[December 11, 2018] Can I pay graduate students using my sponsored research grants? RU's graduate students' salaries/stipends may not be requested on research grants submitted from and awarded to RU investigators. For questions contact Finance or the Dean's office; for questions about grant submissions contact your Sponsored Programs Officer. [Faculty, Postdocs and Resadmin 12/11/2018]
[November 15, 2018] NIH Research Performance Progress Reports (RPPRs) now allow for decimal detail for effort reporting of project personnel
Per NOT-OD-18-202: The NIH has changed its RPPR format to allow effort reported in grant applications to include decimals. Previously, when reporting effort in section “D.1 What individuals have worked on the project?”, the system only allowed whole numbers and rounded up or down accordingly. The lack of the ability to include decimals contributed to significant inaccurate reporting when, for example, a PD/PI has contributed 20% effort or 2.4 calendar months, and the previous system feature rounded effort down to 2 calendar months.
The determination of which individuals to report on the RPPR remains unchanged: Include (1) the PD/PI regardless of effort devoted to the project and (2) each person who has worked at least one person month per year on the project during the reporting period, regardless of the source of compensation. [Faculty, Postdocs and Resadmin 11/15/2018]
[September 25, 2018] Consistent font & margins urged by reviewers
Recent discussions at NCURA*, FDP**, and via social media have presented anecdotal evidence regarding use of consistent font and margins within grant applications. Overall, reviewers commented that inconsistent use of font from section to section of a submitted proposal makes the review process jarring and disjointed.
Based on this feedback, OSPA recommends the following:
• Choose a font at the outset of your writing process, and inform any collaborators of this font.
As always, you can contact your SPO for assistance and advice. [Faculty, Postdocs and Resadmin 9/25/2018]
* NCURA: National Council of University Research Administrators
** FDP: Federal Demonstration Partnership
[September 20, 2018] How do I update my eRA Commons profile? The Personal Profile module in the eRA Commons is a central repository of information for all registered NIH users, and this profile information is used for a variety of purposes, including peer review, application data and trainee data. Students or postdocs listed on Research Performance Progress Reports (RPPRs) must have an eRA Commons ID and have completed their eRA Commons profile with demographic information. These personal profiles should be updated if there are changes in contact information, employment, education, citizenship status, etc. Personal profiles can be edited directly in the Commons – see instructions for the Personal Profile module. [Faculty, Postdocs and Resadmin 9/20/2018]
[June 21, 2018] What tools are available to search for potential study sections to review my NIH application? The Center for Scientific Review (CSR) has a new Assisted Referral Tool (ART), which investigators can use to identify CSR study sections that may be appropriate to review their applications. By entering the project title and/or specific aims or project summary/abstract from a grant application, a list of relevant CSR study sections will be generated. Alternatively, investigators can find study sections using keywords. [Faculty, Postdocs and Resadmin 6/21/2018]
[May 17, 2018] What appendix materials are allowed for NIH applications? The new NIH Policy on Appendices to grant applications (NOT-OD-16-129) eliminates most appendix materials for submissions due on or after January 25, 2017. Under the new policy, the only allowable appendix materials are:
• Clinical trial protocols
• Investigator's brochure from Investigational New Drug (IND), if relevant
• Blank informed consent/assent forms
• Blank surveys, questionnaires, data collection instruments
• Funding Opportunity Announcement (FOA)-specified items.
Applications will be withdrawn and not reviewed if they are submitted with appendix materials that are not specifically listed in the above list or specified in the FOA. More >> [Faculty, Postdocs and Resadmin 5/17/2018]
NOTE: Studies that involve secondary research with biological specimens or health information are not clinical trials.
Please see the case studies available on the NIH website for further information about what now qualifies as a Clinical Trial. [Faculty, Postdocs and Resadmin 1/11/2018]
[January 11, 2018] Specific NIH application packages for studies with clinical trials For due dates on or after January 25, 2018, NIH will require that all applications involving one or more clinical trials be submitted through a Funding Opportunity Announcement (FOA) specifically designed for clinical trials. The purpose of this policy is to improve our ability to identify proposed clinical trials, ensure that key pieces of trial-specific information are submitted with each application, and uniformly apply trial-specific review criteria.
Policy Implementation
Applications/proposals involving clinical trials with due dates on or after January 25, 2018 must be submitted to an FOA or request for proposal (RFP) that explicitly states it will accept clinical trials. After January 25, 2018, NIH will no longer accept clinical trial applications through existing parent announcements.
All existing FOAs have been updated with the following changes:
• All FOAs will specify the allowability of clinical trials in Section II. Award Information
• All clinical trial FOAs will specify allowability of clinical trials in the FOA title
• FOAs that accept clinical trials will incorporate specific review criteria to ensure that reviewers appropriately consider clinical trial-related information
[Faculty, Postdocs and Resadmin 1/11/2018]
[November 15, 2018] NIH Research Performance Progress Reports (RPPRs) now allow for decimal detail for effort reporting of project personnel
Per NOT-OD-18-202: The NIH has changed its RPPR format to allow effort reported in grant applications to include decimals. Previously, when reporting effort in section “D.1 What individuals have worked on the project?”, the system only allowed whole numbers and rounded up or down accordingly. The lack of the ability to include decimals contributed to significant inaccurate reporting when, for example, a PD/PI has contributed 20% effort or 2.4 calendar months, and the previous system feature rounded effort down to 2 calendar months.
