TOPICS TOPICS. Navigating NIH 2016 Policy Changes for Grant Applications and Availability of Proposal Resources

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1 Navigating NIH 2016 Policy Changes for Grant Applications and Availability of Proposal Resources John Ivy, Ph.D. Sr. Research Development Officer Christina Papke, Ph.D. Research Development Officer TOPICS NIH Policy Changes Phase 1 NIH Policy Changes Phase 2 Proposal Resources Research Development Services TOPICS NIH Policy Changes Phase 1 NIH Policy Changes Phase 2 Proposal Resources View from 20,000 Feet Policy changes in 11 topics announced in 16 Notices Implemented in two Phases in 2016 Phase 1, proposals submitted starting Jan. 25 Phase 2, proposals submitted starting May 25 Revised SF424 (R&R) Application Guide (11/25/15) for Phase 1 New instructions New review questions Anticipate revised SF424 (R&R) Application Guide (~3/25/16) for Phase 2 Anticipate new Forms Version-D for Phase 2 Research Development Services, Texas A&M University 1

2 NOT-OD provides overview NIH & AHRQ Announce Upcoming Changes to Policies, Instructions, and Forms for 2016 Grant Applications Relevant primary Notices listed and referenced Implementation summarized Changes to policies, forms, and instructions summarized Policy Changes in 11 Topics Implementation Topic Phase 1 Phase 2 1 Rigor and Transparency in Research F & T applications 2 Vertebrate Animals F & T applications 3 Definition of Child 4 Research Training Program Plan Attachments 5 Inclusion Reporting 6 Data Safety Monitoring 7 Research Training Tables RPPRs 8 Appendices 9 Assignment Request Form 10 Font Requirements 11 Biographical Sketch Clarification Phase 1 Implementation Effective for applications submitted on or after January 25, 2016 Continue using FORMS-C Use the SF424 Application Guide of Nov. 25, 2015 Instructions for individual fellowship applications incorporated into the general guide 1. Phase I Vertebrate Animals Updated Vertebrate Animal Section (VAS) requirements Intention is to remove redundancy with IACUC review while meeting the requirements of PHS Policy on Humane Care and Use of Laboratory Animals. Applicants still must address in the VAS the following: Description of Procedures Justifications Minimization of Pain and Distress Euthanasia Simplifications to the VAS: A description of veterinary care is no longer required Justification for the number of animals has been eliminated A description and justification of the method of euthanasia is required only if the method is not consistent with AVMA Guidelines Research Development Services, Texas A&M University 2

3 2. Phase I Definition of Child For purposes of NIH s inclusion policy, the age of a child is redefined to individuals under 18 years old instead of under 21 years old. Applicants/offerors for NIH funding will still be expected to justify the age range of the proposed participants in their clinical research, with particular attention paid to addressing the inclusion (or exclusion) of children (or subsets of children). Note: this change does not apply to AHRQ applications 3. Phase I Research Training Program Plan Attachments Updates to requirements and instructions for several attachments on PHS 398 Research Training Program Plan form Recruitment and Retention Plan to Enhance Diversity applicants will be asked to focus on recruitment Human Subjects applicants must describe how the institution will ensure that trainees participate only in exempt human subjects research or nonexempt human subjects research that has IRB approval; no longer necessary to provide a list of potential grants trainees may work on and associated IRB information Vertebrate Animals applicants must describe how the institution will ensure that trainees only participate in vertebrate animal research that has IACUC approval; no longer necessary to provide a list of potential grants trainees may work on and associated IACUC information Progress Report requirement to report on publications that arose from work conducted by the trainee while supported by the training grant will be moved to the Just-in-Time process 4. Phase 1 Rigor and Transparency in Research Enhancing Reproducibility through Rigor and Transparency (R&T) (NOT OD ) Applies to the full spectrum of research Focuses on four areas Scientific premise forming the basis of the proposed Significance research Rigorous experimental design for robust and unbiased results Approach Consideration of relevant biological variables, including sex Authentication of key biological and/or chemical resources New Attachment R&T Three elements to implementation 1. Revisions to the SF424 Application Guide instructions (Nov. 25, 2015 version) for preparing your Research Strategy attachment 2. Additional rigor and transparency questions reviewers will be asked to consider when reviewing applications 3. Use of a new Authentication of Key Biological and/or Chemical Resources" attachment Research Development Services, Texas A&M University 3

