Please note: A PDF version of this guide is available for download at the bottom of the article.

This manual will guide you through the process of filling out the Annual COI Disclosure Form. Note: The name of your Institution’s Annual COI Form may be different than what is used in this manual.  The Annual COI and Commitment Reporting Form for Individuals, or the Annual COI for short, is the form you will fill out on a yearly basis to report any financial or effort interests you may have.

Covered persons will see the Conflict of Interest Forms menu on their iRIS home screen and will be able to access the Annual COI form from this menu.

Clicking on the Annual COI and Commitment Reporting Form menu item will bring you to the following screen:

This screen will list any previously started or completed Annual forms you have filled out. The header of the page contains buttons to allow you to copy a previous Annual COI form, Add a New Form, Compare Two Versions, or Delete a form (provided it has not been submitted for review).

The table below the buttons lists any form that has already been started.

The Checkbox column is used to copy, compare and delete a form. Click the checkbox next to the form(s) to delete, and then click the Delete Selected Form(s) button.

Show Rev – If a form has been revised for corrections coming from a management plan, a folder will appear in this column. You can click on it to see the previous versions of the Annual COI. You will be able to open the previous submission, but it will be read only as that version has been submitted previously. You can also compare the differences between two versions of the same form by clicking the checkboxes and then clicking the Compare Two Versions button.

Edit/View – Click on this icon to continue to work on a form you have already started but have not completed yet, or to view a form that has been submitted previously.

Ref Number – For every form that is submitted in iRIS, a unique number is assigned to that form, called the Reference Number. Each Annual COI form that is submitted will get assigned a unique reference number.

Sub. Rounds – Click this button to see the number of times this particular form has been sent back and forth for corrections.

Track Location - If a form has been submitted, this column will populate with the current status of the form. You can click on the text to view detailed information about the steps the form has taken since it was submitted.

Workflow – Submission Tracking

Any steps that are still in process will be displayed at the top of the list with the status of In Process.  The steps that are completed will be displayed with the status of Completed.  Once a step has moved from In Process to Completed the step will order by the date/time stamp. If any step was cancelled, the status will be cancelled and the red X Cancel icon will be displayed.

The date the process was received is displayed in the Date Received/Date Completed column.  The Event Description will display the description of the process.  Each item in this table can be expanded to show more details about the Event Description.  This can be done by clicking the expand button:

This will cause the item to appear as so:

To minimize this view, simply click on the small collapsebutton.

If the details of a step can be viewed, an icon will be displayed under the View Details column.  Select the icon to view the event details. Select the Back button to return to the Workflow Tracking.

Process Submission – This column will populate with the submission process.

Created By – Will display the name of the user who created the form record.

Date Created – Will display the date and time the form record was created.

Modified By – Will display the name of the user who last modified the form record.

Date Modified - Will display the date and time the form record was last modified.

Note: Created By, Date Created, Modified By, and Date Modified can all be turned off in the System Form Designer. Other columns from the Annual COI form can be turned on in their place. See the System Admin - Form Designer Manual for more details on displaying columns in the form table.

My Conflict of Interest Manager

The My Conflict of Interest Manager is a variant of the form library described above that can be turned on under System Administration > System Configuration > Reserved Settings > system.use_coi_my_disclosure_link. The name of the My Conflict of Interest Manager is determined by the name of the Annual COI form itself. If you change the name of the form under System Form Designer > Edit/Save Form Details to My Conflict of Interest Manager, this is what will display from your home screen menu.

The My Conflict of Interest Manager contains the following columns:

Selection – This column is used to select form versions for deletion, copying, and comparisons between versions.

View History – If a form has more than one version, a folder will appear in this column. When the folder is expanded, previous versions of the form will display.

Edit/View – Click the icon in this column to open the disclosure form. If the form has not yet been submitted, it will still be editable.

Ref. Number – For every form that is submitted in iRIS, a unique number is assigned to that form, called the Reference Number. Each Annual COI form that is submitted will get assigned a unique reference number.

