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INTERACTIONS BETWEEN STEM CELLS AND THE MICROENVIRONMENT IN VIVO RELEASE DATE: September 16, 2003 PA NUMBER: PAS-03-172 EXPIRATION DATE: February 1, 2005 unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) National Institute of Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov) National Institute of Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov) National Institute on Aging (NIA) (http://www.nia.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.853 (NINDS), 93.279 (NIDA), 93.173 (NIDCD), 93.273 (NIAAA), 93.866 (NIA) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements 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 National Institute of Neurological Disorders and Stroke (NINDS), the National Institute on Drug Abuse (NIDA), the National Institute of Deafness and Other Communication Disorders (NIDCD) the National Institute of Alcohol Abuse and Alcoholism (NIAAA), and the National Institute on Aging (NIA) invite applications for studies on the cellular and molecular signaling between the local environment within organisms and stem and progenitor cells that are either introduced as transplants or are normally resident within host tissues and organs. The objective of this initiative is to promote a thorough exploration and characterization of the bi-directional communication between multipotent cells and the three-dimensional local milieu or niche that they encounter in vivo under normal and compromised states, such as with aging or following injury, disease or drug exposure. Of particular interest is the rigorous characterization of how interactions with localized cues in space and time regulate stem cell survival, migration, replication and 'plasticity' in the nervous system and other parts of the body. Projects that address comparisons between the responses of stem cells within niches in the developing and mature or aging nervous system in vivo, or in host microenvironments modified by injury, disease, or by exposure to drugs and alcohol would also be directly relevant to this Program Announcement with Set-aside (PAS), as are studies to compare different classes of stem cells or progeny at progressively more advanced stages of differentiation when placed in the same sites in vivo. RESEARCH OBJECTIVES Unlike organs such as the skin and the gut that self-renew throughout life, the nervous system in adult mammals is restricted in its ability to replace neurons and glia that have been lost through injury, disease, alcohol and drug abuse or even advancing age. Stem cell research offers enormous potential for treating many congenital, developmental, psychiatric or degenerative diseases of the nervous system for which there are no treatments or cures. Under the appropriate tissue culture conditions, a variety of multipotent cells appear to acquire many properties of neurons and glia – a first step toward developing cell replacement therapies for neurological dysfunction. The discovery of endogenous stem cells, residing either within the nervous system or in other tissues raises the possibility that these intrinsic systems may be harnessed to restore defective cells and functions. In both cases the expectation is that, when exposed to the optimal microenvironment in vivo, endogenous or transplanted stem cells will differentiate in a manner appropriate to the local brain region, and integrate with the existing circuits in the nervous system. The past decade has seen enormous progress in our understanding of the specific requirements of stem cells to proliferate and differentiate along specified lineages. This progress has been made possible by the discovery of myriad growth factors and substrate conditions followed by careful testing in culture. Unfortunately, the behavior of cells in tissue culture does not adequately predict how these same cells will behave when transplanted into the living host where multiple known and unknown factors converge to influence the biological process. We do not know the whole spectrum of factors present in vivo that influence cell fate. Effective use of stem and progenitor cells for therapeutic purposes hinges on their ability to thrive, integrate, and function in a biologically meaningful manner in vivo without causing adverse events. Therefore the next stage in developing cell restoration therapy requires understanding how the newly generated cells will behave within the host. Recent reports indicate that the "niche" or local microenvironment that a stem cell encounters governs its behavior and fate. For example, adult neural stem cells produced neurons when transplanted into the neurogenic zone of the hippocampus, but produced astrocytes in the environment of the spinal cord. Further investigation showed that a specific component of the local environment, the regional astrocytes from the hippocampus were capable of instructing these stem cells to adopt a neuronal fate in vitro. In addition to regional differences within the nervous system, the microenvironment encountered by a stem cell may vary as a function of age of the host organism. Similarly, alteration of the niche by injury, drugs or other circumstances is likely to affect the ability of transplanted stem cells to survive, differentiate and integrate into existing neural circuitry. Understanding these changes will be important in making decisions about the use of cell replacement therapies in very young or elderly patients, in patients with a history of alcohol or drug usage, or suffering from injury or