# Presentation: 110457

## INNOVATION REVIEW CRITERION

- David Armstrong, Ph.D.
- Chief, Review Branch
- National Institute of Mental Health
- National Institutes of Health
- SEPTEMBER 26, 2005

##  AGENDA ITEMS

- DEFINE INNOVATION
- NIH EFFORTS TO PROMOTE RECEIPT AND REVIEW OF INNOVATIVE APPLICATIONS (e.g., R21, RFAs/PAs)
- POSSIBLE NEW INITIATIVES

## INNOVATIVE (HIGH-RISK) RESEARCH: A CHALLENGE FOR THE NIH

- Excessively conservative peer review process that places more emphasis on feasibility than innovation
- NIH seen as risk-averse
- Funding decisions are too conservative and slow
- Many innovative applications are not submitted to the NIH
- This threatens to deplete the NIH of a vital set of investments that are critical to its future successes

## NIH RESPONSE TO THIS CHALLENGE

- NIH Roadmap for Medical Research
- NIH Neuroscience Blueprint

## INNOVATION DEFINED

**	****Innovation****1**: 1. the action of innovating; the introduction of novelties; the alteration of what is established by the introduction of new elements or forms. 2. A change made in the nature or fashion of anything; something newly introduced; a novel practice, method, etc. 3. *Comm*. The action of introducing a new product into the market; a product newly brought into the market.
- 	1Oxford Dictionary

**Notes:**
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## Definitions

**Creativity**
- Ability to solve problems, generate possibilities, create products
- Within a specific domain (e.g. cooking, engineering, law, music, science)
- Initially novel but eventually broadly accepted

**The definitions are provided by Merton C. Flemings, Toyota Professor Emeritus, MIT**
** ****and Director, Lemelson-MIT Program.  The definitions are based on William Middendorf’s,**
** *****What Every Engineer Should Know About Inventing, Marcel Dekker, *****New York, New York,***** *****1981**
** ****and Howard Gardner’s, *****Intelligence Reframed: Multiple Intelligences for the 21st Century, *****Basics Books,**
** ****New York, New York, 1999.**

**Notes:**
Note: Inventiveness is a form of creativity leading to invention.

## Definitions

- Invention
- Process of devising & producing something which is useful and not previously known or existing
- Developed through independent investigation, experimentation, & mental activity

**Notes:**
Note: An invention involves such high order of mental activity that the inventor is usually acclaimed even if the invention is not a commercial success.

## Definitions

**Innovation**
- Process of introducing novel ideas into use or practice
- Includes entrepreneurship as integral part
- Usually considered noteworthy if commercially successful
- May or may not include invention

**Notes:**
Note: Innovation is usually considered noteworthy only if it is a commercial success. Thus, society benefits from innovation, not from invention alone, and often there is a significant lapse of time from invention to innovation.

## INNOVATION IS A PROCESS

- innovativeness

## INNOVATION DEFINED - NIH

**Innovation** – Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

## NIH Promotion of Innovative Science

- Interviews with ICs/Centers
- How does NIH promote receipt and review of innovative science?
- 13 ICs interviewed
- Completed by Chana Rabiner, PhD (Emerging Leaders Program) and David Armstrong, PhD

**Notes:**
Note: Chana Rabiner, Ph.D. a participant in the Emerging Leaders Program (ELP) conducted structured interviews with representatives from 9 Institutes (NIDA, NIDCR, NIAID, NHLBI, NIEHS, NIAAA, NIDCD, NEI, NHGRI).  In addition, Dr. Armstrong interviewed representatives from NINDS, NIA, and CSR. 

## INTERVIEW STRUCTURE

- Current/past efforts to promote receipt and review of innovative grant applications
- Future initiatives being considered to promote innovation
- Major impediments
- Recommendations

## Summary of Interviews

- RFAs and PAs
- Used to invigorate underserved areas or solicit innovative applications
- Reviewed in-house and resulting from IC-sponsored workshops
- Trans-NIH R21 may fall short of intended goal
- IC authority to fund poorly scored applications rarely used

**Notes:**
Note: Although the trans-NIH R21 mechanism is used by several of the ICs, there is the general belief that it falls short of its intended goal of supporting “exploratory or developmental research allowing investigators to conduct research on innovative ideas or develop new concepts or technologies.”
Most ICs have the authority to fund poorly scored applications, but this rarely occurs.  Funding decisions rely almost exclusively on priority scores and percentiles. 

## Interview Conclusions and Recommendations

- Need more explicit language in PAs
- CSR perceived as conservative
- SRAs should educate reviewers on different mechanisms’ emphasis on innovation
- NIH generally needs to be seen as willing to take greater risks

- “A highly structured bureaucracy is innovation’s worst enemy.”

**Notes:**
Note: 
Program Announcements (e.g., R21) require more explicit language particularly when describing high-risk, potentially high impact research.  As currently written the R21 mechanism fails to attract truly innovative (i.e., paradigm shifting) research. 
CSR is often perceived as conservative with a mindset that focuses largely on the R01. SRAs should be encouraged prior to the meeting to educate their reviewers on the different mechanisms with an emphasis on innovation when appropriate. 

## INITIATIVES FOR CONSIDERATION

- Establish a working group to develop new language for the trans-NIH R21 grant mechanism with greater emphasis on innovation and paradigm shifting research.
- Increase communication in the area of innovation (e.g., workshops, seminar series, national meetings)
- Establish working group to evaluate scoring of individual review criterion (e.g., innovation)

## Project Innovation

- Trans-NIH initiative to promote funding of high-risk, potentially high-impact grant applications that fail to meet the payline
- Involves collaboration between CSR and all funding ICs
- Nominations evaluated and prioritized by Innovation Committee specific for each IC

**Notes:**
Note (point 2): SRAs will identify applications based upon written critiques, discussion and/or variance in individual scores and notify program staff within the respective IC. Program staff may also nominate applications.
Note: Using the R56 mechanism, and/or ‘discretionary’ funds, each IC will provide partial support for a limited period of time to one highly innovative, paradigm shifting application each round.

The goal of Project Innovation is to provide limited support to about 75 highly innovative grant applications per year which otherwise would have gone unfunded.

## Project Innovation

- Using the R56 mechanism and/or “discretionary” funds each IC/Center will provide partial support for a limited period of time to one highly innovative, paradigm shifting application/round.
- The goal of **PROJECT INNOVATION** is to provide limited support to circa 75 highly innovative grant applications per year which otherwise would have gone unfunded.

## PROJECT INNOVATION: BENEFITS

- Provide strong encouragement to investigators particularly if new to the NIH
- Unprecedented collaboration between CSR and the ICs/Center.
- Increase awareness of innovation within NIH and  extramural scientific communities
- Important step to changing public perception about NIH and its willingness to take risk, accept failure and support truly paradigm shifting research.