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.

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COVID-19 and Human Subjects Research Prior to June 21, 2021
You can still read through archived information on COVID-19 restrictions to in-person research procedures.

I have not submitted my protocol yet

If you have not yet submitted your protocol to the IRB, simply make sure you are using the most recent version of our informed consent templates (v.10 for non-exempt templates, v.2 for the exempt template). These are the templates that are currently on our website. If you are not planning to utilize our templates, please be sure that you have downloaded the “Approved Language for COVID-19 Disclosures” template and have included all of that language in your informed consent documentation.

I have an Approved Resumption Request

Great! You can continue to use the COVID-19 Supplement Document that was approved as a part of your Resumption Request, if applicable. You are welcome to use the shorter approved language instead; simply follow the instructions provided in the next tabs, titled “Approved [Protis/Kuali] Protocol but No Resumption Request.”

I have an Approved Protis Protocol, but no Resumption Request

If you have an approved protocol in Protis but have not recruited any in-person participants:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.

If you have an approved protocol in Protis and have Already Recruited Participants:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.

I have an Approved Kuali Protocol, but no Resumption Request

If You Have an Approved Protocol in Kuali Protocols:

  1. 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

Q: Can I require my research assistants or colleagues to wear a face covering during interactions with research participants?

A: No, unless the site where you are conducting research has an independent requirement that you wear a face covering (e.g. a federal office, National Park, airport, etc.). Researchers in public higher education settings are prohibited by state law from requiring a face covering.

Q: Can I require my research assistants or colleagues to be fully vaccinated before engaging in interactions with research participants?

A: No, and Utah State University discourages you from asking your colleagues or students about their vaccination status given a recent state law on the topic of vaccines in state settings.

Q: Can I require a research participant to wear a face covering or be fully vaccinated prior to engaging in in-person interactions with them?

A: No, you cannot; the state laws referenced above prohibit you from doing this as an employee of Utah State University.

Q: What if I do not want to use the IRB-approved COVID-19 language?

A: You must request an alteration of informed consent via amendment to your protocol, and that must be approved prior to in-person interactions with research participants. These disclosures and safety requests are considered a required element of informed consent for in-person studies as of June 21, 2021.

Q: What if I cannot accommodate a research participant’s safety request because I cannot require my staff to wear a face covering or I cannot verify their vaccination status?

A: You must notify the research participant. In many cases, it would be wise to consider running/interacting with the participant yourself, if you meet the parameters of the request from the research participant. We are working on a template that you can use, and this site will be updated with that information when it is available.

Q: What happens if I initiate in-person research procedures without the COVID-19 disclosures?

A: This would be grounds for a noncompliance investigation.

Q: If I cannot request or require masks or vaccines from research participants, is it safe for me to resume in-person study procedures?

A: This is a question only you can answer for yourself. The Utah Coronavirus Task Force maintains a dashboard showing vaccination rates in the State of Utah; as of June 17, 2021, Utah ranked 43 out of 51 for the percentage of the population that has been vaccinated.

Q: My Research Standard Operating Procedures (SOPs for Research) require facial coverings. Can’t I enforce that?

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