HUMAN TEMPORAL BONE RESEARCH RESOURCE ENHANCEMENT CONSORTIUM RELEASE DATE: July 7, 2004 RFA Number: RFA-DC-04-002 (This RFA has been modified, see RFA-DC-06-001) EXPIRATION DATE: November 16, 2004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.173 LETTER OF INTENT RECEIPT DATES: October 15, 2004 APPLICATION RECEIPT DATES: November 15, 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 purpose of this initiative is to solicit applications that will enhance the utility of human temporal bones (HTBs) for auditory and vestibular research. The research projects proposed in response to this RFA must address the collaborative development of a uniform protocol for HTB (and related brain tissue) acquisition and processing, and for the application of modern molecular-biologic assays to HTB research. RESEARCH OBJECTIVES A. Background Clinicopathologic correlation informs our understanding of normal and disordered human processes, including those underlying hearing, balance and facial nerve function. Housed in the temporal bone, the inner ear structures subserving hearing and balance are inaccessible during life, rendering infeasible the conventional techniques of pathologic examination, such as biopsy/surgical excision. Consequently, the assessment of auditory and vestibular structures necessitates the post mortem study of temporal bones. The acquisition, processing, and evaluation of HTBs are expensive and time-consuming endeavors that require specialized equipment and personnel, which lie outside the expertise of conventional human pathology laboratories. Accordingly, these research endeavors have been relegated to specialized HTB laboratories. In 1992 NIDCD established the NIDCD National Temporal Bone, Hearing and Balance Pathology Resource Registry ( the Registry ) to promote HTB research by serving as a national resource for researchers and the public. Despite the success of the Registry in accomplishing its tasks, the number of active HTB laboratories and the population of researchers engaged in HTB research have dwindled to near extinction. In order to assess the needs of HTB research, both in terms of maintaining active laboratories and encouraging new researchers into the field, the NIDCD sponsored a September 2003 workshop entitled Temporal Bone Histopathologic Research: Laboratories and Research Training . The Workshop participants concluded that: there is a need for funds to support the basic acquisition and processing of HTBs; there is a need for a unified protocol for processing HTBs; and, there is a need for a concerted effort to modernize HTB research. This Human Temporal Bone Research Resource Enhancement Consortium ( Consortium ) RFA aims to encourage, through a multidisciplinary, collaborative effort, the development of a unified protocol (or protocols) for HTB acquisition (and related brain tissue) and processing that facilitates modern molecular biologic assessment. B. Objective The objective of this RFA is to solicit applications that will enhance the utility of HTBs to modern auditory/vestibular research. Funding through this RFA will provide resources for investigators to work collaboratively (governed by a Steering Committee, described below) to develop, implement and assess a standardized protocol (or protocols) for HTB (and related brain tissue) acquisition and processing that renders the HTB specimens appropriate for modern molecular biologic study, as well as an initial assessment of the HTBs acquired. It is expected that applicants funded though this RFA will cooperate with the Registry. The data arising from the HTBs collected, processed, and assessed will be transmitted to the Registry for inclusion in its HTB database. Digitized images of salient features of each HTB will be created and made available to researchers in the greater scientific community. Applicants in response to this RFA must describe in detail a process for: 1. defining and completing an initial HTB assessment protocol (or protocols); 2. participating in Consortium collaborative protocols; 3. developing, implementing and testing acquisition and processing protocols that allow for the application of advanced molecular biologic assays; 4. developing and implementing HTB protocols that inform Consortium collaborative protocols; 5. obtaining a clinical history, especially as relevant to auditory/vestibular function; 6. obtaining regularly conducted clinical assessments, especially auditory and vestibular function; 7. acquiring, processing, cataloging and storing HTB specimens; 8. cooperating with the Registry; 9. transmitting the findings from the initial assessment protocol to the Registry; 10. cooperating with the Consortium Consulting Committee (defined below)(do not name potential Consortium Consulting Committee members); and, 11. digitizing and distributing salient images from processed HTBs. In addition: 12. Applications for this RFA must provide detailed documentation describing the ability of the Principal Investigator to assemble a multidisciplinary team capable of carrying out the proposed processes. Similarly, applicants must demonstrate the willingness, the ability and a plan for conducting collaborative research endeavors with applicants funded through this RFA. 13. Applicants interested in serving as Chair of the Steering Committee (see below for definition) should provide detailed documentation of the ability to provide executive leadership and scientific coordination and should include a plan for implementing the scientific, operational, and organizational policies of the Consortium, for managing the logistics of the SC meetings and Consortium workshops/symposia, and for information dissemination among the Consortium members, the Consortium Consulting Committee (defined below), the Registry, and