1. M-Inform: Overview of Changes June 2013

2. Agenda M-Inform is moving to eResearch on 07/01/13 What to Expect What’s Staying the Same What’s Changing M-Inform Overview of Discloser Role Disclosure Form: Training & Question Changes Changes to COI Sub-Contracts Documents M-Inform: Future Enhancements Resources for Help 2

3. What to Expect M-Inform is moving to eResearch on 07/01/13 – Look & feel changes Navigation Home Workspace (i.e., “hub”) Training page – Disclosure question updates Outside interest “screening” questions Family members Travel question Relationship to research question – Data prior to FY13 will not be converted 3 Have a link to M-Inform on your unit’s web site? Update the URL to point to https:// minform.it.umich.edu or to Wolverine Access on or after 07/01/13. https://www.umms.med. umich.edu/minform/https://www.umms.med. umich.edu/minform/ will no longer work

4. What’s Staying the Same Your responsibility to disclose (and the reasons for disclosing) annually per U-M, unit, and/or PHS guidelines The M-Inform name & roles Wolverine Access log-in Disclosure process: – Initial question identifies if outside interest exists – If have an outside interest, complete additional nine questions Resources for help with disclosures: – In M-Inform: Links to help and training – Technical: ITS Service Center (4HELP@umich.edu)4HELP@umich.edu – U-M Policy: COI.Support@umich.eduCOI.Support@umich.edu – Unit guidelines: Check with your unit 4

5. M-Inform TodayM-Inform as of 07/01/13 5 New Concept – Disclosure(s) grouped into one record What’s Changing HUB displays each outside interest disclosure as individual record Access each disclosure individually Sign each disclosure individually Home workspace replaces HUB Displays one record containing all your outside interest disclosures Access the record to: – Add/update outside interest disclosure(s) as a group – Sign once to submit the group – Review disclosure(s) for an individual as a group Navigation in M-Inform will be similar to eResearch applications (e.g., Proposal Management)

6. What’s Changing “Annual Disclosure” – to update previous FY disclosure(s) for annual review “Update” – to add a new disclosure to your group or change an existing disclosure in your group after annual review is complete 6 New Concept – Disclosure(s) grouped into one record Three (3) types of disclosures based on the action required: The Name field shows the type of disclosure, identified by it’s title (e.g., Annual Disclosure) “Research Initiated” – created by a COI Office to obtain more information from the discloser when a new research activity (PAF, HUM, etc.) has a relationship to a disclosed outside interest (may result in COI Management Plan)

7. THE DISCLOSER’S PERSPECTIVE M-Inform Overview: 7

8. The Discloser’s Perspective Four (4) tabs: My Disclosures – displays the disclosure(s) requiring action In Progress – view-only list of your disclosure(s) and it’s state (e.g., Draft) Under Management Plan – list of your research activities where an outside interest is being managed. Inactive – view-only list of your historical outside interests. 8 M-Inform: Discloser Home Workspace (“Inbox”) Remember: Your outside interest disclosure(s) is grouped into a record. The record displays here.

9. The Discloser’s Perspective My Disclosures tab: Action Required lists the disclosure to view, edit, and sign Under Review lists the disclosure you signed and submitted for unit review. Current Outside Interest… lists high-level information about your reported outside interests. 9 M-Inform: Discloser Home Workspace (“Inbox”) You will have only one “annual” or “update” disclosure at a time in the Action Required list

10. The Discloser’s Perspective Disclose & SFI Training Page to complete the annual training requirement Related Outside Interests to change your disclosure qualification (e.g., relatedness, equity, etc.) Disclosure Details to: – Update an existing outside interest – Enter Estimated effort for an outside interest (for FY14) – Add/remove an outside interest – Sign once for the disclosure group (all disclosures) 10 M-Inform: Discloser Home Workspace (“Inbox”) After you’re familiar with navigating in M-Inform, you can “jump to” a specific disclosure page in the Edit menu To edit an Annual Disclosure, select Introduction from the Edit menu to start the disclosure form. Then click Continue in the form to go to:

11. The Discloser’s Perspective If submitted, but not reviewed If submitted & reviewed Action Required & Under Review lists are empty Click to add a new outside interest or update an existing one. 11 M-Inform: Discloser Home Workspace (“Inbox”) The Discloser’s Perspective After signing a disclosure, how you access it to edit depends on where it is in the review cycle: Action Required list is empty Under Review list displays the disclosure – Select “Unsign Disclosure” from the Activities menu to move it to the Action Required list to edit.

