Each year, covered persons must report their financial and effort interests on the Annual COI and Commitment Reporting Form for Individuals (or Annual COI Form). This manual explains the process of completing the Annual COI Form, and responding to a COI Management Plan (where applicable). Note that because each institution can customize forms in the iRIS™ system, the name of the Annual COI Form in use at any institution may vary from that used in this manua.

The Conflict of Interest Form(s) menu (shown below) populates for covered persons on their iRIS™ home screen. A link to the Annual COI Form is included in this menu.

Click the Annual COI Form link to open the Annual COI Form page (shown below).

Buttons are provided at the upper right of the page to Copy Form (copy a previous Annual COI Form to use as a draft for beginning a new one), Add a New Form (begin completion of a blank form), Compare Two Versions, or Delete Selected Form(s). Note that once submitted for review, forms cannot be deleted.

Any Annual COI Forms associated with the logged-in user (draft/incomplete, submitted or completed) are listed in the table beneath the buttons. The table includes the following columns:

select (far left column, no title)— click to select the corresponding form; once selected a form can be copied (Copy Form button) or deleted (Delete Selected Form(s) button); select two forms to use the Compare Two Versions function

Show Rev — a folder icon populates in this column if the corresponding form has management plan correction revisions; click the folder icon to expand a panel containing details of previous versions of the associated Annual COI Form; the panel provides access to view read-only versions of previous submissions, as well as to compare versions via the select column and Compare Two Versions button

Edit/View — click this icon to continue work on a draft form, or to view a read-only version of a previously submitted form

Sub. Rounds — click the icon in this column to view the number of review rounds for the corresponding form

Track Location — current status of a submitted form populates in this column; click the status text to view details of the processing and review steps the form has completed thus far (see the Submission Workflow and Tracking section of this manual for more information)

Process Submission – submission process applied to the corresponding form

Submission Date — date and the time the corresponding form was submitted; blank if the corresponding form has not yet been submitted

Created By — User ID of the user who created the form

Date Created — date and the time the form record was created

Modified By — User ID of the user who last modified the form

Date Modified — date and the time the form record was last modified

Note that different columns from the Annual COI Form can be substituted for the Created By, Date Created, Modified By, and Date Modified columns in the System Form Designer. See the Conflict of Interest — Forms and Workflow manual for more information.

Submission Workflow and Tracking

On the Annual COI Form page, when Track Location column status text is clicked, current workflow and location tracking details display for the applicable form in the Workflow – Submission Tracking page (shown below).

The top of the page shows a workflow diagram for the submission, highlighting its current location processing / review status in the workflow.

In-processing and completed steps for the submission populate in a list table beneath the diagram, as shown below.

In-process steps populate at the top of the list (yellow highlighted items in screenshot above). If a processing step is cancelled, status for the submission reverts to the last applicable status.

Completed steps are displayed with a Task Status of “Completed”. When a step moves from “In Process” to “Completed” the list table is re-ordered, with the newly-completed step inserted in the list by order of date/time stamp.

The list table includes the following columns:

Task Status — process step / status

Task Action/Details — process step / status, and any available action button(s) (e.g., Retract Submission)

Task Name — description of the process

Note that for in-process steps, at the top of the list, the first three columns are combined into a single column containing an expand icon (plus sign, minus sign when activated as shown in screenshot below) and Task Action/Details; this column includes action buttons where applicable (e.g., Retract Submission button in the screenshot below).

Date Created — date the process was created / started

Date Completed — date the process was completed / ended

Total Time — total time in process

My Conflict of Interest Manager

An optional, more detailed alternative to the standard Workflow – Submission Tracking page (described in the Submission Workflow and Tracking section of this manual) is provided via a reserved property setting. The alternative, more detailed page is shown below.

The name of the page is determined by the name of the Annual COI Form; in the example used here the name of the form is My Conflict of Interest Manager (shown in screenshot below). For the remainder of this manual section the page is referred to by that title.

To use the alternative page in place of the standard Workflow – Submission Tracking page, select “Yes” for the system.use_coi_my_disclosure_link property under System Administration > System Configuration > Reserved Settings.

