Gillings Research Compliance
Gillings Research Compliance
The Gillings School of Global Public Health is committed to maintaining the highest standards for conducting research. These resources should help answer any questions you may have about research compliance.
If you have additional questions, please email Jaime O’Brien, Research Compliance Coordinator, at objaimee@unc.edu.
Compliance Resources
External Professional Activities for Pay (EPAP)
Pursuant to the Board of Governors’ Policy on External Professional Activities all EHRA Faculty and EHRA Non-Faculty employees must submit External Professional Activities for Pay (EPAP) requests into the online Activities, Interests, and Relationships (AIR) management system.
External Professional Activities for Pay (EPAP) means any activity that:
- is not included within one’s University employment responsibilities;
- is performed for any entity, public or private, other than the University employer;
- is undertaken for compensation; and
- is based upon the professional knowledge, experience and abilities of the EHRA employee.
For Questions involving EPAPs and Gillings Faculty, please contact Jaime O’Brien, Research Compliance Coordinator, at objaimee@unc.edu.
Activities Interests and Relationships Management System (AIR)
Conflicts of Interest and Commitment
Conflicts of Interest
There are three types of Conflicts of Interest
Individual Conflict of Interest, which relates to situations in which financial and other personal considerations may compromise, may involve the potential to compromise, or may have the appearance of compromising a covered individuals objectivity in meeting university duties or responsibilities – such as carrying out research activities.
The research activities impacted by the biases of COI include:
- collection, analysis, and interpretation of data
- sharing of research results
- choice of research protocols
- and the use of statistical methods
Organizational Conflict of Interest occurs when there are activities or relationships with other entities that impair the Institution’s ability to render impartial assistance or advice to the government, cannot perform contract work in an objective way, or creates an unfair competitive advantage comparatively.
The contract reviews for Organizational COI are completed by request of the Office of Sponsored Programs.
Institutional Conflict of Interest exists when there are potential or existing financial interest relationships between the University and an external entity that compromises the integrity of institutional decision making.
The institutional COI committee is appointed directly by the Chancellor.
Examples of Institutional COI in research include:
- University licensed Intellectual Property is being used in a human treatment study.
- The University is manufacturing the drug or device being used in a human study.
- An entity in which the University owns equity or has a financial interest is the sponsor, particularly for a human study.
- The donor sponsoring a gift supporting a study also has an interest in the data results.
Questions about Institutional COI reviews should be directed to coi@unc.edu.
Conflicts of Commitment
A conflict of commitment is the distribution of effort between a UNC Chapel Hill employee’s university duties and their external professional activities.
UNC Chapel Hill COI Office
UNC Chapel Hill recognizes conflicts of interest often arise in the research enterprise, from technology transfer activities, and from the many facets of our employees, students and trainees’ professional activities and personal lives.
The Conflict of Interest Office is responsible for implementing the policies and processes related to these areas, along with partnering offices and committees across the University. The Office seeks to be a resource to all individuals and units across campus as they navigate multiple responsibilities and activities, particularly related to sponsored research or human studies research. The goal is to manage all relationships appropriately, pursuant to the applicable University policy.
Activities, Interests, and Relationships Management System (AIR)
COI Travel Disclosure Decision Tree
SPH Conflict of Interest Committee
Human Subjects Research
The Office of Human Research Ethics (OHRE) and the Institutional Review Boards (IRB) at UNC are responsible for the ethical and regulatory oversight of research involving human subjects. Any research involving human subjects proposed by faculty, staff, or students must be reviewed and approved by an IRB before research may begin, and before related grants may be funded
IRBIS is the System used to submit protocols involving human subjects research, you can find the link for the IRBIS application below.
In order to conduct Human Subjects Research at UNC (or at any institution) it is required that you take an institutionally approved human subjects ethics and regulations training. UNC’s Human Subjects Research Training is offered via CITI, the link to access this training is below.
Science and Security
Gillings recognizes that collaborations are often the cornerstone of success in research and remains strongly committed to that idea by encouraging and supporting collaborative efforts worldwide.
Concerns have been raised by Federal entities that certain international activities have begun to threaten the integrity of the U.S. research enterprise and they are taking steps to ensure more transparency and better security of confidential information and scientific data.
These concerns are commonly referred to as “Science and Security”. Another name you may have heard, used often by the media, is “Foreign Influence”. It is important that all faculty and staff understand these concerns and the impact on the research efforts at the University.
UNC 2019 Foreign Influence Memo
Information about Transparency and Disclosures
Engaging Visiting Collaborators
Export Control
The Export Compliance Office supports the enterprise-wide efforts of UNC faculty, staff, and students in their research endeavors.
Export control regulations are a complex set of laws designed to control the transfer of information, technology, software, other items, and services considered to be important to the U.S. due to concerns regarding national security, economic competitiveness, or support of international treaties and foreign policy.
Information about Domestic Research and International Engagement
Animal Care and Use
In the US, the use of live vertebrate animals in research and educational programs must comply with the Public Health Service (PHS) policy on Humane Care and Use of Laboratory Animals (if the institution receives NIH funding) and the Animal Welfare Act and the regulations of the United States Department of Agriculture (USDA) if the institution works with USDA-regulated species.
The UNC Chapel Hill IACUC Mission Statement holds that The University of North Carolina at Chapel Hill Institutional Animal Care and Use Committee (IACUC) oversees the University’s animal care and use program and is responsible for reviewing all animal care applications using vertebrate animals, ensuring compliance with federal animal welfare regulations, inspecting animal facilities and investigator laboratories, investigating animal concerns, and overseeing training and educational programs.
In order to conduct research with live vertibrate animals, you must first take IACUC approved training from the university, this training is linked below.
ACAP is the online protocol submission form for research involving live vertibrate animals at UNC Chapel Hill. You can access ACAP via the link below:
Data Stewardship
Data Stewardship covers several integral principles within the research enterprise, including HIPAA and Privacy Laws, Research Integrity, Data Governance, and Intellectual Property.
Global Research Compliance Resources
For information on International Travel Requirements and Resources, please visit the Global Health Travel Toolkit.
U.S. export controls laws govern the transfer of controlled information, items, and technologies to foreign countries and foreign persons for national security purposes. Review the Export Control Guide for International Travel for more details.
COI Travel Disclosure Decision Tree
Required Research Training
There are a number of research trainings that are required for Gillings researchers and research engaged staff and students. The following trainings are required based on the type of research being done and the activities involved.
All UNC researchers (faculty, students, and staff) are required to complete a short training exercise on UNC COI Policy.
Take the training here: https://apps.research.unc.edu/coi-training
Research involved with live vertebrate animals:
Research involved with Human Subjects:
For questions about compliance with Research Training requirements please contact Jaime O’Brien, Research Compliance Coordinator, at objaimee@unc.edu.
Compliance News and Updates
Past Trainings and Upcoming Events
February 21, 2023 – Gillings Research iThenticate Training
April 25, 2023 – Gillings International Research Compliance Corner Part I: Export Compliance and International Research
April 27, 2023 – Gillings International Research Compliance Corner Part II: Science and Security Implications for International Research
February 15, 2024 – International Travel and Telework Q&A
