Research Continuity

Please click this link to find CGU’s COVID-19 Policy for Research Involving Human Subjects

Recognizing the special circumstances resulting from the COVID-19 outbreak, the CGU IRB would like to provide some additional guidance. If you are continuing with your study during the outbreak, we urge you to pause and give consideration as to how these special circumstances impact the risk to human subjects in your study. The information here is intended to provide guidance for such considerations and for human subjects protections decisions specific to our current conditions.

At this time, in accordance with guidance from the CDC, NIH, and CA Department of Public Health, human subject research involving direct interaction with study participants should be suspended to minimize risk of contracting or spreading COVID-19. Exceptions would be (1) studies in which interruption could create greater risks to human subjects, and (2) some studies with therapeutic benefits. You may also be able to avoid suspending your study by adapting procedures to replace in person interaction with online or phone interaction. If you are putting your research on hold during this period, you do not need to notify the IRB unless you think such an interruption might introduce risk to human subjects.

For all major study modifications or modifications that increase risk or introduce new risks, investigators must submit an amendment to the IRB. Changes may not be enacted until the amendment is approved, with rare exceptions for changes that must be enacted immediately to avoid harm to subjects. We have made modifications to the Amendments tab on protocol pages to streamline the process and allow us to prioritize amendments related to COVID-19 response.

We will continue to update the CGU IRB web page (cgu.edu/irb) as needed in light of changing circumstances. Please note, however, that stricter directives (e.g., lockdowns, campus closures, etc.) from CGU leadership, federal and state government, and/or local municipalities governing your research sites would supersede the guidance provided here.

• If you plan on pausing/suspending the research until after the crisis is resolved and CGU returns to normal operations, no changes are needed. Otherwise…
• Does the study involve direct, in person interaction with research subjects (i.e., physical presence in lab; in person interviews, observations, or surveys)?
  • No—Your study probably does not require any changes.
  • Yes, but interrupting or adapting my study would create or increase risks to subjects—You should contact the IRB as soon as possible so that we can work together to consider what changes, if any, can/should be made to continue the study while minimizing new risks introduced by COVID-19. Examples of types of studies this might pertain to:
    • Suspending a study involving an intervention to treat depression or suicidal tendencies could result in greater risk to subjects than the risk of contracting COVID-19.
    • Likewise, risks might be increased by interrupting studies designed to help subjects use new procedures, devices, or apps to manage health conditions.
  • Yes—Your study requires changes to avoid the new risks introduced by COVID-19.

Any substantial changes to a student’s dissertation topic after advancing to candidacy require approval by all members of a student’s dissertation committee and submission of the Declaration of Change to Approved Proposal form to the Registrar’s Office.

Exempt studies

• Will adapting the study to involve only online/phone interaction increase, or introduce new, risks?
  • No—No amendment is required.
  • Yes—Yes, please submit an amendment explaining how, and to what degree, the change impacts risk.

Non-exempt studies (Expedited or Full Board Review)

• Changes to address risks posed by COVID-19 will require an amendment however if the changes consist solely in adapting the study to online and phone interaction and the changes do not increase, or introduce new, risk, investigators may proceed with the changes without waiting for approval.
• Amendments must be submitted and approved for:
  • Protocol modifications that include changes that are not in response to the COVID-19 outbreak
  • Changes that negatively impact risk.
  • Changes in design, purpose, or methods, particularly if such changes might decrease the scientific benefit of the study.

Zoom is the tool of choice for most academic institutions during this time. A student participating in a Qualification Exam or Dissertation Proposal or Dissertation Defense while CGU requires remote learning due to the coronavirus must use distance collaboration and conferencing methods instead of in-person meetings. The requirement for students to be physically present with at least one dissertation committee member has been suspended at least through the end of the Spring 2020 term. Dissertation defenses (final oral exams) are still an event for the broader academic community and will remain open to the public. Be sure to provide a public teleconferencing link when you submit your Dissertation Defense Announcement.

Find out more about how to use Zoom in place of your on ground classes.

