TOOLS FOR COLLABORATIONS THAT INVOLVE DATA SHARING RELEASE DATE: June 4, 2003 PA NUMBER: PAR-03-134 (see addendum NOT-RR-04-007) LETTER OF INTENT RECEIPT DATE: August 15 2003, and June 15, 2004 APPLICATION RECEIPT DATES: September 15, 2003 and July 15, 2004 EXPIRATION DATE: August 1, 2004, unless reissued. National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov) National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov) National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov) National Library of Medicine (NLM) (http://www.nlm.nih.gov) Division of Chemistry, Directorate for Mathematical and Physical Sciences, National Science Foundation (CHEM) (http://www.nsf.gov/mps/divisions/che/start.htm) Division of Biological Infrastructure, Directorate for Biological Sciences, National Science Foundation (DBI) (http://www.nsf.gov/bio/dbi/start.htm) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.389 (NCRR), 93.286 (NIBIB), 93.287 (NIBIB), 93.279 (NIDA), 93.113 (NIEHS), 93.114 (NIEHS), 93.115 (NIEHS), 93.242 (NIMH), 93.853 (NINDS), 93.879 (NLM), 47.049 (CHEM), 47.074 (DBI). 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 Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA Over the past nine years the NSF, the NIH, and other federal agencies, have supported the development of network-based virtual laboratories, following the recommendations of the 1993 National Research Council (NRC) report National Collaboratories: Applying Information Technology for Scientific Research. As described in the NRC report, collaboratories are expected to improve the speed and output of scientific research through Internet access to instruments, data, and colleagues – independent of time and place. Many of the early collaboratory projects focused on remote control of distant equipment with less emphasis on data. Changes since 1993 in both the character of biomedical and chemical research, and in underlying computer and network technologies suggest a re-examination of the collaboratory concept with increased attention to data flow from acquisition to deposition in a data repository, data reuse after deposition, and integration of data across various repositories and databases. The purpose of this program announcement (PA) is to invite proposals to develop tools and techniques to harness the unprecedented volume of data generated by collaborations among researchers. Proposals dealing with data from either research laboratories or from the clinical laboratories are welcome. Using these new tools and techniques, it is expected that two or more laboratories will be able to productively collaborate in ways that are not currently possible. RESEARCH OBJECTIVES Great opportunities are possible as researchers combine rapidly improving information technology and the new availability of data with team and collaborative approaches that enable handling larger scale problems. Understanding these trends, the National Center for Research Resources convened a workshop in September 2002 (http://www.ncrr.nih.gov/biotech/collabmtg2002.asp). Members of that workshop were charged to review the state and future directions of collaboratories and associated technologies. They were asked to focus on opportunities created by the newly data rich environment of biomedical research. Workshop participants concluded that collaboratories focused on data can enable cross-disciplinary work, allow scientific activities to scale to a natural level (not being limited by physical constraints), promote greater data integration and access, build stronger research communities, and broaden the engagement in science beyond the traditional community. Collectively, these advances will drive the digitally enabled translational medicine of the future. Furthermore, the tools and techniques that are developed may help in addressing some of the management issues common to many large NIH or NSF supported projects. This PA invites proposals to develop collaborative tools and techniques that creatively manage and analyze large amounts of data that are generated during research and need to be shared among several (or many) groups. Until recently, data were generated in a single laboratory and served as the basis for publications in the peer-reviewed literature. While that pathway still exists, in the developing data rich environment a second pathway is emerging that is likely to become important. In this second pathway, the raw data generated by the initial laboratory are used by a second laboratory to make new discoveries that, in all likelihood, would not have otherwise been made. Access to this raw data raises a number of issues. How will access actually occur in the absence of a centralized database? How will the essential annotations (metadata) that are required to understand and use the data be attached? What new tools and techniques are necessary to make use of the existing and next generation cyber-infrastructure in order to transfer and process this data? What sort of incentives can be created to encourage sharing among researchers who have traditionally kept raw data in their own laboratory? These are examples of the types of questions that proposals submitted in response to this PA should address. The topics of interest include, but are not limited to: (1) tools and techniques for collaborative analysis, access, and visualization of data, (2) tools and techniques that ensure that new collaboration technologies are compatible with emerging middleware standards, including security and authentication controls, (3) tools that facilitate communication