The My Conflict of Interest Manager page contains the following columns:

View History – a folder icon populates in this column for each form that has more than one version; click the folder icon to display previous versions of the form

Edit/View — click the icon in this column to open the disclosure form for review or revision; note that only forms which have not yet been submitted can be revised

Version — version number

Note that in the iRIS™ system every new form and form revision is automatically assigned a decimal version number with one decimal place. The version number of each new form created via the Add a New Disclosure button is incremented by one whole number. The version number of each revision of a form created via the Add Revision button is incremented by one decimal number.

For example, if versions 1.0 and 2.0 exist in the system for a given form, clicking the Add Revision button for form version 2.0 creates a revision number 2.1. Clicking the Add a New Disclosure button for the same form creates revision number 3.0.

View Details — click the expand (plus sign) icon to view the details of any conflict matches that were generated when the disclosure form was completed (more information below)

Process Submission — current status of the submitted form:

— the form is complete and can be submitted; click the icon to open the signoff page for the form

— the form is submitted

— this icon populates if the form is submitted for review but has not yet been processed; click the icon to retract the submission for revision

— matches associated to the form have been processed by the COI office and marked complete

Submission Date — date the form was submitted

Preliminary Request — populates with the corresponding value from the disclosure form if a preliminary review of a potential interest, activity, or contract is requested

Date Created — date / time the form was created

Date Modified — date / time of the last modification made to the form

Create Revision — click the icon in this column to create a revision of the Annual Disclosure form

The primary feature of the My Conflict of Interest Manager page is the ability to view details of any conflict matches generated when the form is submitted. Click the expand icon in the View Details column to open the subpanel of additional detail for the applicable match item.

Columns of additional detail include:

Nature of Outside Activity/Interest — business type, as defined by the Conflict of Interest & Commitment Match Rules that generated the conflict match

Status — Disclosure Status for the match, as defined on the Outcome tab of the Conflict Match processing screens

Outside Entity — Conflict of Interest Business Associate data value associated with the match, if applicable

Type of Activity — Nature of Activity List data value associated with the match, if applicable

Current Value or Income Received in Last 365 Days — Dollar Amount Configuration List data value associated with the match, if applicable

Date Last Compensation Received — Compensation Date data value, or “Don’t Know”, as applicable

Annual Outside Time Commitment — Time Commitment data value associated with the match, if applicable

Related Research — where matching study information is available, the associated IRB number, Study Title, and Covered Person’s role on the study populate here

Approved by Supervisors — “Yes” displays if all assigned Commitment Reviewers have approved the commitment match; “No” displays if the match is flagged for a Conflict of Commitment and has been routed for review, but the review is not complete or is denied; “N/A” displays if the match is not a Conflict of Commitment

Written Agreement with Outside Entity — where applicable, a link to the document uploaded in the Written Agreement data value populates here

Agreement Approved by OGC? — Office of General Counsel outcome from the Outcome tab of the Conflict Match processing screens

Approved by COI — “Yes” displays if the Conflict Match has been submitted to the COI board and is completed; “No” displays if the Conflict Match has been submitted to the COI board and is not yet completed

Management Plan — if a Management Plan exists for the Conflict Match, a link to the PDF populates here

Completing the Annual COI Disclosure Form

To start a new Annual COI Form, click the Add a New Form button at the top of the Annual COI Form page (shown in screenshot below).

A blank Annual COI Form opens, as shown below. Note that because forms in the iRIS™ system are configurable, form labels and fields can vary by institution and may not match those shown in this manual.

The name of the Covered Person populates at the top left of the form (to the immediate right of the My Workspaces menu link, see screenshot above). Later, when the form is submitted, the Reference Number also populates in this area.

The Print Friendly button can be clicked at any time while completing the form to open a print friendly copy of the current version of the form in a new tab or window.

Click the Save Section button to save the entries made within a section, and either exit the form to return later or continue working within the section.

Additional sections dynamically populate in the Section view of the form when each section is complete and the Continue button at the top right of the screen is clicked.

Typically, the first section displays instructions for the Annual COI Form.

Hover over any boldface, green link for additional information (shown in screenshot above). These links are configurable in the System Form Designer. After reading the instructions, click the Continue button to proceed to the next section.

A navigation menu dynamically builds to the left of the form as sections are completed and the Continue button is clicked (see red box in screenshot above). Previously completed sections of the form can be accessed via the links provided in this menu.

