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Note: This grant announcement amplifies a request for applications (RFA) that was originally published in the NIH Guide for Grants and Contracts on January 22, 1999.
Release Date: January 22, 1999
National Institute of Nursing Research
Letter of Intent Receipt Date: April 30, 1999
The National Institute of Nursing Research (NINR), the Agency for Health Care Policy and Research (AHCPR), the National Cancer Institute (NCI), the National Center for Complementary and Alternative Medicine (NCCAM), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Dental and Craniofacial Research (NIDCR), the National Institute of Mental Health (NIMH), and the National Institute on Aging (NIA) seek research grant applications that will generate scientific knowledge to lead to improved care for those at the end of life. Research applications may include basic, clinical or health care studies focused on the clinical management of physical and psychological symptoms, patient-provider and patient-family communication, ethics and clinical decisionmaking, caregiver support, or the context of care delivery for those facing life-limiting illnesses. The purpose of this initiative is to generate research that will improve the quality of dying for Americans and decrease the distress for their caregivers.
Healthy People 2000
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This request for applications (RFA), "Research on Care at the End of Life," is related to the areas of heart disease and stroke, cancer, diabetes and chronic disabling conditions, and HIV infection. Potential applicants may obtain a print copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone: (202) 512-1800.
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. AHCPR cannot, by law, make grants to for-profit organizations. However, for-profit organizations may participate as subcontractors or members of consortia. Organizations described in section 501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators.
Mechanism of Support
This RFA will use the National Institutes of Health (NIH) research project grant (R01) award mechanism and the exploratory/developmental grant (R21) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This RFA is a one-time solicitation. The anticipated award date is September 30, 1999.
R01 Applications. R01 awards will vary in size and duration reflecting the nature and scope of the research proposed. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to customary peer review.
R21 Applications. 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 dying. Another objective is to encourage necessary initial development to provide a basis for future research project applications.
Exploratory/developmental studies are not intended for large-scale undertakings, nor to support or supplement ongoing research. Instead, investigators are encouraged to explore the feasibility of an innovative research question or approach which may not yet be sufficiently justified through existing research to compete as a standard research project grant (e.g., R01), and to develop a research basis for a subsequent application through other mechanisms.
Exploratory/developmental (R21) grants, may not exceed $75,000 per year in direct costs, not including indirect costs for collaborating institutions, if any. The total project period for an R21 application submitted in response to this RFA may not exceed 3 years. These grants are non-renewable and continuation of projects developed under the R21 program will be through the traditional unsolicited (R01 or P01) grant programs.
The NINR, AHCPR, NCI, NCCAM, NIAID, NIDCR, NIMH, NIA, and NINDS collectively intend to commit at least $2.7 million in FY 1999 to fund 10-12 new grants in response to this RFA. Additional projects will be considered on a case-by-case basis. Because the nature and scope of the research proposed may vary, it is anticipated that the size of awards will also vary. Although the financial plans of the participating institutes provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of applications of outstanding scientific and technical merit. At this time, it is not known if competing renewal applications will be accepted and/or if this RFA will be re-issued.
During the past several decades, biomedical advances have changed the way Americans die. The dying process now tends to be more extended, in part because medical treatments can manage pneumonia, infections, kidney failure, and other immediate causes of death. Many deaths involve a difficult period of decisionmaking between the patient's family and the clinical team about how much aggressive treatment to try and when to stop. Because it is often difficult to recognize futility, many patients experience burdensome diagnostic procedures and therapies that are exhausting, expensive, demoralizing, and of no ultimate benefit. Conversely, there is widespread fear that the only alternative to aggressive treatment is abandonment and suffering.
The healthcare system is primarily oriented to the cure of patients with acute medical conditions and injuries. It does not recognize that the medical needs of the dying patient are fundamentally different and require the integration of both medical and social service interventions. There is little infrastructure coordination between care service organizations. For most dying Americans end-of-life care is fragmented, painful, and emotionally distressing, with unnecessary transitions between medical care institutions.
In response to these fears and concerns, 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 the evidence base for care of the dying. 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 understand the circumstances under which treatment is likely not to succeed, to facilitate communication and decisionmaking among those involved in end-of-life decisions, to support the development of a well integrated health care system and to provide better palliative care when comfort becomes the primary objective.
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.nih.gov/ninr/wnew/end-of-life.html. A subsequent program announcement was published in December 1997, PA-98-019, "Management of Symptoms at the End of Life" at http://grants.nih.gov/grants/guide/pa-files/PA-98-019.html. The research objectives from that program announcement are subsumed within the expanded focus of this request for applications.