the NIDCD. C. Consortium Administrative Structure Organization: The Consortium comprises the PI and personnel of each HTB laboratory funded under this RFA. The HTB laboratory personnel should comprise not only those individuals traditionally involved in temporal bone processing but also individuals (e.g., pathologists, molecular biologists) whose expertise will be important to the modernization of HTB research. Steering Committee (SC): The SC is responsible for scientific management and oversight, including monitoring the activities of the Consortium. For the administrative structure, and responsibilities of the SC, see Collaborative Responsibilities. Consortium Consulting Committee (CCC): Established by the NIDCD after the funding of all Consortium PIs, the CCC advises the SC on relevant scientific issues, including study design, prioritization of technique development, and the development of collaborative study protocols. For further details, see Collaborative Responsibilities. Headquarters: The institution of the SC Chair serves as the Headquarters of the Consortium. The SC Chair can be any Principal Investigator (PI) involved in the Consortium. The Chair serves as the PI of the Headquarters and implements the scientific, operational, and organizational policies of the Consortium. The Headquarters provides the executive leadership and scientific coordination for the Consortium. It serves as a center for information dissemination among the Consortium PIs, the CCC, the Registry and the NIDCD. The Headquarters manages the logistics of the SC meetings and Consortium workshops/symposia. Funds: Funds will reside with the individually funded awardees of the Consortium. The PIs of the awards will have funds available to support the development, implementation, and assessment of the common HTB acquisition and processing protocol, and to cover applicable administrative costs and travel to Consortium SC meetings and workshops. MECHANISM OF SUPPORT This RFA will use the NIH Cooperative Agreement (U24) award mechanism. The NIH U24 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the PI 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 PI as described under the section "Cooperative Agreement Terms and Conditions of Award". As an applicant you will be primarily responsible for planning, directing, and executing Consortium collaborative studies. This RFA will have one submission date: November 15, 2004. The anticipated award date is July 2005. Investigators may not submit more than one application for this RFA. NIDCD program intentions beyond the current RFA are indefinite. This RFA uses just-in-time concepts. U24 is not a modular mechanism. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm. FUNDS AVAILABLE NIDCD intends to commit approximately $1 million in FY 2005 to fund two to three new grants in response to this RFA. An applicant may request a project period of up to five years. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIDCD 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. 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 institutions/organizations o Foreign institutions are not eligible to apply 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. The PIs funded under this RFA will establish a Steering Committee (detailed below) to provide oversight for the development of a common protocol (or protocols) for HTB acquisition and processing that allows for advanced molecular biologic assessment. Each PI will be a voting member of the SC and will attend two SC meetings each year. The PIs will organize and attend at least two workshops/symposia during the project period to inform the scientific community of the progress made toward development and application of HTB acquisition and processing techniques developed through awardee collaboration. Attendance at these meetings is required as part of this cooperative agreement. Cooperative Agreement Terms and Conditions of Award These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. [Part 92 applies when state and local governments are eligible to apply as a "domestic organization."] Under the cooperative agreement, the NIDCD 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 NIDCD Program Coordinator. A. Rights and Responsibilities of Human Temporal Bone Research Resource Enhancement Consortium PIs Collaborative Studies: Each PI will collaborate with other Consortium awardees to develop a common protocol for HTB (and related brain tissue) acquisition and processing that enables modern molecular biologic evaluation. Each PI will be responsible for accepting and implementing the goals, priorities, common protocols, procedures, and policies agreed upon by the Steering Committee (SC see C.1. below for details) for the collaborative studies. Each PI will be responsible for collaborating on common research designs or protocols, including methods and requirements for joint participation and collaboration as recommended by the SC, and handling of data, including appropriate sharing of methods and data among collaborating organizations. Each PI will be responsible for acquiring, processing and performing the initial evaluation of HTB specimens for studies approved by the SC. Each PI will develop procedures for study monitoring to assure compliance with protocol designs and protection of patients from research risk. Each PI will assume responsibility for managing their laboratory’s participation in collaborative projects approved by the SC. Each PI will monitor and maintain appropriate records for protocols, informed consents, assurances, and annual certifications of Institutional Review Board (IRB) review and approval (OMB No. 0990- 0263, "Protection of Human Subjects, Assurance Identification/IRB Certification/Declaration of