1. NOTICE OF POLICY CHANGES FOR NIH GRANTS
Chandan K. Sen
Department of Surgery

2. NEW NIH RULES: KEY POINTS
RIGOR, TRANSPARENCY AND REPRODUCIBILITY
BIOSKETCH
INCLUSION OF CHILDREN
AUTHENTICATION OF KEY BIOLOGICAL AND CHEMICAL RESOURCES
SIMPLIFICATION OF VERTEBRATE ANIMAL SECTION

3. Rigor and Transparency in Research
To support the highest quality science, public accountability, and social responsibility in the conduct of science, NIH’s Rigor and Transparency efforts are intended to clarify expectations and highlight attention to four areas that may need more explicit attention by applicants and reviewers:
Scientific premise
Scientific rigor
Consideration of relevant biological variables, such as sex
Authentication of key biological and/or chemical resources
Role of reviewers: Assess the scientific merit of each application according to the review criteria, which include consideration of scientific premise, rigor, and consideration of relevant biological variables, and the adequacy of the authentication of key biological and/or chemical resources as an administrative issue. Evaluations should be based on current best practices in the field.
SOURCE:NIH,CSR

4. Scientific Premise: Guidance for Reviewers
GOAL: Ensure that the underlying scientific foundation of the project—concepts, previous work, and data (when relevant)—is sound.
Pertains to the underlying evidence/data for the project
Address under Significance (R applications) or Research plan (Ks)
Addition to the review criteria: “Is there a strong scientific premise?”
Specifically, has the applicant:
Provided sufficient justification for the proposed work?
Cited appropriate work and/or preliminary data?
Appropriately identified strengths and weaknesses in prior work in the field?
Proposed to fill a significant gap in the field?
OR has the applicant explained why this is not possible?
The instructions for Significance already include discussing the importance of the research question, critical barriers to progress, how the proposed project will improve scientific knowledge, and how the field will change if the aims are achieved. The Research Plan criterion addresses the scientific and technical merit of the proposed research, plus the contribution of the research plan to the candidate’s career development. Scientific premise extends these instructions to include a retrospective assessment of the foundation for the project in the context of these other factors.
SOURCE:NIH,CSR

5. SIGNIFICANCE SECTION
Explicitly state the scientific premise for the proposed project.
The general strengths and weaknesses of the prior research cited by the applicant, which form the basis for the proposed research
Not your hypothesis. This separates the premise from the hypothesis your grant is trying to address; the premise leads to the hypothesis.
Recommendation: State significance section of your grant application with a paragraph or subsection entitled “Scientific Premise”.
Consider a separate section in the Significance entitled “Strengths and Weakness of Supporting Data” or, alternatively, a 1-3 sentence appraisal of the data at the end of each section where it is presented.
NIH: NOT-OD

6. Scientific Rigor: Guidance for Reviewers
(NIH: NOT-OD )
GOAL: Ensure a strict application of scientific method that supports robust and unbiased design, analysis, interpretation, and reporting of results, and sufficient information for the study to be assessed and reproduced. Give careful consideration to the methods and issues that matter in your field.
Pertains to the proposed research
Address under Approach (R applications) or Research Plan (Ks)
Addition to review criteria: Are there “strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?”
Possible considerations, if appropriate for the scientific field and research question, include plans for:
determining group sizes
analyzing anticipated results
reducing bias
ensuring independent and blinded measurements
improving precision and reducing variability
including or excluding research subjects
managing missing data
SOURCE:NIH,CSR

7. Relevant Biological Variables: Guidance for Reviewers
GOAL: Ensure that the research accounts for sex and other relevant biological variables in developing research questions and study designs. The ways in which sex and other biological variables need to be accounted for will differ across research questions and fields of study.
Pertains to the proposed research
Applies to studies in vertebrate animals and/or human subjects
Address in Approach (R applications) or Research Plan (Ks)
Addition to review criteria: Are there “adequate plans to address relevant biological variables for studies in vertebrate animals or human subjects?”
Consideration of sex is required in all studies involving human subjects or vertebrate animals (see next slide).
Specific considerations to assess include:
Applies broadly to all biological variables relevant to the research such as sex, age, source, weight, or genetic strain.)
Has the applicant considered biological variables, such as sex, that are relevant to the experimental design?
Will relevant biological variables be controlled or factored into the study design appropriately?
Although the review criteria specify that plans to address relevant biological variables are included for studies in vertebrate animals or human subjects, reviewers may extend the same thinking to other model systems or approaches if biological variables are relevant based on the research question, current knowledge, and best practices in the field.
SOURCE:NIH,CSR

