M-Inform: Overview of Changes June 2013

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

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 beconverted • Have a link to M-Inform on your unit’s web site? • Update the URL to point to https://minform.it.umich.eduor to Wolverine Access on or after 07/01/13. • 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) • U-M Policy:COI.Support@umich.edu • Unit guidelines: Check with your unit

5. What’s Changing New Concept – Disclosure(s) grouped into one record M-Inform Today M-Inform as of 07/01/13 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 New Concept – Disclosure(s) grouped into one record • “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 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. M-Inform Overview: The Discloser’s perspective

8. The Discloser’s Perspective M-Inform: Discloser Home Workspace (“Inbox”) 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. Remember: Your outside interest disclosure(s) is grouped into a record. The record displays here.

9. The Discloser’s Perspective M-Inform: Discloser Home Workspace (“Inbox”) 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. You will have only one “annual” or “update” disclosure at a time in the Action Required list

10. The Discloser’s Perspective M-Inform: Discloser Home Workspace (“Inbox”) • Disclose & SFI Training Pageto complete the annual training requirement • Related Outside Intereststo change yourdisclosure qualification (e.g., relatedness, equity, etc.) • Disclosure Details to: • Update an existing outside interest • Enter Estimated effort for an outsideinterest (for FY14) • Add/remove an outside interest • Sign once for the disclosure group (all disclosures) 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: After you’re familiar with navigating in M-Inform, you can “jump to” a specific disclosure page in the Edit menu

11. The Discloser’s Perspective The Discloser’s Perspective M-Inform: Discloser Home Workspace (“Inbox”) After signing a disclosure, how you access it to edit depends on where it is in the review cycle: 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. Action Required listis 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. M-Inform Overview: Disclosure Question & Other changes

13. What’s Changing: Training Page • 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. 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. What’s Changing: Question 1 Family Member Information • 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

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

17. What’s Changing: Question 9 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. SUBK FCOI Process Change Updated Forms Available July 1, 2013 What’s the Same 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. • 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. New Forms will be available at: http://orsp.umich.edu/projects/grants_contracts/subagreements.html

19. M-Inform: Future Enhancements • 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. M-Inform Overview: Resources for Help

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/

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/

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/ Coming Soon!

24. M-Inform Overview: Questions?