Financial Conflict Of Interest Manual

Financial Conflict of Interest Manual

Revised August 2016

Financial Conflict Of Interest Manual

Table of ContentsI Researcher Role..........................................................................................................................................1

1. Create Disclosure from Maestro Home.................................................................................................1

1.1 PURPOSE.......................................................................................................................................1

1.2 RULES............................................................................................................................................1

1.3 NOTES...........................................................................................................................................2

1.4 ACTIONS........................................................................................................................................2

2. Create Significant Financial Interest......................................................................................................3

2.1 PURPOSE.......................................................................................................................................3

2.2 RULES............................................................................................................................................3

2.3 ACTIONS........................................................................................................................................3

3. Link Research to Disclosed Significant Financial Interest (optional)......................................................6

3.1 PURPOSE.......................................................................................................................................6

3.2 STEPS.............................................................................................................................................6

4. Create Disclosure from Worklist...........................................................................................................7

4.1 PURPOSE.......................................................................................................................................7

4.2 RULES............................................................................................................................................7

4.3 NOTES...........................................................................................................................................7

II Conflict of Interest Official Role..................................................................................................................9

1. Review Financial Disclosure......................................................................................................................9

1.1 Review Disclosure – Step 1 - Home...................................................................................................9

1.1.1 PURPOSE...................................................................................................................................9

1.1.2 STEPS.........................................................................................................................................9

1.2 Review Disclosure – Step 2 - Worklist.............................................................................................10

1.2.1 PURPOSE.................................................................................................................................10

1.2.2 STEPS.......................................................................................................................................10

1.2.3 NOTES.........................................................................................................................................10

1.3 Review Disclosure – Step 3 - Review...............................................................................................11

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1.3.1 PURPOSE.................................................................................................................................11

1.3.2 STEPS.......................................................................................................................................11

1.3.3 ACTIONS..................................................................................................................................11

Financial Conflict Of Interest Manual1.3.4 NOTES.....................................................................................................................................12

1.4 Review Disclosure – Step 4 - Link SFI to Research...........................................................................13

1.4.1 PURPOSE.................................................................................................................................13

1.4.2 STEPS.......................................................................................................................................13

1.4.3 ACTIONS..................................................................................................................................13

1.5 Review Disclosure – Step 5 - Attachments......................................................................................14

1.5.1 PURPOSE.................................................................................................................................14

1.5.2 STEPS.......................................................................................................................................14

1.5.3 ACTIONS..................................................................................................................................14

2. Review Potential Conflict.....................................................................................................................15

2.1 Review Potential Conflict – Step 1 - Home........................................................................................15

2.1.1 PURPOSE.................................................................................................................................15

2.1.2 STEPS.......................................................................................................................................15

2.2 Review Potential Conflict – Step 2 - Worklist........................................................................................16

2.2.1 PURPOSE.................................................................................................................................16

2.2.2 STEPS.......................................................................................................................................16

2.3 Review Potential Conflict – Step 3 - Results..........................................................................................17

2.3.1 STEPS.......................................................................................................................................17

2.3.2 ACTIONS..................................................................................................................................18

3. COIO Completes Researcher Disclosure..............................................................................................18

3.1 STEPS.................................................................................................................................................19

Financial Conflict Of Interest Manual

I Researcher RoleResearchers are required to submit a Financial Disclosure to their employers on a yearly basis for review and potential conflict resolution. They can create a Financial Disclosure by clicking on the Create Disclosure icon on the Home page or by navigating to their pending disclosure listed in To-Do section of the Worklist.

1. Create Disclosure from Maestro Home

Figure 1

Path: Home Create Disclosures (Figure 1)

1.1 PURPOSE • The purpose of this screen is to navigate to the create disclosure screen. If user already has a

disclosure created, it will open the existing disclosure for editing. If none exists, a new disclosure will be created.

• User navigates to the Financial Disclosure Screen where user gets option to specify whether there is a Significant Financial Interest or not (Figure 2).

• Based on the Actions, the user will be navigated to respective screen. 1.2 RULES The user must have a researcher role to create a disclosure.

