FAQs for Huron COI, Platform for Research Financial Conflict of Interest Disclosures

• Disclosure Profile: This is a centralized profile where you can add and manage your financial interests. You can view your disclosed interests, your COI training record, and any actions required of you.
• Triggering Event: This is Huron’s term for project.
• Research Certification: A Research Certification is project-specific disclosure. This is what is required for each proposal or funded award.

Proposal

• For any research that goes through the Office of Sponsored Programs, the Proposal Summary Form (PSF) is submitted to OSP and entered into the Kuali Proposals system. Once the proposal is submitted to the sponsor and the proposal Submitted Date, Total Direct Cost (>$0), and Status (pending) are entered into Kuali, the proposal information is queued up for automatic migration to Huron through a nightly feed.
• Once the nightly migration is complete, the named Principal Investigator, and if named in the PSF, the Proposal Contact (who can be a department or grants administrator), will receive a Huron-generated notification email from coi@bu.edu to review and confirm the new Triggering Event (TE), which is Huron’s name for a project. In Huron, the Proposal Contact is called the Primary Contact.
• Industry Engagement contracts will have corresponding TEs manually created in Huron prior to the commencement of negotiations. Whomever is creating the TE will automatically be added as the Primary Contact. This can be changed anytime by the Principal Investigator (PI).

Editing the Triggering Event in Huron

• Both the PI and the Primary Contact have the ability to edit a TE in Huron. The TE that has migrated into Huron can be accessed:
  • directly by clicking on the TE ID number in the system generated email; or
  • logging into Huron COI Huron COI, click on Triggering Events and searching for the project by searching Triggering Event Name or Principal Investigator name.
• Click on the TE and then click on Edit Triggering Event. You can then add any relevant project information, including the personnel and the Aims or Statement of Work. The Aims/Statement of Work is a required field and is essential to a COI review if an investigator has financial interests (which are reviewed in relation to the aims of the project). It is also an essential step in the disclosure process. Without the Aims/Statement of Work, one cannot Manage Certifications.
• Once all the project information is entered, click on the Manage Certifications button, which can be found on the left-hand side menu on the TE page. This button sends an email notification to all personnel named in the TE, including the PI, requiring them to update their Disclosure Profile or to certify that their Disclosure Profile is up-to-date.

  Note: This is the step that results in the most COI Compliance Holds. If the editor of the TE does not Manage Certifications, the project-specific disclosure certifications are not created, no one receives an email to take any action, and the TE just sits in Huron. It is the responsibility of the PI, or the person acting on behalf of the PI, to enter the aims into Huron.

Disclosing in Huron

• Once the certifications for a TE are managed, research certifications are created for the TE and all personnel named in the TE are prompted to update their Disclosure Profile or to certify that their Disclosure Profile is up-to-date.
• When an investigator submits their Disclosure Profile for a research certification, the submission is separated into No Review Required or Under Review. COI Staff are only notified of those submissions requiring review. Because of this, if the investigator has not disclosed any financial interests, it does not require review, and we are not made aware of the submission.
  • Note: This is the second most common reason for COI Compliance Holds. The Project Status that appears on the TE (Yes, Cleared or No, Not Cleared) does not automatically change when a submission is No Review Required.
  • We have trained the OSP Award Maintenance Team to look not only at the Project Status, but also at the Review Status for each certification for the TE so that projects that are compliant are not unnecessarily placed on a Compliance Hold.
• If an investigator has disclosed a financial interest and it is under review, then the status will be Under Review and the project is on hold until the review is completed. We receive notification of submissions requiring review and conduct these reviews as soon as we are able.
• If an investigator has disclosed a financial interest and the COI Office has determined that the project needs to be reviewed by the COI Faculty Review Committee (because the financial interest appears related to the aims or because the investigator has a financial interest in the sponsor), then the status will be Committee Review. A project cannot be taken off hold until the committee’s review is complete and there is a signed Management Plan. When all of those steps have been taken, the status will be changed to Review Complete and the project will be taken off hold.
• If one or more investigators have not certified for the project, then the status for that investigator will be Awaiting Profile Update. The project will remain on hold until all personnel have submitted their certifications, and any required review has been conducted.
  • Note: A third reason for COI Compliance holds is that the PI or Primary Contact does not update the personnel list. Personnel who have left BU, retired, or are no longer involved in the project remain on the list of investigators who are required to submit a disclosure until they are removed from the personnel list or submit their Disclosure Profile.

