COVID-19 IRB Amendments: Streamlined Contingency Protocol Form Available for Researchers
The VCU HRPP is aware that the current COVID-19 situation will have a significant impact on human subjects research, with many study protocols requiring amendments to adjust study procedures in light of the risks introduced by the COVID-19 outbreak, and the need for social distancing.
To assist investigators in developing COVID-19 contingency plans, the VCU HRPP has developed a COVID-19 Contingency Protocol form, intended to guide investigators through the process of creating these contingency plans. For existing studies, this form can be completed by investigators and uploaded as a separate document in an amendment submission in RAMS-IRB. This will allow investigators to develop contingency plans for COVID-19 without the need to make granular changes within the RAMS-IRB SmartForm itself, which will streamline the review of these amendments, and allow investigators to easily revert back to approved study procedures upon the conclusion of the situation. If you need to amend your research protocol to address COVID-19 concerns, we strongly encourage the use of this form.
To use the form, follow these instructions:
- Access and download the COVID-19 Contingency Protocol form from either the OVPRI COVID-19 site (under the Human Subjects Research section), or our Forms page (under the Supplemental Submission Forms section).
- Follow the instructions in the form to develop your COVID-19 contingency plan
- Create an amendment to your currently-approved IRB submission in RAMS-IRB, and indicate within the amendment cover sheet that this amendment is in response to COVID-19.
- Upload the completed COVID-19 Contingency Protocol form to the amendment.
- Submit the amendment in RAMS-IRB.
The form is intended to address the areas of a research protocol most likely to be impacted by the COVID-19 situation. If the form is utilized, most amendments will not require modifications within the SmartForm itself. However, we encourage investigators and research teams to contact the IRB Coordinator assigned to their study with questions or concerns, prior to submitting an amendment.
As a reminder, all changes to a research protocol require IRB review and approval, prior to implementation, with the exception of changes made to avoid apparent immediate hazard to a study participant. Changes implemented to avoid apparent immediate hazard to a participant may be implemented without prior IRB approval but must be reported to the IRB using the RAMS-IRB reporting function within 30 days as required by WPP VIII-5 section 2.7.
During this time, the VCU HRPP will be prioritizing amendments related to addressing COVID-19. For investigators submitting new studies or amendments not related to COVID-19, we appreciate your patience as we shift our priorities for the duration of this situation.
We thank the research community for its collaboration in ensuring the health and safety of research participants and personnel during this time. We encourage the research community to continue to monitor the OVPRI COVID-19 page for updates and guidance as the situation develops. We encourage investigators and research staff to subscribe to our listserv to receive updates and guidance. You can subscribe to the VCU HRPP Listserv on our News & Events page.