The determination of which individuals to report on the RPPR remains unchanged: Include (1) the PD/PI regardless of effort devoted to the project and (2) each person who has worked at least one person month per year on the project during the reporting period, regardless of the source of compensation. [Faculty, Postdocs and Resadmin 11/15/2018]
[September 25, 2018] Consistent font & margins urged by reviewers
Recent discussions at NCURA*, FDP**, and via social media have presented anecdotal evidence regarding use of consistent font and margins within grant applications. Overall, reviewers commented that inconsistent use of font from section to section of a submitted proposal makes the review process jarring and disjointed.
Based on this feedback, OSPA recommends the following:
• Choose a font at the outset of your writing process, and inform any collaborators of this font.
- For NIH, font must be 11 points or larger, and they recommend Arial, Georgia, Helvetica, or Palatino Linotype. Reviewers appear to like Arial best. Margins must be ½ inch or larger.
- For DOD, font must be 12 points or larger, with Times New Roman “strongly recommended". Margins must be ½ inch or larger.
- For other sponsors, check the instructions and/or contact your SPO for assistance.
As always, you can contact your SPO for assistance and advice. [Faculty, Postdocs and Resadmin 9/25/2018]
* NCURA: National Council of University Research Administrators
** FDP: Federal Demonstration Partnership
[September 20, 2018] How do I update my eRA Commons profile? The Personal Profile module in the eRA Commons is a central repository of information for all registered NIH users, and this profile information is used for a variety of purposes, including peer review, application data and trainee data. Students or postdocs listed on Research Performance Progress Reports (RPPRs) must have an eRA Commons ID and have completed their eRA Commons profile with demographic information. These personal profiles should be updated if there are changes in contact information, employment, education, citizenship status, etc. Personal profiles can be edited directly in the Commons – see instructions for the Personal Profile module. [Faculty, Postdocs and Resadmin 9/20/2018]
[June 21, 2018] What tools are available to search for potential study sections to review my NIH application? The Center for Scientific Review (CSR) has a new Assisted Referral Tool (ART), which investigators can use to identify CSR study sections that may be appropriate to review their applications. By entering the project title and/or specific aims or project summary/abstract from a grant application, a list of relevant CSR study sections will be generated. Alternatively, investigators can find study sections using keywords. [Faculty, Postdocs and Resadmin 6/21/2018]
[May 17, 2018] What appendix materials are allowed for NIH applications? The new NIH Policy on Appendices to grant applications (NOT-OD-16-129) eliminates most appendix materials for submissions due on or after January 25, 2017. Under the new policy, the only allowable appendix materials are:
• Clinical trial protocols
• Investigator's brochure from Investigational New Drug (IND), if relevant
• Blank informed consent/assent forms
• Blank surveys, questionnaires, data collection instruments
• Funding Opportunity Announcement (FOA)-specified items.
Applications will be withdrawn and not reviewed if they are submitted with appendix materials that are not specifically listed in the above list or specified in the FOA. More >> [Faculty, Postdocs and Resadmin 5/17/2018]
[April 19, 2018] Do references cited in an NIH application impact its review? In a recent survey conducted by NIH’s Center for Scientific Review (CSR), most of the reviewers surveyed reported that they check references, and about 2/3 of the respondents said that the citations affected their scoring of the research proposals. In these cases, the references were slightly more likely to improve review scores. More>> [Faculty, Postdocs and Resadmin 4/19/2018]
[March 15, 2018] Are special characters allowed in NIH application titles and/or file names? The NIH does NOT allow special characters in application titles nor in names of associated files. File name characters are validated and enforced by Grants.gov. Valid file names may only include A-Z, a-z, 0-9, underscore (_), hyphen (-), space, and period. If special characters are included in applications’ project titles and/or file names, they can cause ERRORs and rejections. (The use of special characters and symbols in the body of your research plan is allowed and expected as needed.)
In addition, here are our suggested file names:
• Abstract
• Strategy
• VertAnimals
• Biosketch_(LastName) ex: Biosketch_Smith
• References, etc.
In addition, here are our suggested file names:
• Abstract
• Strategy
• VertAnimals
• Biosketch_(LastName) ex: Biosketch_Smith
• References, etc.