Notice of Award

• When we receive a Notice of Award or IPAR for Advance Account Setup, we log the information in the Huron TE.
• We check to ensure that disclosures have been submitted, all reviews are complete, management plans signed, and trainings, when necessary, are current. If all are current and compliant, and Project Status requires an update to Yes, Cleared, a clearance email is sent to the OSP Award Maintenance Team.
• If the TE has not been completed and/or Disclosure Profiles not submitted, the TE will be placed (or remain) on a COI Compliance Hold.
• Once all disclosures have been submitted and reviewed, the COI office will send an Award Clearance email to the Award Maintenance team to lift any COI Compliance Holds.
• Please note there can be a delay of 1-2 days between the COI Team lifts a Compliance Hold and when this is reflected in the system.

Proposal Not Awarded

• Per BU’s Investigator Financial Conflicts Of Interest Policy For Research, disclosures must be filed at the time of application or submission of a formal proposal.
• If a proposal is ultimately not awarded, please email coi@bu.edu so that the TE can be closed.
• Disclosures will not be required for a closed TE.

You need a BU Kerberos username and password to log in — even if you work somewhere other than BU. DUO Two-Factor Authentication is required to log into Huron COI for all users.

• Don’t remember your BU username and/or password? Call the BU IS&T Help Desk (617-353-HELP (4357)) and they will help you reset your password or login.
• Get an internal server error message when you attempt to log in? Email coi@bu.edu with the details and a screenshot of the internal server error message, and we will adjust your account settings so you can log in.
• Get an “account disabled” error when you attempt to login? Email coi@bu.edu with the details and a screenshot of the error message, and we will get your account reactivated.
• Incoming faculty members who are transferring grants in advance of their start at BU will be unable to access Huron until they are active in HR’s system. COI disclosures cannot be submitted until then. Grants/Department Administrators who are submitting Proposal Summary Forms (PSF) for this purpose will not be able to provide the PI’s date of last disclosure. Email coi@bu.edu with any questions.
• Outside investigators will need to have their BU PI set up an affiliate account for them so they are able to access Huron COI, if they do not have an active affiliate account already.
  • This process cannot be used for students or individuals in the process of being hired by the University
  • Have your BU PI or supervisor sponsor a new or renew an existing affiliate account on BU’s IS&T site
    1. To request an affiliate account, the sponsor will need the following information:
       • Full name of external investigator
       • Date of Birth of external investigator
       • Personal email address of external investigator
       • Has the external investigator had a BU account in the past? This may be from working, attending classes, or applying to BU. If yes, please provide the username.
    2. Affiliate Account Creation link
       • Navigate to Extended access to wireless, email, other resources and select Sponsors – set up an Affiliate Account
       • Log in, and select Affiliates
       • Select Request New Affiliate Account
       • Complete the required fields
         • If the external investigator is a US resident, select the “Research Affiliate” assignment type
         • If the external investigator is not a US resident, select the “Non-Compensated Affiliate” assignment type
       • Submit the form
       • Once the form is submitted, the sponsor and affiliate will receive an email providing a BUID and BU Affiliate Email Address (created by BU IT)
       • There will be a link the affiliate should use to update their password
       • Affiliate accounts must be renewed every 365 days. Notice of expiration will be sent to both the Affiliate and Sponsor 30 days and 15 days prior to expiration

To complete the Proposal Summary Form (PSF) now that Huron COI has launched, include the date that the PI last completed their Disclosure Profile update in the PI Assurance section on p. 3 of the PSF.

