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

The Conflict of Interest Assistant is available to streamline and assist in an institution’s Conflict of Interest management. The Conflict of Interest Assistant works similarly to other review boards. However, the main feature of this module is that it works in conjunction with the rest of the software to avoid financial conflicts that may occur throughout the entire process of submission reviews, signoffs, member reviews, and so on.

Whenever a submitted Annual COI or Study COI form has a conflict match, that match will populate in the Conflict Matches queue. Within the Conflict of Interest Assistant, you can manage these matches, search already reviewed COI matches, and review management plans.

Note: Depending on a user’s access, they may not have all the items shown above available to them. See the Review Board Administration manual for additional details regarding adding or removing access for roles on review boards.

Find A Study

Use Find a Study to look up studies. After clicking on this icon from the COI Assistant section of your main screen, a search tool will appear.

Using the dropdown lists and text fields, you can narrow your search using any known information. Depending on your system settings, studies can be displayed by the IRB Number, Project Number, IACUC Number, IBC number, or Study Nickname. Changing the Display Studies by field will update the table accordingly.

Some of the search fields are auto-populating fields. Begin by typing the name, and the system will return any resulting matches for you to select. Sponsor, Principal Investigator, Department, and IRB Number are all auto-populating fields.

The Principal Investigator field allows you to flip between Active and Inactive PIs. Inactive PIs are any user accounts in the system that have been flagged as Inactive that also are listed as Principal Investigators on studies. Active PIs are any user accounts that are flagged as Active and also are listed as Principal Investigators on studies.

Also available is a drop down of available Study Status and Study Classification that you can choose from.

The Reference Number field allows you to search for studies by Submission Reference Number. Enter a reference number for a specific submission form. When you filter the results, the study matching the reference number will populate in the results.

Note: You must enter the entire Reference Number in this field, except for the leading zeros. Example, for a submission with Reference Number “000288,” you would need to enter “000288” or “288” to filter the results correctly.

You can search by an expiration date range by entering in the appropriate information in the Expiration Date fields.

Reset Find Options – This button will allow you to reset the study filters and begin a new search.

For more advanced search options, click on the Advanced Find Options button.  

This will allow you to filter by study personnel, study drugs, devices, issue reports, and key words in the Study Title. You can choose to use one or all options in the Advanced Search Options by selecting an item from a drop-down list and/or typing in the keywords. When you are finished, click the Apply button at the bottom right corner. Click the Cancel button to close the window without applying the filters.

When you click the Find button, the system will return any matching studies, depending on the filters you selected. If you added Advanced Search Options, the button will update with a yellow border to indicate extra filters are in use.

Once you find the study you are looking for, you can click the icon in the Open column to open the study record.

The other columns on this page are as follows:

Study Status - This displays the current status of the study (i.e. Open, Pending, Draft, Completed).

IRB Number - If an IRB Number has been associated with a study, it will display here. This column will change to whatever you choose to display the studies by, when using the “Display Studies by” filter.  

IRB Expiration Date - If an expiration date has been associated with a study, it will display here. This column will also change with whatever you choose to display the projects by.  

Study Number - This displays the Study Number/Nickname given to the study in the initial section of the Study Application.

Study Title - This displays the Study Title given to the study in the initial section of the Study Application.

Principal Investigator - This displays the name of the Principal Investigator on the study.

Sponsor – This displays the name of the Sponsor on the study.

To view a study, click the icon in the Open column and you will be brought to the Study Management page.  By default, this page opens to the Submissions tab, which will look similar to the screen shot below.

The submissions tab will display any forms available for viewing by the COI.

Clicking on the Study Management tab brings you to a screen where you can access all information regarding the study (with the exception of subject information).

Depending on the COI’s access to a study record in the system, you may or may not see the same links as shown in the screenshot above. This screen will allow you to see specific details about the study. One of the most important pieces of information for the COI is the Study Summary/Profile link.