Exemption, (Common Rule) "http://www.hhs.gov/ohrp/humansubjects/assurance/OF310.rtf ). Each PI will assume responsibility and accountability to the applicant organization officials and to the NIDCD for the performance and proper conduct of the research supported by the U24 in accordance with the terms and conditions of the award. Each PI will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. B. NIDCD Extramural Staff Responsibilities The NIDCD Program Coordinator will have substantial scientific programmatic involvement during conduct of this activity, through technical assistance, data sharing and analysis, composition of reports, and advice and coordination above and beyond normal program stewardship for grants as described below. The Program Coordinator will convene the initial meeting of the SC, have voting membership on the SC, and, as determined by that committee, its subcommittees. Although the PI will have lead responsibilities in all collaborative tasks and activities, it is anticipated that the NIDCD Program Coordinator will have lead responsibilities in managing and sharing the broad programmatic issues among awardees. An NIDCD Program Official will also be responsible for normal programmatic stewardship and monitoring of the awards. The NIDCD Program Official may serve as the NIDCD Program Coordinator. The NIDCD reserves the right to adjust funding, withhold support, suspend, terminate or curtail a study or an individual award in the event of: a failure to comply with the Terms and Conditions of Award; a substantial shortfall in HTB specimen acquisition, processing, or evaluation; lack of data reporting or quality control; other major breach of scientific conduct; or human subject ethical issues, whenever applicable. C. Collaborative Responsibilities 1. Steering Committee (SC): The SC will have major scientific management oversight and responsibility for developing collaborative research projects, facilitating the conduct and monitoring of studies, and reporting study results. The SC will be composed of the PI from each awardee institution and the NIDCD Program Coordinator. Each member will have one vote. The Chair (non-NIH person) will be selected by the SC. The institution of the SC Chair serves as the Headquarters of the Consortium. The SC Chair can be any Principal Investigator (PI) involved in the Consortium. The SC Chair serves as the PI of the Headquarters and implements the scientific, operational, and organizational policies of the Consortium. The Headquarters provides the executive leadership and scientific coordination for the Consortium. It serves as a center for information dissemination among the Consortium PIs, the CCC, the Registry and the NIDCD. The Headquarters manages the logistics of the SC meetings and Consortium workshops/symposia. 1. After all the Consortium awardees have been funded, the SC will convene. Thereafter, the SC will meet twice yearly. Responsibilities of the SC include but are not limited to: o developing and refining a common protocol (or protocols) for HTB acquisition, processing and initial evaluation; o developing collaborative policies and procedures, including publication policies; o developing policies and procedures for maintaining liaison and sharing data with the Registry; o developing policies and procedures for reviewing changes in projects not showing promise; and, o developing standards or decision criteria for pursuing techniques for further study. 2. The SC will review HTB accrual, protocol compliance, results of audits, and regulatory requirements at the participating laboratories and formally report the results of its reviews to the NIDCD. 3. The SC will promote and foster the inclusion of women and ethnic minorities in clinical studies and assure the completeness of informed consent. 4. The SC will track collaborative research progress and assure that the results are published in peer-reviewed journals in a timely manner and in accordance with established publication policies. 5. The SC will discuss, develop and implement collaborative projects to be pursued jointly. 6. Collaborative studies/protocols will be approved by the SC. Data will be submitted to the Headquarters. The SC will define the rules regarding access to data and publications consistent with NIDCD policies. 8. The SC will plan at least two workshops/symposia during the project period to inform the scientific community of the progress made toward development and application of HTB acquisition and processing techniques developed through awardee collaboration. The Consortium Consulting Committee and the NIDCD Program Coordinator will provide the SC with advice on participants for the workshops and symposia. The Headquarters will manage the logistics for these meetings. 2. Consortium Consulting Committee (CCC): 1. Established by the NIDCD, the CCC advises the SC on relevant scientific issues, including study design, prioritization of technique development, and the development of collaborative study protocols. 2. The membership of the CCC and duration of service will be established by the NIDCD in consultation with the SC. The membership includes researchers/institutions not participating in the Consortium. The CCC will include molecular biologists, pathologists, and temporal bone researchers. 3. The Chair of the CCC is elected by its members. The Chair of the SC also serves as an ad hoc member of this advisory committee. The NIDCD is represented by relevant program staff, which will be responsible for meeting logistics. 4. The CCC advises the NIDCD on the progress and success of the Consortium against the criteria developed by the SC. 5. The CCC helps the NIDCD in site visits to the participating institutions, as necessary. 