- Please refer to the UWM COVID-19 website for current UWM information.
Restrictions on in-person human subjects research have been lifted, and Safety Plans are no longer required.
- If a researcher becomes ill, they should follow current campus policy regarding contact tracing and quarantine requirements.
- Consideration should be made for additional precautions (such as masking or conducting research remotely) when working with populations who are at an increased risk of complications or hospitalization due to COVID-19.
- Disinfect space, equipment, and surfaces before and after visits.
- Feel free to modify and use this “Caring for you during your research visit” info sheet for participants (does not require IRB review/approval). Many thanks to the Center for Cognitive Medicine at Vanderbilt University Medical Center and the University of Arizona for this document.
Remote Consent Options
There are several options for obtaining consent remotely:
- Request a waiver of documentation of consent. You still provide the consent information to participants (mail, email, online, verbal, etc.) but are not required to collect a signature. The fact that they complete the study procedures can be taken as indication of their consent.
- This waiver can be granted if your study is minimal risk and doesn’t have any procedures where written consent would be required outside the research context.
- This option cannot be used if your research involves accessing FERPA- or HIPAA-protected records. A written signature is required under those regulations.
- Have participants sign and return a consent form to you, either electronically (print/sign/scan) or hard copy via mail.
- Consider whether all your participants have the ability to print and scan materials before choosing this as the sole option.
- Have participants sign an electronic consent form in Qualtrics, using the Signature question type.
- Insert your consent information as a static text question, then insert additional questions for participants to type their name and to electronically sign on their device.
- Remind participants to print or save the screen if they wish to keep a copy of the consent for their records.
- DO NOT collect any study data in this survey. If you are collecting data via Qualtrics, you may include a link to a separate survey on the second page after they sign.
- Consider whether all your participants have access to a device and internet before choosing this as the sole option.
Do I need to list the risk of COVID-19 in my consent document for in-person research?
The IRB discussed this question and concluded that the risk of contracting COVID-19 is part of daily life and is so widespread that it doesn’t need to be specifically mentioned in consent forms. While the IRB did acknowledge that asking participants to meet in person does potentially increase this risk, they felt that including it in every consent form is unnecessary.
If we’re asked to give a participant’s name for contact tracing purposes, is that a breach of confidentiality?
In the vast majority of cases, no. Identifying who you’ve been in contact with doesn’t necessarily identify what study they were involved in, and in any case does not link their identity to the research data. Few of our studies involve such a sensitive topic that harm can arise simply by someone knowing they participated in the study. We encourage researchers to cooperate fully with university and public health officials in contact tracing efforts.
If you do have a study where the topic is so sensitive that even identifying who you met with would potentially cause harm, it would be best to explore alternate methods of data collection (e.g. virtual) or postpone conducting the research altogether.