The Study Summary/Profile contains basic information about the study like personnel, review board information, study details, etc. The screenshot above should look similar to your Study Summary screen, but might contain extra fields about the study. Certain fields may or may not be in use and can be turned on and off under Review Board Administration.

This area can be used to gather information about a specific study for COI purposes.

Conflict Matches

The Conflict Matches link allows you to view all conflict matches that have been generated as users have filled out their disclosure forms, as well as process those matches.

When you click on the Conflict Matches link, a page will open displaying all matches, divided into four tabs:  Not Assigned, Assigned, Completed, and Agendas. Upon opening the link, the system will automatically default to the Not Assigned tab.  See the COI Assistant - Match Processing manual for more information.

Search Conflict Matches

Search Conflict Matches is a tool for the COI Office to look up users in the system and see information about their submitted disclosures and view and change their current COI Due Date, commitment reviewers, and Covered Person flag. Any previously submitted conflict match can be accessed from this area, documents uploaded within a Covered Person’s match will populate here, and management plans can be accessed.

The Search Conflict Matches page will list out all users in iRIS. Displayed in this table are the Open User, Open User Role, User Name, Primary Department, Annual COI Due, Status, Documents, Management Plan, and Conflict Matches columns. Annual COI Due is the date a user’s Annual COI Form is due in the COI queue. Status is the user’s status in iRIS. This can be either Active, meaning they have an active account in iRIS, or it can be Inactive, which means the user is not active in the system, and any COI Due Dates for this user will not be enforced.

Filters

The top of the page contains fields so you can search for a particular user or search for users that have a COI Lapse or a due date coming up.

You can search for a user by Last Name, First Name, Employee ID, User ID, and Status. Once you enter in the information, click on the Find button. Any users matching your search criteria will populate in the list.

You can also use a combination of filters to narrow down a list of users meeting certain criteria related to the COI due date, sponsors, and information from a processed Conflict Match. The items you can filter by are as follows.:

Annual COI Lapsed – Any user who has a COI Due date in the past that has not submitted the Annual COI form will populate in the list when this option is selected.

Annual COI Due in next 120 Days – Any user who has an Annual COI due date in the next 120 days will populate in the list when this option is selected.

No Annual COI Submitted – This filter will only display Covered Persons who have never submitted the Annual COI form with an Annual COI Due Date in the future.

By Outcome – Select an outcome type from the dropdown list to locate any user whose Conflict Match has been assigned the selected outcome.

You can use a combination of the search items to narrow down the results to find a particular user or users.

Download/Upload Templates

The Search Conflict Matches page contains options to download and upload spreadsheets that give you an easy way to enter multiple users’ COI due dates or Institutional Roles.

COI Due Date Template

This will be the template that you want to use if you wish to upload COI due dates for multiple users to the system.

Click Download COI Due Date Template to start. A new screen will open with download instructions.

You will be prompted to select whether you wish to open or save the file. Be sure to save the file to a known place on your computer so you will be able to edit it.

Click Download Complete when you are finished downloading the template to return to the Search Conflict Matches screen, or Cancel to return without downloading the file.

The template will appear as follows, giving you instructions about the proper formatting.

When you are finished entering user names and COI Annual Due Dates, you can click the Upload COI Due Date button. You will be prompted to browse for the file on your computer.

Click the Browse button to locate the file on your computer, and click Save Selected File to select the file and upload it into iRIS. Click Cancel to proceed without uploading a file. You can see the users’ Annual COI Due dates in the table of conflict matches.

Institutional Roles Template

This will be the template that you want to use if you wish to upload institutional roles for multiple users to the system.

Click Download Institutional Roles Template to start. A new screen will open with download instructions.

You will be prompted to select whether you wish to open or save the file. Be sure to save the file to a known place on your computer so you will be able to edit it.

Click Download Complete when you are finished downloading the template to return to the Search Conflict Matches screen, or Cancel to return without downloading the file.

The template will appear as follows, giving you instructions about the proper formatting.

When you are finished entering user names and Institutional Roles, you can click the Upload Institutional Roles button. You will be prompted to browse for the file on your computer.

