# Presentation: 778042

## Review Outcomes for R01 Human Subjects Research at CSR

**Review Outcomes for R01 Human Subjects Research at CSR**

**Michael R. Martin, Ph.D.**
**Director, Division of Physiology and Pathology**
**Center for Scientific Review**
**National Institutes of Health**
**January 23, 2006**

**Notes:**
Personal notes

## Definition:Human Subjects

- A living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information.
- Applications designated Exemption 4 not considered human subjects research for this analysis

## Definition:New Investigator

- The principal investigator has not previously served as such on any PHS-supported research project other than a small grant (R03), an Academic Research Enhancement Award (R15), an exploratory/developmental grant (R21), or mentored career development awards for persons at the beginning of their research career (K01, K08, K22, and K23, K25).

## Slide 4

## Slide 5

## Slide 6

## Slide 7

## Slide 8

## Slide 9

## Slide 10

**Notes:**
The proportion of type 1 A0 applications from new PIs with percentiles better than 20 is not as great as type 1 A0 applications from established PIs or type 2 A0 applications

The proportion of HS+ type 1 A0 applications from new PIs with percentiles better than 20 tends to be less than the proportion of HS- type 1 A0 applications from new PIs

The same is true for HS+ versus HS- applications from established type 1 and type 2 PIs

## Observation:

- There are differences between HS+ and HS- within each type of application and across types of A0 applications [new versus experienced PI]

## Slide 12

## Slide 13

## Slide 14

## Observation:

- Differences across types of A1 applications [new versus experienced PI]
- Difference is not as great as with the initial A0 application.

## Slide 16

## Slide 17

## Slide 18

## Observation:

- No differences between HS+ and HS- within type of A2 application or across types of A2 applications [new versus experienced PI]

## Question:

- Why do the HS+ applications improve so much on resubmission?
- Do new HS+ PIs submit applications at the same rate as new HS- PIs?

## Percent of all HS+ or HS- applications

|  | HS+ | HS- | delta |
| --- | --- | --- | --- |
| Type1NewA0 | 24.59% | 20.20% | 4.39% |
| Type1NewA1 | 9.20% | 7.68% | 1.52% |
| Type1NewA2 | 2.30% | 1.94% | 0.36% |
|   |   |   |   |
| Type1ExpA0 | 28.12% | 27.58% | 0.54% |
| Type1ExpA1 | 12.57% | 11.55% | 1.02% |
| Type1ExpA2 | 3.62% | 3.40% | 0.22% |
|   |   |   |   |
| Type2A0 | 11.71% | 17.11% | -5.40% |
| Type2A1 | 5.95% | 7.90% | -1.95% |
| Type2A2 | 1.96% | 2.65% | -0.69% |
|   |   |   |   |
| Total | 100% | 100% | 0% |

## Slide 22

## Slide 23

## All funded Type 1 R01, and R29 awards between 1996-1999 reviewed by CSR, and subsequent Type 2 applications

| PI on T1 | Human
Subj in T1 | T1
awards  | # with 
subsequent T2
application | % with 
subsequent T2
application |
| --- | --- | --- | --- | --- |
| Established PI | HS- | 4,894 | 2,826 | 57.70% |
|   | HS+ | 2,165 | 958 | 44.20% |
| New PI  | HS- | 3,472 | 2,119 | 61.00% |
|   | HS+ | 1,330 | 603 | 45.30% |

## Questions:

**Why, on a percent basis, are HS+ PIs more **_**un**_**likely to apply for a type 2 A0 or A1 applications?**
**To what extent is the different percentage  of applications in each category a factor in the reported difference in the global review outcomes? **

## Acknowledgements	

**Charles Dumais, CSR**
**Teresa Lindquist, CSR**
**Ted Kotchen, MCW and CSR**
**Ray Hoffman, MCW**
**The staff of OER/OD/NIH**

## Review Outcomes for R01 Human Subjects Research at CSR

**Review Outcomes for R01 Human Subjects Research at CSR**

**Michael R. Martin, Ph.D.**
**Director, Division of Physiology and Pathology**
**Center for Scientific Review**
**National Institutes of Health**
**January 23, 2006**

**Notes:**
Personal notes