Research and Sponsored Programs - 2018

Human Subjects (IRB) Study Modifications

March 26, 2020

The IRB committee and staff understand that many of you are anxious for guidance about how to continue research in the time of social distancing and "Safer At Home" orders.

Due to concerns and risks related to the COVID-19 outbreak, CSUN's Committee for Protection of Human Subjects is allowing for accelerated review of modifications by IRB staff to allow remote data collection to replace face-to-face data collection. Studies that have been determined to be expedited or exempt may be eligible for accelerated review of modifications if they involve changing in-person surveys and interviews to remote methods of data collection.  Modifications that involve more complex changes will undergo the usual modification review by an IRB committee member. 

It is the PI’s responsibility to ensure that all parts of the study to be modified are updated in the Cayuse protocol. In completing the modification, investigators will need to: a) specify all electronic platforms to be used, b) include updated recruitment procedures and materials, c) describe the revised consenting process, and d) make other changes as needed.  Please give careful thought to whether the risks and benefits of research, outlined in Cayuse Section G, will change with the modification. Please review your modification to ensure internal consistency and consider having a second team member, colleague or mentor review the modification.  If IRB staff encounter inconsistencies, this will trigger a revise-resubmit process, and delay approval of the modification.

Guidance for modifications that can be approved administratively:

  • Only modifications that transition from face-to-face data collection to remote data collection procedures will be considered for accelerated review. Any other changes to research procedures will need to go through the normal IRB review process. 
  • Data collection should take place using one or more of the following screened services, which provide appropriate confidentiality and security for research data:
    • Qualtrics and SurveyMonkey for online surveys
      • Note: PIs must state that recording of respondent IP addresses will be disabled in order to qualify for administrative review and approval
      • MyCSUNBox for cloud-based storage
      • Zoom for interviews
      • Qualtrics where documented (signed) consent is required, whether or not the remainder of the study activities occur in Qualtrics 

Use of these services will facilitate accelerated review as they have already been screened by the IRB and are known to provide appropriate confidentiality and security for research data storage. If PIs choose to use other services, they must provide the necessary documentation to demonstrate compliance. This will delay the review and approval processes. 

  • Transitioning the consent process from face-to-face data collection to remote data collection can be addressed with one of the following modifications:
    1. Electronically Documented Consent - Projects that are not eligible for a waiver of documented consent can use the Qualtrics signature feature to collect signed consent. Please ensure that study procedures and data handling are updated in Cayuse to align with the changes to the main study protocol.
    2. Waiver of Documented Consent - Some projects may be able to transition to a waiver of documented consent, and use a Participant Information Form (PIF) instead of a signed consent form.
      • Please download our example PIF and make appropriate revisions to your existing consent form.  Much of the contents of your consent form will probably copy directly over to the PIF.  The primary changes are:
        • Revise the title of the document to PARTICIPANT INFORMATION FORM
        • Changes in the verbiage of the Voluntary Participation Statement
        • The addition of “agree to participate” check boxes instead of signature lines
        • Ensure that study procedures and data handling are updated to align with the changes to the main study protocol.
        • Cayuse Question I1.a.3 requires a justification for the waiver of documented consent ("Please provide a justification for not documenting consent from your adult participants").

Suggested language is as follows:

Study has moved to an online consent process to comply with applicable state and local regulations intended to reduce COVID-19 transmission, and reduce risks to study participants.

If study is an anonymous survey that does not collect identifiable data:

Researcher is requesting a waiver of documented consent to reduce risk and protect participants by preserving anonymity; the only record linking the participant to the research would be the informed consent and the principal risk is a breach of confidentiality.

If study only collects interview data and questions are not sensitive:

Researcher is requesting a waiver of documented consent as research presents no more than minimal risk, the waiver will not affect the rights and welfare of the participants, and the research cannot practicably be carried out without a waiver.

As a reminder, pursuant to guidance from the CSU Chancellor's Office, the LA County Department of Public Health, and the State of California, in-person research interactions should currently be suspended.  Protocol deviations and unanticipated problems associated with the Novel Coronavirus should be reported to the IRB within one week of the time that the investigator becomes aware of the incident.   

If you have any other questions, please reach out to our office by emailing irb@csun.edu.