Current as of May 26, 2022:

Guidelines for in-person research with human participants

At this time, local case numbers are significantly increasing in Santa Barbara County. As a result, the campus has modified its COVID-19 safety protocols. Individuals conducting research with human participants on campus should follow the updated protocols described in the May 26, 2022 campus memo.

All researchers conducting research with in-person human participants are expected to follow UCSB’s COVID-19 guidelines and any COVID-19 guidelines of off-campus facilities where their research takes place.

If an off-campus location has more stringent safety procedures in place, then those must be followed while conducting research at that location. Researchers should continue to assess whether participation in their studies puts participants at undue risk of infection, particularly in areas with higher levels of transmission or lower vaccination rates.

 

Guidelines

Vaccination status

The UC Vaccination Policy must be followed for research activities.

  • Researchers must follow the campus requirements for providing evidence of their vaccination status or obtaining an exemption.
  • Participants invited to campus should be informed that you will ask them to complete the On-Demand Daily COVID-19 Screening Survey or the COVID-19 Screening for Minor Children prior to their arrival on campus, and every day thereafter while they are on campus. The survey will ask them to self-attest their vaccination and/or negative COVID-19 status. This will fulfill the requirement that campus visitors using UCSB facilities attest that their COVID-19 vaccines are up to date, or show proof of a recent negative COVID-19 test.

 

Symptom screening & testing

  • As of May 16, 2022, daily symptom screening is no longer required for researchers. Individuals should continue to evaluate their own symptoms daily before coming to campus, and should follow the campus process if they have symptoms consistent with COVID-19.
  • Participants unaffiliated with UCSB and coming to a campus facility must complete the On-Demand Daily COVID-19 Screening Survey or the COVID-19 Screening for Minor Children prior to their arrival on campus, and every day thereafter while they are on campus.
  • Based on the participant’s responses, a COVID-19 test may be required. Researchers are permitted to ask to see the negative test result, or may rely on self-attestation. Researchers should not store participant testing results, unless this is part of your study design and approved by the IRB.
  • Participants will receive a PDF of their clearance certificate by email, and researchers are allowed to ask to see the certificate. 

 

Masks

As of May 27, 2022, masking requirements have changed and the indoor and outdoor requirements are described below. Any researcher or participant may wear face coverings in any setting, even if not required. Researchers conducting studies away from campus are expected to comply with any requirements at their study location.

Indoors

  • Masks are required in classrooms and other indoor campus shared spaces from May 27, 2022 through June 12, 2022. All indoor spaces on campus, even research spaces, are subject to this requirement, with the exception of individual residences in campus housing, dining halls while eating, or individual offices with one person with the door closed.
  • Research study procedures that require the removal of a mask are permitted, so long as masks are worn by study participants when they are not actively participating in that procedure.
  • More information may be found on the COVID-19 Campus Updates webpage.

Outdoors

  • Masking outdoors is optional.
  • Masking is strongly recommended for individuals who are not fully vaccinated and will be in situations where they will be in sustained close contact with others.

 

This web page pertains to the Office of Human Subjects Research, including the Human Subjects Committee (HSC). UCSB researchers and research administrators should also refer to the UCSB COVID-19 webpage for general University updates and the COVID-19 Interim Visitors Protocol.

For more information, contact us at hsr-covid@research.ucsb.edu.

Specific guidance regarding human subjects research and COVID-19

Modify your project to include an electronic or remote method of communication (see detailed instructions below). 

In the modification, please consider and address the following, where applicable:

  • Potential impact on subject safety and protections
  • Potential privacy and confidentiality concerns
  • Data security requirements for projects that collect sensitive and/or identifiable data
  • Explain how recordings are to be made remotely. Please note that Zoom is NOT HIPAA compliant  
  • Implications of these changes on the benefits of the study and the value of previously collected data
  • Describe how existing subjects will be notified (if their participation will be affected by the modification)

Components of previously approved studies that do not involve face-to-face interactions may continue during the pause.

Yes, changes to the project must be reviewed by the IRB prior to implementation. Currently the IRB is prioritizing review of study-related changes in response to the COVID outbreak.  If you need to change data collection procedures in response to the pandemic, please place in CAPS “COVID” on the One Tab of the protocol application. 

Include in your submission that the study will return to previously approved procedures, once in-person research is allowed again.  (Doing so will eliminate the need to submit another modification later when/if the PI wishes to resume normal study activities.)

