email: marich@od.nih.gov Dr. Frederick Batzold Division of AIDS National Institute of Allergy, Immunology, and Infectious Diseases Rockledge Drive 6700B, Room 5154 Bethesda MD, 20892 Telephone: (301) 496-8214 FAX: (301) 402-1505 Email: fbatzold@niaid.nih.gov Dr. Patricia Bryant Division of Extramural Research National Institute of Dental and Craniofacial Research Building 45, Room 4AN-24E Bethesda, MD 20892-6500 Telephone: (301) 594-2095 FAX: (301) 480-8318 Email: BryantP@DE45.nidr.nih.gov Dr. Peter Muehrer National Institute of Mental Health 6001 Executive Blvd., Room 6189, MSC 9615 Bethesda, MD 20892-9615 Telephone: (301) 443-4708 FAX: (301) 443-4415 Email: pmuehrer@mail.nih.gov Dr. Sidney M. Stahl Behavioral and Social Research Program National Institute on Aging Gateway Building, #533 7201 Wisconsin Ave. Bethesda, MD 20892-9205 Telephone: (301) 402-4156 FAX: (301) 402-0051 Email: Sidney_Stahl@nih.gov AHRQ Statement: The Agency for Healthcare Research and Quality (AHRQ) supports the development of knowledge that improves health care services provided for patients at the end of life. AHRQ is interested in supporting research on the most appropriate sites of health care for patients at the end of life (e.g., home, nursing home, hospice, acute care), and on the quality, costs and access to the services provided in these settings. Methods of improving the process of decision-making by family, providers and patients themselves, and of relieving the financial and social burden on family caregivers, are also of interest. For inquiries regarding AHRQ programmatic issues, contact: Dr. David Lanier, Center for Primary Care Research, AHRQ, (301) 594-1489. Email: dlanier@ahrq.gov Direct inquiries regarding fiscal matters to: Mr. Robert Tarwater Office of Grants and Contracts Management National Institute of Nursing Research Building 45, Room Number 3AN12, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-2807 FAX: (301) 480-8260 Email: Robert_tarwater@nih.gov Mr. William T. Wells Grants Administration Branch National Cancer Institute 6120 Executive Blvd. Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800 FAX:(301) 496-8601 Email: William_Wells@nih.gov Ms. Suzanne White Grants Management Branch National Center for Complementary and Alternative Medicine 6201 Rockledge Drive, MSC 7926 Bethesda, MD 20817-7926 Telephone: (301) 435-0171 FAX: (301) 480-3310 Email: whitesa@nhlbi.nih.gov Ms. Jane Unsworth Grants Management Branch Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2128 6700-B Rockledge Drive - MSC 7614 Bethesda, MD 20892-7614 Telephone: (301) 402-6824 FAX: (301) 402-0369 Email: junsworth@niaid.nih.gov Mr. Martin Rubinstein Office of Grants Management National Institute of Dental and Craniofacial Research Natcher Bldg, Rm 4AN-44A Bethesda, MD 20892-6402 Phone: (301) 594-4800 FAX: (301) 594-8301 Email: Martin.Rubinstein@nih.gov Ms. Diana S. Trunnell Division of Extramural Activities National Institute of Mental Health Parklawn Bldg, Room 7C-08 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: diana_trunnell@nih.gov Mr. David Reiter Grants Management Office National Institute on Aging Gateway Building, #2N212 7201 Wisconsin Ave. Bethesda, MD 20892 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: David_Reiter@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.361 (NINR), 93.399 (NCI), 93.213 (NCCAM), 93.855 and 93.856 (NIAID), 93.121 (NIDCR), 93.242 (NIMH), 93.866 (NIA), and 93.854 (NINDS). 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 and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-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, and 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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