4 R&T SF424 Application Guide Instructions Research Strategy (starting on p. I-133) Significance. Describe the scientific premise for the proposed project, including consideration of the strengths and weaknesses of published research or preliminary data crucial to the support of your application. Approach. Describe the experimental design and methods proposed and how they will achieve robust and unbiased results. Explain how relevant biological variables, such as sex, are factored into research designs and analyses for studies in vertebrate animals and humans. For example, strong justification from the scientific literature, preliminary data, or other relevant considerations, must be provided for applications proposing to study only one sex. Refer to NOT-OD for further consideration of NIH expectations about sex as a biological variable. R&T New Evaluation Questions Research Project Evaluation Criteria Significance Is there a strong scientific premise for the project? Approach Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? R&T Preparation of Research Strategy, Significance Significance The scientific premise, including consideration of the strengths and weaknesses, of published research and preliminary data will be considered under the Significance criterion Thus, present the rigor and transparency of the published literature supporting (1) the critical need for the research and (2) for the experimental approach and methods of your proposed research, as well as the rigor and transparency of (3) the preliminary data for each of the aims in the Significance section. R&T Preparation of Research Strategy, Significance (cont.) Guide the reviewers to the information needed to assess, Is there a strong scientific premise for the project? Significance Scientific Premise. Overall Scientific Premise. Scientific Premise for Aim 1, Literature and Preliminary Results. Scientific Premise for Aim 2, Literature and Preliminary Results. Research Development Services, Texas A&M University 4

5 R&T Preparation of Research Strategy, Approach Approach ensure a robust and unbiased approach Scientific rigor is the strict application of the scientific method to ensure robust and unbiased experimental design, methodology, analysis, interpretation and reporting of results. Robust results are obtained using methods designed to avoid bias and can be reproduced under well-controlled and reported experimental conditions. Describe how you will achieve robust and unbiased results when describing the experimental design and proposed methods R&T Preparation of Research Strategy, Approach (cont.) Approach other relevant biological variables Consider other biological variables, as appropriate, in the design and analyses or proposed studies Underlying health conditions, weight, age, sex Research plans and findings should indicate which biological variables are tested or controlled Justify exclusion of variables that may be relevant but are not considered in the research plan Sex as a biological variable should be factored into research design, analysis, and reporting invertebrate animal and human studies R&T Preparation of Research Strategy, Approach (cont.) Guide the reviewers to the information needed to assess (1) the rigor and transparency of the experimental approach and (2) the adequacy of plans to address relevant biological variables Approach Specific Aim X. Experimental Design. Strategies to ensure a robust and unbiased approach. Sex and other biological variables. R&T Authentication of Key Resources Instructions Briefly describe methods to ensure the identity and validity of key biological and/or chemical resources used in the proposed studies. Key biological and/or chemical resources may or may not be generated with NIH funds and: 1) may differ from laboratory to laboratory or over time; 2) may have qualities and/or qualifications that could influence the research data; and 3) are integral to the proposed research. These include, but are not limited to, cell lines, specialty chemicals, antibodies, and other biologics. Standard laboratory reagents that are not expected to vary do not need to be included in the plan. Examples are buffers and other common biologicals or chemicals. Research Development Services, Texas A&M University 5

6 R&T Authentication of Key Resources Instructions (cont.) Save this information in a single file named Authentication of Key Resources Plan, and attach it as Item 12, Other Attachments, on the Other Project Information form. Information in this section must focus only on authentication and/or validation of key resources to be used in the study; all other methods and preliminary data must be included within the page limits of the research strategy. Applications identified as non-compliant with this limitation will be withdrawn from the review process (see NOT-OD and NOT-OD ). R&T Authentication of Key Resources Preparation of Attachment Focus only on authentication and/or validation of key resources Confine other methods and preliminary data to the Research Strategy Do not use this attachment to circumvent page limits R&T Authentication of Key Resources Evaluation Criteria Additional Review Considerations Authentication of Key Biological and/or Chemical Resources For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources. Any reviewer questions associated with key biological and/or chemical resource authentication will need to be addressed prior to award. TOPICS NIH Policy Changes Phase 1 NIH Policy Changes Phase 2 Proposal Resources Research Development Services, Texas A&M University 6