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Financial Conflict Of Interest ManualFigure 2

1.3 NOTES User has two options: 2) specify “Yes” and then create the SFI (Significant Financial Interest), or 2) “Certify No SFI” (Significant Financial Interest)”.

1.4 ACTIONS Figure 3

Actions Description

By clicking on this Action, user confirms that there is a significant financial interest and user is navigated to the Significant Financial Interest Screen.

By clicking on this Action, user confirms that there is no significant Financial Interest and user is navigated to the My Disclosures Screen.

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Financial Conflict Of Interest Manual

2. Create Significant Financial Interest

Figure 4

2.1 PURPOSE • The purpose of this screen is to create the Significant Financial Interest.

• Inserts a blank row for the user to enter SFI information. • User can specify PI Name /Family Member Covered, Company Name, Description of the related

entity and the value of the entity.• User can create multiple SFI’s in the table.• Once the information has been entered, user can also link their existing research to the SFI using

the “Link Research” hyperlink.• User can upload SFI related Conflict Resolution Plans or documents.• All features are explained briefly in Figure 5.

2.2 RULES Name of PI/Family Member Covered and Source Company Name are required fields.

2.3 ACTIONSFigure 5

Actions Description

This Action removes the selected SFI from the Researcher’s Significant Financial Interest Related to Institutional Responsibilities table (figure 4).

This Action has been described in the section 2.1

This Action is used to upload any documents which are related to conflict resolution or any supporting documents. User can find this action

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Financial Conflict Of Interest Manualunder Conflict Resolution Plan Attachments table (figure 4). This Action is used to download the file, if any, selected in the Conflict Resolution Plan Attachment table (figure 4).

This Action is used to delete the selected document in Conflict Resolution Plan Attachment table (figure 4).

This Action takes the user to the next screen where they ‘Certify and Submit’ their disclosure.

This action lists the users Conflict of Interest Official(s) to contact regarding any information about COI or their disclosure.

This action takes the user back to the previous screen.

This action saves the details entered by the user on the SFI screen.

This action undoes all changes and reverts the screen to its previous state.

Once user clicks on , they can certify the information and click Submit.

Figure 6

In Figure 6, the user has the option to either certify the information provided or to go back and make appropriate changes before submitting. User can also print the respective disclosure. Actions are described briefly in Figure 7.

Figure 7

Actions Description

By clicking on this Action, user confirms that the information provided is true and certifies that it complies with all applicable system and federal rules and regulations.

This action will print the disclosure.

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Financial Conflict Of Interest Manual

This action takes the user back to the previous screen.

Once the Disclosure is created, user can view them in the My Disclosure Section. User also can

create a new disclosure using option. There is also a search feature to search for disclosures containing a particular Proposal or Project.

If user clicks on the Disclosure Number hyperlink (Disclosure #), then the user will navigate to the Significant Financial Interest Screen for that disclosure.

Figure 8 shows the My Disclosure Screen and the actions provided to the user to perform. All the actions are described in Figure 9.

Figure 8

Figure 9

Action Description

By clicking on this Action, user can edit the Significant Financial Interest information and documents that are related to SFI’s.

By clicking on this Action, user can remove the disclosure.

This Action is already described in section 2.1

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Financial Conflict Of Interest Manual3. Link Research to Disclosed Significant Financial Interest (optional)

Figure 10

3.1 PURPOSEThis screen allows the Researcher to link research proposals or projects to the selected SFI.

3.2 STEPS Select each research item that is related to this SFI by clicking the checkbox located in the link

column.

Click to save changes.

Click to return to previous screen.

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Financial Conflict Of Interest Manual4. Create Disclosure from Worklist

Figure 11

Path: Home To-Do Financial Disclosure (Figure 11)

4.1 PURPOSE • The purpose of this screen is to show pending disclosure tasks for the user to complete. • User can find the tasks to complete in the To-Do Section Financial Disclosure.

4.2 RULES The user must have a researcher role to access the disclosure in their worklist.

4.3 NOTES • Once user clicks on the task, they are navigated to ‘My Worklist’ screen where they can view the

Disclosure to review/renew/complete. (Shown in below Figure 12.)

