Guidance related to COVID-19 and associated impacts on human subjects research at OSU -- Updated July 7, 2021

Effective June 21, the research resumption approval process is no longer in use. OSU is currently operating under the Safety and Success Plan, Pathway to Fall. Under this guidance, in-person and on-site research and fieldwork are allowed. While resumption approvals are no longer required to either initiate or resume IRB approved in-person activities, researchers must still follow the OSU Safety and Success policy with regard to physical distancing, face covering or PPE use requirements, or other applicable health authority requirements when conducting research activities.

While resumption approvals are no longer required to resume research activities, OSU continues to align COVID-related university policy with OHA and CDC guidelines. Please read the current OSU Safety and Success policy.

IRB approved face-to-face research activities may proceed, provided they adhere to the following requirements:

  • Research activities can take place on campus or at on-site locations while remaining in compliance with the physical distancing, face covering or PPE use requirements, cleaning protocols, travel restrictions or other applicable health authority requirements or OSU policies that may be in effect in fall 2021. This includes considerations related to research with human subjects or animals.
  • Activities related to training of staff, postdocs and students for research can take place while adhering to physical distancing, face covering or PPE use requirements, cleaning protocols, travel restrictions or other applicable health authority requirements or OSU policies.
  • Field work or other off-site activities will adhere to physical distancing, face covering or PPE use requirements, cleaning protocols, travel restrictions or other applicable health authority requirements or OSU policies Travel to such sites is informed by OSU’s travel guidance that is in effect at the time of travel.
  • Visitors for the purposes of engaging in research activities on campus or other on-site facilities can proceed provided all distancing, face covering or PPE use, and quarantine or other applicable health authority requirements can be met.
  • Effective June 21, 2021 the research resumption approval process is no longer in use.Please reference university specific guidelines as needed.
  • Researchers should have a plan for non-contact screening of all participants within the 24 hours prior to each visit. If a subject indicates that they have symptoms of illness or have possibly been exposed to someone with COVID-19, the visit must be cancelled or postponed for a minimum of 14 days. See section below, “Screening of Research Participants.”

The Human Research Protection Program (HRPP) office is open, but will not be staffed in person. 

The main HRPP phone number is currently a message-only number. All messages are automatically forwarded to irb@oregonstate.edu, and a coordinator will respond via email as soon as possible. Messages sent to irb@oregonstate.edu will be monitored throughout the workday.

Institutional Review Board (IRB) meetings will continue as scheduled, but will be conducted remotely.

The HRPP Office has suspended in-person advising. If you are in need of HRPP advising, please send an email to irb@oregonstate.edu and we will set up a remote advising appointment via Zoom. Please provide a brief description of the reason for the meeting to ensure that the appointment is scheduled with the appropriate staff person. If you have an existing IRB study number or title, please include that in your message.

The OSU Safety and Success policy contains the current requirements for all OSU staff and students engaging in OSU activities while interacting in-person with others outside of their household.

Please note that OSU researchers conducting activities at non-OSU locations or facilities will be required to comply with that location’s safety requirements in addition to OSU’s requirements.

Any approved in-person interactions must strictly adhere to the requirements below to reduce exposure.

  1. Researchers should 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 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 had a positive COVID-19 test for active virus in the past 10 days, or are you awaiting results of a COVID-19 test?
  • If you are not fully vaccinated, have you been in close contact with anyone with COVID-19 in the past 14 days?
  • Within the past 14 days, has a public health or medical professional told you to self-monitor, self-isolate, or self-quarantine because of concerns about COVID-19 infection?

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.

  1. 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.
  2. When possible, study team members should consider taking 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

If a study activity needs to be cancelled, participants should be informed of the reason and that they will be contacted again when the activity can be rescheduled. IRB approval is not needed to communicate this message to study participants if a study activity is being cancelled because of COVID-19.

Review of submitted applications will continue as usual. Studies that involve in-person interactions can be approved and PIs are required to follow OSU policies and relevant OHA and OSHA guidelines.

Where possible, the Research Office recommends studies re-schedule in-person visits so that they may be carried out remotely. Researchers may replace in-person meetings with phone calls or online meetings using conference tools like Zoom.

Appropriate safeguards must be applied to remote study activities to ensure continued respect for subject privacy and to maintain confidentiality and data security.

Purpose:

The information in this guidance outlines privacy and confidentiality considerations for working remotely (e.g., telecommuting) on human subjects research.