[Faculty, Postdocs and Resadmin 3/15/2018]
[February 15, 2018] What is the new NIH process for submitting final progress reports? As of January, 2017, the NIH has replaced the Final Progress Report with the Final Research Performance Progress Reports (F-RPPR) to close out grants (details in NIH Notice). The F-RPPR format is generally the same as the current annual RPPR. However, there is a new requirement to report on Project Outcomes, which will be made publicly available, thus allowing grantees the opportunity to provide the general public with a concise summary of the findings of the project (analogous to the Project Summary/Abstract section of the competing application). The deadline for submitting final reports remains the same, i.e. within 120 calendar days of the project end date. More>> [Faculty, Postdocs and Resadmin 2/15/2018]
[February 15, 2018] Does the new NIH policy on final progress reports apply if I submitted a competing renewal for the same project? Yes. As of February 9, 2017 NIH will no longer accept the progress report contained within a competing renewal to serve as a separate final progress report. The NIH now requires that an “Interim-RPPR” be submitted (within 120 calendar days of the project end date) even while a competing renewal is under consideration. If the renewal is funded, the NIH will treat the Interim-RPPR as the annual performance report for the final year of the previous competitive segment. If the renewal is not funded, the Interim-RPPR will be treated by NIH staff as the Final-RPPR. More>> [Faculty, Postdocs and Resadmin 2/15/2018]
[February 15, 2018] What is the new NIH process for submitting final progress reports? As of January, 2017, the NIH has replaced the Final Progress Report with the Final Research Performance Progress Reports (F-RPPR) to close out grants (details in NIH Notice). The F-RPPR format is generally the same as the current annual RPPR. However, there is a new requirement to report on Project Outcomes, which will be made publicly available, thus allowing grantees the opportunity to provide the general public with a concise summary of the findings of the project (analogous to the Project Summary/Abstract section of the competing application). The deadline for submitting final reports remains the same, i.e. within 120 calendar days of the project end date. More>> [Faculty, Postdocs and Resadmin 2/15/2018]
[February 15, 2018] Does the new NIH policy on final progress reports apply if I submitted a competing renewal for the same project? Yes. As of February 9, 2017 NIH will no longer accept the progress report contained within a competing renewal to serve as a separate final progress report. The NIH now requires that an “Interim-RPPR” be submitted (within 120 calendar days of the project end date) even while a competing renewal is under consideration. If the renewal is funded, the NIH will treat the Interim-RPPR as the annual performance report for the final year of the previous competitive segment. If the renewal is not funded, the Interim-RPPR will be treated by NIH staff as the Final-RPPR. More>> [Faculty, Postdocs and Resadmin 2/15/2018]
[January 11, 2018] New NIH rules qualifying what is considered a clinical trial The NIH defines a Clinical Trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
Use the following four questions to determine the difference between a clinical study and a clinical trial:
1. Does the study involve human participants?
2. Are the participants prospectively assigned to an intervention?
3. Is the study designed to evaluate the effect of the intervention on the participants?
4. Is the effect being evaluated a health-related biomedical or behavioral outcome?
Note that If the answers to the 4 questions are yes, your study meets the NIH definition of a clinical trial, even if…
• You are studying healthy participants
• Your study does not have a comparison group (e.g., placebo or control)
• Your study is only designed to assess the pharmacokinetics, safety, and/or maximum tolerated dose of an investigational drug
• Your study is utilizing a behavioral intervention
NOTE: Studies intended solely to refine measures are not considered clinical trials.Use the following four questions to determine the difference between a clinical study and a clinical trial:
1. Does the study involve human participants?
2. Are the participants prospectively assigned to an intervention?
3. Is the study designed to evaluate the effect of the intervention on the participants?
4. Is the effect being evaluated a health-related biomedical or behavioral outcome?
Note that If the answers to the 4 questions are yes, your study meets the NIH definition of a clinical trial, even if…
• You are studying healthy participants
• Your study does not have a comparison group (e.g., placebo or control)
• Your study is only designed to assess the pharmacokinetics, safety, and/or maximum tolerated dose of an investigational drug
• Your study is utilizing a behavioral intervention
NOTE: Studies that involve secondary research with biological specimens or health information are not clinical trials.
Please see the case studies available on the NIH website for further information about what now qualifies as a Clinical Trial. [Faculty, Postdocs and Resadmin 1/11/2018]
[January 11, 2018] Specific NIH application packages for studies with clinical trials For due dates on or after January 25, 2018, NIH will require that all applications involving one or more clinical trials be submitted through a Funding Opportunity Announcement (FOA) specifically designed for clinical trials. The purpose of this policy is to improve our ability to identify proposed clinical trials, ensure that key pieces of trial-specific information are submitted with each application, and uniformly apply trial-specific review criteria.
Policy Implementation
Applications/proposals involving clinical trials with due dates on or after January 25, 2018 must be submitted to an FOA or request for proposal (RFP) that explicitly states it will accept clinical trials. After January 25, 2018, NIH will no longer accept clinical trial applications through existing parent announcements.
All existing FOAs have been updated with the following changes:
• All FOAs will specify the allowability of clinical trials in Section II. Award Information
• All clinical trial FOAs will specify allowability of clinical trials in the FOA title
• FOAs that accept clinical trials will incorporate specific review criteria to ensure that reviewers appropriately consider clinical trial-related information
[Faculty, Postdocs and Resadmin 1/11/2018]