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Financial Conflict Of Interest ManualFigure 12

Clicking on the link highlighted will navigate the user to the SFI (Significant Financial Interest) screen where they will enter any Significant Financial Interest, if applicable, as described in section 2.

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Financial Conflict Of Interest Manual

II Conflict of Interest Official RoleConflict of Interest Officials review financial disclosures and work with researchers to find resolutions to potential conflicts.

1. Review Financial Disclosure

1.1 Review Disclosure – Step 1 - Home

This section contains the steps to follow to complete a disclosure review. This review appears in the Conflict of Interest Official’s (COIO) worklist whenever a researcher submits a disclosure with Significant Financial Interest (SFI).

Figure 13

Path: Home Tasks Financial Disclosure Review (Figure 13)

1.1.1 PURPOSEThis screen shows the amount of outstanding review tasks.

1.1.2 STEPSClick on the detailed Financial Disclosure Review item under tasks highlighted in figure 13

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Financial Conflict Of Interest Manual1.2 Review Disclosure – Step 2 - Worklist

Figure 14

Path: Home Worklist

1.2.1 PURPOSE This screen shows a detailed view of all outstanding tasks.

1.2.2 STEPSSelect the review you want to work with and click on the Researcher’s name in the table. This will open the review for editing. Shown in Figure 15.

1.2.3 NOTESYou can search by Type, if you want only to review potential conflicts or financial disclosure reviews.

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Financial Conflict Of Interest Manual

1.3 Review Disclosure – Step 3 - Review

Figure 15

1.3.1 PURPOSEThis is the main review screen which also allows you to edit the disclosure’s details if they need modification.1.3.2 STEPS

Review the information submitted in this disclosure. Edit any details that are erroneous. Click “Link Research” item on each SFI to view the details and

edit the review fields. Click “Complete Review” once editing is done and you are finished with the review.

1.3.3 ACTIONSAction Description

This action completes the review process. Click this once you have completed all other steps in this process.This action opens a popup window with the current Researcher’s name and contact details.Prints the current page (switch the printer to landscape mode for better details).This action will save any changes that have been made.

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Financial Conflict Of Interest ManualThis action undoes all changes and reverts the screen to its previous state.This action takes the user back to the previous screen.This action uploads a new document to the document list.This action downloads the document to your computer.This action deletes the selected document from the document list.This action adds another row to the table.

This action removes the selected row from the table.

1.3.4 NOTESSection 2 on Figure 15 - Researcher's Significant Financial Interest Related To Institutional Responsibilities (as defined in System Regulation 15.01.03)

This is a list of all Significant Financial Interests for the selected researcher. You can edit the SFI details in each row of the table. If you want to link these SFI’s to research or complete review information click the “Link Research” link in the appropriate SFI row.

Section 3 on Figure 15 -Research or Research Activity (as defined in System Regulation 15.01.03)This is a display only section which shows the researcher’s current research items.

Section 4 on Figure 15 - Researcher's Significant Financial Interest Attachments This table contains the master list of all researcher attachments for this disclosure. You can manage the attachments using the actions detailed in the notes section

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Financial Conflict Of Interest Manual1.4 Review Disclosure – Step 4 - Link SFI to Research

Figure 16

1.4.1 PURPOSEThis screen allows the COIO to review and link research to the selected SFI. You can also add attachments to each research item.

1.4.2 STEPS Select each research item that is related to this SFI by clicking the checkbox located in the link

column. (box 1 – Figure 16) View proposal or project detail screens by clicking on the number. (box 2– Figure 16) Provide review feedback, decisions, and add comments to each research item listed in the table.

(box 3– Figure 16) You can add attachments to each item by clicking the Attachments hyperlink which will open up a

new page for you to upload documents. (box 4– Figure 16)

1.4.3 ACTIONS

Button Description

This action will save any changes that have been made.

This action undoes all changes and reverts the screen to its previous state.

This action takes the user back to the previous screen.This action completes the review process. Click this once you have completed all other steps in this process.