There are three ways to find the PI’s last Disclosure Profile update date:

1. Ask the PI to log in and check on their Disclosure Profile.
2. Find an existing Triggering Event (COI → Triggering Events) that you and the PI both have access to, and check the Read-Only Certifications tab for the last profile update date.
3. Check the Disclosure Profile Update Date report for PIs in your department and the date they last updated their Disclosure Profile.
• We will update the report weekly on Fridays here and link to it in the Help Center in Huron COI (COI → Help Center → Disclosure Profile Update Date Report) so DAs and GAs have access to the most recent updates.

Most project proposals submitted to the Sponsor/Funding Agency by the Office of Sponsored Programs will migrate as new Triggering Events into Huron via a nightly migration. Generally, projects that will migrate are found in Kuali Proposals and have not yet been awarded. Once OSP submits the proposal to the Sponsor/Funding Agency and enters a Submitted Date, Total Direct Cost (>$0), and Status (pending) the proposal record will be queued up for migration. Although the migration occurs nightly, please allow 1 business week for all back-end processes to occur before reaching out to us for assistance finding your TE.

• If you are the Proposal Contact listed on the PSF, you will be automatically named as the Primary Contact on the Huron TE. Both the Primary Contact and the PI will receive an automatic Huron-generated notification email from coi@bu.edu once the TE has been created in Huron.
• If you do not receive this notification or are unable to find the TE in Huron after waiting 1 business week, please have your PI verify whether they have received the notification or are able to find the TE in Huron. If the PI is unable to locate the TE, email coi@bu.edu with the PI name, Proposal Title (as submitted to OSP), and Kuali Institutional Proposal Number if you know it.
• If you are unable to find a Triggering Event, please do not create a new Triggering Event before checking with the PI and/or the COI team , as this may create duplicates in the system and may lead to unnecessary Compliance Holds. You may not be able to see the Triggering Event if you are not listed as the Primary Contact.

Please note that the migration from Kuali Proposals into Huron applies only to those proposals that were submitted after the Huron system went live (March 13, 2023). This does not apply to those projects that do not require a PSF or proposal submission. Beginning August 2023, Industry Engagement contracts will have corresponding TEs created in Huron prior to the commencement of negotiations. Please do not hesitate to reach out to coi@bu.edu with any specific questions.

The answer depends slightly on your role in the project and the disclosure process. The project PI, the Primary Contact, and research personnel other than the PI will each experience this slightly differently.

First, try navigating to the Triggering Events tab (COI → Triggering Events), which is where all project information lives.

1. Log into Huron COI Huron COI
2. Navigate to Triggering Events (COI → Triggering Events)
3. You will see a list of all Triggering Events you are listed on as a PI, research personnel, or Primary Contact
4. To see only Triggering Events where you are the Primary Contact, filter by Primary Contact and type your last name into the search box
5. To see only Triggering Events where you are the PI, filter by Principal Investigator and type your last name into the search box. Additionally, when you complete your Disclosure Profile update and certify that your disclosure is complete and accurate, you will see a list of open research triggers that your disclosures will be compared against.

Primary Contact/Department or grants administrator: Viewing Triggering Events

If you are unable to see a Triggering Event that you expect to see in Huron, please do not create a new Triggering Event, as this may create duplicates in the system and may lead to unnecessary Compliance Holds. You may not be able to see the Triggering Event if you are not listed as the Primary Contact. Please see below.

Instructions for a PI to add you as primary contact to an existing Triggering Event)

1. Log into Huron COI Huron COI
2. Navigate to the Triggering Events tab (COI → Triggering Events)
3. Click Edit Triggering Event on the left
4. On the first page (Basic Information), add you as the BU primary contact (question 2)
5. Save the Triggering Event
6. You (the DA/GA) should then have edit access for the Triggering Event

Getting added as a primary contact to a new project through a PSF submission

• List yourself and your email for the Proposal Contact on p. 1 of the PSF. You will be automatically added as the Primary Contact in Huron the information migrates into the Huron COI system.

