Conflicts of Interest in Human Subject Research
All individuals listed as key personnel on a research study must complete the Human Subject Research questionnaire (conflict of interest disclosure) in COI-Smart. The RSPP office will not review any research submission until all key personnel have completed their disclosure in COI-Smart.
- If you are an Aurora Caregiver you should already have the ability to access COI-Smart. You must add the Human Subject Research role to your profile. Reminder, if your research is federally funded you must also add the PHS funded role to your profile. See instructions.
- If you are NOT an Aurora Caregiver please contact the RSPP office at (414) 219-7744 for assistance.
Please note that any new or changed significant financial Interest must be reported via COI-Smart within 30 days.
Aurora Health Care has established processes to ensure that significant financial and other interests held by those involved in the design, conduct or reporting of research, or held by those involved in the review and approval of research, do not create unmanaged conflicts with their primary obligation to design, conduct, review and/or report scientifically sound and ethical research. Aurora Health Care's Conflicts of Interest in Research-Individual policy includes the following key components:
- A prohibition on situations felt to create deep-seated conflicts.
- Educational requirements, including education about the policy and regulatory requirements initially and every four years, education when the policy changes and education when non-compliance occurs.
- An annual requirement to disclosure significant interests, along with a requirement to update disclosures within 30 days of discovering or acquiring a new significant interest.
- A requirement and process for determining whether significant interests are related to ongoing or proposed research activities and for reviewing any related interests to determine if they create a conflict of interest.
- For any interest determined to create a conflict, a requirement and process for creating a management plan and managing conflicts to an extent that the significant interest no longer directly and significantly affects the design, conduct or reporting of the research.
- A requirement and process to monitor management plans.
- A requirement to report conflicts of interest to Federal funding agencies that support the research involving the conflict.
- A process for reviewing and reporting significant interests related to Public Health Service funded research that are not disclosed, reviewed or managed in a timely manner.
- A requirement that Aurora's policy be posted on a publicly accessible website and specific information concerning a conflict of interest related to Public Health Service funded research be made available to anyone who requests such information.
- A requirement that any sub-recipient of Aurora's Federal funding comply with Aurora's policy, or their policy if it meets Federal regulatory requirements.
- Sanctions for non-compliance with the policy or a management plan.