View Details – Clicking the expand icon will allow you to view the details of any conflict matches that were generated when the disclosure form was completed, to be discussed further.

Track Location – If a form has been submitted, this column will populate with the current status of the form. You can click on the text to view detailed information about the steps the form has taken since it was submitted.

Process Submission – Allows you to see the current status of the submitted form:

–  When a form is filled out and can be submitted, this icon will display. When clicked, you will be brought to the signoff page for the form.

–  Once the form has been submitted, this icon will populate.

–  When the matches associated to the form have been processed by the COI office and completed, the column will update to this icon.

Submission Date – Indicates the date that the form was submitted.

Preliminary Request – This form will populate with a value from the disclosure form if you have indicated that you are requesting a preliminary review of a potential interest, activity, or contract.

Date Created – Indicates the date the form was created.

Date Modified – Indicates the last time the form was modified.

Create Revision – Click the icon in this column to create a revision of the Annual Disclosure form.

A primary feature of the My Conflict of Interest Manager is the ability to view details of any conflict matches generated when the form was submitted. Click the Expand icon in the View Details column.

A description of the columns is as follows:

Nature of Outside Activity/Interest – This pulls in the business type, as defined by the Conflict of Interest & Commitment Match Rules that generated the conflict match.         

Status – This pulls in the value of the Disclosure Status for the match, as defined on the Outcome tab of the Conflict Match processing screens.

Outside Entity – This displays the business associate associated with the match (Conflict of Interest Business Associate data value).

Type of Activity – Displays the nature of activity associated with the match, if applicable (Nature of Activity List data value).

Current Value or Income Received in Last 365 Days – Displays the value/income entered for the match, if applicable (Dollar Amount Configuration List data value).

Date Last Compensation Received – Displays the date selected from the Compensation Date data value, or “Don’t Know,” if applicable.

Annual Outside Time Commitment – Displays the value selected from the Time Commitment data value, if applicable.

Related Research – If there is matching study information, the associated IRB number, Study Title, and Covered Person’s role on the study will be displayed.

Approved by Supervisors – This column is related to Conflicts of Commitment generated by the form. This column will display “Yes,” “No,” or “N/A”. “Yes” displays if all assigned Commitment Reviewers have approved the commitment match. “No” displays if the match has indicated a Conflict of Commitment and has been routed for review, but the review is not complete or has been denied. “N/A” displays if the match is not a Conflict of Commitment.

Written Agreement with Outside Entity – This column will link to the document uploaded in the Written Agreement data value, if applicable.

Agreement Approved by OGC? – This column displays the Office of General Counsel outcome from the Outcome tab of the Conflict Match processing screens.

Approved by COI - This column will display “Yes” or “No”. “Yes” displays if the Conflict Match has been submitted to the COI board and has been completed. “No” displays if the Conflict Match has been submitted to the COI board and has not been completed.

Management Plan – If a Management Plan has been generated for the Conflict Match, a link to the PDF will appear here.

Filling out your Disclosure Form

To start a new Annual COI form, click the Add a New Disclosure button. This will initiate the Annual COI form. Depending on the form’s configuration in your system, the Annual COI form you see may not be configured exactly like the one in this manual.

At the top left of the form, the name of the Covered Person will populate. Later, when this form is submitted, the Reference Number will also populate in this area.

As you navigate through the Annual COI form, additional sections will populate in the Section view of the Form when you click the Continue button on the top right of the screen. Typically, the first section will display the instructions for the Annual COI from. At any point in the process, you can click the Print Friendly button to open a new page that will list out the form in a printable format.

Some of the text is bold, underlined, and green. You can hover your mouse over these links for additional information. These links are configurable in the System Form Designer. After reading the instructions, click the Continue button to proceed to the next section.

Notice that as you move through the form, the navigation builds to the left of the form. At any time during the completion of the form, you can navigate back to previously completed sections by clicking on the particular section in the navigation pane.