Updating Primary Contact for entire portfolio

When the Primary Contact for a portfolio of PIs changes, you can email coi@bu.edu with a list of PIs in the portfolio, the name and BU email of the previous Primary Contact, and the name and BU email of the new Primary Contact. Please allow one full business week for processing.

If you do not have any existing grant proposals, and do not plan to submit to any grant proposals to OSP, that match up directly with your IRB submission, then you would create the Triggering Event (what Huron calls projects) for your IRB submission in Huron COI following the steps below:

1. Log into Huron COI Huron COI and navigate to the Triggering Events tab (COI → Triggering Events).
2. Click Create Triggering Event on the left.
3. For the BU primary contact (Question 2), select your grants or department administrator (instead of yourself) so that they can also edit and manage the Triggering Event.
4. Fill out the project details, and for question 3 Event Type, select “IRB Proposal.”
5. Add research personnel and details for the project.
6. For Unfunded or Internally Funded projects, list Boston University as the Sponsor.
7. Add the Aims or Statement of Work. Failure to provide this information will lead to delays in reviewing and clearing any compliance holds on the project.
8. Once you have added all required details and saved, click Manage Certifications (left menu of the Triggering Event page) from the Triggering Event’s workspace. This will send out an email notification to all research personnel listed on the project that they need to provide certification that their Disclosure Profile is up-to-date.

If you plan to submit a grant proposal to OSP related to your IRB protocol, please do not create a new Triggering Event, as this may create duplicates in the system and may lead to unnecessary Compliance Holds. Once OSP submits the proposal the proposal record will be queued up for migration. Although the migration occurs nightly, please allow 1 business week for all back end processes to occur. If you are still unable to locate a Triggering Event related to your IRB submission, email coi@bu.edu.

Per BU’s Investigator Financial Conflicts Of Interest Policy For Research, disclosures must be filed at the time of application or submission of a formal proposal. Disclosure at the time of proposal provides sufficient time should your disclosure require review by the Faculty Review Committee on Research FCOIs. BU’s policy is in alignment with federal requirements:

1. PHS: 42 CFR Part 50 and 45 CFR Part 94;
2. Department of Energy: Department of Energy Interim Conflict of Interest Policy Requirements for Financial Assistance;
3. NASA: Section 3.3 of NASA’s Grant and Cooperative Agreement Manual

All investigators must submit a Research Certification for each Triggering Event that they are listed as personnel on, even if they just submitted a Research Certification for a different Triggering Event or updated their Disclosure Profile. A project may be on hold because:

1. All investigators have submitted their Disclosure Profile Update. One or more reviews are in the COI team’s Under Review queue or require Committee Review. Certifications that are under review will appear with a status of Under Review or Committee Review.
2. One or more investigators have not submitted their Disclosure Profile Update. These certifications will have a status of Awaiting Profile Update.
3. Certifications for Triggering Event have not been managed. This means that investigators have not yet been prompted to submit their Disclosure Profile for this project. Triggering Events for which certifications have not yet been managed will show a blank Read-Only Certifications tab.
4. The Triggering Event has not been completed by the PI or Primary Contact. Before certifications for the Triggering Event can be managed, the Triggering Event must have all required fields filled in. This includes providing the project’s Aims or Statement of Work. Failure to provide this information will lead to delays in reviewing and clearing any compliance holds on the project.

If all Certifications have a status of Review Complete and it seems as if the project should be clear, please email coi@bu.edu with the Triggering Event ID, Triggering Event Name, and Principal Investigator’s Name so the COI Team can look into the hold for you.

Please note there can be a delay of 1-2 days between the COI Team lifts a Compliance Hold and when this is reflected in the system.

