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TECHNOLOGY DEVELOPMENT FOR BIOMEDICAL APPLICATIONS RELEASE DATE: January 20, 2004 RFA Number: RFA-RR-04-005 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.389 APPLICATION RECEIPT DATE: June 18, 2004 and October 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 This RFA replaces PAR-03-075. The purpose of this request for applications (RFA) is to invite innovative applications for (1) the development of new and improved instruments or devices, (2) the development of new methodologies using existing instruments, or (3) the development of software related to instrumentation. Any of these projects should propose tools, methodologies, or software that can be used by a wide range of biomedical or clinical researchers. Projects that are focused on a specific organ or disease will be returned without review; however, proposals may use a specific organ or disease as a model system. Awards made for applications received in response to this announcement will employ the R21 and the R21/R33 mechanisms that are designed to support high-risk applications for which few if any preliminary findings are available. Investigators with substantial preliminary data should seek an R01 grant by submitting an unsolicited application at the standard receipt date or by responding to a particular program announcement. Questions about the suitability of proposals should be addressed to program staff listed in the "Where to Send Inquiries" section well before submission. Proposals in the areas of biomedical imaging, sensors, biomaterials, microelectromechanical systems (MEMS), tissue engineering, and nanotechnology will be considered nonresponsive and returned without review. Investigators considering research in these areas may want to look at the NIBIB (http://www.nibib1.nih.gov/research/investigators.htm) and BECON (http://www.becon.nih.gov/becon_funding.htm) web pages for funding opportunities in bioengineering research or biomedical imaging research. In addition, proposals that are focused on a specific organ or disease will be considered nonresponsive and also returned without review; however, proposals may use a specific organ or disease as a model system. The proposed research may involve conceptualization, design, fabrication, and/or testing of new instruments or devices. Applications to develop new experimental techniques and protocols using existing instrumentation are also welcome. Applications to develop new software related to instrumentation are encouraged, with the exception of proposals with a primary focus in the area of medical informatics. The overall objective of applications for new instruments, techniques, or software should be the development of more powerful and more precise technology with broad applicability to biomedical research. RESEARCH OBJECTIVES The primary intent of this RFA is to stimulate the development of new techniques for biomedical research that will allow scientists to achieve biomedical breakthroughs. High-risk applications are encouraged, and the innovative nature of the application will be part of the review criteria. For some high-risk applications, it may be appropriate to use the R21 mechanism alone to generate preliminary data. For applications with two distinct phases where the high-risk portion of the research occurs early, the R21/R33 mechanism is appropriate. As a simple example, consider an applicant who had developed a new material that might be used to fabricate a lens. The R21 portion of such a research plan would be the fabrication and testing of the lens. In the R21 portion of the application, the Principal Investigator would propose a set of quantitative milestones that the new lens would have to achieve. Such quantitative milestones might deal with the focal length, field of view, and aberrations of the lens. Once the lens had been made, the R33 phase of the research could be to incorporate this lens into a working microscope. At the end of a successful R21/R33 award, it is expected that there be a working instrument or new technique. Since the R21/R33 award cannot be renewed, it is not suitable for establishing a long-term research project in a particular area. Investigators should not propose to test a biological hypothesis as the R33 phase of an application. Examples of new tools and techniques that are responsive to this RFA include optical spectroscopy, mass spectrometry, electrophoresis and other separation techniques, microscopy, lasers and optics, X-ray tools and techniques, nuclear magnetic resonance spectroscopy, bioreactors and other forms of cell culture, centrifugation, proteomics, genomic sequencing, functional genomics, comparative genomics, microarrays, and human sequence variation (e.g., genotyping). This list is not exhaustive, but investigators outside of these areas are encouraged to contact program staff to ensure that their applications are responsive. This program announcement is similar in spirit to the "Instrument Development for Biological Research" program in the Directorate for Biological Sciences at the National Science Foundation (http://www.nsf.gov/cgi-bin/getpub?nsf98119). The major difference between the two programs is that instrumentation for the conduct of disease-oriented research is specifically excluded from the NSF program. Some instrument development proposals could be considered either under this program announcement or by NSF. Applicants are encouraged to contact program staff at either NSF or NIH to identify the best program for the application. MECHANISM OF SUPPORT This RFA will use NIH R21 and R21/R33 award mechanism(s). As an applicant you will be solely responsible for planning, directing, and executing the proposed project. Specific features of this mechanism include: o Single submission and evaluation of both a feasibility/pilot phase (R21) and an expanded development phase (R33) as one application. o Expedited transition of the R21 feasibility phase to a R33 development phase for combined applications. o Flexible budgets. o Flexible staging of feasibility and development phases. Applications under this program announcement will use either the combined R21/R33 mechanism or the R21 mechanism alone. Applications using just the R33 mechanism will not be considered. An application using the R21 mechanism alone is appropriate when the possible outcomes of the proposed research are unclear; under these conditions, it would not be possible to propose quantitative milestones or describe the R33 phase of the research. Applicants are strongly encouraged to contact program staff with any questions about the appropriate mechanism. Refer to the "Where to Send Inquiries" section of this program announcement for program staff contacts. This RFA uses just-in-time concepts. It also uses only the non-modular budgeting format. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE NCRR intends to commit approximately $1 million in FY 2005 to fund five to eight new grants in response to this RFA. 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 vary. Although the financial plans at NCRR 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, however applicants from for- profit organizations should contact program staff prior to submitting an application o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign institutions/organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The applicant can choose to submit an independent R21 application, or a combined R21/R33 application. The advantage of the combined R21/R33 mechanism is that it offers a seamless transition between the exploratory phase and the development phase of a project. Transition from the R21 to the R33 is dependent on completion of negotiated milestones. Once these milestones have been achieved, the investigator will submit a progress report to program staff. Upon determination that the milestones have been accomplished, the R33 phase can begin. 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: Gregory K. Farber, Ph.D. Division of Biomedical Technology National Center for Research Resources 6701 Democracy Boulevard, MSC 4874 Bethesda, MD 20892-4874 TEL: (301) 435-0755 FAX: (301) 480-3659 Email: gf48a@nih.gov o Direct your questions about peer review issues to: Bo Hong, Ph.D. Office of Review National Center for Research Resources 6701 Democracy Boulevard, MSC 4874 Bethesda, MD 20892-4874 TEL: (301) 435-0813 FAX: (301) 480-3660 Email: bh219i@nih.gov o Direct your questions about financial or grants management matters to: Mary Niemiec Team Leader Office of Grants Management National Center for Research Resources 6701 Democracy Boulevard, MSC 4874 Bethesda, MD 20892-4874 TEL: (301) 435-0842 FAX: (301) 480-3777 Email: mn20z@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) 435-0714, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted on June 18 and October 15. Both new applications and revisions to previously reviewed applications are due on the same date. 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: Contact the IC program staff at least six 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. SPECIFIC INSTRUCTIONS FOR THE APPENDIX The only items that may be included in the appendix are original glossy photographs or color images of gels, micrographs, etc., provided that a black and white photocopy of the same size is included within the research plan. SPECIFIC INSTRUCTIONS FOR PREPARING A COMBINED R21/R33 PHASED INNOVATION AWARD APPLICATION The combined R21/R33 application must include the specific aims for each phase and the feasibility milestones that would justify transition to the R33 phase. Applications must include a specific section labeled Milestones following the Research Plan of the R21 phase. Milestones should be well described, quantifiable and scientifically justified. A discussion of the milestones relative to the progress of the R21 phase and the implications of successful completion of the milestones for the R33 phase should be included. The Milestone section should be indicated in the Table of Contents. Applications lacking this information, as determined by the NIH staff, will be returned to the applicant without review. Prior to funding an application, the Program Director will contact the applicant to discuss the proposed milestones and any changes suggested by the review panel as indicated in the Summary Statement. The Program Director and the applicant will negotiate and agree on a final set of milestones. These will be the basis for judging the success of the R21 work. For funded applications, the Principal Investigator will submit a progress report to the program upon completion of the R21 milestones. Receipt of this progress report will trigger a review that will determine whether or not the R33 should be awarded. The release of R33 funds will be based on successful completion of negotiated scientific milestones, program priorities, and on the availability of funds. The R21/R33 Phased Innovation Award application must be submitted as a single application with one face page. Although it is submitted as a single application, it should be clearly organized into two phases. To accomplish a clear distinction between the two phases, applicants should submit Sections a-d (Specific Aims, Background and Significance, Preliminary Studies, Research Design) for the R21 phase, then the milestones, and then sections a and d (Specific Aims, Research Design) for the R33 phase. The Form 398 Table of Contents should be modified to show the sections for each phase as well as the milestones. There is a page limit of 25 pages for the composite research plan. Section a-d of the R21 research plan must not be longer than 15 pages. The milestones, and the a and d sections for the R33 application can take, at most, an additional 10 pages. The clarity and completeness of the R21/R33 application with regard to specific goals and feasibility milestones are critical. The presentation of milestones that are not sufficiently scientifically rigorous to be valid for assessing progress in the R21 phase will reflect upon the approach as proposed by the investigator and may affect the priority score. 1. Face Page of the application: Item 2. Check the box marked "YES" and type the number and title of this program announcement. Items 7 and 8: Costs Requested For the R21 phase of the application, direct costs are limited to a maximum of $125,000 per year for no more than three years. R21 budgets can only exceed this cap to accommodate F&A; costs of subcontracts to the project. The combined R21/R33 application is limited to five years in duration, and the R33 phase may not exceed three years in duration. 2. Page 2 - Description: As part of the description, identify concisely the fundamental research and/or technology or tool to be developed, its innovative nature, its relationship to presently available capabilities, and its expected impact on biomedical research. 