For a temporary period of time, CGU Zoom Basic accounts can now hold meetings with up to 300 participants without the 40 minute time limit. The Basic accounts do have other limitations which include:

• Recording only to Local Computer not Zoom Cloud
• Cannot be an alternative host
• Cannot schedule on behalf of others

Each Academic Department also has a General Zoom account that can be used to schedule these meetings. Please contact your Program Coordinator or Dean’s office for information on using these accounts

Use cases for Zoom include:

• How to log into Zoom
• First time using Zoom App
• Scheduling live meetings with your committee
• Sharing content with the committee
• Chatting in Zoom Webinars
• Zoom on your mobile device (Android or iOS)

Tips for the best online live class experience

• Setting yourself up for success
  • Use Headphones instead of speakers, to mitigate feedback and get the best hearing experience possible
  • Setup in a place with little activity in the background of the webcam
  • Setup your computer as close to your Internet Router as possible
  • Use a wired connection if possible
  • Make sure other high bandwidth use is mitigated, e.g. other individuals streaming video, gaming, nonessential devices using the internet are turned off
  • Close any programs you are not using for the Zoom meeting. Zoom meetings can demand significant memory and processing power from your computer. Closing other applications, ones you do not need during the session, will help Zoom run better. Virtual background feature also uses significant processing power.
  • Disable HD video

Sending high definition (HD) webcam video requires more bandwidth than sending non-HD. Disabling HD video will free up more of your Internet connection for other parts of your Zoom meeting.
To Disable HD Video from within the Zoom Client:

• Click the “Home” tab.
• Click ” Settings”.
• In the Settings window that opens:
• Click the “Video” tab.
• Uncheck “Enable HD”.
• Close the Settings window.
• Troubleshooting Zoom 
  • If your Audio or Video start to get choppy, turn off your video, and ask others to turn off their’s
  • If your audio is still unreliable, join the Zoom meeting by phone (you can stay online for the screen sharing functionality)

Qualtrics is now available to the students, faculty, and staff at CGU.

Qualtrics is an online service that allows users to easily collect, analyze, and act on large amounts of unstructured data with little or no programming.  One can easily create surveys, have people take the surveys, and then analyze the results.  Features include:

• the ability to display survey results graphically and statistically
• the ability to export raw data in a variety of formats (CVS, XML, SPSS)
• libraries of customizable templates and question banks that can be shared by users and groups
• a “quick survey builder” guide for beginners
• continuous file saving, minimizing potential data loss due to browser crashes
• folders for survey organization

To get started, log in to Qualtrics. If this is your very first time using Qualtrics at CGU, then a web page will appear with two buttons.  Click on the one labeled “I don’t have a Qualtrics account”.  Qualtrics will create an account based on your CGU credentials and then ask you to fill in your name and other information.  Once done, you will be able to start using Qualtrics.

Click the Here  to find out more about how to use this tool.

Protecting Human Subjects is paramount to any research being conducted by students, faculty and other researches at CGU. Conducting research through a digital medium is even more important. The following are some considerations that should be considered when conducting research digitally, especially over the internet:

Use a CGU Issued Laptop If Possible:

• OIT has security settings applied to all issued laptops
• CGU issued laptops already use full disk encryption
• Device will already be up to date
• OIT can assist you more easily

If You Need to Use a Personal Computer:

Make sure the computer’s operating system and software is up to date

• Use whole disk or file/folder encryption such as FileVault/Disk Utility on MacOS, BitLocker/EFS on Windows, or VeraCrypt on any system.
• Use up to date Anti-Virus software.
• Ensure that the Operating System’s built in Firewall is enabled.
• Avoid using shared public networks such as public WiFi
• If possible, use a separate computer for research, rather than the one used for personal computing
• Install as few programs as possible on the computer being used for research

Ensure Your Research Data is Secure:

Maintain backups of your data

Only keep data in a few places for redundancy, but not more places than necessary, to mitigate data loss or breaches (e.g. Thumb Drives getting lost)

Enable encryption on the backup that you take and save the encryption key somewhere secure.

If using online tools that store and/or share Human Subject Data:

• Use a strong password or passphrase to protect data
• Share data to unique users/email address, rather than using generic links
• Store data in CGU network shares over the VPN, use OneDrive for less secure data
• Encrypt any data being transmitted
• Maintain an inventory of all research data being kept
• Maintain a system to separate (as much as possible) Identifiable Information from Raw data being analyzed
• Keep a catalog of names of subjects separate from audio and video recordings
• Create a naming convention for data files and data assets that are unidentifiable from human subjects
• Delete any data that is not necessary to keep