Revised July 17, 2014

I. GENERAL COI FAQS FOR ALL INDIVIDUALS
II. COI FAQS FOR RESEARCHERS
III. FAQS ON COI TRAINING
IV. FAQS FOR COI TRAVEL and PAID AUTHORSHIP DISCLOSURES

I. GENERAL COI FAQS FOR ALL INDIVIDUALS:

Access to the current UNC-CH Policy for Individual Conflict of Interest and Commitment is available at the web site: http://policies.unc.edu/policy-category/university/

Q: What is a conflict of interest (COI)?

A: Conflict of interest relates to situations in which financial or other personal considerations may compromise, may involve the potential for compromising, or may have the appearance of compromising an employee’s objectivity in meeting University duties or responsibilities, including research activities. – UNC General Administration Policy Manual.

Q: Where does the UNC-CH COI policy come from?

A: The UNC-CH COI policy is a Chancellor approved policy specific to the Chapel Hill Campus. It is based on a combination of federal regulations (Code of Federal Regulations, 42 CFR Part 50 and 45 CFR Part 94), UNC General Administration Policy (http://www.northcarolina.edu/policy/index.php?pg=vs&id=283) and applicable North Carolina State statutes.

Q: Who is covered by UNC-CH COI policy?

A: Faculty, staff, students, trainees. That means everybody (including temporary and part-time employees). In some cases, non-UNC persons participating in research at this campus will have to fall under UNC-CH COI Policy. Please see II. COI FAQS FOR RESEARCHERS below.

Q: Where can I go to access or begin my personal COI Disclosures?

A: UNC persons with an ONYEN/ password can log into air.unc.edu. The AIR (Activities, Interest and Relationships) system serves as a portal to manage all disclosure and request forms related to Conflicts of Interest and Commitment. You may access any COI disclosure form, COI training or EPAP request form through this website.

Q: The AIR system is down and I keep getting error messages. What do I do?

A: If you or any personnel experience technical issues within the AIR system, you can call the Office of Research Information Systems (ORIS) Helpdesk at 919-843-2594. Example: 404 Error Message Servers Not Found.

Q: I don’t know how to answer the questions on the COI disclosure forms. Where can I get help?

A: If you or any personnel do not know how to answer a question then please email coi@unc.edu or call 919-843-9953.

Q: I made mistakes on my COI disclosure. How do I re-open it and make corrections?

A: Send an email to coi@unc.edu, explain the mistake and ask the Conflict of Interest to re-open the disclosure.

Q: What happens if the University determines that I have a conflict of interest?

A: The Conflict of Interest Program seeks to be a resource to all individuals across campus. Conflicts of interest can exist even if no improper acts have occurred. Having a conflict of interest does not necessarily mean you are guilty of anything. The COI Program and appropriate University offices and committees at UNC-CH will give guidance as to how to manage personal and financial interests and relationships appropriately, pursuant to University Policy.

Q: What is the procedure for handling Conflicts of Interests?

A: When an individual responds affirmatively to certain fields on a COI disclosure form, additional questions will appear on the screen. On the expanded form, the individual is asked to explain or provide more details in regards to the “Yes” answer. The explanation is reviewed by the COI team (the staff, the COI Chairs and the Committees), which determines if there is a conflict, if it is permissible and how best to manage it. The individual may be involved in a meeting to help a Committee better understand the situation, depending on the circumstances.

Q: Are my COI disclosures confidential?

A: The information that you provide on a COI disclosure is considered part of your personnel file and not subject to public record request. Information will be shared internally as necessary and pursuant to a COI review, e.g. such as the IRB or members of Conflict of Interest Committees. For certain PHS funded studies, other guidelines may also apply. Please see V. Research H.6(b) and VI. RECORDS CONFIDENTIALITY AND RETENTION of the Policy.

Q: What will happen if I don’t disclose my personal or financial interests related to my institutional responsibilities for the University?

A: The consequences of failing to disclose one’s interests, as they relate to one’s University duties, can vary depending on the circumstances. Please see section VIII. POLICY BREACHES of the University’s Policy on Individual Conflicts of Interest and Commitment.

II. COI FAQS FOR RESEARCHERS:

The University of North Carolina at Chapel Hill recognizes that conflicts of interest will arise  from the research enterprise, from technology transfer activities, and from the many facets of our  investigators’ professional activities. We seek to identify and manage these conflicting  relationships to preserve transparency, protect research subjects, ensure the integrity of the  educational experience, and maintain the credibility of investigators. Conflict of Interest  administration resides within the Research Compliance Program as part of the Office of University Counsel.

Q: Who is an “Investigator”?

A:Investigator” means the principal investigator, project director, key personnel and any other  person, regardless of title or position, who is responsible for the design, conduct or reporting of a Project. Please see section II. DEFINITIONS OF SELECTED TERMS of the University’s Policy on Individual Conflicts of Interest and Commitment.

Q: What triggers a COI disclosure to generate for an “Investigator” on a RAMSeS proposal/ award or an IRB submission?

A: COI Disclosures are project/ study specific which are created when an application is certified by the Department in RAMSeS or the PI in IRBIS.

Q: How do I know if I am entering the right person onto my study when selecting from the Persons List?

A:

  1. Review the person’s information that auto-populates in demographic fields when you select an individual’s name.
  2. If the information you know to be true does not match the John Smith’s information that auto-populated, then you may have selected the wrong John Smith. Deleting incorrect information and typing in correct information will NOT work, since the system automatically links the profile which appears to a PID behind the scenes.
  3. You must delete the incorrect entry entirely, go back to the list and select the correct name from the Persons list. Alternatively, you can manually enter a person’s information if they are a non-UNC person. See next question.