8. Sex as a Biological Variable: Guidance for Reviewers
SEX = CHROMOSOME; GENDER = BEHAVIOR
Consideration of sex, included under the umbrella of “Relevant Biological Variables”, is required in all studies involving human subjects or vertebrate animals.
NIH expectations for applicants:
If little is known about sex differences, the application should include both sexes.
Sufficient numbers should be provided to inform the presence or absence of sex differences. Statistically powered comparisons between sexes may not be warranted.
Specific hypotheses about sex differences may not be possible.
Findings should be reported separately by sex in progress reports and publications.
If sex differences are known not to exist, a strong justification should be provided if the application proposes to study one sex.
If sex differences are known, experiments should be designed with appropriate group sizes to detect sex differences.
Since much of the published literature has been conducted either in one sex or sex was not reported, an important consideration for research applications will be what is known about males and females in relation to the disease, condition or question under study. If little is known about males and females, the application should address this gap by including both sexes in the proposed research project(s), in sufficient numbers to inform the possibility that sex differences may be present and to report separately by sex in their reported research. These grant applications may not be able to propose specific hypotheses about sex differences or justify sufficient numbers of males and females to conduct statistically powered comparisons between sexes, but the inclusion of both sexes and the analysis of results for each sex represent an important advancement of our knowledge in areas where this information is currently lacking. A strong justification should be provided if the application proposes to study one sex.
Cost and absence of known sex differences are not valid justifications for not addressing sex as a biological variable.
Hyperlink to NOT-OD supplement:
SOURCE:NIH,CSR

9. Sex as a Biological Variable: Guidance for Reviewers
Consideration of sex
NIH expectations for reviewers:
As part of the Consideration of Relevant Biological Variables, assess whether the plans to address sex as a biological variable are adequate (for studies in vertebrate animals or human subjects).
If the study involves only one sex, is this justified scientifically?
Assess within the context of the research question and current scientific knowledge.
SOURCE:NIH,CSR

10. AUTHENTICATION OF KEY BIOLOGICAL AND/OR CHEMICAL RESOURCES
BRIEF DESCRIPTION OF METHODS TO ENSURE IDENTITY AND VALIDITY OF KEY REAGENTS USED IN PROPOSED STUDIES
Key biological resources include:
Those that differ from lab to lab
Qualities or qualifications that influence results
Integral to proposed research
Include: cell lines, specialty chemicals (homegrown/ developed in-house) antibodies, other biologics
Focus only on authentication/validation; other methods and preliminary data will be within research strategy
***IF APPLICATIONS ARE NON-COMPLIANT THEY WILL NOT BE REVIEWED***
NIH: NOT-OD

11. AUTHENTICATION OF KEY BIOLOGICAL AND/OR CHEMICAL RESOURCES
Transparent reporting of what was done to authenticate key resources
One description for multiple resources in same category: example – authenticating cell lines
Not necessary to show actual data on authentication
If key resource is being made as part of project or under development – include in research strategy
Could include company/manufacturer’s information/criteria for validation
Save this information in a single PDF file named “Authentication of Key Resources Plan,” and attach it on the R&R other project information
NO PAGE LIMITS
NIH: NOT-OD

12. Plan for Resource Authentication: Guidance for Reviewers
NIH: NOT-OD
GOAL: Ensure processes are in place to identify and regularly validate key resources used in their research and avoid unreliable research as a result of misidentified or contaminated resources.
Researchers are expected to authenticate key biological and/or chemical resources used in their research, to ensure that the resources are genuine.
New Additional Review Consideration
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.
Rate as acceptable/unacceptable (provide brief explanation if unacceptable)
Does not affect criterion scores or overall impact score
If reviewers have serious concerns about the authenticity of resources and the feasibility of the research given the resources to be used, these concerns can be addressed in the approach and affect the overall impact score; concerns about the plan to authenticate resources should be noted as unacceptable but should not affect the approach or overall impact score.
SOURCE:NIH,CSR

13. Related review issues:
Different research fields may have different best practices for and reach different conclusions about scientific premise and rigor. Assess based on best practices in the field.
Page limits have not changed. Be alert for page limit violations (e.g. inappropriate use of appendices or other application sections). Alert the SRO if you see a potential issue.
Page limits, cost and time are not valid reasons to disregard attention to these issues.
Investigators address rigor and transparency differently (e.g. in labeled sections vs. throughout the research plan). Focus your evaluation on the likely outcome, not grant writing preferences.
Rigor and transparency considerations apply to R03 (small grant) and R21 (exploratory/developmental) applications. However, preliminary data are not required and the extent to which approach details can be provided may differ. Reviewers should evaluate the scientific merit of these applications, including rigor and transparency, in light of the goals and reviewer guidelines for these activities.

