April 26, 2021 update:

The current stage of the research ramp-up allows for a limited expansion of in-person human subjects research. Please refer to our guidance document to learn about which studies are eligible for review and the process for requesting approval. All work that can be done remotely must continue to be done remotely. Lab research that does not involve in-person interaction with participants, but requires access to on-campus equipment, should follow the standard research ramp-up process as described at the Office of Research COVID-19 webpage.

Any studies or study procedures not eligible for review during this stage of the ramp-up, whether conducted at the UCSB campus or off campus, involving in-person interaction between participants and members of your research team, shall remain paused during this stage of the research ramp up. Otherwise, the only human subjects research allowed at this time is  that which can be done entirely remotely (e.g., by phone or Zoom). 

You are encouraged to modify your study to add remote procedures that would allow you to continue some or all of your work without face-to-face interaction with participants.
 

Eligible for review

Studies in the current stage are limited to the following:

  • Short to moderate duration one-on-one interactions where campus physical distancing and mask wearing requirements can be followed throughout the research activity.
    • Outdoor activities are not subject to time limits.
  • Study participants are otherwise healthy adults who are not exhibiting symptoms of COVID-19 and pass a symptom screening survey.  
  • Research involving children will be reviewed on a case-by-case basis.
  • Studies taking place indoors where the current density limit can be adhered to, which is currently one person per 250 square feet.
  • The HVAC performance for indoor spaces (meeting the campus density limits) should include 100% fresh air supply with at least 6 air changes per hour or with at least MERV 13 rated filtration. If these standards cannot be met, additional mitigation measures will be required.

 

Potential Study Populations: 

A. Studies that only involve participants who are affiliated with UCSB and already have permission to be on campus (faculty, postdocs, graduate students, and staff). On a case-by-case basis, undergraduate students living in campus housing or taking classes on-campus may also serve as participants, so long as they comply with campus testing and symptom screening requirements.

  • No individual should feel compelled to participate in such a study if they are not comfortable doing so.
  • The study activity must comply with any COVID-19 safety requirements/restrictions imposed by UCSB or the building/department.
  • UCSB affiliated participants are required to have a negative COVID test within 72 hours.
     

B. Studies that include members of the public as participants.

  • On-campus studies that take place indoors are limited to activities involving one-on-one interactions. Researcher(s) required to have a negative COVID test within 72 hours.
  • Off-campus studies that take place outdoors
  • Small group studies will be reviewed on a case-by-case basis. 
  • Studies that take place at the Brain Imaging Center (BIC), using the MRI, and following the BIC’s COVID-19 safety protocol 
  • The study activity must comply with any COVID-19 safety requirements/restrictions imposed by UCSB or the building/department.
     

C. Off-site studies involving in-person human subjects research which would be conducted on behalf of UCSB, by individuals carrying out work under UCSB’s direction and under the oversight of the UCSB IRB require review by the Participant Safety Committee. These studies are reviewed on a case-by-case basis if the project plan meets or exceeds UCSB’s COVID-19 safety requirements/restrictions relating to the activity, such as when the work is carried out at another institution of higher education or a governmental facility.
 

Resources

 

This web page pertains to the Office of Human Subjects Research, including the Human Subjects Committee (HSC). UCSB researchers and research administrators should also view the Office of Research COVID-19 information page for additional guidance. See also the UCSB COVID-19 webpage for University updates.

UCSB Research Integrity Offices Remain Fully Operational

Our staff, including the Human Subjects Committee (HSC), is fully operational. Our staff are working remotely and all meetings are being held via Zoom. Staff are happy to arrange Zoom meetings with researchers as needed. All email addresses continue to be monitored with the same or greater frequency, however, responses to inquiries and applications that are not related to COVID-19 or its impact on research may be delayed. We advise against leaving voicemails at our University phone numbers, as the email notification system has not been reliable. This website will remain the best source of information during this time; please plan to check back often.

Highest priority is being given to all inquiries, requests, applications, and modifications related to SARS-CoV-2 or COVID-19.  

For more information, contact us at hsc@research.ucsb.edu.

Specific guidance regarding human subjects research and COVID-19

Studies or research procedures that do not involve any direct interaction with participants may continue, such as:

  • Web surveys (e.g., Mturk)
  • Telephone or
  • Audio-video conferencing (e.g., Zoom, Skype)
  • Data analysis, either secondary use projects or data analysis activities on other projects

In general, no, you do not need to notify our office. If your study requires continuing review, you should document this voluntary pause in your next progress update within ORahs. If you believe that pausing your research would harm your study participants, please contact our office as soon as possible. 

Investigators may be required to notify the study sponsor, and should follow any applicable guidance provided by the Office of Research or the sponsor.

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. 

The IRB is accepting and reviewing new studies.  New studies must include electronic (e.g., Qualtrics) or remote methods of data collection or certify on the One Tab from the Faculty Advisor that any in-person interactions will not occur until the pause on in-person interactions is removed. 

The IRB will prioritize new studies studying the COVID-19 outbreak, provided the study includes electronic or remote communication methods. 

  • Include COVID-19 or SARS-CoV-2 in the Human Subjects Title
  • Please remember that in-person interactions cannot be conducted, unless:
    • You certify on the Correspondence Box on the One Tab that in-person interactions will not occur until the pause on these interactions has been lifted; or
    • In-person interactions are in direct response to the COVID-19 outbreak AND you have received approval through the Vice Chancellor for Research process AND the project has been reviewed and approved by an IRB AND any other required approvals are in place (e.g., Biosafety, agreements with collaborating institutions, etc.)

Please keep in mind travel restrictions implemented by government agencies and the University. International research must also comply with the ongoing shutdown of University research. Prior HSC approval of international research should not be considered as approval to override institutional or CDC/WHO requirements that are currently in place. Researchers must comply with institutional requirements as described on the UCSB and UCSB Office of Research COVID-19 websites.

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