From: Penny Cook [mailto:gcacommunications@yale.edu]
Sent: Monday, November 03, 2008
To: Faculty and Staff

Revised Proposal Summary and Certification Form (ProSum) dated 11/1/2008.
http://www.yale.edu/grants/forms/docs/ProposalSummaryandCertificationForm.xls

The revised ProSum, which was introduced on October 30th at a Grants and Contracts Administration (GCA) Brown Bag, contains a number of changes including important enhancements to Section IX – Subrecipient Information.

Effective Date:  Beginning November 1, proposals that include subrecipients engaged in animal and/or human subject research at the subrecipient site must be accompanied by the revised ProSum.    Although you are strongly encouraged to use this version of the ProSum for all submissions starting November 1st the old form will be accepted until December 1, 2008 for submissions that do not meet the above criteria.

Rationale for the enhancements in Section IX – Subrecipient Information
Federal requirements place the responsibility on the grantee organization (Yale) to ensure that subrecipients have appropriate assurances, approvals and certifications in place.  This becomes particularly important when research involving human subjects and/or animals occurs at a subrecipient site.  Therefore, when Yale is the prime awardee of a sponsored project and intends to subcontract a portion of the research activity that involves the use of human subjects and/or animals to a subrecipient, Yale must be assured of the following:

• the existence of a current Federal Wide Assurance (FWA) and Institutional Review Board (IRB) approval for research involving human subjects
• certification of required human subject training
• the existence of a current Animal Welfare Assurance and Institutional Animal Care and Use Committee (IACUC)  approval for animal research.

Additional ProSum Changes
Updates include enhancements to:

• Section IV – Compliance, which provides clearer language regarding export controls
• Section VII – Renamed Personnel Responsible for the Design, Conduct or Reporting of the Proposed Research
• Section VII – Internal GCA section now includes verification of Veterans Administration (VA) Memorandum Of Understandings (MOUs) and PI Sponsored Project Training
• The inclusion of the new Subrecipient Compliance and Certification Form as tab #4
• The inclusion of the Clinical Trial Addendum as tab #5 

In addition, we used this opportunity to make substantial enhancements to the ProSum Instructions in order to clarify terms and acronyms and to ensure that the instructions follow the ProSum sections exactly.

Your GCA Teams are available to discuss any questions you may have regarding use of the revised ProSum and/or the new Subrecipient Compliance and Certification Form.