6. The CCC collaborates with the SC to suggest participants for and to assist in the implementation of workshops and symposia and to provide liaison between the human temporal bone research community and the Consortium. 7. The CCC will meet at least once yearly in the Bethesda, MD area. D. Arbitration A panel will be formed to review any scientific or programmatic disagreement (within the scope of the U24 award) between the award recipients and the NIDCD. The panel will be composed of three members: one selected by the SC (with the NIDCD Program Coordinator not voting); a second member selected by the NIDCD; and, the third member selected by the two prior selected members. Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between award recipients and the NIDCD may be brought to arbitration. 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 CFR Part 16. 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: A. Julianna Gulya, MD Division of Scientific Programs National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400D-7 MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 435-4085 FAX: (301) 402-6251 Email: julie_gulya@nih.gov o Direct your questions about peer review issues to: Chief, Scientific Review Branch Division of Extramural Activities National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400C MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 496-8683 FAX: (301) 402-6250 Email: s8k@cu.nih.gov o Direct your questions about financial or grants management matters to: Chief, Grants Management Branch Division of Extramural Research National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400B MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 402-0909 FAX: (301) 402-1758 Email: stones@nidcd.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 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 NIDCD 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: A. Julianna Gulya, MD Division of Scientific Programs National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400D-7 MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 435-4085 FAX: (301) 402-6251 Email: julie_gulya@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 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 (please also refer to SPECIAL REQUIREMENTS listed above) Special Instructions for Preparation of the Application 1. COMPLIANCE WITH TERMS OF THE CONSORTIUM COOPERATIVE AGREEMENT In a separate, labeled section, specific issues related to the cooperative agreement must be addressed. Applicants must include their specific plans for responding to the Cooperative Agreement Terms and Conditions of Award section. Applicants should state their willingness to collaborate and share data freely with the other Consortium members, to participate in planning and attending workshops and symposia, to serve on the SC and be bound by its decisions, and to share data and research resources with each other and the NIDCD. Successful applicants will be expected to submit information on specimen collections to the Registry (through the Headquarters). At the end of this section, applicants must append a letter from the applicant institution describing how that institution intends to meet the NIH policies for sharing of data or why data sharing is not possible. In this regard, attention is drawn to the NIH Final Statement on Sharing Research Data (http://grants.nih.gov/grants/policy/data_sharing/index.htm and http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html), which was published in the NIH Guide on February 26, 2003. This is an extension of NIH policy on sharing research resources, and reaffirms NIH support for the concept of data sharing. The new policy became effective with the October 1, 2003 receipt date for applications or proposals to NIH. Applicants to this RFA must also include a research tools and resources sharing plan in the letter to be appended to this section. Investigators conducting biomedical research frequently develop unique research resources. The policy of the NIH is to make available to the public the results and accomplishments of the activities that it funds. NIH recognizes that certain research activities may result in inventions and that grantees are entitled to protect such inventions through patenting and licensing activities in accordance with the Bayh- Dole Act, 35 USC 200 et seq. and the implementing regulations, 37 CFR Part 401 ( Bayh-Dole Act ). However, the Consortium’s mission of collaboration among Consortium members and between Consortium members and the larger community of researchers necessarily anticipates the sharing of intellectual property arising out of research resources developed in Consortium-related activities. To address the interest in assuring that research resources are accessible, NIH expects applicants who respond to this RFA to submit plans (1) for sharing the unique research resources generated through the grant; and (2) for addressing how they will exercise intellectual property rights, should any be generated through this grant, while making such research resources available to the broader scientific community. The sharing of research resources and intellectual property plans must make unique research resources readily available for research purposes to qualified individuals within the scientific community in accordance with the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps/) and the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice, December 1999 (http://www.ott.nih.gov/policy/rt_guide_final.html and http://ott.od.nih.gov/NewPages/64FR72090.pdf)( NIH Research Tools Guidelines ). These documents define terms, parties, and responsibilities. The documents also prescribe the order of disposition of rights, and a chronology of reporting requirements and delineate the basis for and extent of government actions to retain rights. Patent rights clauses may be found at 37 CFR Part 401.14 and are accessible from the Interagency Edison web page, (http://www.iedison.gov); see also, 35 USC 210(c); Executive Order 12591, 52 FR 13414 (Apr. 10, 1987); and Memorandum on Government Patent Policy (Feb. 18, 1983). 