PARKINSON’S DISEASE DATA ORGANIZING CENTER RELEASE DATE: November 20, 2003 RFA Number: RFA-NS-05-001 Update: The following update relating to this announcement has been issued: January 21, 2010 - This RFA has been reissued as (RFA-NS-11-001). Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov) National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.853, 93.113, 93.114, 93.115 LETTER OF INTENT RECEIPT DATE: December 22, 2003 APPLICATION RECEIPT DATE: January 22, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA 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 Letter of Intent o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute of Neurological Disorders and Stroke (NINDS) invites cooperative agreement applications from qualified institutions for support of a Parkinson’s Disease Data Organizing Center (PD-DOC), designed to serve as a shared research resource to facilitate research in Parkinson’s disease (PD). This resource is intended to compile clinical data, as well as to provide virtual catalogues for both basic scientific and clinical research in PD. Parkinson’s disease research would benefit from analysis of combined data collected systematically from existing PD Centers (Udall Centers, NIEHS centers, NIA Alzheimer’s Disease Centers) and, eventually, from other sources where longitudinal data are collected. Such data on patients and unaffected, age-matched controls would support 1) clinical, molecular and pathological research on disease natural history, heterogeneity, diagnosis, and clinical-pathological correlations; and 2) epidemiological research related to the identification of risk factors, neuroprotective factors or biomarkers. As clinical components are built into the Morris K. Udall Parkinson’s disease Centers of Excellence and other PD Centers, the advance funding of this data coordination initiative will function to systematize data collection and analysis across centers. In addition, existing databases should be assessed as to their relevancy and incorporation into this national resource. Data from all PD center resources can thus be combined, coordinated, and made available to researchers from PD centers as well as the wider PD research community. The primary objectives will be to: 1) Establish, maintain, and disseminate a data base of clinical, pathological and biochemical information collected at Udall Centers, Collaborative Centers for Parkinson’s Disease Research (CCPDER), or other PD centers, from persons with Parkinson’s disease and related disorders and from unaffected age-matched controls; 2) Assess availability and potential use of existing databases and how they could be incorporated or made compatible, as well as provide training and data quality control across all participating sites. 3) Provide assistance to investigators in planning and conducting research studies using the database; 4) Make available virtual data and a catalog of tissues and other biological samples collected from PD patients and controls for use in epidemiological, clinical, molecular and pathological studies by qualified investigators, and 5) Coordinate annual meetings of its steering committee and the annual Udall (and other) PD Centers’ meeting to discuss progress and collaborations. With the establishment of this data coordinating center, important and novel research issues can be addressed which would not be possible with the individual resources available at any one individual center. Research activities that use PD-DOC resources may be supported through the usual National Institutes of Health (NIH) and other federal and non-federal sources for the funding of investigator-initiated applications. RESEARCH OBJECTIVES A. Background Since March of 2000, the National Institutes of Health (NIH) has expended tremendous effort and has made significant progress on the implementation of the Parkinson's Disease Research Agenda. As part of the implementation process, NIH convened a summit with several outstanding scientists in late July 2002 - to gain a better sense of where the field of PD research stands internationally, and to collect information on the "roadblocks" that may still be impacting progress. (The results of the summit meeting are articulated the Parkinson’s disease Matrix: http://www.ninds.nih.gov/funding/research/parkinsonsweb/matrix.htm) Recommendations made at this meeting included the integration and clinical expansion of the Udall centers. The ultimate goal of improving the integration of centers is to create a patient-centric system in which community physicians, research centers, and NIH are all part of a cohesive network. With such a system, information on patients can be better captured and managed, and research can be integrated at both the basic and clinical levels. Clinical expansion of the network of integrated centers could link basic, translational, and clinical research, further the development of outcome tools, brain banks, and biomarkers, and would necessarily include cores for clinical pathology and tissue banks. This will require formal coordination, thus it was recommended that a coordinating center facilitate the continuing development of standards for data collection, centralize the systematic collection of patient data, provide this data to the PD research community, and manage joint centers meetings where progress and collaborations could be addressed. B. Research Goals and Scope Applications should present a plan for a data coordinating center which includes approaches to the following activities and any others that would complement the functions outlined here: 1) Data Coordination a. assume responsibility for the minimum common data set (tracking multiple variables) currently in existence on basic clinical and pathological information about patients in a standard format. In anticipation