The Background Information section lists any current positions associated to the logged-in user within the iRIS™ system, and allows for selection of additional positions. The roles listed are configured in the Review Board Administration area of COI Assistant. Make any additional role selections and click the Continue button. Note that, depending on the role configurations, selecting certain roles on this page can trigger a series of Form 990 questions later in the form.

Following the Background Information section, the form presents a series of sections to detail specific interests the logged-in user or related person may have with certain biomedical or non-biomedical third parties (e.g., compensation, intellectual property interests, etc.).

Each section asks a different question regarding a specific interest, with detail provided and hover help available for certain keywords.

When “Yes” is the selected answer to a question within a section, additional questions related to the specific interest populate within that section.

Enter the requested values. If entering a Biomedical third party, type in part of the third party name to open a search list of Sponsors; click to select the applicable Sponsor. If the applicable third party name is not in the list, click in the field to enter the name of the third party.

Other fields are dynamically populated to prompt for additional information as needed.

As shown above, if > $100,001 is selected for the Select the estimated current value of the investment field, a second field populates for entry of the specific amount.

If more than one interest is associated with a question, click the Click here to add another entry button (red box in screenshot above) to open another numbered Entry tab.

A new Entry is created in the section, containing the same questions as the first Entry.

If an Entry is created by mistake, click the Click Here to Delete this entry button to remove it from the section. As many entries as are needed can be added. When all entries are added, click the Continue button to proceed to the next section.

As form completion proceeds, the logged-in user is asked a series of questions about specific interests to help identify if that user has a conflict of interest with any sponsor or project in the system.

For each section where the logged-in user indicates “Yes”, the system flags that the user indicated an interest and automatically reports that information to the Conflict of Interest board upon submission of the COI Annual Form.

When the Annual COI Form is complete the logged-in user has the option to initiate the signoff process, so the form can be submitted for review. Click the Signoff and Submit button to start the signoff process.

Depending on system settings and the configuration of the form, the informational countdown popup message shown above can be displayed to the user before they are redirected to the Submission Routing Signoff page.

The Submission Routing Signoff page includes a Submission Routing Signoff sheet. This page list the following information:

Submission Reference Number — unique, system-generated reference number for this Annual COI Form

Submission Form(s) — listing of all components of the submission, including documents the user uploaded; select the checkbox in the Include in PDF Packet column for any item(s) to be included in a PDF packet, then click the Printable Version button to generate the packet in a new tab or window; click the Submission Component Name text for any item listed here to open that component

Electronic Signature — enter the logged-in User ID and password for iRIS™ to automatically apply that user’s electronic signature, no other user can apply the signature. Note that this is a configurable setting, the system may or may not require submission of an electronic signature

After signoff is complete the user can check the status and location of their submission by going to their homepage and clicking on “Steps” under the Conflict of Interest Submission Status panel. Here, the user can respond to, view, or track the status of their submission (see screenshot below).

Responding to a Management Plan

If the COI office sends a conflict management plan in response to a COI submission, the user who submitted the form receives a “Respond to Conflict Management Plan” task on their home page. A View Details link populates for any “Respond to Conflict Management Plan” task, as shown below.

Click the View Details link to open the Management Plan Document popup window, shown below. Any associated management plan(s) are listed here.

Click the icon in the Click to open the Management Plan column to view the document in a separate window.

Full details, associated documents and available processing options for all home page COI task items are shown in the Management Plan Response page. To access the page, click the icon in the Click to open column for the applicable task.

As demonstrated below, the selected item is opened in the Management Plan Response page.

The top two panels contain Management Plan Document and Outcome Letter details, as well as icons to open read-only versions of associated documents. Click the applicable PDF icon to open a document.

The Management Strategies panel lists any requested strategy(ies).

The user must respond to each strategy in the panel. Click in the drop down list of options to open it, then click an item in the list to select it. If applicable, click the Details button to open a text editor for entry of any comments.

After entering a response to the strategies, the user must apply their electronic signature by entering their User Id and Password in the fields provided at the bottom of the page.

When changes are complete, scroll back to the top of the page and click the Return Management Plan Response button (shown in screenshot below).

The system notifies the COI office of the user’s response.