Click the Browse button to locate the file on your computer, and click Save Selected File to select the file and upload it into iRIS. Click Cancel to proceed without uploading a file. You can see the user’s Institutional Roles by clicking the icon in the Open User Role column next to the user’s name.

Open User

In the list of users, the first column allows you to open specific, COI-related information about a user. From here, you can set Annual COI Due Dates, change commitment reviewers, and see any Annual COI forms sent to the office in the past.

Clicking on the icon in the Open User column will open a new page containing the user’s specific COI-related information.

Researcher – If the user is used as study personnel on a study, this flag will be set to “Yes.” This can be changed on this page if for any reason a certain user should no longer have access to the Study Assistant tab (this would restrict that user’s ability to access studies they have a role on).

Is Covered Person – If the user is a Covered Person, this flag will be set to “Yes.” A user is typically set as a Covered Person at the time their account is created, but you can set their flag at any time. Once a user is flagged as a Covered Person, the system will include them in the Annual COI Due Date assignment and will send notifications to the user about completing the form before the due date.

Annual Report Due - This is a date field where you can set the Annual COI Due Date. You can set up a system-wide Annual COI Due Date in Review Board Administration > System Setup > Setup COI Annual Due. If this date is in the future and is set up, any user who is flagged as a Covered Person will update to this date. Otherwise, you can manually enter a due date on this screen, or change the due date if necessary. The individual user’s Annual Report Due date is the date that drives the COI related notifications (Annual COI Due, COI Past Due, COI Lapse notifications and tasks).

Primary Reviewer – If you are tracking Conflict of Commitment as well as Conflict of Interest, you can assign a Primary Reviewer to the user here. Click on the Add button to search the iRIS database for this user’s commitment reviewer. When you add the reviewer, their name will be listed next to the Primary Reviewer label. Whenever an Annual COI form is submitted for this user and the user has indicated a conflict of commitment, the reviewer will be assigned to review this conflict.

Secondary Reviewer – If you are tracking Conflict of Commitment as well as Conflict of Interest, you can assign a Secondary Reviewer to the user here. Click on the Add button to search the iRIS database for this user’s commitment reviewer. When you add the reviewer, their name will be listed next to the Secondary Reviewer label. Whenever an Annual COI form is submitted for this user and the user has indicated a conflict of commitment, the reviewer can be assigned to review this conflict.

If you are not using Primary or Secondary Reviewers, you can set the system up so that it does not require you to provide a Primary and Secondary Reviewer for the Covered Person. This can be set in the system properties found under System Administration > System Configuration > COI Settings > system.coi_primary_reviewer_required.

COI Form Type – From this dropdown list, you can select what type of forms you would like to display in the table of results. Select from between Annual COI and COI Miscellaneous.

In the table below the setting information, any COI forms submitted to the COI Office will display. You can view these forms by clicking on the icon in the Edit/View column. You can also view the reference number for the submission, the date the form was created, and when it was received into the COI processing queue. The Outcome Status column will populate if an outcome has been given to the form. If you make any changes to the page, click the Save Changes button before navigating away.

Open User Role

To view any institutional roles assigned to a user, click the icon in the Open User Role column. This page will allow you to change the roles if needed.

The column on the left side of the page lists the user’s current roles in the system. This list is configured in Review Board Administration > List Maintenance Setup > Setup Institutional Role Name List. A user is assigned to a role by selecting the role themselves in their Annual COI form (if that data value is used in the form). When they submit the form, the system will update this page to contain any of the roles they selected. You can also assign a user roles on this page. You can remove a role from the user’s list by selecting the checkbox next to the role name, and then clicking the Delete Role Assignment(s) button.

The column on the right displays other roles from the Institutional Role list that have not been assigned to this user. You can add a new role for the user by selecting a role in this list and then clicking the Save Role Assignments button.

User Details

You can look up user details like contact information, training information, licenses, and CVs by clicking on the name of the user in the User Name column.