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Financial Conflict Of Interest Manual1.5 Review Disclosure – Step 5 - Attachments

Figure 17

1.5.1 PURPOSEThis screen allows the COIO to upload any documents related to this research item.

1.5.2 STEPS Researcher's Significant Financial Interest Attachments: You can add any document here. Researcher's SFI Attachments Related to This Proposal/ Project: By clicking the edit button you

can link attachments created in the first (Researcher's Significant Financial Interest Attachments) section to this research item.

COIO's Attachments Related to This Proposal: This section allows you to manage any COIO documents related to this research item.

1.5.3 ACTIONSAction Description

This button will save any changes that have been made.

This action undoes all changes and reverts the screen to its previous state.

This action takes the user back to the previous screen.Uploads a new document to the document list.

Downloads the document to your computer.

Deletes the selected document from the document list.

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Financial Conflict Of Interest Manual

2. Review Potential Conflict

2.1 Review Potential Conflict – Step 1 - Home

This section contains the steps to follow to complete a potential conflict review. Potential conflict review tasks are generated with regards to investigators whose active disclosures contain SFI records at the following times:

When proposal starts routing When project is created from proposal When new investigator is added into proposal/project

Once the review process is complete, the information will be added to the investigator’s last disclosure completed.

Figure 18

Path: Home Tasks Review Potential Conflict (Figure 18)

2.1.1 PURPOSEThis screen shows the amount of outstanding review tasks.

2.1.2 STEPSClick on the Review Potential Conflict item under tasks highlighted in figure 18.

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Financial Conflict Of Interest Manual2.2 Review Potential Conflict – Step 2 - Worklist

Figure 19

Path: Home ->Worklist2.2.1 PURPOSEThis screen shows a detailed view of all outstanding tasks.

2.2.2 STEPS

Select the review you want to work with and click on the Researchers name in the table. This will open the review for editing. Shown in Figure 19.

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Financial Conflict Of Interest Manual2.3 Review Potential Conflict – Step 3 - Results

Figure 19

2.3.1 STEPS Actions that can be performed on this page are explained in detail in the Actions section below.

(box 1 – Figure 19) This is the section for COIO findings and details. (box 2 – Figure 19) This is the current list of the researchers SFI’s. If you click the checkbox located in the Link

column, this will indicate that this SFI relates to the project or proposal which generated this potential conflict. (box 3 – Figure 19)

This is the master list of documents for the researcher’s previously submitted disclosure. You can upload and link new documents here. (box 4 – Figure 19)

This is the list of COIO documents for the potential conflict research item. (box 5 – Figure 19) You can add any notes needed to this section. (box 6 – Figure 19)

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Financial Conflict Of Interest Manual

2.3.2 ACTIONSActions Description

This action completes the review process. Click this once you have completed all other steps in this process. After completion any results will be added to the researcher’s latest disclosure.This assigns the task back to the PI to complete. (only appears if Link box is checked)This action opens a popup with the current Researchers name and contact details.This action will save any changes that have been made.This action undoes all changes and reverts the screen to its previous state.This action takes the user back to the previous screen.This action uploads a new document to the document list.This action downloads the document to your computer.This action deletes the selected document from the document list.

3. COIO Completes Researcher Disclosure

Figure 20

Path: Administrator FCOI Disclosure Researcher Query (Figure 20)

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Financial Conflict Of Interest Manual3.1 STEPS

On this page enter the UIN of the researcher you wish to work with and click search (box 5 – Figure 20).

Click on the researcher’s name in the first column to open the second page.Figure 21

This screen (Figure 21) will allow you to modify the disclosure even if the disclosure was started by the researcher. Submitted disclosures are not editable.

You can change the subject to FCOI indicator for the selected researcher which will update BPP record.

You can select the add button to add a new disclosure.

You can select the delete button to remove the selected disclosure. This can only be performed on disclosures which have not been submitted. If the disclosure was submitted in error you can create a new disclosure and correct it. (all information from the previous disclosure will be copied into the new one)

You can select the edit button to edit the selected disclosure.

From this point you can follow the disclosure process as normal.

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