RESEARCH TO IMPROVE CARE FOR DYING CHILDREN AND THEIR FAMILIES RELEASE DATE: July 29, 2002 RFA: NR03-003 National Institute of Nursing Research (http://www.ninr.nih.gov) National Institute of Mental Health (http://www.nimh.nih.gov) LETTER OF INTENT RECEIPT DATE: October 28, 2002 APPLICATION RECEIPT DATE: November 22, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanisms of Support o Funds Available o Eligible Institutions o Individuals Eligible to become Principal Investigators o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute of Nursing Research (NINR) and the National Institute of Mental Health (NIMH) invites applications for research grants to encourage research that will improve the quality of life for children who are approaching the end of life and the quality of the dying process and bereavement following the death for the children"s families, friends and other care providers. For this RFA, family is defined broadly in terms of traditional families and non-traditional families including children being cared for in foster situations, by distant relatives, or friends. RESEARCH OBJECTIVES Background A recent Institute of Medicine (IOM) report, "When Children Die: Improving Palliative and End of Life Care for Children and Their Families," highlights the importance of facing the challenges of caring for dying children and their families (IOM, 2002). (Hyperlink: http://www.iom.edu). In 1997, the five leading causes of death in children under the age of 15 were accidents, congenital anomalies, cancer, homicide and diseases of the heart (National Vital Statistics Report, 1999). While these deaths are relatively uncommon in the United States (55,000 in 1999), the international burden of childhood death is staggering. For example, the Joint United Nations Program on HIV/AIDS (UNAIDS) estimates that 580,000 children under the age of 15 succumbed to HIV/AIDS during 2001. Regardless of the number of deaths, the death of a child can be a devastating event for the family, friends and care providers. Despite the importance of this issue, there is very little science to guide the care of dying children and their families. What is known is primarily anecdotal. For example, many, if not most, care providers avoid discussing the possible death of a child with the families and the children themselves. This reluctance leads to care that focuses so single-mindedly on cure or life-prolongation that the possibility (or even likelihood) of death is ignored and the potential burdens of treatment are not adequately weighed against potential benefits. Consequently, opportunities to combine curative therapies, such as anticancer regimens, with palliative therapies that will prevent or relieve a child"s suffering are neglected. The cause of the child"s death is important to consider. When a child dies of a sudden and unexpected event, the parents, siblings, extended family and friends become the focus. Interactions between the family and the health care providers in the emergency room or between the family and other emergency response personnel can leave a lasting, and often unpleasant memory with the survivors. When a child dies of a chronic condition, such as cancer, it is likely that the family and the health care providers have established relationships that are truncated when the child dies. Loss of this ongoing support system can impair the family"s ability to cope with the loss of their child, particularly if health care providers have served as the primary support, as can be the case with stigmatized illnesses such as HIV/AIDS. The death of a child due to a genetic illness or to HIV/AIDS adds further complexity because parents sometimes feel guilty for passing the life-threatening illness to their child. Genetic illnesses or HIV/AIDS may be one of the few scenarios where there can be foreknowledge of impending death in a child who is currently in good health or where a fatal congenital condition can be diagnosed prenatally. Children dying from stigmatized diseases such as AIDS may face significant barriers to high-quality end-of-life care. No matter the cause of death, health care providers need to focus on promoting the quality of life of the child and family. Managing symptoms, such as cancer related pain or chemotherapy induced nausea and vomiting, can be particularly difficult in children because of dosing uncertainties, side effects and the reluctance of care providers to give opiate medications to children. Communication with the child and family that focuses on cure, rather than the potential for death, can also affect the quality of life at the end of life because the child may be unaware that he/she is dying. Age appropriate communication that includes the child and family can prevent unwanted interventions and facilitate a peaceful death. The siblings of chronically ill children are often isolated and grieve in silence or harbor feelings of anger and guilt as family attention and resources are focused on the ill child. Ways to appropriately include and support siblings throughout the dying process need to be elucidated. Where the child dies can have a profound impact on his/her quality of life at the end of life and the family"s experience of the dying process. When the possibility of death has not been discussed until very late in the dying process, dying children are often admitted to intensive care units and die a "high tech" death. Such deaths can isolate the family from the dying child and prevent a peaceful death. Research is needed to identify and test approaches that care providers can implement to improve the care of dying children in all settings, including children dying from a stigmatized illness such as HIV/AIDS in areas with limited resources. Research Scope The chapter on research directions in the IOM report (2002) offers suggestions for future research directions regarding care for dying children and their families. Examples of potential research topics include, but are not limited to the following: o Identify age specific end-of-life issues from preterm babies through adolescents and determine how the age of the parents influences the dying process. o Test ways of integrating palliative care with life prolonging therapies in children with life threatening illnesses. o Identify the dying trajectories of children (e.g., sudden death vs. life threatening condition) and determine if interventions can and should be structured according to the trajectories. o Test interventions to facilitate communication among health professionals and the extended family in different situations such as prenatal diagnosis of a fatal condition, premature birth, and death of a child from traumatic injury or chronic illness such as cancer. o Evaluate the role of health care providers in the lives of chronically ill children and their families, especially when the emphasis changes from cure to end-of-life care, or when families have few supports outside of the health care system. o Study school-based interventions to assist teachers and classmates who are continuing to interact with the child through a life threatening illness. Interventions may include ways to reduce stigma and improve palliative care in this environment. o Determine ways to help a child cope with the visible signs (e.g., hair loss, fatigue, frequent