2. APPLICANTS FOR STUDY CHAIR Applicants interested in serving as Chair of the Steering Committee should provide detailed documentation of their ability to provide executive leadership and scientific coordination. They should include a plan for implementing the scientific, operational, and organizational policies of the Consortium, for managing the logistics of SC meetings and Consortium workshops/symposia, and for information dissemination among the Consortium members, the CCC, the Registry, and the NIDCD. 3. BUDGET 1. Applicants must budget for travel and per diem expenses for SC meetings. In the first year, applicants should plan for the Principal Investigator and an additional senior investigator to attend a Planning Meeting and two Steering Committee meetings. In the second and subsequent years, applicants should plan for the Principal Investigator and an additional senior investigator to attend two SC meetings per year. 2. Applicants must budget for travel and per diem expenses for participation in Consortium workshops and symposia. Applicants should plan that at least two investigators will attend at least two Consortium workshops/symposia. 3. Applicants interested in serving as SC Chair must budget for expenses solely related to the Headquarters function (see above) and the yearly meetings of the CCC; only the applicant elected Chair will be awarded such budgeted funds. The use of these set aside funds will be restricted and be released from the U24 by NIDCD. Indicate this amount in the Other Expenses category under the heading Headquarters Funds . 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 and all copies of the appendix material must be sent to: Chief, Scientific Review Branch Division of Extramural Activities National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400C MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 496-8683 FAX: (301) 402-6250 APPLICATION PROCESSING: Applications must be received on or before 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 NIDCD. Incomplete applications will not be reviewed. If the application is not responsive to the RFA it will be returned without review. 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 NIDCD, 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, may be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the National Deafness and Other Communication Disorders Advisory Council. 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 the proposed work enhance research resources for HTBs? APPROACH: Are the plans for developing, assessing and implementing a standardized protocol (or protocols) for HTB acquisition and processing adequately developed and appropriate to the aims of the Consortium? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is the timeline for the proposed work reasonable? Are organizational and administrative plans likely to lead to a well functioning, cohesive research group? Are there adequate plans for effective interaction and collaboration with the Consortium components, the Steering Committee, the Consortium Consulting Committee, the Registry, and the NIDCD? For applicants interested in serving as Steering Committee Chair: are there adequate plans for accomplishing the tasks of the SC Chair? Are the plans for information dissemination among the components of the Consortium, the Registry, the Consortium Consulting Committee and the NIDCD adequate? Are the plans for managing meeting logistics adequate? INNOVATION: Will the project provide improved utility, methodologies, or knowledge to facilitate researcher use of HTBs? INVESTIGATOR: Are the investigator and key personnel sufficiently knowledgeable, experienced and 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? Does the investigator propose the establishment of an appropriate multidisciplinary team? For applicants interested in serving as Steering Committee Chair: Does the investigator demonstrate the requisite scientific, operational and organizational skills? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Does the proposed work take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). 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). ADDITIONAL REVIEW CONSIDERATIONS PLAN FOR SHARING RESEARCH RESOURCES The reviewers will provide an administrative comment evaluating the adequacy and feasibility of the resource sharing plan. Recommendations regarding such plans are at http://www.ott.nih.gov/policy/rt_guide_final.html. This comment will not affect the priority score of the proposal. NIH staff will consider the adequacy of the plan in determining whether to recommend an application for award. The sharing plan as approved, after negotiation with the applicant as necessary, will become a condition of the grant award. 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: October 15, 2004 Application Receipt Date: November 15, 2004 Peer Review Date: Feb/Mar 2005 Council Review: May 2005 Earliest Anticipated Start Date: July 2005 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic 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 SHARING RESEARCH DATA: 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. 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. 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). 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.healthypeople.gov/. 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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