# Presentation: 531326

## APPENDIX MATERIALS: Who Wants Them and What Should NIH Do with Them?

- Kirt Vener, Ph. D.
- Chief, Special Review and Logistics Branch
- National Cancer Institute
- Suzanne Fisher, Ph.D.
- Director, Division of Receipt and Referral
- Center for Scientific Review
- PRAC January 2006

## TOPICS TO CONSIDER

- Content of Appendix Materials
- Format of Appendix Materials
- Delivery of Appendix Materials to NIH
- Provision of Appendix Materials to Reviewers
- Storage of Appendix Materials by NIH
- (not of critical interest to applicants/reviewers)

## GOALS OF THIS PRESENTATION

- Provide background on NIH considerations about appendix materials
- Get your input
- Not make final decisions but these will be needed soon

## APPENDIX MATERIALS

- Current PHS 398 instructions for R01 applications allow:
- Up to 10 publications, manuscripts accepted, patents, printed materials
- Surveys, questionnaires, data collection instruments, clinical protocols, informed consent documents
- Glossy photographs or color images provided copy (may be reduced in size) is included within Research Plan

## NEED AND VALUE OF APPENDIX MATERIALS

- Kirt Vener, Ph. D.
- Chief, Special Review and Logistics Branch
- National Cancer Institute

## Is Appendix Material of Value?

- Peer Review  (CSR & NCI)
- Program Management

## Slide 7

## Slide 8

## Slide 9

## Conclusion:

- Grant application appendix material is of value to both the NIH peer review  and the program management processes.
- Based on the limited findings, there is no enthusiasm on the part of the queried stakeholders to eliminate grant application appendix material.

## WHAT SHOULD NIH DO WITH APPENDIX MATERIALS?

- Suzanne Fisher, Ph.D.
- Director, Division of Receipt and Referral
- Center for Scientific Review

## TRANSITION TO ELECTRONIC SUBMISSION

- Grants.gov allows submission of appendix materials as pdfs
- Opportunity to evaluate content and format of appendix materials
- Opportunity to consider what is part of application and what is part of appendix
- Opportunity to achieve consistency within a mechanism and variation where appropriate between mechanisms

## OPPORTUNITIES FOR CHANGE

- PUBLICATIONS
- Propose submit as urls for publicly available sites whenever possible; pdfs only when necessary
- Propose variation by mechanism:
- 10 for R01
- 5 for R21
- 0 for R03
- Other mechanisms pick 0, 5, 10

## OPPORTUNITIES FOR CHANGE

- FIGURES
- Initially have used standard language to allow larger version
- Since images are very good and in color, is this needed?

## OPPORTUNITIES FOR CHANGE

- OTHER MATERIALS
- Best opportunity for mechanism specificity
- Should clinical protocols, informed consent information be part of Human Subjects section in application?
- Other opportunities to incorporate into application (other than Research Plan)?
- Other media – movies, DVDs, etc.  What is reasonable?
- Will always be special items that will require contact with SRA.

## OTHER GRANT MECHANISMS

- Multicomponent applications – P01s, U19s, etc.
- Career and Training applications
- Will need to have special considerations for certain mechanisms

## SUBMISSION TO NIH

- Working on “Dos and Don’ts for pdfs” – to avoid large files and problems with Grants.gov

## PROVISION OF APPENDIX MATERIALS TO REVIEWERS

- Options
- On CDs with applications
- Thumb drives
- Via IAR or another secure way that will allow downloading
- ?

## STORAGE OF APPENDIX MATERIALS BY NIH

- Part of Official Grant File
- Electronic whenever possible