Preparing to Work Remotely:

  • Develop a communication plan for the research team. Ensure personnel know whom to contact if problems or concerns arise.
  • Verify that research personnel have resources and information necessary to carry out protocol activities and ensure privacy and confidentiality.
  • Establish research team policy and guidance related to privacy, confidentiality and data security. A research team specific policy may include instituting confidentiality agreements, logs to maintain in physical files, creating guidance in case of a confidentiality breach, etc.
  • 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 the appropriate level of protection according to the OSU Baseline Standards of Care for Confidential/IRB Level 3 information. This includes the use of a VPN and secure network share for remote access, encrypted hard drive and/or storage media, and secure configuration validated by your IT Pro. Please remember that Box and other cloud storage options are not approved for the storage of Confidential/IRB Level 3 information.
  • Download and install any necessary software while on campus (e.g., VPN clients, Microsoft Teams or Zoom for web conferencing, etc.).

NOTE: Researchers remain obligated to follow the privacy and confidentiality protections specified to participants as part of informed consent.

Researchers also must follow the privacy and confidentiality protections outlined in the approved IRB protocol. In general, applications approved by the IRB have some degree of flexibility, as researchers are asked to agree to follow the HRPP Data Security Guidance and the OSU Baseline Standards of Care, as opposed to identifying specific data security methods. However, researchers may have noted more specific security provisions which they are obligated to follow.

Working Remotely:

Electronic data/records considerations

  • Data must be stored according to the OSU Baseline Standards of Care.
  • Avoid working on shared computers and devices if possible.
  • Generally avoid using public Wi-Fi. Use of public Wi-Fi is prohibited for protocols with Level 3 Data.
  • Use strong passwords for home networks and devices.
  • Share or access data via secure network shares. Cloud storage platforms are not approved for the storage of Confidential/IRB Level 3 data. Do not send data sets via email.

Identified or sensitive paper records/documents/questionnaires/log considerations

  • 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.
  • Research labs may choose to implement a log in/log out process for physical records and material.

Data collection activities

  • When conducting interviews via phone or videoconferencing, take precautions to protect participant privacy. For example, 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.
  • 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: This may change the IRB’s data security/confidentiality assessment. Such a change may not be implemented without prior approval or confirmation of exempt determination by the IRB office. 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.

Additional Information

Remote work guidance adapted with permission from Iowa State University

Researchers must modify the application before implementing any changes if the study is expedited or full board and the application specifies in-person visits.  If changes are necessary to eliminate apparent hazards and there is not time to obtain IRB approval, make the change and then immediately notify the HRPP Office.

Researchers may consider whether additional flexibility is needed in order to continue implementing the protocol. For example, many low risk procedures qualify for a waiver of written documentation (signed) consent. If the application describes written consent, it may be modified to remove that requirement to allow for easier remote implementation.

Please see additional information for when and how to submit project revisions.

NOTE: Prior IRB approval may be required to move activities online for studies that involve level 3 data security or if there are plans to use the recording feature of online tools like Zoom. Please consult with the HRPP office before moving these study activities online.

Even with such modifications, there will be some research activities that are non-critical and not amenable to remote visits; such research visits must stop until these restrictions are lifted.

Modification of the application in NOT NECESSARY in order to hold visits remotely or change the schedule if the study protocol has been determined to be exempt or flex, or if the approved protocol does not describe whether visits would be in-person, remote, or take place following a particular schedule.

Some protocols are approved that provide research subjects with gift cards or cash incentives at the time of an in-person visit. When visits are removed to remote environments, researchers will need to deliver these incentives remotely, as well.

If you have already purchased gift cards, you may mail them to subjects. To ensure confidentiality, let subjects know during the call or online meeting that you will mail them the incentive, but do not include the study title or any explanation beyond "payment for study participation".

If cash incentives were approved, you can switch to digital gift cards through any reputable commercial site. So long as the amount is the same as was specified in the protocol, this will not require a protocol revision.

Track an account for gift cards the same way that you would cash incentives because you will have to report them to your Business Center.

Please be mindful of the possible impact of cancelling study activities utilizing research incentives that would have been provided to subjects. Payment for visits cancelled as a result of the current restrictions will be left to each researchers’ discretion.

When OSU is not the IRB of record, OSU researchers should contact their collaborators at the primary site to obtain information and follow that site’s current requirements if they are more restrictive than those outlined here.

OSU researchers currently conducting studies outside of the U.S. should follow the public health recommendations of the host country or OSU’s requirements; whichever is more conservative.

Please email irb@oregonstate.edu if you have questions or concerns about how to proceed with, or modify, an approved or planned protocol.