3. Budget: The application should provide a detailed budget for Initial Budget Period (form page 4) for the first year of the R21 phase and a second detailed budget (form page 4) for the first year of the R33 phase. Form page 5 should be used to provide a budget for the entire proposed period of support. Form pages should indicate which years are R21 and which are R33. All budgets should include a written justification. The modular budget format should not be used. 4. Research Plan: Item a: Specific Aims. Specific aims must be presented which the applicant considers to be scientifically appropriate for the relevant phases of the project. Research that develops new technologies or tools is likely to require application of principles from fields such as analytical chemistry, mathematics, physics, and engineering. Clear statements of the underlying principles should be made within this section. Item b: Background and Significance Elaborate on the innovative nature of the proposed research. Clarify how the fundamental tools or technologies to be developed will result in a significant improvement over existing approaches. Explain the potential of the proposed technology for having an impact on a compelling area of biomedical research. Clearly identify how the project, if successful, will result in new capabilities for biomedical research, the immediacy of the opportunity, and how any proposed technologies or tools differ from existing technologies or tools. This item should not be included in the R33 portion of the application. Item c: Preliminary Studies While preliminary data are not required for submission of the R21 phase, this section should provide current thinking or evidence in the field to substantiate feasibility of the R21 phase. If the applicant does have preliminary data, it should be presented in this section. This item should not be included in the R33 portion of the application. Item d: Research Design and Methods Follow the instructions in the PHS 398 form. Applicants should also address plans to make the products, tools, or technologies forthcoming from this research available to the relevant biomedical research user community. 5. Milestones: For combined R21/R33 applications, a specific section labeled Milestones must be included following the Research Design and Methods of the R21 phase. Milestones should be well described, quantifiable, and scientifically justified. Applicants should write the milestones assuming that a scientifically literate non-expert will use them to evaluate the progress that has been achieved. Milestones should not be simply a restatement of the specific aims or a timeline. The milestones section should be indicated in the Table of Contents. Applications lacking this information will be returned to the applicant without review. For funded proposals, peer review is not likely between the two phases of the project. When the R21 milestones have been achieved, the Principal Investigator must submit a progress report to program staff. Receipt of this progress report will elicit a review to determine whether or not the R33 should be awarded. The release of R33 funds will be based on successful completion of milestones, program priorities, and on the availability of funds. SPECIFIC INSTRUCTIONS FOR PREPARATION OF THE R21 APPLICATION WHEN SUBMITTED WITHOUT THE R33 PHASE 1. Face Page of the application: Item 2. Check the box marked "YES" and type the number and title of this program announcement. Item 7a: DIRECT COSTS REQUESTED FOR INITIAL PERIOD OF SUPPORT For the R21 application, direct costs are limited to a maximum of $125,000 per year for a maximum of three years. R21 budgets can only exceed this cap to accommodate F&A; costs of subcontracts to the project. 2. Page 2 - Description: As part of the description, identify concisely the fundamental research and/or technology or tool to be developed, its innovative nature, its relationship to presently available capabilities, and its expected impact on biomedical research. 3. Budget: The application should provide a detailed budget for Initial Budget Period (form page 4), as well as a budget for the entire proposed period of support (form page 5). All budgets should include a written justification. The modular budget format is not to be used. 4. Research Plan: The research plan for an R21 application is limited to 15 pages. Item a: Specific Aims. Specific aims that the applicant considers to be scientifically appropriate for the relevant phases of the project must be presented. Research that develops new technologies or tools is likely to require the application of principles from fields such as analytical chemistry, mathematics, physics, and engineering. Clear statements of the underlying principles should be made within this section. Item b: Background and Significance Elaborate on the innovative nature of the proposed research. Clarify how the fundamental tools or technologies to be developed in this project will result in a significant improvement over existing approaches. Explain the potential of the proposed technology for having an impact on a compelling area of biomedical research. Clearly identify how the project, if successful, would result in new capabilities for biomedical research, the immediacy of the opportunity, and how any proposed technologies or tools would differ from existing technologies or tools. Item c: Preliminary Studies While preliminary data are not required for submission of the R21 phase, this section should provide current thinking or evidence in the field to substantiate feasibility of the R21 phase. If the applicant does have preliminary data, it should be presented in this section. Item d: Research Design and Methods Follow the instructions in the PHS 398 form. 5. Milestones: Applications using the R21 mechanism without the R33 phase do not need to include milestones. 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 five copies of the appendix material must be sent to: Office of Review National Center for Research Resources 6701 Democracy Boulevard, MSC 4874 Bethesda, MD 20892-4874 Bethesda, MD 20817 (for express/courier service) 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. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NCRR. Incomplete 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 NCRR 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 the National Advisory Research Resources 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 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: o To what degree does the research or development of technologies or tools support the needs of the targeted biomedical research community? o What is the time frame for developing the proposed approaches, tools, or technologies? Is this time frame suitable for meeting the relevant biomedical research community's needs? o For R21/R33 proposals, are the proposed milestones appropriate for judging the success of the R21 work? o For R21/R33 proposals, are the proposed milestones appropriate in determining whether the R33 phase should be awarded? o For R21/R33 proposals, are the milestones quantitative? Will a scientifically literate non-expert be able to determine whether the milestones have been achieved? 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. ADDITIONAL REVIEW CONSIDERATIONS 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 Application Receipt Date: June 18, 2004 and October 15, 2004 Peer Review Date: October 2004 and February 2005 Council Review: January 2005 and May 2005 Earliest Anticipated Start Date: April 1, 2005 and July 1, 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: 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.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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