COVID-19 Information

Last updated July 20, 2020

Contacting Our Office

RSP is open and continuing operations as normal but will not be staffed in person. Phones and emails are being answered as normal. Institutional Review Board (IRB) meetings will continue during the academic year but will be conducted remotely. The IRB does not meet during intersession or over Summer quarter.

My study is about COVID-19 or is specifically related to the pandemic, can my application be prioritized?

Applications specific to the pandemic will be prioritized to the extent possible. We are receiving many applications related to the pandemic however, so we appreciate your patience.

I am unable to obtain a written signature on the Application Approval Signatures page. What can I do?

The Human Subjects Application Approval Signatures E-sign Form can replace written signatures. Please continue to submit the rest of your application materials to the compliance email inbox for review.

Research Consult Appointments

We are available for remote advising appointments via Zoom. Please contact our office to request a virtual Zoom meeting or call.

Guest Lectures

Do you need a guest lecturer about research? Invite a research compliance member to attend your virtual class! We can join your Zoom class session to discuss requested topics.

Please email compliance@wwu.edu with the topics of interest, possible dates and times, and the length of time desired for the lecture.

Restrictions on In-Person Study Activities

RSP is following the Governor’s Stay Home, Stay Healthy directive and the guidance of University administration.

Study activities that are limited to remote interactions (online, phone, mail) may continue without disruption.

In-person study interactions AND on-premises activities must be discontinued until further notice.

Exceptions may be requested for on-premises research activity that does not involve in-person interaction. Information about this is posted on the main RSP website. If you believe your research qualifies under the exemption criteria described on the main RSP website, please follow the instructions given there to apply for authorization to continue your work. These applications are being handled on an expedited basis, typically within 24 hours.

If in-person study activities are required for studies related to COVID-19, contact our office immediately to discuss feasibility.

Effect of the Restrictions on Pending IRB Applications

Review of submitted applications will continue. Studies that involve in-person interactions may be approved with the condition that enrollment cannot begin until after these COVID-19 restrictions are lifted and an exemption to conduct the research is allowed.

Modifying Research Activities

To facilitate smooth transitions from in-person activities to temporary online activities, certain minimal risk studies are allowed to temporarily revise their procedures without submitting a modification *so long as certain criteria are met*:

Is your study greater than minimal risk?

If yes, you need to submit a modification for review by the IRB committee. Wait to make revisions until you receive IRB approval.

Is your study categorized as “Expedited”?

If yes, you need to submit a modification for review by the IRB committee. Wait to make revisions until you receive IRB approval.

Is your study categorized as “Exempt Category 2 Limited Review”?

If yes, you will see the words “Limited Review” in your approval memo. You will need to submit a modification for review. Wait to make revisions until you receive IRB approval.

If none of the above apply, please see the conditions below under which you are allowed to revise your study activity temporarily without submitting a modification.

First, please read these important points for making a temporary revision:

  • Deviations from the specific conditions below necessitate submitting a modification.
  • The expectation from the IRB is that when social distancing restrictions are lifted, that you will return to your IRB approved procedures. If you want to make these revisions permanent, please submit a modification form.
  • It is required that you document this temporary revision to be reported to the IRB at a later time.
  • Review the data and privacy considerations in the FAQ below.

For studies with written consent collected by an investigator WITHOUT a dual role you can...

Transition to a process of electronic consent using Qualtrics where:

1. The first page of the survey is the approved text of your consent form.

2. At the bottom of the consent text, replace the “signature line” add:

a. A text box/text boxes to collect the participants first and last name.

b. A “Signature Block”

3. *Only* the specific text regarding the method of consent is changed. All other previously approved language on the consent form should remain the same, unless a modification is submitted. See below for other allowable changes in consent form language.

4. Consistent with the general recommendation of storing consent forms and identifiers separately from data, researchers should plan for a method of separating consent records from data as soon as possible. One method is to collect consent and data on two different, but linked Qualtrics surveys. Another method is to plan to manage this disconnection as soon as possible after collection.

For studies with written consent WITH a dual role, where consent forms were intended to be sealed until grades have been submitted to the Registrar’s Office or collected by another investigator to mitigate a dual role you can...

Transition to a process of electronic consent using Qualtrics where:

1. For studies that have a research team member without a dual role, the non-dual role research member will administer the Qualtrics survey consent form responses and will not share who participated in the research until grades have been submitted to the Registrar’s Office.

2. If all investigators have a dual role, you must not access the Qualtrics survey until grades have been submitted to the Registrar’s office.

3. The first page of the survey is the approved text of your consent form.

4. At the bottom of the consent text, replace the “signature line” add:

a. A text box/text boxes to collect the participants first and last name.

b. A “Signature Block”

5. *Only* the specific text regarding the method of consent is changed. All other previously approved language on the consent form should remain the same, unless a modification is submitted. See below for other allowable changes in consent form language.

6. Consistent with the general recommendation of storing consent forms and identifiers separately from data, researchers should plan for a method of separating consent records from data as soon as possible. One method is to collect consent and data on two different, but linked Qualtrics surveys. Another method is to plan to manage this disconnection as soon as possible after collection.

For studies with an in-person written or administered survey you can...

Transfer your paper survey to a Qualtrics survey with the following conditions:

1. Turn off the collection of IP addresses.

2. Follow the consent guidelines above regarding shifting written consent to electronic consent.

3. Language in your consent form or documents specific to distributing paper forms or that process can be edited to describe an online administration. For example, you can replace language about handing out surveys in class with language about distributing a link to a survey, etc.

