IMPROVING CARE FOR DYING CHILDREN AND THEIR FAMILIES RELEASE DATE: February 5, 2004 PA NUMBER: PA-04-057 January 3, 2007 - Effective with the February 5, 2007 submission date, all R01 applications must be submitted through using the electronic SF424 (R&R) application. Accordingly, the R01 portion of this funding opportunity expires on January 3, 2007. Unsolicited or investigator-initiated R01 electronic SF424 (R&R) applications may be submitted through the Research Project Grant (Parent R01) announcement. 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 using the electronic SF424 (R&R) application. This announcement will stay active for only the May 1, 2006 AIDS and AIDS-related application submission date for these mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms expires on the date indicated below. Other mechanisms relating to this announcement will continue to be accepted using paper PHS 398 applications until the stated expiration date below, or transition to electronic application submission. 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 for AIDS and non-AIDS applications thereafter. Applications relating to R33 and R34 activities must be in response to NIH Institute/Center (IC)-specific announcements. EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006 EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006 EXPIRATION DATE for All R01 Applications: January 3, 2007 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) ( COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute of Nursing Research (NINR) ( National Cancer Institute (NCI) ( National Institute of Child Health and Human Development (NICHD) ( CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.361 (NINR), 93.865 (NICHD), 93.395 (NCI) 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 Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute of Nursing Research (NINR), the National Cancer Institute (NCI), and the National Institute of Child Health and Human Development (NICHD) invite applications to encourage research that will improve the quality of life for children who are approaching the end of life, the quality of the dying process, and bereavement following the death for the children's families, friends and other care providers. For this PA, 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. Children are defined according to NIH as individuals below 21 years of age. Attention to children of all developmental stages, infancy through adolescence, is highly encouraged. RESEARCH OBJECTIVES 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). 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 scientific knowledge 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. This initiative fits with the overall NIH Roadmap activities that are underway, particularly the two goals of increasing the interdisciplinary research teams of the future and re-engineering the clinical research enterprise. 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 infancy through adolescence and determine how the age of the child and or 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 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 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. 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 Test interventions to determine the optimum time to initiate end-of life options and the impact of early versus later initiation on the dying and the bereavement process (e.g., prenatal diagnosis of a fatal condition, very premature or very low birth weight birth, traumatic injury or chronic illness such as cancer). o Evaluate the effect of a child's death on the family unit, especially siblings. 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 PA will use the NIH R01 and R21 award mechanisms. All participating Institutes have agreed to follow the NIH Guidelines for the R21 mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The objective of the R01 mechanism is to support a discrete, specified circumscribed 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 improving care for dying 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 projects. Exploratory/developmental grants (R21) are limited to 2 years of support with a combined budget for direct costs of up $275,000 for the two-year period. For example, the applicant may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of the project. Normally, no more than $200,000 may be requested in any single year. Please see the NIH-wide R21 program announcement (PA-03-107) (see Please see the "Submitting an Application" section for more details. This PA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats (see Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format. Otherwise follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign institutions/organizations o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Data and safety monitoring is required for all types of clinical trials. The establishment of data and safety monitoring boards (DSMBs) is required for clinical trials involving interventions that entail potential risk to the participants. Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking more than $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Dr. Alexis D. Bakos Office of Extramural Programs NIH, National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-2542 Fax: (301) 480-8260 Email: Dr. Lynne M. Haverkos Child Development and Behavior Branch NIH, National Institute of Child Health and Human Development 6100 Executive Blvd., Room 4B05, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6881 Fax: (301) 480-0230 Email: Dr. Ann O Mara Division of Cancer Prevention NIH, National Cancer Institute 6130 Executive Boulevard, Room 2011, MSC 7340 Bethesda, MD 20892-7340 Telephone: (301) 496-8541 Fax: (301) 496-8667 Email: o Direct your questions about financial or grants management matters to: Diane E. Drew Office of Grants and Contracts Management NIH, National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-2807 FAX: (301) 451-5651 or (301) 402-4502 Email: SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at in an interactive format. For further assistance contact Grants Info, Telephone (301) 710-0267, Email: The title and number of this program announcement must be typed on line 2 of the face page of the application and the YES box must be checked. SUPPLEMENTARY INSTRUCTIONS When submitting an R21 application, all instructions for the PHS 398 (rev. 5/2001) must be followed, with these exceptions: o Research Plan Items a - d of the Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed a total of 15 pages. No preliminary data is required but may be included if it is available. Please note that a Progress Report is not needed; competing continuation applications for an exploratory/developmental grant will not be accepted. Appendix. Use the instructions for the appendix detailed in the PHS 398 except that no more than 5 manuscripts, previously accepted for publication, may be included. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget grant format. The modular budget 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 includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting 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 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 mailed on or before the receipt dates described at 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 unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures ( will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o 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 written critique o Receive a second level review by the appropriate national advisory council or board REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment 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. 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? 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? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 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)? 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: The NIH R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools or technologies that have the potential to significantly advance our knowledge or the status of health- related research. Because the research plan is limited to 15 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications. PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. The Final NIH Statement on Sharing Research data is found at 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 HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking more than $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. 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 "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 (; a complete copy of the updated Guidelines are available at 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 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 HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, 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 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website ( provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at 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 AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at 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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