• Per BU’s Investigator Financial Conflicts Of Interest Policy For Research, disclosures must be filed at the time of application or submission of a formal proposal.
• If a proposal is ultimately not awarded, please email coi@bu.edu so that the TE can be closed.
• Disclosures will not be required for a closed TE.

No, unless you are research personnel, involved in the design, conduct, or reporting of research activities.

You would receive this email if you are listed as a primary contact or a PI on a Triggering Event. To complete the disclosure and review process, the PI or primary contact will need to log into Huron and perform the following actions:

1. Log into Huron COI Huron COIand navigate to the Triggering Events tab (COI → Triggering Events). Select the Triggering Event in question by searching by Triggering Event Name or Principal Investigator name.
2. Click Edit Triggering Event to review and update the details of the project.
3. Update the list of research personnel associated with the project who are involved in the design, conduct or reporting of research activities.
4. Add the aims or statement of work. This allows the COI team to determine relatedness of reported Significant Financial Interests to the project. This is a required field and the Triggering Event cannot be submitted for review by the COI team without it. Failure to provide this information will lead to delays in reviewing and clearing any compliance holds on the project.
5. Click Save or Finish to save your updates.
6. Manage Certifications (left menu of the Triggering Event page) to send email notifications to personnel to either make updates to their Disclosure Profile or certify that their Disclosure Profile is up-to-date. Certifications for the project will not be generated and the project cannot be reviewed and cleared if certifications are not managed.

Unfortunately, Huron only allows one PI to be listed in the Principal Investigator field. The PI listed here should match the PI on record in OSP’ssystem.

For multi-PI studies where the Co-Investigator designation is not appropriate, please add the investigator to the personnel list and write “Principal Investigator” in the text box for “Additional Roles” (question 3). Investigators will show up in the personnel list as Principal Investigators but will not have the same access to edit and manage the TE as the investigator listed in the PI field.

You will get an email every time a Triggering Event is created that lists you as Primary Contact. As Primary Contact, you are able to:

1. Update project details.
2. Add all research personnel involved in the design, conduct, or reporting of the research.
3. Add the aims or statement of work.
4. Save any updates and finish.
5. Manage Certifications (left menu of the Triggering Event page) to send email notifications to personnel to either make updates to their Disclosure Profile or certify that their Disclosure Profile is up-to-date. Certifications for the project will not be generated and the project cannot be reviewed and cleared if this step is not done.
6. Track submission of certifications by all listed personnel on each Triggering Event.

Unless you are research personnel involved in the design, conduct, or reporting of research activities, you do not need to disclose.

Please see here.

The Disclosure Profile is where you disclose and manage your financial interests (if any). When you are asked to submit a Research Certification, you will either make updates to your Disclosure Profile or certify that your Disclosure Profile is up-to-date. The Disclosure Profile centralizes your financial interests and Triggering Events you have been associated with for easier reviewing by the COI office.

Removing an entity from your Disclosure Profile:

• Log into Huron COI Huron COI and navigate to your Disclosure Profile (COI → Disclosures).
• Click Edit Disclosure Profile.
• On the Entity Disclosure Page, look to the far right side of the entity disclosures table, and click the X next to each entity you want to delete.
  • Note: Clicking the Update button on the left will not allow you to remove the entity — you must select the X on the right of the table.
• Save your Disclosure Profile
• Once you’ve completed all entity disclosures, click Complete Disclosure Profile update to submit it and certify that your disclosures are complete and accurate.

This is likely due to the language and date format settings on your browser. This is a somewhat common issue, where individual users have their browser language settings configured with a language where the standard date format is something other than MM/DD/YYYY.

Change your browser language settings so that it’s set to “English (United States).” The specific steps will depend on the particular browser you are using, but for Chrome, the steps are:

1. Click the upper-right vertical ellipses button
2. Select Settings from the menu
3. Navigate to the Languages section from the list on the left
4. In the “Preferred Languages” section, ensure “English (United States)” is at the top of the list.

