*PAMS and CoI *ORA Processes:Subawards , MTAs/CDAs *NIH Administrative Supplements in Commons

1. *PAMS and CoI*ORA Processes:Subawards, MTAs/CDAs*NIH Administrative Supplements in Commons 9/25/12

2. New CoI Procedures 8/24/12 • http://www.uthsc.edu/policies/w932_document_show.php?p=155

3. Applicability • All UTHSC Personnel who are planning to participate in any sponsored activity are required to disclose their financial interests (and those of the Investigator's spouse and dependent children) no later than the time of application for the sponsored activity.

4. CoI Training Requirements • Investigators are required to complete conflict of interest training prior to engaging in activities related to any sponsored activity, and at least every three years thereafter, and immediately when any of the following circumstances apply: • 1. The HSC revises its conflict of interest policies or procedures in any manner that affects the requirements of Investigators; • 2. An Investigator is new to the HSC; or • 3. The HSC finds that an Investigator is not in compliance with the HSC’s financial conflict of interest policy or management plan.

5. PAMS and CoI • For all documents routed in PAMS, we are checking to see if everyone has completed the CoI training and made appropriate disclosures.

6. FAQs • Q: Do volunteers have to take CoI training and make disclosures? • A: Yes, if they are involved in proposed or funded Sponsored Activity. Personnel subject to this procedure include: •  ALL full-time faculty and staff regardless of their involvement in Sponsored Activities; •  Any and all other (e.g. part-time, affiliated, volunteer, adjuncts, etc.) faculty and staff (including post docs) who are involved (with or without compensation) in a proposed or funded Sponsored Activity; and •  Undergraduate, graduate or professional students (including residents and fellows) who are involved (with or without compensation) in any proposed or funded Sponsored Activity.

7. FAQs • Q: Do my collaborators at other institutions have to comply? • A: If UT is the prime awardee, collaborators that meet the definition of “investigator” must take the CoI training and disclose any outside interests. • Investigator means the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research and/or other sponsored projects externally funded, or proposed for such funding, which may include, for example, collaborators or consultants. This term includes Sub-Investigators, Senior/Key Personnel and any other person identified as senior/key personnel by the HSC in the grant application, progress report, or any other report submitted as part of a sponsored project.

8. FAQs • Q - What does ORA need from collaborators/consultants/subawardees? • A – If the collaborator is an individual/consultant, we need a statement in the support letter to indicate that he/she has no conflicts and that the individual has completed required training. If the subawardee is an institution, we need the institutional letter to contain a statement that it is in compliance with the new PHS policies.

9. FAQs • Q: Is it OK if I take the NIH module instead of CITI? • A: CITI is the official UTHSC CoI module; if CITI is not yet available on your campus (e.g., GSM/COM-C), then you may take the NIH module until CITI is available.

10. FAQs • Q: How will I know when I have to re-take the training? • A: You will receive an automatic notification from CITI when your certification is about to expire.

11. FAQs • Q: Does my post-doc have to take the CITI training? • A: Yes, if the post-doc meets the definition of “investigator” • Investigator means the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research and/or other sponsored projects externally funded, or proposed for such funding, which may include, for example, collaborators or consultants. This term includes Sub-Investigators, Senior/Key Personnel and any other person identified as senior/key personnel by the HSC in the grant application, progress report, or any other report submitted as part of a sponsored project.

12. CITI Tips • Log into CITI (or create account if new) https://www.citiprogram.org/Default.asp? • CITI Conflict of Interest course is different from other CITI courses (e.g. human subjects) • “Add a course” • Scroll down until you see Conflict of Interest

13. Revised ORA Processes • Subawards– ORA will contact departments to see who will prepare and start in PAMS; reminder: subaward # is NCJ # • MTAs/CDAs – ORA will start if we get them first

14. Admin Supplements in Commons • Type 3 non-competing application • Not subject to peer review • Initiated by PI in eRA Commons • Dates, Budget, Justification, type, can add attachments • Route in Commons and also in PAMS • User Guide: http://era.nih.gov/files/eRA_Commons_Admin-Supp_UG.pdf