among collaborators, and (4) tools and techniques that facilitate the creation and curation of data repositories used in a collaborative fashion. Preference will be given to tools that operate on multiple desktop platforms and, if appropriate to tools that operate on larger systems. These tools should have applications beyond one isolated problem. These tools and techniques must allow two or more collaborators to accomplish science that otherwise would or could not be done working independently. It is important that these proposed tools and techniques have a formal, systematic evaluation component. The goal of this evaluation is to assess the impact of the newly developed technologies on the organization and conduct of science, as well as on the evolution of collaboratory-based communities. This requirement can be satisfied in one of two ways. Milestones can be presented in the text of the proposal. These milestones should provide quantitative targets for both the middle and end of the project period. Alternatively, an external evaluation of the tools and techniques can be proposed. This external evaluation should use tools and techniques from sociology or other appropriate social sciences. If this evaluation method is chosen, plans to present the results of the evaluation to the research community must be presented in the Research Plan. MECHANISM(S) OF SUPPORT This PA will use the NIH 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 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. 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 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 and NSF programs. SPECIAL REQUIREMENTS This proposal must contain a method to evaluate the use of the proposed tools and techniques. The applicant can choose from two methods to conduct this evaluation, "milestones" or "external evaluation". In either case, a specific section labeled Evaluation must be included following the Research Design and Methods. The goal of this evaluation is to assess the impact of the newly developed technologies on the organization and conduct of science, as well as on the evolution of collaboratory-based communities. If the milestones method is chosen, the milestones presented should be well described and scientifically justified. Milestones should not be simply a restatement of the specific aims. The milestones should be written so that a scientifically literate, non-expert individual will be able to compare the proposed milestones to the work presented in a progress report and decide whether the milestones have been achieved. In the application, milestones should be presented for the period half way through the grant and for the end of the grant. It is expected that progress toward achieving the milestones will be addressed in the annual progress report. It is also expected that the milestones will be used to evaluate any application for a competitive renewal. If the external evaluation method is chosen, the proposer must identify who the evaluators are, the techniques they will use, and how the results of the evaluation will be presented to the community. The evaluation section should be presented at the end of the Research Design and Methods section (D) of the Research Plan. This section should have a separate heading and must be included in the 25 page limit of the Research Plan. Applications lacking this information, as determined by NIH staff, may be returned to the applicant without review. In addition to the evaluation component, investigators must specify their plans to distribute the tools and techniques that they are going to develop. This information should have a separate heading, should follow the evaluation section in the Research Plan, and must also be included in the 25 page limit. Applications lacking this information, as determined by NIH staff, may be returned to the applicant without review. 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 three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Dr. Gregory K. Farber Division of Biomedical Technology National Center for Research Resources 6701 Democracy Boulevard, MSC 4874 Bethesda, MD 20892-4874 Telephone: (301) 435-0778 FAX: (301) 480-3659 Email: gf48a@nih.gov Dr. Grace Peng National Institute of Biomedical Imaging and Bioengineering 6707 Democracy Boulevard, MSC 5469 Bethesda, MD 20892-5469 Telephone: (301) 496-9178 Fax: (301) 480-4973 Email: gp119w@nih.gov Dr. Karen Skinner National Institute on Drug Abuse 6001 Executive Boulevard, Room 4271 Rockville, MD 20852 Telephone: (301) 443-1887 Fax: (301) 594-6043 Email: ks79x@nih.gov Dr. Claudia Thompson National Institute of Environmental Health Sciences MD EC-27 P.O. BOX 12233 Research Triangle Park, NC 27709 Telephone: (919) 541-4638 Fax: (919) 541-4937 Email: ct68w@nih.gov Dr. Michael F. Huerta Division of Neuroscience and Basic Behavioral Science National Institute of Mental Health 6001 Executive Boulevard, Room 7202, MSC 9645 Bethesda, MD 20892-9645 Telephone: 301-443-3563 FAX: 301-443-1731 Email: mhuerta@helix.nih.gov Dr. Yuan Liu National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Room 2110 Rockville, MD 20852 Telephone: (301) 496-1917 Fax: (301) 480-2424 Email: yl5o@nih.gov Dr. Carol Bean National Library of Medicine 6705 Rockledge Drive, Room 301 Bethesda, MD 20892-7968 Telephone: (301) 594-4882 FAX: (301) 402-2952 Email: cb389x@nih.gov Dr. Janice Hicks Division of Chemistry Directorate for Mathematical and Physical Sciences National Science Foundation 4201 Wilson Boulevard Arlington, VA 22230 Telephone: (703) 292-4956 FAX: (703) 292-9037 Email: jhicks@nsf.gov Dr. Gerald F. Guala Division of Biological Infrastructure Directorate for Biological Sciences National Science Foundation 4201 Wilson Boulevard Arlington, VA 22230 Telephone: (703) 292-8470 FAX: (703) 292-9063 Email: gguala@nsf.gov o Direct your questions about peer review issues to: Dr. Donald Schneider Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Bethesda, MD 20892 Telephone: (301) 435-1727 FAX: (301)480-1988 Email: schneidd@csr.nih.gov o Direct your questions about financial or grants management matters to: Judith Musgrave Office of Grants Management National Center for Research Resources 6701 Democracy Boulevard, MSC 4874 Bethesda, MD 20892-4874 Telephone: (301) 435-0841 FAX: (301) 480-3777 Email: jm133b@nih.gov Nancy Curling National Institute of Biomedical Imaging and Bioengineering 6707 Democracy Boulevard, Suite 900 Bethesda, MD 20892-5469 Telephone: (301) 451-4782 Fax: (301) 480-4974 Email: curlingn@mail.nih.gov Gary Fleming 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 Carol Robison Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6118 Bethesda, MD 20892 Telephone: 301-443-3858 FAX: 301-443-6885 Email: crobinso@mail.nih.gov Chris Zimmerman Grants Management Specialist NINDS NSC, Rm 3290 6001 Executive Blvd. Rockville, MD 20852 (Express Mail) Bethesda, MD 20892-9537 (Regular Mail) Phone (301) 496-3107 Fax (301) 402-0219 zimmermc@ninds.nih.gov Laurence Dash Extramural Programs National Library of Medicine Rockledge 1, Suite 301 6705 Rockledge Drive Bethesda, MD 20892 Telephone: (301) 496-4221 FAX: (301) 402-0421 Email: ld72i@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of PAR Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Gregory Farber, Ph.D. Division of Biomedical Technology National Center for Research Resources 6701 Democracy Boulevard, MSC 4874 Bethesda, MD 20892-4874 Telephone: (301) 435-0778 FAX: (301) 480-3659 Email: gf48a@nih.gov Applicants are strongly encouraged to send the letter of intent by e-mail. JOINT NIH/NSF SUBMISSION A recent NIH/NSF Memorandum of Understanding permits both agencies to participate in this program announcement. The Division of Chemistry and the Division of Biological Infrastructure at NSF are participating. Proposals intended for NSF consideration should be submitted to NIH for review at the deadlines announced above. After the review has occurred, NSF may choose to fully fund certain applications or co-fund the application. For chosen applications, the principal investigator will be required to re-submit the application as a proposal through the NSF FastLane system in accordance with the NSF Grant Proposal Guide (GPG). (Additional information is available at: http://www.nsf.gov/cgi-bin/getpub?gpg and http://www.fastlane.nsf.gov/a1/newstan.htm.) Applicants contemplating joint NIH-NSF submission are strongly urged to contact appropriate staff at both the National Science Foundation (Dr. Janice Hicks at NSF Division of Chemistry, 703-292-4956; jhicks@nsf.gov or Dr. Gerald Guala at NSF Division of Biological Infrastructure, 703-292-8470; gguala@nsf.gov) and NCRR (Dr. Gregory K. Farber, 301-435-0778; gf48a@nih.gov) for information concerning eligibility and required documentation. SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at 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. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget 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 received by the receipt dates listed at the beginning of this document. 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 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 Receive a written critique 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 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. The goals of NSF-supported research within the context of this PA are to advance our fundamental understanding of biology and chemistry. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. 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). 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 CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. OTHER REVIEW CRITERIA: 1) Are the evaluation criteria suitable to allow an assessment of the impact of the newly developed technologies on the organization and conduct of science, as well as on the evolution of collaboratory-based communities. 2) Will the plans for sharing the proposed tools and techniques ensure a broad distribution of those tools and techniques? 3) Proposals submitted to the National Science Foundation are evaluated through the use of NSF's two merit review criteria: the intellectual merit and the broader impacts of the proposed activity. To cover the broader impact review criteria, reviewers will be asked to evaluate whether a proposal will enhance the infrastructure and integration of research and education. In addition, reviewers will be asked to evaluate the proposal on whether it upgrades the computation and computing infrastructure while broadening participation. Description of NSF's review criteria can be found at http://www.nsf.gov/pubs/2003/nsf032/032_3.htm#IIIA. Examples of activities that demonstrate broader impacts can be found at http://www.nsf.gov/pubs/2003/nsf032/bicexamples.pdf. 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 Overall 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. MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "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 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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