Non-exempt protocols - please review the following sections and update the ORahs Tabs with the relevant information where applicable:

  • Subjects Tab - if you will be including an updated recruitment method, for example recruiting subjects online (e.g., Mturk or other participant panel), sending out an email to a listserv, calling potential participants, etc., include an updated description of the subject population and recruitment method. Describe how you will be receiving contact information from potential participants if contact information is not publicly available. Attach any new recruitment materials (e.g., online advertisements, phone scripts) to the Attachments Tab. 
  • Location Tab - add that the study will be done online, over the phone, via Zoom, Skype, etc. 
  • Procedures Tab - include a description of the remote data collection methods and any updated or new compensation. 
  • Risks Tab - evaluate and include any new confidentiality, privacy and/or data risks associated with remote or electronic data collection. For example, if you are calling individuals for a phone interview, how are you getting their phone number and where is their contact information stored? Will the phone numbers be deleted at the end of the study? 
  • Consent Tab - request a Waiver of Documentation for not collecting signed consent forms for portions of the research being conducted remotely or electronically. Review the consent process description and update as needed.
  • Consent Forms - create a new form or update an existing consent form with the new data collection method and new privacy and/or confidentiality risks. 
  • Risk-Benefit Analysis Tab - update any new benefits or risks to subjects with the revised data collection methods.
  • Attachments Tab - include any new recruitment materials, phone scripts, screening procedures, and new or updated surveys, questionnaires, instruments, etc. 

 

Exempt protocols - please review the following sections and update the sections within the exempt application with the relevant information where applicable:

  • Procedures Section - include a description of the remote data collection methods.
  • Consent Process Section - provide an updated description of how consent will be obtained for remote or electronic data collection. For example, oral consent may be an option for a phone interview or having a participant click “I agree” to the consent on their computer screen for electronic data collection.
  • Research Sites Section - include an update for conducting the study remotely (e.g., online).
  • Subject Population Section - update the recruitment methods and strategies for contacting potential participants. Describe how you will be receiving contact information from potential participants if contact information is not publicly available. Attach any new recruitment materials (e.g., online advertisements, phone scripts) to the Attachments Tab. 

 

Note: For studies that qualify as “exempt-limited” review and/or if the remote data collection procedures add a privacy and/or confidentiality risk to the subjects, the IRB may require additional information for ensuring privacy of the subjects and confidentiality of the data. 

Unless previously waived by the IRB for non-exempt IRB-approved studies, a complete informed consent process must still be given to all participants. 

However documenting signed consent may be waived by the IRB for remote or electronic methods of data collection, provided certain regulatory criteria are met. Examples of acceptable methods for obtaining consent include:

  • Emailing consent documents to participants
  • Obtaining verbal consent from participants
  • Faxing consent documents to participants
  • Having participants click “I agree” to the consent page before proceeding to the online studies

If you intend to switch to a remote or electronic method of data collection, you must submit a modification to update your consent procedures. 

Please keep in mind travel restrictions may be imposed by both government agencies and the University. International research must also comply with any relevant travel restrictions. HSC approval of international research should not be considered as approval to override institutional or CDC/WHO requirements that are currently in place. 

If you are conducting an interview remotely via Zoom (or other similar platform) create a private meeting with a unique meeting ID. Consider creating a meeting password to access the interview. If multiple participants are involved, use certain functionality, such as enabling/disabling screen sharing or joining before host, muting participants upon entry, enabling a waiting room, etc. If protecting anonymity is a concern, conduct the interview with audio only, not with video.

Do not use Zoom or other similar services (e.g., WebEx, GoToMeeting) to collect sensitive data (for example questions on illegal or illicit activities) as these platforms may have access to any audio and/or video recorded under the company’s terms and conditions.  Participants must be made aware that Zoom may have access to audio and video created from any interviews. Consider open-source tools such as Signal for collecting sensitive data. 

If you will be recording the meeting, all participants must be aware of and consent to being audio and/or video recorded. Do not record the meeting to the Cloud, but record it to your computer and immediately transfer the recording to a secure storage platform such as your Google Drive or UCSB BOX account.  UC Santa Barbara IT provides guidance on securely storing information within Google Drive.  

For more information on using Zoom, visit the UC Santa Barbara Information Technology guidance on increasing Zoom security