of this process, NINDS convened a workshop to explore potential features of a minimum data set for PD. The resultant draft minimum data set for clinical and pathological features of PD can be found at: http://www.ninds.nih.gov/parkinsonsweb/clinical_research.htm. It is hoped this will serve as a useful starting point for potential applications. b. to gradually expand and/or modify the minimum data set to include information of greater depth and breadth about the clinical, pathological, genetic status, exposure histories, and risk factors of the patients and controls. c. perform surveys of existing PD database structures and propose ways to integrate common variables and index non-conforming variables in a central database, and continue to identify sites from which data should be collected. d. develop protocols and methods for data collection and its transmission to and from individual centers and the PD-DOC, as well as to ensure quality control and uniform collection of data across participating sites. e. prepare a virtual catalog of all tissues, biological specimens, cell lines, reagents and molecular probes, relevant neurotoxicants, etc, and make it available to investigators both within and outside of the PD centers. f. coordinate with the NINDS genetic repository for PD when appropriate. g. develop and maintain a comprehensive set of procedures to assure confidentiality of subjects. 2) Consultation on study design and statistical analysis a. provide advice and consultation to investigators planning studies which utilize the database to encourage its maximum and most efficient use b. provide guidelines and information to investigators planning prospective epidemiological, genetic or clinical studies c. provide advice and consultation to investigators planning or conducting pooled or secondary analyses of exposure histories or existing risk factor databases; 3) Coordination of meetings and reports a. establish a steering committee with NINDS to oversee PD-DOC operations made up of the Principal Investigator of the PD-DOC, NINDS and NIEHS staff, representatives from the PD research community, and special consultants; The steering committee must be kept informed and approve of any changes in policy. b. organize regular meetings or teleconferences of the PD-DOC Steering Committee to allow the steering committee to monitor operations and approve changes in procedures; provide administrative support to the annual Udall Center’s meeting. c. prepare guidelines for publications that use the PD-DOC, as well as prepare annual reports for the steering committee. 4) Staff Requirements (see also “Description of Capabilities and Experience” under application content) a. The Principal Investigator and/or other key staff must have appropriate expertise and capability in biostatistics, data management, data analysis, and project management; prior experience in complex large-scale collaborative studies is desired. b. The Principal Investigator and/or other key staff should have experience in Parkinson's disease and related disorders research (for example in the form of publications) and have familiarity with the PD research literature including genetics, epidemiology, molecular pathogenesis and clinical course of the disease. c. The Center staff must have the ability to assist in designing protocols, study manuals and data collection systems, including distributed data entry and plans for data analysis. d. The Center staff must have experience in developing and maintaining data quality control, including accurate collection of the minimum data set across sites. e. The Center staff must demonstrate successful experience in assisting clinical investigators prepare manuscripts for publication that utilize data gathered from collaborative research. MECHANISM OF SUPPORT This RFA will use NIH U01 award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated earliest award date is December 1, 2004. This RFA uses just-in-time concepts. The NIH U01 is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award". FUNDS AVAILABLE NINDS intends to commit approximately $1 million and NIEHS approximately $300,000 in FY05 to fund one award for a Data Coordinating Center in response to this RFA. An applicant may request a project period of up to 5 years and a budget for total costs of up to $1.3 M per year. Although the financial plans of the NINDS and NIEHS provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBILE 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 The applicant organization should have experience in functioning as a data coordinating center for clinical studies of a medical and/or behavioral nature, or in other large-scale data management and analysis projects and have knowledge about the unique characteristics of Parkinson’s disease and related disorders, the various NIH PD Centers Programs, and the status of current PD research, including important unanswered questions that could be addressed using the larger data sets. 