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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

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