other neurological conditions. Transplanted cells can act to influence and change host cells in their vicinity. Stem cells may release agents that alter the activity or resiliency of damaged host cells. These dynamic interactions are inevitable as living cells and tissue contact, react and respond to each other in time and space. Teasing out and understanding these interactions poses a major challenge that must be faced in order to develop realistic cell replacement therapies and enhance normal tissue regeneration. Objectives and Scope This Program Announcement with Set-Aside is intended to promote studies that establish and identify the nature and action of microenvironmental cues in the nervous system that regulate stem cell fate. This Program Announcement specifically targets cellular, molecular and genetic mechanisms that act in vivo to influence stem cell survival, homing/migration, adhesion, differentiation, plasticity and tumorigenicity in both the central and peripheral nervous systems. Applications that only propose in vitro studies will not be responsive to this initiative. The following examples illustrate areas that are of high interest; other innovative projects are also encouraged. These examples of research approaches are not meant to be all-inclusive or restrictive. Plans for data and/or reagent sharing and promulgation of results will be integral to the applications. o Identification, localization and comparison of known or novel cues within the developing, adult and aging nervous system that influence the mitotic potential, cell cycle and differentiation of stem and progenitor cells along specific lineages. o Characterization of the cell-extrinsic and cell-intrinsic signaling pathways and components involved in transducing the action of local cues on stem and progenitor cells in vivo. o Investigation of the causal relationship between site-specific changes of endogenous cues resulting from injury, disease, exposure to alcohol, drugs of treatment or abuse, and any resulting alterations of stem cell activity. o Evaluation of the effects of external factors such as stress, exercise, or an enriched versus impoverished living conditions on the microenvironment within the host organism, and how these changes in microenvironment influence the behavior of stem cells at different periods throughout the life span of the organism. o Investigation of local cellular interactions that determine and maintain the structural and functional integration of progenitor cells into the host nervous system and existing circuitry. o Development of assays facilitating the discovery of novel endogenous signals that modulate stem cell behavior and fate, as well as signals generated by stem cells that regulate components of the local host tissue. These may include the development of measures (physiological, behavioral, neurochemical, imaging) to evaluate the integration and function of progenitor cells in the developing, adult and aging nervous system. o Assessment of the short and long-term local effects of the interactions between the immune system and glial reactions gendered in response to the infiltration of stem cells and their progeny in the host. The NIDA is interested in how drugs of abuse and factors such as stress and environment affect the behavior of stem cells and the functional consequences of such alterations, which might be related to the cognitive impairments, developmental deficits, neuroadaption and addictive behaviors seen in drug abuse. The NIDCD is particularly interested in stem cell research targeting the various peripheral components of the auditory (hearing), olfaction (smell) and gustatory (taste) systems. The NIAAA is interested in how alcohol exposure alters the biochemical environment of tissues, thus interfering with the capacity of stem cells to establish contact, differentiate and function in target tissue. The NIA is interested in stem cell research and neurogenesis in the aging nervous system with emphasis on basic neurobiology, motor and sensory systems, integrative neurobiology, cognition and the dementias of aging, particularly Alzheimer's disease. MECHANISM(S) OF SUPPORT This PAS will use the NIH Exploratory/Developmental Grant (R21) and the Research Project Grant (R01) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The proposed project period during which the research will be conducted should adequately reflect the time required to accomplish the stated goals and should be no more than 5 years for R01 grants. The R21 grants are one-time awards to support innovative, high impact research projects that would either 1) generate pilot data to assess the feasibility of a novel avenue of investigation, 2) involve high risk experiments that could lead to a breakthrough in a particular field, or 3) demonstrate the feasibility of new technologies that could have major impact in a specific area. Support for the R21 grants is limited to two years with a cumulative maximum of $275,000 direct costs requested for both years. This program is appropriate both for new investigators seeking to establish independent research careers and for established investigators wishing to explore new areas of neuroscience or develop novel technologies. For further information on the R21 mechanism, including Institute-specific information, see http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html This PAS uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non- modular research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE The participating ICs have set aside a total of $2 million dollars per year to support this initiative. The amount and timing of awards paid from set aside funds will depend on the overall scientific merit of the applications and the availability of funds throughout the duration of this solicitation (2 years). 