2,654
edits
Research Conflict of Interest Procedures: Difference between revisions
Research Conflict of Interest Procedures (view source)
Revision as of 14:08, September 21, 2021
, September 21, 2021no edit summary
mNo edit summary |
No edit summary |
||
| Line 57: | Line 57: | ||
# '''Grant Applications and Sponsored Programs Agreements.''' Covered Persons who are principal investigators on grant applications or who submit a sponsored program agreement shall submit a current Disclosure of Potential Conflict of Interest Form to Sponsored Programs Administration as a part of the application process. All other Responsible Persons (individuals who are responsible for the conduct, design, or reporting of the research, whether or not salaries are requested) shall submit a current Disclosure of Potential Conflict of Interest Form to Sponsored Programs Administration at the time the grant is awarded. Sponsored Programs Administration shall report the existence of a COI and the management plan to federal grant administering agencies when required by federal regulation or the terms of the research grant. | # '''Grant Applications and Sponsored Programs Agreements.''' Covered Persons who are principal investigators on grant applications or who submit a sponsored program agreement shall submit a current Disclosure of Potential Conflict of Interest Form to Sponsored Programs Administration as a part of the application process. All other Responsible Persons (individuals who are responsible for the conduct, design, or reporting of the research, whether or not salaries are requested) shall submit a current Disclosure of Potential Conflict of Interest Form to Sponsored Programs Administration at the time the grant is awarded. Sponsored Programs Administration shall report the existence of a COI and the management plan to federal grant administering agencies when required by federal regulation or the terms of the research grant. | ||
# '''IRB Applications.''' Covered Persons listed in Section I of the IRB application shall submit a conflict of interest disclosure form as a part of the application process to the Office of Regulatory Affairs pursuant to UNMC Human Research Protection Program Policy 1.22. | # '''IRB Applications.''' Covered Persons listed in Section I of the IRB application shall submit a conflict of interest disclosure form as a part of the application process to the Office of Regulatory Affairs pursuant to UNMC Human Research Protection Program Policy 1.22. | ||
# '''Changes in Existing COI.''' Any increase that would make the total remuneration greater than $5,000 would elevate the financial interest to a significant financial interest and requires disclosure within 30 days of increase. | # '''Changes in Existing COI.''' Any increase that would make the total remuneration greater than $5,000 would elevate the financial interest to a significant financial interest and requires disclosure within 30 days of increase. | ||
# '''Foreign support and activities supported by foreign entities.''' Pursuant to UNMC Policy No. 8014, [[Disclosing Foreign Support and International Activities]], Covered Persons who participate in activities supported by foreign entities or who otherwise receive foreign support must disclose the nature of the activities and/or support on an Annual Disclosure of Financial Interest Questionnaire and submit it to the COI Officer. | |||
===Institutional Conflict of Interest=== | ===Institutional Conflict of Interest=== | ||
In order to avoid real and perceived favoritism in long-term or repeated dealings with research sponsors, each/every potential Institutional COI shall be reported. Any Covered Person that has knowledge of potential Institutional COI shall complete an [https://unmc.coi-smart.com/ Annual Disclosure of Financial Interest Questionnaire] for review. The COI Officer shall convene a group of senior UNMC officials appointed by the Chancellor to review the disclosure and implement a management plan if appropriate. Sponsored Programs Administration shall report the significant Institutional COI to federal grant administering agencies when required by federal regulation or the terms of the research grant. | In order to avoid real and perceived favoritism in long-term or repeated dealings with research sponsors, each/every potential Institutional COI shall be reported. Any Covered Person that has knowledge of potential Institutional COI shall complete an [https://unmc.coi-smart.com/ Annual Disclosure of Financial Interest Questionnaire] for review. The COI Officer shall convene a group of senior UNMC officials appointed by the Chancellor to review the disclosure and implement a management plan if appropriate. Sponsored Programs Administration shall report the significant Institutional COI to federal grant administering agencies when required by federal regulation or the terms of the research grant. | ||
| Line 66: | Line 67: | ||
== Management of COI == | == Management of COI == | ||
The following is a non-exhaustive list of '''example''' Management Plan strategies provided to serve as guidance to the COI Officer and the COI Committee. | The following is a non-exhaustive list of '''example''' Management Plan strategies provided to serve as guidance to the COI Officer and the COI Committee. | ||
# Take no action beyond disclosure of the COI to UNMC and/or the research sponsor. | # Take no action beyond disclosure of the COI to UNMC and/or the research sponsor. | ||
# Disclose the COI to the academic and professional communities in presentations and publications; the research sponsor through written notification; and research participants through informed consent documents when human subjects are involved. | # Disclose the COI to the academic and professional communities in presentations and publications; the research sponsor through written notification; and research participants through informed consent documents when human subjects are involved. | ||