The Background Information section of the Annual COI form will list any current positions you are associated to within iRIS and will allow you to check off any additional positions that are not listed. The roles listed on this page can be configured in the COI Assistant’s Review Board Administration.

Make any additional role selections and click the Continue button.

Note: As you work in each section of the form, you may click the Save Section button to save your work within the section and either exit the form to return later or continue working within the section.

Depending on the role configurations, selecting certain roles on this page will trigger a series of Form 990 questions later in the form.

After the Background Information section, you will be presented with a series of sections that ask for specific interests you or a related person may have with certain biomedical or non-biomedical third parties, compensation, intellectual property interests, etc. Each section will ask a different question regarding a specific interest, with detail provided and hover help available for certain key words.

When you answer “Yes” to a question within a section, additional questions will populate within the section related to the specific interest.

Begin filling in the values. You will be asked to identify the Biomedical third party. Type in part of the third party name, and a list of matching Sponsors will populate in a list below the field so you can select the Sponsor.  If the name of your third party is not in the list, the system will allow you to click in the field and enter the name of your third party.

Click on the message that appears below the Biomedical third party field.

The page will refresh. Other will be identified as the third party, and a new field will populate below, allowing you to type in the name of your third party.

 Other fields will prompt you for additional information.

The example above shows that if > $100,001 is selected, the amount must be specified in the field below. You will not be presented with this field unless > $100,001 is selected.

If more than one interest is associated with a question, you can add additional entries by clicking the button at the bottom of the Entry 1 information.

This will cause a second entry to be created in the section, containing the same questions as the first entry. If you created the entry by mistake, you can click on the red X icon on the top right of the entry to remove it from the section. You can add as many entries as needed. When you are finished, click the Continue button to proceed to the next section.

You will continue to be asked a series of questions about specific interests that will help identify if you have a conflict of interest with any sponsor or project in the system. For each section that you indicate “Yes” in, the system will flag that you indicated an interest and will report that information to the Conflict of Interest board upon submission of the Annual form.

After navigating through the Annual COI form you will be able to initiate the signoff process so the form can be submitted for review. Depending on your system settings, you will be brought to the Electronic Signature Required screen. Click the Signoff and Submit button to start the signoff process.

When you click Signoff and Submit you will be presented with a Submission Routing Signoff sheet. This page will list the following information:

Submission Reference Number – Lists the reference number of this Annual form. This is a unique number in the system. No other form will have this number and it will be a means of identifying this form.

User ID and Password – For iRIS to successfully apply the electronic signature, you must provide your ID and password. No other user can apply the signature.

After you complete your signoff, you will be brought to a screen where you can download a copy of the form for your records and/or log out of the system. This will show that the Conflict of Interest board received your submission. If you click the Back button, you will then be brought back to the My Conflict of Interest Manager page. If you wish to view the workflow routing for the form you just submitted, click the green checkmark icon in the Track Location column.

Responding to a Management Plan

If the COI Office sends a response to your COI submission, you will receive a task on your home page under the Respond to Conflict Management Plan group.

Clicking on the task will open a Management Plan Response page. This page will list out any Management Plan Document and Outcome Letter generated, Management Strategies, and allow you to provide feedback.

To view any Management Plan or Outcome letter, click on the PDF icon in either the Management Plan Document or Outcome Letter table.

Any Management Strategies from the COI Office will appear in the Management Strategies table.

The COI Office will need you to respond to each strategy in the table. You can respond by selecting an option from the dropdown list, and then provide any additional details, if necessary, by clicking the Details button. This will open a new page with a text editor allowing you to type in or copy and paste your text.

After responding to the strategies, you will need to apply your electronic signature in the fields provided at the bottom of the page. Enter your User ID and Password.

The last step is to save this page by clicking Return Management Plan Response. Once you save the page, the system will notify the COI Office of your response to the Management Plan Response.