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 award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this PAS 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 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 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 Upon initiation of the program, the participating institutes will sponsor an annual meeting to encourage the exchange of information among investigators who participate in this program. In the preparation of the budget for the grant application, applicants should REQUEST ADDITIONAL TRAVEL FUNDS for one meeting each year to be held in Bethesda, Maryland. Applicants should also include a statement in the applications indicating their willingness to participate in such meetings. Applicants are also strongly encouraged to include plans for data and/or reagent sharing and promulgation of results. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PAS 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: Arlene Y. Chiu, Ph.D. Program Director, Repair and Plasticity Program National Institute of Neurological Disorders and Stroke Neuroscience Center, Room 2207, MSC 9525 Bethesda, MD 20892-9525 Telephone: (301) 496-1447 FAX: (301) 480-1080 Email: chiua@ninds.nih.gov Geraline C. Lin, Ph.D. Division of Neuroscience and Behavioral Research National Institute on Drug Abuse 6001 Executive Boulevard Room 4282, MSC 9555 Bethesda, MD 20892-9555 Telephone: (301) 435-1305 FAX: (301) 594-6043 Email: glin@nida.nih.gov Barry Davis, Ph.D. Director, Taste and Smell Program National Institute of Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C, MSC-7180 Rockville, MD. 20892-7180 Telephone: (301) 402-3464 FAX: (301) 402-6251 Email: davisb1@nidcd.nih.gov Sam Zakhari, Ph.D. Director, Division of Basic Research National Institute of Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0799 FAX: (301) 594-0673 Email: sz14w@nih.gov Bradley C. Wise, Ph.D. Program Director, Fundamental Neuroscience Neuroscience and Neuropsychology of Aging Program National Institute on Aging 7201 Wisconsin Avenue, Suite 350 MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9350 FAX: (301) 496-1494 Email: wiseb@nia.nih.gov o Direct your questions about financial or grants management matters to: Michael J. Loewe Chief, Grants Management Branch National Institute of Neurological Disorders and Stroke 6001 Executive Blvd., Suite 3290, MSC 9537 Bethesda, MD 20892-9537 Telephone: (301) 496-9231 FAX: (301) 402-0219 Email: ml70m@nih.gov Or to Gavin Wilkom Grants Management Specialist Grants Management Branch, DER National Institute of Neurological Disorders and Stroke Neuroscience Center, 6001 Executive Blvd. Room 3250, MSC 9537 Bethesda MD, 20892 Telephone: (301) 496-7480 FAX: 301-402-0219 Email: gw62m@nih.gov Michael Costa Grants Management Specialist Grants Management Branch National Institute on Drug Abuse 6001 Executive Boulevard Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 435-1354 Fax: (301) 594-6849 Email: mcosta@nida.nih.gov Ms. Sara Stone Chief, Grants Management Branch Division of Extramural Research National Institute of Deafness and Other Communication Disorders Executive Plaza South – 400C 6120 Executive Blvd. MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 402-0909 Fax: (301) 402-0219 Email: stones@nidcd.nih.gov Judy Fox Simons Chief, Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 504 Bethesda, MD 20892-7003 Telephone: (301) 443-4704 Fax: (301) 443-3891 E-mail: jsimons@willco.niaaa.nih.gov Linda Whipp Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212 MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 Fax: (301) 402-3672 E-mail: whippl@nia.nih.gov 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 http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR 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 http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PAS 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 PAS 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 (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o 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? 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). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 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. 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. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 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: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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. http://grants.nih.gov/grants/policy/data_sharing. 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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, 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 http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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 (http://www.hhs.gov/ocr/) 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 http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ 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 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 http://grants.nih.gov/grants/policy/policy.htm. 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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