absences, medication regimes) of their illness or treatments. o Evaluate effective bereavement interventions for siblings, parents, and other family members or caregivers and determine the effect the type of death (e.g., violence, suicide, cancer, stigmatized illness) has on the bereavement process. o Study hope versus uncertainty in the rapidly evolving field of genetics where advances such as transplants and gene therapy are prolonging life well beyond expectations. o Identify specific issues in vulnerable children (e.g., those who are from resource poor settings, handicapped, stigmatized or who have experienced multiple losses, ) who are diagnosed with life threatening conditions. Develop and test culturally relevant interventions to support the child and family through death and bereavement in domestic and international settings. o Determine approaches appropriate to the cognitive and emotional maturity of the child, to assess and manage physical and psychological symptoms associated with conditions that are likely to be fatal. o Test culturally sensitive communication models, appropriate to the cognitive and emotional maturity of the child, that involve him/her in decision making throughout a life threatening illness and death. o Evaluate the effect of a child"s death on the family unit, especially siblings, including the financial impact and long-term consequences. o Develop and test culturally sensitive individual, peer, family, community and structural interventions that promote a peaceful death for the child within the cultural context of the family. MECHANISMS OF SUPPORT This RFA 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 the end of life for children and their families. Investigators are encouraged to explore the feasibility of an innovative research question or approach that will provide a basis for future research project applications. Exploratory/developmental grants (R21) are limited to 3 years of support and up to $125,000 per year in direct costs. For further guidance on the R21 mechanism, please see: http://grants1.nih.gov/grants/guide/pa-files/PA-99-134.html. This RFA is a one-time solicitation. Future unsolicited, competing continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is July 1, 2003. This RFA uses just-in-time concepts. It also uses modular and non- modular grant formats. (see https://grants.nih.gov/grants/funding/modular/modular.htm). If you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise, follow the standard PHS 398 application instructions for detailed budgets. FUNDS AVAILABLE NINR intends to commit approximately $2 million in FY 2003 to fund 5-7 applications in response to this RFA. NIMH intends to commit approximately $500,000 in FY 2003 to fund 1-3 new and/or competitive continuation grants. For the R01 mechanism, an applicant may request up to 5 years of support and up to $340,000 per year in direct costs. For the R21, applicants may request up to 3 years of support and up to $125,000 per year in direct costs. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each application will also vary. Although the financial plans of the NINR provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution/organization 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 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 inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Dr. Ann Knebel Office of Extramural Programs National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-5966 FAX: (301) 480-8260 Email: ann_knebel@nih.gov Dr. Nicolette Borek Center For Mental Health Research on AIDS National Institute of Mental Health 6001 Executive Blvd., Room 6206, MSC 9619 Bethesda, MD 20892-9619 Telephone: (301) 443-4526 FAX: (301) 443-9719 Email: nborek@mail.nih.gov o Direct your questions about peer review issues to: Dr. John Richters Office of Review National Institute of Nursing Research 6701 Democracy Blvd, Room 707, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-5971 FAX: (301) 451-5645 Email: john_richters@nih.gov o Direct your questions about financial or grants management matters to: Ms. Cindy McDermott Office of Grants and Contracts Management Division of Extramural Activities National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-6869 FAX: (301) 451-5648 Email: cindy_mcdermott@nih.gov Brian Albertini Grants Management Branch Division of Extramural Activities National Institute of Mental Health 6001 Executive Blvd, Room 6134, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-0004 FAX: (301) 443-6885 Email: balberti@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Dr. John Richters Office of Review National Institute of Nursing Research 6701 Democracy Blvd, Room 707, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-5971 FAX: (301) 451-5645 Email: john_richters@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 https://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. 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). 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 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 https://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular applications. Additional information on modular applications is available at https://grants.nih.gov/grants/funding/modular/modular.htm. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center For Scientific Review National Institutes Of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Dr. John Richters Office of Review National Institute of Nursing Research 6701 Democracy Blvd, Room 707, MSC 4870 Bethesda, MD 20892-4870 APPLICATION PROCESSING: 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. 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the (IC). Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, CSR staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. 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 NINR in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Advisory 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 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: o 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. o 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) o DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: October 28, 2002 Application Receipt Date: November 22, 2002 Peer Review Date: February/March 2003 Council Review: May 2003 Earliest Anticipated Start Date: July 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. 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: https://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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are available at https://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 https://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 https://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 https://grants.nih.gov/grants/stem_cells.htm and at https://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 https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation. Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance Nos. 93.361 (NINR) 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 https://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 discourages 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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