Q: How do I enter a non-UNC person onto my RAMSeS/ IRBIS application?

A: Scroll to the bottom of the Persons List and select “Person Not listed”. Manually type in all of the person’s information. A non-UNC person will always have to access their COI disclosure via an email notification link. ***Make sure the email entered for a non-UNC person in the IRB/ RAMSeS application matches the email that the non-UNC person used to complete UNC-CH training.***

Q: Someone who no longer works on this study or project keeps getting reminders to complete a COI disclosure. How can I make the reminders stop?

A: If the person is no longer working on the research study or project, then he or she should be deleted as personnel in the related campus research system. For IRB studies, please contact the IRB. For RAMSeS proposals or awards, please speak with your Office of Sponsored Research (OSR) contact.

Q: How can I check to see who on the research team has not completed the COI requirement for an IRB study?

A: For study coordinators or PIs:

  1. Log into IRBIS > Go to My Studies > Select the IRB study > click on the reference ID for the most recent renewal or initial IRB submission/application for that study
    >Select Personnel Tab > Scroll down to “Conflict of Interest Entered for this Submission”. NOTE: COI generally does not generate for modifications except for a change in PI.
  2. A Red X means that the disclosure has not been completed. A green check means the form has been completed and received into the online system.
  3. A red PENDING under COI Review status means that a potential conflict is being reviewed by the COI team for that individual.

Q: When do reminder email notifications to complete a study specific disclosure go out for “Investigators” listed on IRBIS/ RAMSeS applications?

A:

IRBIS:

Monday Tuesday Wednesday Thursday Friday
UNC persons UNC persons
UNCH/ Non-UNC persons UNCH/ Non-UNC persons UNCH/ Non-UNC persons

RAMSeS: COI reminder email notifications are manually sent by the OSR program staff as needed.

Q: What is the COI Process?

A: Process Outline:

  • Individuals receive email notification at time of certification for OSR proposal (IPF) or IRB application (IRBIS).
  • Individual answers the questions on disclosure form in order for disclosure to be received into the online AIR system.
  • Once disclosure is received into online AIR system, the form is reviewed by the COI staff within the Conflict of Interest Program.
  • Every disclosure starts with an Administrative Review. Depending on the nature of the potential/ appearance of a conflict, the disclosure may go through additional reviews, starting with the Chair of the applicable COI Committee. Each disclosure is reviewed on a case by case basis.

Q: Will checking “yes” on a conflict of interest disclosure form put me at risk of losing my funding?

A: No, sometimes it is determined that no conflict exists and other times the conflicts can be managed through a combination of oversight and disclosure.

III. FAQS ON COI TRAINING:

Q: Where can I access the COI training?

A: Go to https://apps.research.unc.edu/coi-training/ or type “coitraining.unc.edu” into your web address bar.

Q: I am working on my dissertation and I am not receiving funding from anyone. I am using a secondary dataset (no live subjects). Do I need to complete COI training?

A: Yes. In February 2012, the Chancellor determined that COI training should be completed by all individuals who are involved in research.

Q: I completed conflict of interest (COI) training at another institution. Do I need to take UNC’s training also?

A: Yes. Although each institution can be consistent with the federal regulations, COI policies can vary widely between institutions. The federal regulations require that if an individual moves between institutions, the individual must complete COI training at the new university before funding can begin.

Q: Is there a separate COI training that UNC Hospital employees need to take?

A: No. UNC Healthcare employees involved in research at the University should take the University’s COI Training since it is research specific.

Q: How can I get confirmation that I have completed the UNC-CH COI Training?

A: After successfully completing the online UNC-CH COI training, you will receive a confirmation email to the email address associated with your ONYEN (for UNC individuals) or the identifying email address entered for Non-UNC individuals.

UNC individuals can also log in to coitraining.unc.edu at any time. The home page will show your training record, including the date on which training was completed. Individuals can take a screen shot of this page to be inserted into an email.

IV. FAQS FOR COI TRAVEL and PAID AUTHORSHIP DISCLOSURES:

A COI Travel Disclosure Decision Tree is available at: http://www.unc.edu/depts/legal/rcp/traveldisclosuretree.pdf

Q: Where can I go to start a COI Travel or Paid Authorship Disclosure?

A: UNC persons with an ONYEN/ password can log into air.unc.edu. This system serves as a portal to manage all disclosure and request forms related to Conflicts of Interest and Commitment. You may access any COI disclosure form, COI training or EPAP request form through this website.

Q: If my travel related to my institutional responsibilities is sponsored or reimbursed by universities outside of the US, a government of another country, or a non-governmental organization (NGO), do I still need to disclose it to the University?

A: Yes. All exclusions listed in the federal regulations only apply to United States (U.S.) Institution of higher education or a federal, state or local government agency within the U.S.

Q: When do I have to submit my COI Travel disclosures for reimbursed or sponsored travel related to my institutional responsibilities?

A: COI Travel disclosures can be submitted before the travel occurs. An individual can disclosure up to 30 days after the travel.

Q: I am traveling to World Health Organization (WHO) in Switzerland this year and they are reimbursing me for travel. I am not doing any research with WHO and I have no contract or grants with them. Is this travel something I need to report? If so – how do I report it?

A: You should disclose this travel to the University because if it is travel related to your institutional responsibilities. You can disclose this travel through a new COI Travel disclosure form.

Q: I am paid to edit a text book for Organization X, which is CME supported. I don’t conduct any research with them so is this something I need to report? If so – how do I report it?

A: Yes. You should disclose this instance paid authorship to the University because it is paid authorship related to your institutional responsibilities. You can disclose paid authorship through a new COI Paid Authorship disclosure form.