Updated August 27, 2021:

Participant Safety Review Process

At this time vaccines are widely available within the U.S. and restrictions have eased across many parts of the country. Given that context, we have relaxed our COVID safety review criteria. However, researchers should carefully assess whether participation in their studies puts participants at undue risk of infection, particularly in areas with higher levels of transmission or low vaccination rates. We continue to encourage the use of remote research methods wherever possible.

Some research studies will continue to require review by the Participant Safety Committee (PSC). Other studies do not require PSC review, but must follow the guidelines listed on this page. It is the responsibility of the PI to identify when PSC review is required.

If your study meets any of the criteria listed below and has not already been approved by the PSC, you will need to complete a Participant Safety Plan form and submit it to the PSC for review (hsr-covid@research.ucsb.edu). If your paused or newly proposed study does not meet any of the following criteria, then you may follow the normal IRB approval process. Participant Safety Plans previously approved by the PSC that don’t meet any of the following criteria can discontinue any restrictions previously determined by the PSC. 
 

Research that requires Participant Safety Committee Review

  • Researcher who is working indoors directly with participants but is not vaccinated; or
  • Indoor or outdoor research that involves groups from more than one household and where high-quality* masks can not be worn by participants from these different households and the researcher; or
  • Non-UCSB affiliated collaborators who are directly interacting with participants on behalf of UCSB.


Investigators are welcome to request review by the PSC, even if their study does not meet the criteria listed above. 

* High-quality masks include: N95, KN95 or a 3-ply blue surgical mask covered by a 3-ply cloth mask that fits well enough to inhibit leakage around the edges.


Process

PIs who need to submit their studies to the Participant Safety Committee for review should follow the process listed below. For more information on the process, please refer to our detailed submission process guide.

  1. Review the criteria and guidelines on this page to determine whether your study requires review by the Participant Safety Committee. It is the responsibility of the PI to identify when PSC review is required.
  2. Save and complete a Word version of the Participant Safety Plan form.
  3. Submit the completed form to the Participant Safety Committee by emailing: hsr-covid@research.ucsb.edu
  4. Work with the Participant Safety Committee to ensure risks are appropriately mitigated.
  5. Once PSC approval is granted, make sure that IRB approval is in place. If substantial changes are made to the study procedures, a modification to a previously approved IRB protocol may be required.

 

Guidelines

Vaccination verification (Summer 2021)

  • Vaccinated researchers wishing to be exempted from PSC review must self-attest to their vaccination status.
  • Self-attestation of COVID-19 vaccination status will be acceptable for the interim summer period.
  • Self-attestation of vaccination and clearance to work as a vaccinated faculty, staff or graduate student will be completed through the daily symptom survey. Undergraduate students should follow the instructions on the Student Health website.
  • If your research takes place off campus, you only need to self-attest once via the daily symptom screen.
  • Principal investigators for protocols should ask any research team member who is interacting with participants to demonstrate they have met the “cleared to work indoors without a mask requirement” by asking to see the individual’s green “cleared to work” badge. They should not ask about that member’s vaccination status.
  • Researchers should not ask participants about their vaccination status unless it is included in the IRB approved research protocol.
     

Symptom screening

  • All faculty, staff, researchers, and students returning to work on campus will need to enroll in and complete the daily symptom survey to obtain a “cleared to work” digital badge. Enrollment information can be found at the Return to Campus Requirements webpage.
  • If a researcher is working off-campus they must conduct daily symptom checks, but are not required to use the campus screening system. An approved list of questions is available in this COVID-19 Symptom Screening Checklist.
  • All participants must be screened for COVID-19 symptoms using the campus screening questions.
    • UCSB-affiliated participants must complete the daily COVID-19 Symptom Screening survey through Student Health. Students, faculty and staff receive daily email reminders about symptom screening. 
    • Participants not affiliated with UCSB, and participating in a research study on campus, should be asked to complete the On-demand COVID-19 screening form. In order to complete the form, researchers will need to provide participants with a primary contact (name and email) and the names of any buildings that will be accessed. Researchers will not receive detailed responses provided by the participants. 
       

Masks

  • Effective August 3, 2021 – All faculty, staff, students, and visitors to campus, whether vaccinated or not, must wear masks in shared indoor spaces. All indoor campus spaces where in-person human subjects research is conducted are subject to the masking requirement.
  • Any employee who chooses to do so may continue to wear face coverings in any setting.
  • Unvaccinated individuals are required to wear face coverings in all indoor campus spaces and in vehicles used during the course and scope of employment.
  • Unvaccinated researchers should wear a mask outdoors if 6 feet of separation can’t be maintained with other people.
  • Researchers must comply with masking requirements at facilities or locations that require the use of masks (shared indoor spaces on campus, medical facilities, public transportation, international settings, etc.)
  • Participants should be advised to follow CDPH masking guidelines, unless the research site has more stringent requirements.
     

Testing

  • Unvaccinated students are required to undergo weekly COVID-19 testing to gain access to the campus buildings.
  • If participants are UCSB undergraduate students, the research team should verify that the student(s) are cleared to be on campus.
     

Distancing

  • Unvaccinated researchers who work within six feet of others must wear a mask, unless required to wear a mask at all times regardless of distance.
  • Vaccinated researchers do not need to maintain a specific distance, whether indoors or outdoors.
     

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. Contact via email is preferable to voicemail. This website will remain the best source of information during this time; please plan to check back often.

For more information, contact us at hsc@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. 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