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FINE MAPPING GENES AND GENE VARIANTS FOR DRUG ADDICTION SUSCEPTIBILITY RELEASE DATE: September 24, 2003 PA NUMBER: PA-03-175 EXPIRATION DATE: January 21, 2006, 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 on Drug Abuse (NIDA) (http://www.nida.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.279 THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This PA seeks investigator-initiated applications for research that builds on the initial goals of the RFA DA-99-003 and PA-00-115, "Genetics of Drug Addiction Vulnerability," which were to identify chromosomal regions involved in addiction and addiction vulnerability (including addiction to, or dependence on, stimulants, narcotics, nicotine, benzodiazepines, barbiturates, cannabis, hallucinogens and/or poly drug abuse). Once chromosomal regions are identified, the natural progression of the research is to identify the gene and gene variants responsible for the initial localization of the chromosomal region. The objectives of this PA, then, are to build on, encourage and support innovative research from investigators who have, or can obtain access to data and resources to conduct fine mapping of chromosomal regions and quantitative trait loci (QTL) involved in addiction vulnerability and/or can uncover genetic variants within those regions to assess their association with addiction vulnerability. Mapping susceptibility genes for common, complex diseases like addiction are difficult, in part, due to the tenuous correlations between genotype and phenotype. For this reason, applicants must demonstrate the availability of well-characterized families with addiction and/or well-characterized genetic animal models of addiction in which linkage has already been demonstrated. Successful applicants are encouraged to take part in the NIDA Genetics Consortium through the NIDA Center for Genetic Studies. In addition, this PA encourages the development of proposals to fine map quantitative trait loci (QTLs) and ENU induced mutations in mice and rodents associated with responses to substances of abuse. Many of these QTLs span large regions, where the underlying genetic variant(s) responsible for the QTL remains unknown. Knowledge of the complete sequence of the mouse and human genomes, the use of congenic, consomic, and transgenic strains, and the use of gene expression profiling to map genetic variants that control gene expression now make it possible to fine map QTLs involved in responses to substances of abuse. These studies may be informative for human candidate gene studies of addiction. Wide distribution to the scientific community of the methods and data resulting from this program is essential to establishing validity of molecular targets identified. Wide distribution will also facilitate the rapid transfer of technology for the development of diagnostic tools and treatment interventions for addiction disorders. For additional NIDA funding opportunities in genetics, refer to the NIDA Genetics Workgroup homepage http://www.nida.nih.gov/genetics/geneticshome.html. RESEARCH OBJECTIVES Background Drug addiction is a genetically complex disease in which many genes and many environmental factors interact. Identification of the gene variants associated with substance abuse disorders will greatly facilitate the characterization of the contributions that genes and environment play in the development of substance abuse disorders. Since there has been progress in determining chromosomal regions that show linkage to certain drugs of abuse (for review, see Uhl et al, Trends in Genetics, 2002 18(8):420-5), and to the extent the necessary resources are accessible to investigators, now is an opportune time for research to gradually move from initial chromosomal localization towards gene identification. Therefore, the next step is to generate fine maps of these chromosomal regions to the level of the gene and the variations within those genes. Fine mapping these very large (megabase) regions, in which there may be hundreds of biologically plausible candidate genes, is cumbersome. For this reason, applicants should: 1) focus on a specific drug of abuse, 2) focus on specific well-explained phenotypes associated with that drug, and 3) consider combining several approaches to strengthen and expedite the identification of relevant genes and gene variants (for example, traditional positional mapping approaches combined with gene expression profiling in post-mortem human brain tissue). Association studies in candidate genes and haplotype analyses are also favorable approaches in identifying relevant genes and variants. Fine mapping QTLs and/or chemically induced mutations in mice has been made possible by the development of consomic and congenic strains, and knowledge of the sequence of the mouse genome. Combining QTL analyses with gene expression profiling will help in the identification of gene variants responsible for QTLs or induced mutations in mice associated with responses to drugs of abuse, and may assist in the development of strategies for identifying candidate genes for substance abuse disorders in humans. Research Scope This initiative is primarily intended to support follow-up research conducted under the RFA DA-99-003 and PA-00-115 and to solicit applications to fine map the gene(s) and gene variants to chromosomal regions shown to be associated with addiction and addiction vulnerability, and then to demonstrate that the variation in the gene(s) is associated with addiction. Thoughtful documentation on the use of heritable phenotypic definitions and high statistical rigor is vital. Applicants who are seeking to link chromosomal regions to substance abuse disorders or addiction phenotypes or to recruit new subjects for identifying gene variants for addiction vulnerability should respond to PA-03-155, "Molecular Genetics of Addiction Vulnerability." Fine mapping QTLs affecting drug response in rodents is also within the scope of this PA. The types of projects supported by this initiative include but are not limited to: o Gene Identification - Some addiction vulnerability traits have been linked to multiple regions of the genome. Research is needed to identify specific genes and polymorphisms within those genes that lie within these linkage regions. Prioritizing a candidate gene list combined with other, more high- throughput approaches, is encouraged. o Association Studies – Specific gene variants have been shown to be more strongly associated with addiction