4. Follow your approved methods for collection of identifying information. For example, if you were not approved to collect identifying information, do not collect identifying information in the online survey.

For studies with class observations...

If you are replacing in-person classes with Zoom sessions, you may continue observations so long as:

1. You follow the approved methods of data collection. For example, if you were approved to take notes about class discussions, you are still approved to take notes on Zoom sessions.

2. DO NOT use video recordings of Zoom meetings for research unless you were approved to video record your classroom.

For studies with in-person interviews you can...

Transition from in-person interviews to interviews via phone or videoconferencing software (Skype, Zoom, etc.) so long as:

1. You ensure the confidentiality of the interview. See considerations for data and security protections FAQ section below.

2. If you were approved to audio record, you may continue to audio record so long as you maintain the same data and security protections.

3. DO NOT use video recordings unless you were approved specifically to video record.

For studies that involve giving cash or gift card incentives in person ...

• If you have already purchased physical gift cards, you may mail them to subjects. Please notify your participants that you will be mailing the incentive, before it is mailed. To ensure confidentiality, do not include the study title or any explanation in the mail beyond “payment for study participation”.

• If cash incentives were approved, you can switch to e-gift cards. If your research is funded, please speak with your RSP award contact before making this shift, so that they can ensure the correct controls are in place.

Will you require modifications to undo the changes made during the outbreak once things can return to normal practice?

For protocols where revisions required submission of a modification form (see questions above), another modification will be required to change back to normal practice.

For protocols where revisions were deemed allowable without submitting a modification form (see the allowable revisions above), these changes were considered temporary deviations to the protocol in response to the pandemic. A second modification is therefore not needed to “undo” these changes when social distancing restrictions are lifted. When social distancing restrictions are lifted, the expectation is to return to your approved protocol.

Data and Security Protection Considerations for Remote Work with Human Subjects

General Considerations

  • Confirm that data/records/equipment/supplies are permitted to be taken off-campus and accessed remotely.
  • Remove identifiers from data (de-identify) or create subsets of de-identified data with which to work remotely.
  • Ensure that remote access to electronic data files meets your approved level of data protection. This includes the use of a VPN and encrypted hard drive and/or storage media.

Electronic Data Records

  • Avoid working on shared computers and devices if possible.
  • Generally, avoid using public Wi-Fi.
  • Do not send Level 3 or Level 4 data sets via email without encryption.

Identifiable or Sensitive Paper Records/Documents/Questionnaires/Logs

  • Keep records in a secure location when not in immediate use. Use locked storage whenever possible.
  • Flip-over or cover identifiers when stepping away from such records.
  • Stay organized and know what physical information is in your possession.

Data Collection Activities

  • When conducting interviews via phone or videoconferencing, take precautions to protect participant privacy.
    • Secure your space before the meeting.
      • Do not conduct a video interview in a common room where other members of the household may overhear.
      • Inform other members of the household of confidentiality expectations.
      • Ensure that identifying information about participants is not visible through your camera.
      • If you intend to share your screen, be mindful of what you might be sharing. Be careful to avoid sharing identifying information about other participants.
    • Ensure only the intended people are in the meeting.
    • Do not use identifying information in meeting titles or descriptions, including participant initials or names.
  • Separate participant contact/identifier information from data, or link indirectly via codes and a key. Store the key linking identifiers and data in a secure location separate from the data.
  • Do not utilize video or audio recording data collection activities unless approved by the IRB. Note: Recording may change the IRB’s data security/confidentiality assessment. Such a change may not be implemented without prior approval or confirmation. This applies to both Exempt and Non-exempt human subjects research.
  • Ensure any necessary safety precautions can be followed in a remote site, including spotters to prevent falls, and presence of available and functional safety equipment.

Screening of Research Participants

If your study has been approved for an exception to continue in-person activities, all in-person interactions must strictly adhere to the requirements below to reduce exposure.

  1. Researchers must contact study participants for a short screening process within the 24 hours prior to in-person visits. Use of this screening procedure does not require IRB approval. The following screening questions and process are recommended:

    In the past 14 days have you:
    • Travelled outside of the United States?
    • Visited a long-term care facility in the U.S.?
    • Have you had any symptoms of any contagious illness, including but not limited to:
      • Fever
      • Cough
      • Shortness of breath or difficulty breathing
      • Sore throat
      • Nausea, vomiting, or diarrhea
    • Have you been in close contact (within 6 feet) of a person who is under investigation for or has been diagnosed with COVID-19?
    If a study participant says “yes” to any of the above questions, it is recommended that you postpone the visit and follow public health recommendations for the timing of rescheduled visits.
  2. Ensure every day that all research staff who interact with participants are symptom-free and have not, to their knowledge, been exposed to the novel coronavirus.
  3. Train all study team members to take appropriate infection control measures at the site of the visit.
    1. Stagger participant visits to enable social distancing
    2. Stop shaking hands – use non-contact methods of greeting
    3. Clean hands at the door and wash hands before and after meeting with each participant
    4. Create habits and reminders to avoid touching your face and cover coughs and sneezes
    5. Disinfect surfaces like cell phones, keyboards, laptops, doorknobs, tables, desks, writing instruments, and handrails regularly. At a minimum, do this every two hours; as well as before and after each visitor arrives
    6. Increase ventilation by opening windows or adjusting air conditioning
    7. Ensure availability of hand sanitizer, hand washing facilities, disinfectant wipes, etc.
    8. Use appropriate personal protective equipment when handling human specimens