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 Cooperative Agreement Terms and Conditions of Award These terms are in addition to, not in lieu of, otherwise applicable Office of Management and Budget (OMB) administrative guidelines, HHS Grant Administration Regulations at 45 CFR Part 74 and 92, and other HHS, PHS, and NIH Grants Administration policy statements. The administrative and funding instrument used for the PD-DOC is the cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NINDS Project Scientist. A. Awardee Rights and Responsibilities The awardee will have substantial and lead responsibilities in all tasks and activities. These include data collection, database design, training, quality control, data analysis, and assistance with preparation of publications. The awardee agrees to work cooperatively with PD research centers and agrees to accept guidance from the PD-DOC Steering Committee. B. NINDS/NIEHS Staff Responsibilities The NINDS will name a Program Official whose function will be to assist the Principal Investigator and the Steering Committee in oversight of the Coordinating Center. The Program Official will have substantial scientific-programmatic involvement, above and beyond normal program stewardship, including being a voting member of the steering committee and all key study group subcommittees, participation in database development, budget monitoring, identification of relevant research questions, modification of protocols, quality control, data analysis and interpretation, preparation of publications, and coordination and performance monitoring. The prime responsibility for these activities resides with the awardee although specific tasks and activities in overseeing the studies will be shared between the awardee and the NINDS Program Official. An NINDS Program Director will be responsible for normal program stewardship and monitoring of the award. The Program Director may also serve as the Program Official described above. The NINDS reserves the right to terminate or curtail the award in the event of a lapse in data reporting, quality control, or other major breach of the protocol. C. Steering Committee The PD-DOC Steering Committee will include the PD-DOC Principal Investigator, the NINDS and the NIEHS Program Officials, three Udall Center Directors, one CCPDER director and three additional members selected from the PD research community. Other outside members with data center expertise may be appointed by the Steering Committee. A Chairperson will be elected from the membership of the Steering Committee. The functions of the Steering Committee are to oversee the creation of the data center and the expansion of the minimum database; approve operating procedures and changes in operating procedures; identify, prioritize, and review study topics; consider the relevant research questions and available resources; review proposals submitted to the PD-DOC for feasibility; consult with and advise the leadership of the PD-DOC and the NINDS and monitor the data center's progress in meeting goals; help the PD-DOC analyze and interpret data from studies associated with the PD-DOC; and approve the composition of a publications committee. D. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NINDS may be brought to arbitration. An arbitration panel will be composed of three members, one member selected by the PI, one member selected by the PO, and one member selected jointly. The arbitration Panel will recommend a course of action to the Director of Extramural Activities, NINDS. This special arbitration procedure in no way affects the awardee’s right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 Part 16 or the rights of NINDS under applicable statutes, regulations and terms of the award. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Dr. Diane D. Murphy Neurodegeneration Group National Institute for Neurological Disorders and Stroke Neuroscience Center Room 2223 6001 Executive Blvd. Rockville, MD 20852 Telephone: (301) 496-5680 FAX: (301) 480-1080 Email: Murphyd@ninds.nih.gov Dr. Cindy Lawler Cellular, Organ, Systems Pathobiology Branch National Institute of Environmental Health Sciences Box 12233 MD EC-23 Research Triangle Park, NC 27709 Telephone: (919) 316-4671 FAX: (919) 541-5064 Email: firstname.lastname@example.org Dr. Annette Kirshner Cellular, Organ, Systems Pathobiology Branch National Institute of Environmental Health Sciences Box 12233 MD EC-23 Research Triangle Park, NC 27709 Telephone: (919) 541-0488 FAX: (919) 541-5064 Email: email@example.com o Direct your questions about peer review issues to: Alan Willard, Ph.D. Chief, Scientific Review Branch National Institute of Neurological Disorders and Stroke 6001 Executive Blvd., Room 3208 Bethesda, MD 20892 Telephone: (301) 496-9223 FAX: (301) 402-0182 Email: firstname.lastname@example.org 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: email@example.com LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent is to be sent to Dr. Diane Murphy at the address listed above. 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.dnb.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTARY INSTRUCTIONS See also B. Research Goals and Scope above for additional information on application instructions and requirements. The application should include: 1) a description of capabilities and experience of the key personnel, 2) a research plan for the first five years of the data center, and 3) a budget with justification of expenses. 1. Description of Capabilities and Experience (as outlined above under staff requirements) a. Describe the applicant organization's facilities, resources, and how the staff's strengths in biostatistics, data management, data analysis, and project management skills have been used in previous, successful large-scale collaborative research. b. Describe the knowledge and experience of the Principal Investigator and/or other staff in research on Parkinson’s disease and related disorders. c. Describe the experience of the key personnel in assisting protocol design, data entry procedures and manual preparation, and in data collection and data quality control for previous large-scale, complex research projects. d. Present the applicant's record in generating reports on data collection and performance in previous large-scale collaborative projects, including preparation of manuscripts. e. Describe how logistical services and organizational support have been utilized in managing resources and monitoring performance in previous large-scale, collaborative research. 