When you click on the user’s name, a new page will open, displaying the user’s information as it has been entered into their user account record. Click the Back button to return to the Search Conflict Matches page.

Documents

The Documents column within Search Conflict Matches provides the ability to look up any Internal Documents associated to the Covered Person within the match processing screens.

The Documents link will direct you to the Covered Person’s document library, which stores any document you have attached to conflict matches or added through the library itself.

From this area, you can edit existing documents, add new documents, and compare documents. You can also filter the documents based on the Document Category assigned. The document category is defined within Review Board Administration > List Maintenance Setup tab > Internal Document Category.

The Matched Object Number column will only populate with data if the document was uploaded through Internal Documents within the conflict match processing screens. Any document added through this area will not be associated to a conflict match.

Management Plan

Management Plan Letters that have been generated and sent for a Covered Person will populate in the Management Plan column within Search Conflict Matches.

Expanding the details for the Management Plan column will cause the Management Plans associated to the Covered Person to display within the page.

You can filter the letters by selecting a status in the drop down list.

Available filters:

All – will pull all letters regardless of status

Open Matches – will pull letters associated to conflict matches that are still in process

Conflict Processing Complete – will pull letters associated to conflict matches that have been completed within the COI Conflict Matches queue.

Some of the columns are sortable. You can click on the column header to sort by that field. The default sort is Date Letter Received, oldest to newest.

The columns available for the management plan details are as follows:

View Letter – This will open the letter in a separate window.

Click to Open - This will navigate you to the Conflict Match processing screens.

Group Name – If the letter is associated to grouped conflict matches, this column will populate with the assigned Group Name.

Matched Object Num – Will display the unique Matched Object Number that the letter is associated to.

Ref Number – Will display the Submission Reference Number associated to the form that the Conflict Match was submitted with.

Date Letter Created – Will display the date the letter was created in the Management Plan & Outcome Letter tab.

Date Letter Received – Will display the date the letter was received by the Primary Recipient.

Response Status – Will display one of the following status: “Open” – meaning the Covered Person has not sent the response back to the COI yet; “Acknowledged” – meaning the Covered Person has returned the response to the COI but the match is still being processed by the board; “Closed” – meaning the board has closed the Conflict Match that this letter is associated to.

Letter Title – Will display the title of the letter.

Assigned Analyst – Will display the Assigned Analyst, if one has been associated to the Conflict Match associated to this letter.

Conflict Matches

The Conflict Matches column will allow you to look up any Conflict Match associated to the Covered Person.

Expanding the details for the Conflict Matches column will cause the Conflict Matches associated to the Covered Person to display within the page.

The Conflict Match records will be split into three tabs: Not Assigned, Assigned, and Completed. These tabs follow the same logic as within the COI Conflict Matches queue, where unprocessed matches populate in the Not Assigned tab, matches assigned a process that have not been completed populate in the Assigned tab, and any completed match populates in the Completed tab.

The columns available for the detail are as follows:

Open - This will navigate you to the Conflict Match processing screens.

Matched Object Number – Will display the unique Matched Object Number for the match.

Group Name – If the letter is associated to grouped conflict matches, this column will populate with the assigned Group Name.

Show Form – Will display the submission form that the Conflict Match originated from. When clicked, the form will open in a separate window.

Reported Interest Third Party – This column will populate with the indicated third party interest (the sponsor the user indicated the interest with).

Reported Interest Type – Depending on the specific issue, this column will populate with the type of interest, as noted within the form. It could be a Financial Interest, a Financial Commitment, Gifts from a Biomedical Company, etc.

Reporting Action – This column will display where the match has come from – whether the Annual COI (Individual Annual Reporting Form), from a Study COI, or a Miscellaneous Disclosure.

Date Submitted– The date the conflict form was submitted into the workflow.

Ref Number – This column will populate with the reference number of the Study COI form.

Reviewer Assignment

The Reviewer Assignment link is available for you to access any open reviews you have been assigned to. You can also access this area to view reviews you completed in the past.

