M-Inform: Overview of Changes

June 2013

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

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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

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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/ will no longer work

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

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M-Inform Today M-Inform as of 07/01/13

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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)

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

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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)

THE DISCLOSER’S PERSPECTIVEM-Inform Overview:

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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.

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M-Inform: Discloser Home Workspace (“Inbox”)

Remember: Your outside interest disclosure(s) is grouped into a record. The record displays here.

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.

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M-Inform: Discloser Home Workspace (“Inbox”)

You will have only one “annual” or “update” disclosure at a time in the Action Required list

The Discloser’s Perspective

Disclose & SFI Training Pageto complete the annual training requirement

Related Outside Intereststo 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:

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.

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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.

DISCLOSURE QUESTION & OTHER CHANGES

M-Inform Overview:

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What’s Changing: Training Page

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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

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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

Family Member Information

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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

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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

What’s Changing: Question 9

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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

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.

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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

M-Inform: Future Enhancements

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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

RESOURCES FOR HELPM-Inform Overview:

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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/

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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/

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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!

QUESTIONS?M-Inform Overview:

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