phenotypes (ex., withdrawal). Validation of existing studies is an essential component in identifying addiction- associated variants. Testing candidate variants and haplotype variants is encouraged. Particular attention to phenotype definition and statistical limitations must be clearly addressed. o Gene x Environment and Gene x Gene Interactions – Candidate chromosomal regions identified by linkage studies may not account for the variability in addiction. Thus, studies examining gene x environment and gene x gene interactions are also encouraged. o Mouse Models – A number of mouse models have provided important genetic clues through identification of QTLs or ENU induced mutations that can then be further fine mapped and extrapolated to humans by syntenic localization. Mouse models with careful attention to phenotype definition are needed to refine QTLs and identify genes associated with addiction. Data Sharing Plan: Dissemination of Data and Biological Materials The sharing of biological materials, interview and other assessment data, and genotype information (including software) in a timely manner has been an essential element in the rapid progress that has been made in the genetic analysis of human diseases. PHS policy states that investigators must make unique research resources readily available for research purposes to qualified individuals within the scientific community when first results based on these resources have been published (PRINCIPLES AND GUIDELINES FOR RECIPIENTS OF NIH RESEARCH GRANTS AND CONTRACTS ON OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES), published on December 23, 1999 in the Federal Register, http://ott.od.nih.gov/NewPages/RTguide_final.html. Accordingly, to address the interests of the research community and government in promoting the science of the genetic basis of drug addiction vulnerability, NIDA expects applicants who respond to this PA to develop and propose detailed plans for sharing the data and materials generated through the grant. It is expected that the Data Sharing Plan will specify the following elements: 1) creation of comprehensive and verified databases that contain all clinical, diagnostic, pedigree structure, and genotypic information collected and produced by the grant, 2) a mechanism or protocol by which all databases and biological materials (DNA samples, cell lines) can be widely searched or distributed to qualified investigators in the scientific community, 3) a timetable specifying when various elements of the database (e.g., diagnostic, assessment, or genetic data) will be available for distribution. Investigators are encouraged to use the data management resources of the NIDA Center for Genetic Studies to comply with these expectations. For more information about NIDA's policy concerning sharing of research resources and data dissemination see NIDA Human Molecular Genetics Research: Frequently Asked Questions (FAQs) http://www.nida.nih.gov/about/organization/genetics/FAQ_DataSharing.html. In addition NIDA expects mouse resources, rat resources, or any other research resources generated with the aid of NIH funding to be distributed in a timely fashion and shared with the scientific community. Investigators submitting an NIH application must include a concise plan addressing the timely distribution of these resources, unless the proposed research will not generate such resources. The NIDA Genetics Consortium (NGC) The nucleus of the NIDA Genetics Consortium (NGC) are investigators who have been awarded grants under the RFA, "Genetics of Drug Addiction Vulnerability" (DA-99-003) as well as those who have modified their projects to conform to the guidelines listed in that RFA to use the resources provided by the NIDA Center for Genetics Studies. The NIDA Center for Genetics Studies is a resource for creating databases, cell lines, and DNA samples, and for wide distribution of the data and DNA to the scientific community. After a proprietary period, the NIDA Center for Genetics Studies will, upon proper application and approval, distribute both the data and DNA samples to qualified researchers. Clinical data and DNA from projects of investigators belonging to the NIDA Genetics Consortium will begin to be available for analysis in July 2005. The process for gaining access to this resource is described in the following document (Frequently Asked Questions About the NIDA Center For Genetic Studies) http://www.nida.nih.gov/about/organization/genetics/FAQ_GeneticStudies.html. Investigators interested in knowing what research projects participate in the NIDA Genetics Consortium (NGC) should see http://zork.wustl.edu/. Members of the NGC meet two times a year to discuss issues related to the molecular genetics of addiction vulnerability. MECHANISM OF SUPPORT This PA will use the NIH research project (R01) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This PA uses just-in-time concepts. It also uses the modular budgeting 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 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 http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. 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 Principal Investigators and key personnel as appropriate are expected to adhere to the NIDA Data Sharing Plans and participate in the NIDA Genetics Consortium. Funds for travel to the meeting should be requested in the budget. 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: Joni L. Rutter, Ph.D. Division of Neuroscience and Behavioral Research National Institute on Drug Abuse, NIH, DHHS 6001 Executive Boulevard, Room 4282, MSC 9555 Bethesda, MD 20892-9555 Telephone: (301) 435-0298 Fax: (301) 443-594-6093 Email: jrutter@nida.nih.gov o Direct your questions regarding financial or grants management matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: gf6s@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 NIH program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from NIH staff that NIH 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 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 (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 an appropriate 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 the 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: 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://grants.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. 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 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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