After you complete your Disclosure Profile update, you can change your language settings back. We are working on a more comprehensive and permanent solution, but the above steps are the fastest solution right now.

If you changed your browser language settings to English (United States) and are still unable to edit or complete your Disclosure Profile, please email coi@bu.edu with a screenshot of any error(s) you received and on which page(s) the error occurred.

To add entity information, you have to be added to the Research Category in Huron COI, and if you encounter this issue, you are likely not yet included in this category.

• If you are research personnel for an existing project, have your PI or the Primary Contact for the Triggering Event add you as research personnel to the Triggering Event and then Manage Certifications. Once that is done, you will get an email prompting you to disclose and you will be able to add and edit entity information.
• If you need to create a Triggering Event for a project that will not be automatically generated through the processes described on this page (like an IRB protocol) , email coi@bu.edu and ask to be added to the research category so that you can disclose.

You would receive this email if you are listed as a primary contact or a PI on a Triggering Event. To complete the disclosure and review process, the PI or primary contact will need to log into Huron and perform the following actions:

1. Log into Huron COI Huron COIand navigate to the Triggering Events tab (COI → Triggering Events). Select the Triggering Event in question by searching by Triggering Event Name or Principal Investigator name.
2. Click Edit Triggering Event to review and update the details of the project.
3. Update the list of research personnel associated with the project who are involved in the design, conduct or reporting of research activities.
4. Add the aims or statement of work. This allows the COI team to determine relatedness of reported Significant Financial Interests to the project. This is a required field and the Triggering Event cannot be submitted for review by the COI team without it. Failure to provide this information will lead to delays in reviewing and clearing any compliance holds on the project.
5. Click Save or Finish to save your updates.
6. Manage Certifications (left menu of the Triggering Event page) to send email notifications to personnel to either make updates to their Disclosure Profile or certify that their Disclosure Profile is up-to-date. Certifications for the project will not be generated and the project cannot be reviewed and cleared if certifications are not managed.

Unfortunately, Huron only allows one PI to be listed in the Principal Investigator field. The PI listed here should match the PI on record in OSP’s system.

For multi-PI studies where the Co-Investigator designation is not appropriate, please add the investigator to the personnel list and write “Principal Investigator” in the text box for “Additional Roles” (question 3). Investigators will show up in the personnel list as Principal Investigators, but will not have the same access to edit and manage the TE as the investigator listed in the PI field.

You will get an email every time a Triggering Event is created that lists you as Principal Investigator. As Principal Investigator, you are able to:

1. Update project details.
2. Add all research personnel involved in the design, conduct, or reporting of the research.
3. Add the aims or statement of work.
4. Save any updates and finish.
5. Manage Certifications (left menu of the Triggering Event page) to send email notifications to personnel to either make updates to their Disclosure Profile or certify that their Disclosure Profile is up-to-date. Certifications for the project will not be generated and the project cannot be reviewed and cleared if this step is not done.
6. Track submission of certifications by all listed personnel on each Triggering Event.

Navigate to your Disclosure Profile (COI → Disclosures). The orange box on the left side of the page will tell you the status of your profile. A status of “No Action Required” means that you have completed all outstanding requests.

You can also verify that you have provided certification for a particular project:

1. Open up the Triggering Event.
2. Look at the Read-Only Certifications tab.
3. If the Review Status next to your name says:
• No Review Required → You are all set! No further action required.
• Under Review → No further action required. The COI team will review your disclosure and reach out with any questions.
• Clarifications Requested →Respond to the COI team’s questions so that your disclosure can be reviewed.
• Committee Review → No action required at this point. Your disclosure will go to the Faculty Review Committee on Research Conflicts of Interest for review. The COI team will reach out to you once a decision has been made.
• Awaiting Profile Update → You have not submitted a certification for this project. Please make sure you are hitting the “Complete Profile Update” button when submitting. The “Finish” button will not submit your Disclosure Profile.