2. Research Plan a. Describe the applicant's conception of the role of the Data Coordinating Center in furthering Parkinson’s disease research using large data sets. b. Describe examples studies on Parkinson’s disease etiology, pathogenesis and clinical course that would be feasible using an expanded data set. Describe the statistical methods to be used, the unique analytic challenges these studies may face, and strategies for dealing with these challenges. c. Provide a statement of intent to collaborate with all recognized PD research Centers as well as the NINDS Genetic Repository when appropriate. Also describe leadership role of the PD-DOC in developing clinical programs at new centers. d. Describe the platform for the database and procedures for maintaining data integrity across centers and assuring confidentiality of subjects. e. Describe the nature of additional data, over a proposed minimum data set (see http://www.ninds.nih.gov/parkinsonsweb/clinical_research.htm), that may be collected in future. f. Describe the importance of having prospective hypotheses for each set of data and an ordered and well-considered process for adding additional hypotheses to test. g. Propose an administrative and management structure that would support the PD-DOC. h. Describe procedures and guidelines for access, use and publication of data. i. Describe involvement of human subjects and human specimens in the Research Plan, Section e. Human Subjects. Applications must include documentation of the ability to properly acquire human samples and clinical data for the proposed studies. The NIH brochure entitled "Research on Human Specimens: Are You Conducting Research Using Human Subjects?" (http://www-cdp.ims.nci.nih.gov/policy.html) and OHRP guidance on Repositories, Tissue Storage Activities and Data Banks (http://www.hhs.gov/ohrp/humansubjects/guidance/reposit.htm) are available for guidance on these topics. 3. Budget Considerations All PD-DOC proposals should request and provide justification for five years of support. The total costs (direct plus indirect) requested for applications for the PD-DOC may not exceed $1,000,000. These costs may include those for logistical arrangements (e.g., meeting room rental, audio video expenses, speaker expenses, etc.) of meetings each year for the PD-DOC Steering Committee and the Annual Udall Center’s meeting. Funds should be budgeted for regular teleconferences for the Steering Committee. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Dr. Alan L. Willard, Ph.D. Chief, Scientific Review Branch, NINDS 6001 Executive Blvd, Room 3201 Rockville, MD 20852 (couriers) Bethesda, MD 20892-9529 (for US Mail) APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. 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. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NINDS. Incomplete and/or nonresponsive applications will not be reviewed. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NINDS in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by an 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 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 in the evaluation of the PD-DOC applications: 1. The organizational and administrative structure of the proposed program including evidence of the degree of commitment and support of the organization/institution for the proposed program. 2. The scientific merit of the proposed approach to data collection, management and coordination, as outlined in the RFA. Documentation of the specific competence and previous experience of professional, technical, and administrative staff pertinent to the data center. Prior experience should be demonstrated in similar studies, for the collection of data from multiple locations, as well as experience in monitoring the quality and timeliness of such data. 3. Documentation of the specific competence and previous experience of professional staff with the unique features of Parkinson’s disease and related disorders research. The extent to which proposed uses for data collected in the Center demonstrate an understanding of this complex disease process and logical approaches to answering questions fundamental to the disease. 4. Suitability of proposed data management and data analysis plan, the adequacy of the proposed facility and technical hardware and appropriateness of the budget for the work proposed. 5. Suitability of plans for managing meetings of the steering committee and the annual Udall meetings. 6. Understanding of human subject research protection issues as demonstrated in the Human Subjects section of the application. 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. 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. Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research must 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. (http://grants.nih.gov/grants/policy/data_sharing) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE: Letter of Intent Receipt Date: December 22, 2003 Application Receipt Date: January 22, 2004 Peer Review Date: Summer, 2004 Council Review: September, 2004 Earliest Anticipated Start Date: December 1, 2004 AWARD CRITERIA Applications will be considered for award based upon (1) scientific and technical merit; (2) program balance, including in this instance sufficient compatibility of features to make a successful collaborative program a reasonable likelihood; and (3) availability of funds. 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 $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 RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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 RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance 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 Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non- 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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