When you click on the Reviewer Assignment link, a new page will open, displaying any of your incomplete reviewer assignments. From this page, you can open the Reviewer Checklist by clicking on the icon in the Click to open column.

You can flip between the Incomplete and Complete tabs to cycle through your open reviews and closed reviews. If you need to make any changes to a closed review, you can open that assignment by navigating to the Complete tab, locating your review, and clicking the icon in the Click to Open column. This will open the Reviewer Checklist you completed before. You can make any necessary edits before saving and navigating back to the Reviewer Assignments page.

Meeting Management

The Meeting Management section of COI Assistant contains four subsections, Meeting Manager, Meeting Agenda, Meeting Minutes, and Meeting Availability. This functionality will allow you to manage all aspects of meetings within iRIS.

Meeting Manager

Meeting Manager allows you to view meeting agendas and set meeting availability. Access to this menu item can be controlled through the Role Access Matrix in Review Board Administration. The Meeting Manager is typically reserved for a review board administrator. You can view current agendas and publish/create Word document versions of Agendas and Meeting Minutes to send to IRB members. The Agenda and Meeting Minutes templates are created under Review Board System Setup.

Please see the IRB Assistant - Meetings manual for more information.

Meeting Agenda

The Meeting Agenda area of the system allows you to view information related to specific meeting dates. You can access past and future meetings from this area. If you have a review board administrator role, you can come to this area to prepare for an upcoming meeting. If your role does not have this administrative privilege, you can come to this area to look at submissions placed on a particular meeting date. Read/write access for the meeting agenda is configured under Setup Role Access in Review Board Administration.

The meeting agenda page will open by default to the next upcoming meeting. You can flip to a different meeting date by clicking on the arrows by the meeting date at the top of the page. See the COI Assistant - Meetings manual for more information

Meeting Minutes

Meeting Minutes allows you to access published meeting minutes for any past meeting. This is an area where board members can go to pull minutes from a past meeting.

This page will display a link for each board meeting that has been held from newest to oldest. If minutes have been generated and a Finalized version has been published, a View Finalized Minutes button will populate next to the meeting link. If a Draft version of the minutes has been published, the button will read View Draft Minutes. If the meeting minutes have not been published yet, no button will display. You can click on the View Finalized Minutes or View Draft Minutes button to view the PDF document for that meeting. You can also open to the meeting agenda by clicking the link for the meeting date.

When you click to view the draft or finalized minutes, they will open in a new screen displaying the information entered from the meeting. The fields in the minutes document will reflect what was defined in the Meeting Minutes Template. If it is a draft version of the minutes, a watermark will appear with the word DRAFT across the minutes. See the COI Assistant - Meetings manual for more information.

Meeting Availability

The Meeting Availability menu option brings you to a screen where, if you are an COI administrator, you can scroll through meeting dates and set the availability for different board members for those dates.

If you open the screen with a non-administrative role, you will be able to set your own availability for upcoming meetings.

For more information about Meeting Availability, see the IRB Assistant – Meetings manual.Audit System Notifications

Correspondence and Notifications

The Correspondence and Notifications menu contains the Audit System Notifications sub-item.

Audit System Notifications

The Audit System Notifications tool can be used by board administrators to search for a particular notification already sent by the system.

The Audit System Notifications menu item is typically accessible by Review Board Coordinators and Administrators. Its accessibility can be provided to all roles via the Setup Role Access matrix found in Review Board Administration.  

Every notification that is sent out by the iRIS™ system is logged, making it possible to track.  Since the system automatically generates the notifications, this notification audit tool can be very useful for Coordinators who need to check the status of a reviewer notification.  All system notifications can be audited here to ensure that they were sent.

Clicking on the Audit System Notifications link opens the above Audit Notifications screen, which provides several filters to search for notifications you would like to see.

A list of found notifications will display with fifty items per page.  Selections can be made using the following filter tools:

Notification Type – Select a notification type from the drop-down list to filter the “Notification Type.”

