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 by Role • Discloser • Unit Reviewer • Unit Administrator • Unit Assistant (i.e., discloser’s proxy) • Disclosure Form: Training & Question Changes • 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 Institutional Responsibilities 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. M-Inform Overview: The Unit Reviewer’s perspective

19. The Reviewer’s Perspective M-Inform: Reviewer Home Workspace (“Inbox”) Tabs replace some previous reports & actions Four (4) tabs: • Disclosures Pending Review – lists all disclosures assigned to you for review • Disclosers Under My Review • Lists all disclosers from your unit who are “required to disclose” • Shows disclosers for whom you are assigned as a Special Reviewer • Includes a function to assign a Special Reviewer to an individual • Batch Review of “No Outside Activities” Disclosed – action to approve disclosures with no outside interests reported from multiple individuals • Send Reminder Emails for Missing Disclosures – action to email people “required to disclose” who have not yet done so

20. The Reviewer’s Perspective M-Inform: Reviewer Home Workspace (“Inbox”) To review the disclosure(s) for an individual, click the Name of a record.

21. The Reviewer’s Perspective Disclosure Review Workspace View link (not shown) allows you to see additional information for each outside interest • Three (3) tabs: • Summary – overview of outside interest(s) reported in the group • Documents – management plans and other associated documents • History – log of all activities performed on the disclosure record

22. The Reviewer’s Perspective Disclosure Review Workspace • Two (2) activities used for Unit Review: • Approve – activity used to approve a disclosure (as a group) • Reviewer Requests Changes – activity to notify a discloser that changes are required to one or more outside interests reported in the group

23. The Reviewer’s Perspective Batch Review tab • Unit Reviewers can perform a “batch approval” of disclosures with no outside activities reported.

24. The Reviewer’s Perspective Send Reminder Emails tab Listed in order of Last Reminder Date. If sent previous email to discloser, the date populates. A blank field indicates no email sent. Unit Reviewers can send “batch emails” to disclosers from their department who have not yet signed/submitted a disclosure.

25. M-Inform Overview: The Department Administrator's perspective

26. The Administrator’s Perspective M-Inform: Unit Administrators have the Department Role What’s the Same What’s Different Set M-Inform roles per department No need to manually add employees to provide access Employees auto-assigned based on their administrative home department New disclosers (UM employees) are auto-assigned their Reviewer based on their administrative Dept ID • Responsibility for reviewing & maintaining department role assignments to ensure appropriate workflow • Administrators • Assistants (proxy for disclosers) • Unit Reviewers • Ability to: • View a list of disclosers in the department • Assign a reviewer (other than default) to an individual discloser • Send reminder emails through M-Inform Current M-Inform role assignments will be converted

27. The Administrator’s Perspective Department Admin Home Workspace Five (5) tabs; last three most commonly used by Administrators • Inbox– list of certification records you are working on (as a proxy) • Disclosure Updates in Progress – list of open disclosures for your departmental employees. • My Departments – list of department(s) that you administer • My Disclosers – list of employees in the department(s) that you administer • Send Reminder Emails for Missing Disclosures – action to email disclosers

28. The Administrator’s Perspective Department Admin Home Workspace My Departments tab: • Departments in Need of Review = a visual reminder to verify data • All Departments = department(s) that you administrate Click Edit to assign/change departmental roles: • There must be a least one Department Administrator • The Reviewer(s) listed here are the “default” reviewers for the department • More than one person can hold a departmental role My Departments tabreplaces need to “manage” per individual employee

29. The Administrator’s Perspective Department Admin Home Workspace My Disclosers tab: • Lists the faculty and staff in your department(s) required to disclose or who have opted to disclose • “Required to Disclose” = PHS + unit rules • Click Edit to assign a reviewer other than the default departmental reviewer

30. The Administrator’s Perspective Department Admin Home Workspace Send Reminder Emails tab: • Same email function as Unit Reviewer • Send “batch emails” to disclosers from your department who have not yet signed/submitted a disclosure Other Administrator functions will be found under the Reports menu

31. M-Inform Overview: The Department Assistant’s (Proxy) perspective

32. The Unit Assistant’s Perspective M-Inform: Unit Assistants have the Department Role Two (2) Tabs: • Inbox – list of disclosers you are currently working on (initially this tab is empty) • Disclosure Updates in Progress – list of all open certification records for disclosers in your department(s)

33. The Unit Assistant’s Perspective Two ways for the Unit Assistant to work on a disclosure: Update Existing Disclosure Create New Disclosure Click to start a new outside interest disclosure or modify an existing disclosure for another individual • Click to open the disclosure from the “In Progress” tab • Select Move to Inbox from Activities menu • Disclosure record appears in Inbox tab. Can now click to update Remember: As a Unit Assistant, you can’t sign & submit a disclosure on behalf of another. Use the Alert Discloser to Sign activity to notify the discloser to view, sign, and submit.

34. M-Inform Overview: Resources for Help

35. 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/

36. 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/

37. 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!

38. M-Inform Overview: COI Unit Contact Tasks

39. COI Unit Contact Tasks Go-live emails • How do you want to communicate to your faculty & staff on 07/01/13? • Direct email from OVPR • Disclosers and Department Assistants • Reviewers • New users • Email from OVPR sent to COI Unit Contact, to be forwarded with unit-specific information • Your unit will handle communications

40. COI Unit Contact Tasks • Update school/college web pages with new M-Inform URL (https://minform.it.umich.edu)on or after July 1 • Updating before July 1 won’t help disclosers because system will not be available. • Communicate to faculty & staff: • Annual Disclosure period starting July 1 • Training resources and more available on OVPR web site at: http://research.umich.edu/conflict-of-interest/outside-interest-disclosure/ Communicate to unit reviewers to expect Annual Disclosures to review in July & August • Obtain the updated Subcontract forms from http://orsp.umich.edu/projects/grants_contracts/subagreements.html • Letter of Commitment (includes PHS policy attestation) • “Non-UM Affiliated Disclosure” (for PHS, if U-M managing)

41. COI Unit Contact Tasks • Opportunity to update your School/College COI Implementation Plan with a PHS statement: “Faculty with PHS funding, or with funding from an agency or organization that follows the PHS FCOI regulation, must disclose outside interests in M-Inform.” • Approved implementation plans are posted to the Provost’s web site at: http://www.provost.umich.edu/programs/COI_COC/units.html • Update now to help avoid confusion for faculty and staff looking for unit-specific instructions on the web

42. 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 • Ability to maintain unit-based COI management plans in M-Inform (TBD) • Unit impact: • More people using M-Inform in your unit • Not limited to “Faculty with PHS funding” • Use the July disclosure period to encourage study team members to disclose before the change in September!

43. Upcoming Change Management • In June/July: • Communications (e.g., U-M disclosure period reminder, SUBK form updates) • M-Inform training materials • Web site updates http://research.umich.edu/conflict-of-interest/outside-interest-disclosure/ • In August/September: • Communications about COI changes to eResearch Regulatory Management (eRRM)

44. M-Inform Overview: Questions?