12. DISCLOSURE QUESTION & OTHER CHANGES M-Inform Overview: 12

13. What’s Changing: Training Page 13 One training page - streamlined text, definitions, and policy links (not shown) in one location Page automatically displays once per year to fulfill U-M policy & PHS regulations Discloser must attest to reading the SFI Training. Unit Assistant can see attestation, but can’t complete on behalf of a discloser

14. 14 What’s Changing: Initial Question Answer one multiple choice question to identify if outside interest needs to be disclosed (same categories) If you mark “None…,” continue to sign and submit your disclosure If you select an option, continue to provide outside interest details New! Ability to identify if a family member is a U-M employee

15. Family Member Information 15 Identifies for whom you are disclosing Only see names listed as UM Family Member(s) if you selected “yes” to the family member question on the Related Outside Interests page of the disclosure What’s Changing: Question 1

16. 16 Question displays for all disclosers (not just PHS). Frequent traveler? Upload & maintain a spreadsheet to report travel. What’s Changing: Question 7 Travel Instructions and examples provided for clarity

17. What’s Changing: Question 9 17 Related Research If you answer “Yes,” click Continue to go to the Research Activities page – Select from a list of your PAFs, HUMs, SUBKs (etc.) or add projects to identify their relationship to the outside interest If you answer “No,” click Continue to return to the Disclosure Details page to sign your disclosure

18. What’s the Same Conflict of Interest Policy Certification required for each Subrecipient – Required at time of proposal – Captures the subcontractor’s COI policy certification method Certified to the Federal Demonstration Partnership (FDP) Clearing House Not certified to the FDP Clearing House, but agrees to adopt the PHS FCOI policy. Does not have a PHS FCOI policy and will report through University of Michigan. What’s Different Updated Letter of Commitment to Establish a Subrecipient Agreement (i.e., Form 1) – U-M will accept verification that subrecipient is listed on FDP Clearing House New Non-UM Affiliate Disclosure Form for subrecipients that choose to disclose to UM. Elimination of Conflict of Interest Policy Certification (i.e., Form 2) – Language in the Subcontract agreement replaces the need for this form. 18 Updated Forms Available July 1, 2013 SUBK FCOI Process Change New Forms will be available at: http://orsp.umich.edu/projects/grants_contracts/subagreements.html

19. M-Inform: Future Enhancements 19 IRB COI integrating with M-Inform (September 2013) All study team members required to disclose IRB application (Accept Role activity) to display disclosure status and link to M-Inform Ability to accommodate non-UM disclosers via “Friends” account

20. RESOURCES FOR HELP M-Inform Overview: 20

21. Resource: Decision Tree Need help? Use the decision tree to determine if you should disclose an activity. Available on: – OVPR web site @ http://research.umich.edu /conflict-of-interest/m- inform-decision-tree/ 21

22. Resource: Web Pages Need a definition for an M-Inform term (e.g., outside interest)? Use the Glossary Available on: – http://research.umich.edu/conflict-of-interest/m-inform-glossary/ 22

23. Resource: Web Pages A revamped OVPR Conflict of Interest web page will provide: – Links to M-Inform job aids for all roles – Contact information for COI Offices – Links to applicable PHS and U-M policies for COI Available on: – http://research.umich.edu/conflict-of-interest/outside-interest- disclosure/ 23 Coming Soon!

24. QUESTIONS? M-Inform Overview: 24