Resuming In-Person Research Procedures
The IRB’s primary responsibility is the protection of the rights and welfare of human participants. In line with the principle of Respect for Persons in the Belmont Report, the IRB has lifted most restrictions on in-person research, and is instead requiring that all in-person work with research participants be preceded by a supplement to the informed consent process that shares the risks associated with COVID-19, and permits research participants to request certain safety precautions by the research team. Information on how to incorporate this new information is contained below; please click on the right-hand tab that best represents the project(s) you are interested in resuming.
COVID-19 Resources
- Go to Protis (recalling that you need to be on campus or using the VPN!). Download the “Approved” (Word) version of your informed consent document (IC or LOI) from the Informed Consent section (for General Applications) or from the Procedures section (for Exempt Applications), and insert the IRB-approved COVID-19 language. We recommend that you add the “COVID-19 Disclosures” between “Benefits” and “Confidentiality” and that you add the “COVID-19 Safety Requests” after the signature block.
- Follow these Protis instructions to amend your protocol in Protis. Amend the upload field where your IRB-approved Informed Consent documentation is provided. If the field is open (red), you may upload that documentation directly to the field; if it is not, you must upload it in the upload box that is provided. Please note that Protis can be quite slow to generate the Amendment Upload box.
- Do not forget to go to the “Submit Amendment” tab to submit your amendment once your informed consent documents are uploaded to the correct field.
- Once you receive a notification that the IRB has approved your amendment, you can locate your approved informed consent documentation in your protocol in Protis, where you retrieved your approved informed consent documentation at Step 1.
- You must effectuate that informed consent process with your participants prior to engaging in in-person research procedures (with the exception of your informed consent process, if that is listed as taking place in person in your approved protocol). If you cannot fulfill any of the safety requests, you must inform the research participants that you are unable to do so and give them an opportunity to withdraw.
- Go to Protis (recalling that you need to be on campus or using the VPN!). Follow these Protis instructions to begin an amendment to your protocol in Protis.
- Download the Supplement of COVID-19 Disclosures. Fill in the red text, and save that document. Amend the upload field where your IRB-approved Informed Consent documentation is provided. If the field is open (red), you may upload that document that you have just finalized directly to the field; if it is not, you must upload it in the upload box that is provided. Please note that Protis can be quite slow to generate the Amendment Upload box.
- Do not forget to go to the “Submit Amendment” tab to submit your amendment once your informed consent document(s) are uploaded to the correct field.
- Once you receive a notification that the IRB has approved your amendment, you can locate your approved informed consent documentation in your protocol in Protis, where you retrieved your approved informed consent documentation at Step 1.
- You must effectuate that document with your participants prior to engaging in in-person research procedures (with the exception of your informed consent process, if that is listed as taking place in person in your approved protocol). If you cannot fulfill any of the safety requests, you must inform the research participants that you are unable to do so and give them an opportunity to withdraw.
If you have an Approved Kuali Protocol, but no Resumption Request:
- Go to Kuali (Protocols). Open the protocol for which you wish to resume in-person research interactions. Click the “Amend” button on the right side of your protocol. Answer the questions that appear, and they will direct you to the appropriate steps.
FAQs
A: As of June 21, 2021 SOPs for Research are not required. The Office of Research encourages you to revisit them and engage with them as appropriate, but listing face coverings in your SOPs for Research does not permit you to enforce them in your research environment unless your research is at a site that has its own face coverings mandate.
Last updated June 20, 2021