Recipient(s) – Use this field if you wish to perform an audit for a specific user within the system. Only user(s) with existing criteria who have received notifications will be displayed. When the Select User button is clicked, a new screen will be displayed (see below).  Enter the search criteria and click the Find button.

When you have found the user, click the “Select User” icon next to his/her name. Once added to the search filter, you can clear a name by selecting the Clear User button. This tool will only allow for searching one user at a time. If you happen to attach more than one user from the above page, only the top-listed user will be selected by the system and be inserted into the search tool (shown below).  Additional filtering can be selected from the other fields on the page.

Date Range – If the approximate date of a notification is known, this would be the best filter to use.  

IACUC/IRB/Project/IBC Number – This option is dependent on the selection made from the Display Projects by drop-down list.

Subject – Enter a key word or phrase that would appear in the subject line of the notification.  You can use the wildcard “%” to administer this type of search.

Content – Enter a key word or phrase that would appear within the content section of the notification.  You can use the wildcard “%” to administer this type of search.

Provide information in one or all of the search fields to locate the necessary notification. Click the Search button to initiate the search engine. The results will be displayed in the table located under the search engine, with the most recent notification placed at the top of the page.  You can sort the notification results in ascending or descending order by clicking on the column headings (as shown below). This feature is not included in the View and Recipient(s) columns.

The following columns will populate with your search results:  View, Notification Type, <chosen> Number (dependent on selection made in field: “Display Projects By:”), Date Posted, Subject, Recipient(s), and Additional Recipient(s).

Click the View icon to view the entire body of the notification that was sent.  You will see a screen similar to the screenshot below (notification information is read-only):

User Management

The Correspondence and Notifications menu contains the Grant User Access and Define Roles sub-item.

Grant User Access and Define Roles

This page will list any users who currently have a role on the review board.

Any user who has a role on the COI Review Board will populate in this list. You can see their name, what committee on the board they belong to, and what their role is, along with if they are a voting member. If their account has the information set up, their Specialty and Affiliation will display as well.

You can change a user’s access by clicking on the icon in the Edit column.

A page listing contact information as well as role information will open. You can change the board member’s role by selecting another role within a committee. Click on the Save Member Info button if you make any changes before returning to the list.

You can also add a new member to the board if their account has already been created in iRIS. Click on the Add a New Member button. This will take you to a search list of all other users in the database who do not have a role on the board. You can select a user and click on the Save Selected Members button to add them to the board.

Reports

The Reports tool allows you to access and run the pre-canned reports that come with the COI Assistant module.

The Reports page lists the available reports.  Clicking on a report link will allow you to set specific parameters and run the report. The parameters and filter options for each report will vary based on the requested information.

Within each report, you will have the option to display the report in PDF, HTML, or Excel format.

When you click the Helpful Information button, the Report Generation Help window will populate. The Helpful Information window displays notes that assist you in running the report and displays the description of the report.  

The reports that are available through the COI Assistant are as follows:

Annual COI Form – Status and Disclosure – This report will display the status of Annual COI forms and if a Covered Person has an active Disclosure.

Annual COI Form Not Submitted – This report will display Covered Persons who have not submitted their Annual COI form for the selected Annual COI Due Date Range.

Annual COI Form Status – This report displays a total number of Annual COI forms completed for the current Annual COI period by Department and Job Title.

Covered Person by Department – This report will display Covered Persons by their Primary Department.

Disclosure Summary Report – This report displays Conflict Matches reviewed at a meeting along with outcomes and the management plan.

New Hire – This report will display any New Hires within the dates selected.

Outstanding Management Plans – This report will display any Covered Person with an outstanding Management Plan that falls within the dates selected.

Review Board Administration

Review Board Administration allows you to configure many options related to the functioning of the board, set up configuration lists, define document templates including Outcome Letters, Meeting Agendas, and Meeting Minutes, and set up automatic review board-related notifications. Review Board Administration is typically reserved for Review Board Administrators. See the COI Assistant - RB Administration manual for more information.