7 Phase 2 Phase 1 Extensions Vertebrate Animals Phase 1 changes extended to institutional training and individual fellowship applications Changes regarding euthanasia will be in FORMS-D application packages Rigor and Transparency Phase 1 changes extended to institutional training and individual fellowship applications Authentication of Key Biological and/or Chemical Resources will have attachment field T and F applications will use new Plan for the Instruction in Methods for Enhancing Reproducibility attachment 5. Phase 2 Inclusion Reporting FORMS-D application packages will include an optional PHS Inclusion Enrollment Report form. The new form will replace the optional Planned Enrollment Report and the Cumulative Inclusion Enrollment Report forms in the FORMS-C application packages. Look for more details in spring Phase 2 Data Safety Monitoring Plans 7. Phase 2 Research Training Tables Applications involving clinical trials will need to include a Data Safety Monitoring Plan as a new attachment in the FORMS-D application packages. Although inclusion of a data safety monitoring plan is not new, use of a separate attachment is. Format of the research training data tables is changed The number of required tables is reduced from 12 to 8 Individual-level information is minimized Tracking of trainee outcomes is extended from 10 to 15 years Example data tables are available at Research Development Services, Texas A&M University 7

8 Phase 2 Research Training Tables (cont.) NIH s xtract system to help prepare the new tables and to store the information provided in the tables was available on Oct. 16, 2105 Use of xtract is optional for FY2016 and not yet ready for all training grant mechanisms Required for RPPRs due Dec. 1, 2015 or later 8. Phase 2 Appendices The appendix policy is under review. A notice will be issued in spring 2016 describing specific policy changes. 9. Phase 2 Assignment Request Form To make requests relevant to Institute or Center assignment and initial peer review, applicants must use a new PHS Assignment Request Form. The new form will include these fields: PHS Awarding Component, both positive ("assign to") and negative ("do not assign to") Study Section or Special Emphasis Panel requests, both positive and negative List of potential reviewers in conflict, and why List of scientific expertise needed to review the application Making requests is optional, but using the form to do so will be required. Applicants need not use all fields on the form. Inclusion of a Cover Letter is still allowed to address other issues 10. Phase 2 Font Requirements Font size: must be 11 points or larger (smaller text in figures, graphs, diagrams and charts is acceptable as long as it is legible when the page is viewed at 100%) Type density: must be no more than 15 characters per linear inch (including characters and spaces) Line spacing: must be no more than six lines per vertical inch Text Color: must be black (color text in figures, graphs, diagrams, charts, tables, footnotes and headings is acceptable as long as it is legible) Recommended fonts: Arial, Garamond, Georgia, Helvetica, Palatino Linotype, Times New Roman, Verdana Other fonts (both serif and non-serif) are acceptable if they meet the above requirements. Research Development Services, Texas A&M University 8

9 11. Phase 2 Biographical Sketch Clarification A URL for a publication list is optional and, if provided, must be to a government website (.gov) like My Bibliography Publications (peer-reviewed and non-peer-reviewed) and research products may be cited in both the personal statement and the contributions to science sections Graphics, figures, and tables are not allowed SciENcv (Science Experts Network Curriculum Vitae, see allows you to populate your NIH or NSF biographical sketch and data can be imported from era Commons. My Bibliography can be used to create your.gov publication list. TOPICS NIH Policy Changes Phase 1 NIH Policy Changes Phase 2 Proposal Resources Jorja Kimball, Ph.D. Executive Director Shannon Eyre Administrative Assistant Monica Holder International Programs Coordinator Who We Are Services We Offer Research Development Services John Ivy, Ph.D. Sr. Research Development Officer Jim Izat, Ph.D. Sr. Research Development Officer Christina Papke, Ph.D. Research Development Officer Proposal Development Support Research Interest Groups Professional Development Shannon Prescott Sr. Administrative Coordinator Research Development Services, Texas A&M University 9

10 6 months 4 6 months 2 3 months 1 month 2 weeks Proposal Development Support Faculty consultation, review of summary statement, and strategic planning; assessment of competitiveness for various grant mechanisms Strategic planning, timeline development and tracking, facilitation of external reviews (as applicable) In depth review, critiquing, and editing of proposal text, bio sketches, and other documents for match with FOA requirements Assistance with grantsmanship, in depth proposal critiquing and editing Proposal editing and review for match with FOA requirements Goals Facilitate interaction among faculty with common research interests Promote interdisciplinary collaboration Focused Subject Areas Imaging Science Healthy Aging Research Interest Groups Networking Events Presentations two minutes; one slide Networking and Poster Session 1 week Proposal final edits and review Faculty Professional Development Grant Writers Seminars and Workshops Next event: September 2016 Internal seminars Federal agencies: NIH, NSF, and others Texas A&M internal programs: PESCA International research grant programs through partnerships with international universities Humanities & Arts Fellows Program Proposal preparation and resubmission support for NIH, NSF, and other funding agencies NSF and NIH proposal writing groups (as needed) Research Development Resources Research Development Services, Texas A&M University 10