In addition to basic biomedical research into the epidemiology and pathophysiology of symptoms and the mechanisms of symptom relief, the foundation for improved care at the end of life requires social, behavioral, and health services research. More needs to be understood about the emotional, social, cultural, and spiritual experiences of people who are dying and about the attitudinal, organizational, legal, cultural, and other factors which influence the care of those persons.
Currently, issues related to research methods play an important role in constraining 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 the scientific knowledge base for end-of-life care can only occur if resources are committed to these fundamental requirements.
Deficiencies in basic scientific knowledge about dying affect, at some point, the care of every individual. Biomedical, behavioral, social, and health services research is needed to provide the scientific foundation to support public and professional efforts to improve care at the end of life.
Specific areas of interest include, but are not limited to, the following topics:
Ethics and clinical decisionmaking
Context of care delivery
Research applications may be descriptive or correlational, but where possible should be hypothesis-driven. New knowledge should be anticipated that can be generalized beyond the program being studied. Applicants may propose secondary analyses of existing data, provided that new questions will be answered. Applications addressing the methodologic issues that constrain research into the care of the dying would also be appropriate.
Applicants are encouraged to make use of ongoing research efforts, where feasible. Applications from institutions that have a General Clinical Research Center (GCRC) may wish to identify these programs as a resource for conducting the proposed research. If so, a letter of agreement from the program director or the Principal Investigator should be included with the application.
Inclusion of Women and Minorities in Research Involving Human Subjects
It is the policy of the NIH and AHCPR 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 on the Inclusion of Women and Minorities as Subjects in Clinical Research," published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and printed in the NIH Guide for Grants and Contracts of March 18, 1994. AHCPR follows these guidelines, as applicable.
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 subject research conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the Inclusion of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at: http://www.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.
Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows staff to estimate the potential review workload and avoid conflict of interest in the review.
The letter of intent is to be sent to:
Robin L. Gruber, M.P.S.
The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from:
Division of Extramural Outreach and Information Resources
The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the "Yes" box must be marked.
Submit a signed, typewritten original of the application, including the Checklist, and five signed photocopies, in one package to:
Center for Scientific Review
At the time of submission, please also send one additional copy of the application to:
Robin L. Gruber, M.P.S.
Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review.
The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique.
Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness by the participating institutes. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the CSR in accordance with the review criteria stated below. As part of the initial merit review, a process will be used by the initial review group in which applications 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 the applications under review, will be discussed, assigned a priority score, and may receive a second-level review by the institutes' National Advisory Councils or Boards.
The goals of the supported research are to advance our understanding of biologic systems, improve the control of disease, improve health care services, 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.
In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following:
The initial review group will also examine the provisions for the protection of human subjects and the safety of the research environment.
Letter of Intent Receipt Date: April 30, 1999
Award criteria that will be used to make award decisions include:
Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome.
Direct inquiries regarding general programmatic issues to:
Dr. June Lunney
Dr. Claudette G. Varricchio
Dr. Richard L. Nahin
Dr. Frederick Batzold
Dr. Patricia Bryant
Dr. David M. Stoff
Dr. Sidney M. Stahl
Dr. Cheryl A. Kitt
An application in response to this RFA may be of interest to the National Heart, Lung, and Blood Institute (NHLBI). Possible assignment to that institute will be considered on a case-by-case basis depending on the objectives of the study. For inquiries regarding NHLBI programmatic issues, contact:
Dr. Gail G. Weinmann
Direct inquiries regarding fiscal matters to:
Mable L. Lam
William T. Wells
Diana S. Trunnell
Karen D. Shields
Authority and Regulations
This program is described in the Catalog of Federal Domestic Assistance, No. 93.361 (Nursing Research), No. 93.226 (AHCPR), No. 93.399 (Cancer Control), 93.213 (Alternative Medicine), No. 93.855 (Immunology, Allergy, and Transplantation Research), No. 93.856 (Microbiology and Infectious Disease Research), No. 93.121 (Dental), No. 93.242 (Mental Health), No. 93.866 (Aging), and No. 93.854 (Neurology). Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and Title IX (42 USC 299-299c-6). Awards are administered under PHS grants policies and Federal Regulations 42 CFR 52 and 67, subpart A, and 45 CFR Part 74. 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 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, 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.
AHCPR Publication No. 99-R034
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