14. Reviewing Rigor and Transparency of Research: RPG Applications
Applies to which applications?
Where will I find it in the application?
Where do I include it in my critique?
Addition to review criteria
Affect overall impact score?
Scientific Premise
All
Research Strategy (Significance)
Significance
Is there a strong scientific premise for the project?
Yes
Scientific Rigor
Research Strategy (Approach)
Approach
Are there strategies to ensure a robust and unbiased approach?
Consideration of Relevant Biological Variables,
Such as Sex
Projects with vertebrate animals and/or human subjects
Are adequate plans to address relevant biological variables, such as sex, included for studies in vertebrate animals or human subjects?
Authentication of Key Biological and/or Chemical Resources
Project involving key biological and/or chemical resources
New Attachment
Additional review considerations
Comment on plans for identifying and ensuring validity of resources. No
Rigor and transparency do not apply to all applications.  See List of Eligible Activity Codes: Also, certain Funding Opportunity Announcements are exempt from rigor, by request from the ICs.
SOURCE:NIH,CSR

15. Reviewing Rigor and Transparency of Research: Mentored Career Development Applications
Applies to which applications?
Where will I find it in the application?
Where do I include it in my critique?
What should I consider?
Affect overall impact score?
Scientific Premise
All
Research Strategy
Research Plan
Is there a strong scientific premise for the project?
Yes
Scientific Rigor
Are there strategies to ensure a robust and unbiased approach?
Consideration of Relevant Biological Variables,
Such as Sex
Projects with vertebrate animals and/or human subjects
Are adequate plans to address relevant biological variables, such as sex, included for studies in vertebrate animals or human subjects?
Authentication of Key Biological and/or Chemical Resources
Projects involving key biological and/or chemical resources
New Attachment
Additional review considerations
Comment on plans for identifying and ensuring validity of resources. No
Rigor and transparency do not apply to all applications.  See List of Eligible Activity Codes: Also, certain Funding Opportunity Announcements are exempt from rigor, by request from the ICs.
SOURCE:NIH,CSR

16. NIH BIOSKETCH (NIH: NOT-OD-16-080)
KEY: HIGHLIGHTING SCIENTIFIC CONTRIBUTIONS
BE OBJECTIVE: DON’T OVERSELL OR UNDERSELL YOURSELF
CLAIMS TO BE BACKED UP BY PUBLICATIONS
Provide subheader to each of 5 thematic areas
DATA (GRAPHS/FIGURE/TABLES) DO NOT BELONG HERE
CONFERENCE PROCEEDINGS – MEETING ABSTRACTS, POSTERS AND OTHER PRESENTATIONS CAN BE INCLUDED
MANUSCRIPTS UNDER DEVELOPMENT CAN BE MENTIONED IN NARRATIVE BUT CANNOT BE CITED
Optional: PROVIDE LINKS TO PUBLICATIONS VIA SciENcv or MyBibliography
Examples: Google Scholar page:
Link to all publications:
Complete List of Published Work in MY Bibliography:

18. INCLUSION OF CHILDREN IN CLINICAL RESEARCH: CHANGE IN DEFINITION
NIH’s long-standing policy has been that children 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.  The policy was developed because medical treatments applied to children are often based upon testing done only in adults, and scientifically evaluated treatments are less available to children due to barriers to their inclusion in research studies.  Therefore, applicants/offerors conducting human subjects’ research must include a description of plans for including children.  If children (or a subset of children) will be excluded from the research, the application or proposal must present an acceptable justification.  
What’s Changing: 
Age: individuals under 18 years old (previously under 21 years)
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). 
NIH: NOT-OD

19. SIMPLIFICATION OF VERTEBRATE ANIMAL SECTION
DESCRIPTION OF PROCEDURES:
Concise
Identify species, strains, ages, sex, number of animals
For studies involving dogs/cats – source of animals
JUSTIFICATIONS: Why must the proposed model be used?
MINIMIZATION OF PAIN: Description of interventions to minimize discomfort or distress
EUTHANASIA: American Veterinary Medical Association (AVMA) Guidelines must be followed – just need to state it. If not, describe method and provide scientific justification
NO LONGER NEED: DESCRIPTION OF VETERINARY CARE OR JUSTIFICATION OF NUMBER OF ANIMALS
NIH: NOT-OD

26. Additional resources
Rigor and Reproducibility in grant applications (OER site):
NIH presentation of background and goals of Rigor and Transparency (video)
Reviewer Guidance on Rigor and Transparency: r_and_Transparency.pdf
Consideration of Sex as a Biological Variable in NIH-funded Research
Rigor and transparency do not apply to all applications.  See List of Eligible Activity Codes: intranet.od.nih.gov/d/sites/default/files/RigorActivityCodes pdf.  Also, certain Funding Opportunity Announcements are exempt from Rigor and Transparency, by request from the ICs.
Questions about the NIH policy should be directed to