1. Use and Care of Laboratory Animals Grant Protocol Congruence Slide 1

2. Intro RARC Office Contacts –congruence@rarc.wisc.educongruence@rarc.wisc.edu Todd Forsythe: forsythe@rarc.wisc.eduforsythe@rarc.wisc.edu RSP Contacts –preaward@rsp.wisc.edupreaward@rsp.wisc.edu David Ngo: dvngo@rsp.wisc.edudvngo@rsp.wisc.edu Kurt McMillen: kmmcmillen@rsp.wisc.edukmmcmillen@rsp.wisc.edu Slide 2

3. Agenda What are the PHS rules? Overview: Federal regulations What do the new PHS rules require us to do? New requirements in federal policy that intersect with IACUC protocol approval and grants management How does all of this relate to research administration? Revised Campus/RSP business processes JIT, Award Setup Slide 3

4. PHS Agencies Office of Global Affairs (OG) Office of the Assistant Secretary for Health (OASH) Office of the Assistant Secretary for Preparedness and Response (ASPR) Agency for Health Care Research & Quality (AHRQ) Agency for Toxic Substances and Disease Registry (ATSDR) Centers for Disease Control and Prevention (CDC) Food and Drug Administration (FDA) Health Resources and Services Administration (HRSA) Indian Health Service (IHS) National Institutes of Health (NIH) Substance Abuse and Mental Health Services Administration (SAMHSA) Slide 4

5. Grant-Protocol Congruence The 5 W’s (or is it 6 ?...) Why What Who Where When How

6. Why To meet unfunded Federal mandate: PHS Policy states: “PHS awarding units may not make an award for an activity involving animals unless…the awardee institution has provided verification of approval by the IACUC of those components of the application or proposal related to the care and use of animals.” (IV.D.2) Animal Welfare Requirements has similar language (Part II, A, 4.1.1)

7. What Starting August 1, 2013 Check for congruence between IACUC Protocols and PHS-Funded grants proposing use of animals. “Congruence” = substantially similar, not necessarily identical 1:1 ratio of Grant:Protocol is NOT required

8. Grant Protocol Exact Match

9. Grant Protocol 1 Grant: 1 Protocol, but the Protocol has extra details

10. Grant Protocol A Protocol B Extra in Protocol but NOT Grant 1 Grant: Multiple Protocols which may/not have extra details

11. Grant 2 Grant 1 Protocol Extra in Protocol but NOT Grant Multiple Grants: 1 Protocol which may/not have extra details

12. Grant 1 Protocol A Grant 2 Grant 3 Protocol B Protocol C Protocol D Extra in Protocol but NOT Grant This section doesn’t appear in any protocol = NOT congruent! Multiple Grants: Multiple Protocols which may/not have extra details

13. Who Principal Investigators with PHS-funded animal use protocols

14. Where Congruence check will be conducted by the RARC office. RSP will continue to coordinate all pre- award activities, including confirmation of congruence to PHS. PLuS will display documentation of congruence.

15. Example of PLuS View

16. IACUC Approval Letters Slide 16

17. When Procedurally “When” –Upon notification of potentially fundable score Implementation “When” –Already have done alpha-testing –February-June, 2013, beta-testing –August 1, 2013, no grants will be allowed through without congruence check.

18. How PI will submit a Congruence Review Request Form to RARC (to Todd Forsythe) –If PI forgets, or is not yet aware, RSP will notify RARC at a later time, when RSP hears from PHS. This could jeopardize timely review of congruence and result in delayed release of funds by RSP!

19. RARC, Grant-Protocol Congruence Congruence Review Request Form

20. Notification of Non- Congruence

21. RARC, Grant-Protocol Congruence Pre-Review Cover Sheet

22. Key Points Grant is the Primary Document, & Protocol(s) are the supporting document(s) Educating PIs to submit a Request as soon as they learn of a fundable score will expedite award setup, and prevent delays in funding INCENTIVE: RSP will no longer set up awards until congruence has been established!

23. Summary Our goal is to minimize the burden to PI, and be helpful in facilitating any needed changes. RARC is providing a service to aid the PI and Institution in meeting compliance.

24. Just In Time Slide 24

25. JIT Overview – Pre 2010 A Just-in-Time request was a good indication of pending funding. Just-in-Time information had to be submitted all at once. NIH eRA Commons did not have the capability of appending information to previously submitted information. NIH required that all JIT information had to be submitted within 2 weeks of the date of the request. IACUC approvals –PI notified RARC that he/she wanted a funding source added to an animal protocol. –RARC would then issue an approval letter with that funding source indicated. –Congruency reviews were typically not conducted. Slide 25

26. JIT Overview - Currently A request for Just-in-Time information is NOT an indication of funding. NIH issues a “canned” JIT request for ALL proposals that have undergone scientific review and received a score of 40 or less (regardless of the IC’s payline). Applicants are encouraged to submit JIT information at least 60 days before expected start date. NIH understands that approvals may take more than 2 weeks to obtain. Slide 26

27. RSP JIT Process – Approved Protocols 1.RSP will review PLuS (an IACUC “approval letter” is NOT necessary) 2.If RARC has determined that the IACUC approval is congruent or a review is not needed, RSP can submit a screenshot and enter the IACUC approval date in ERA Commons. Slide 27

28. RSP JIT Process – ERA Commons It is the responsibility of the Authorized Official to ensure that information submitted to NIH is correct and accurate. When RSP presses the submit button, we are assuring NIH that the protocol is approved for this project. –Legal Attestation Slide 28

29. JIT Process at RSP – In Some Cases… 1.RSP will review PLuS 2.If RARC has determined that the IACUC approval is under review by RARC, RSP can submit a screenshot and will leave the IACUC approval date blank in ERA Commons. This will not hold up or prevent a funding decision at NIH. Slide 29

30. Award Acceptance Slide 30

31. When award is received RSP will review WISPER record Projects that have a “yes” answer on general tab question #3 will be subject to the IACUC congruency screening Slide 31

32. Award Setup In order to have an award setup RSP will require the following 3 items: –Approved protocol For the particular grant awaiting set-up –Grant # –Valid dates Must be current as of date of set-up –RARC review: completed and congruent If protocol does not meet all items above, RSP will send approval in WISPER Slide 32

33. Congruent protocol can be provided to RSP in one of two ways… 1) PLUS Slide 33 Valid Dates Approved & Congruent Grant # - or- title match

34. 2) IACUC Approval Letter in WISPER Attachments Slide 34 Congruent Approved & Valid Dates Grant # - or- title match

35. When Congruent protocol data is added to WISPER, RSP can continue with set-up Slide 35

36. Questions? Todd Forsythe, RARC –890-4829; forsythe@rarc.wisc.eduforsythe@rarc.wisc.edu –congruence@rarc.wisc.educongruence@rarc.wisc.edu Web Resources –www.rarc.wisc.edu/faq/protocol_help_sheets.html#relatewww.rarc.wisc.edu/faq/protocol_help_sheets.html#relate –https://www.rsp.wisc.edu/awardsetup/rarc/https://www.rsp.wisc.edu/awardsetup/rarc/ Available to come to your individual Departments for presentations with PIs and anyone else who would benefit. Slide 36