Human Research Protection Program and Institutional Review Board

To resume face-to-face research with human subjects, principal investigators (PIs) must first apply for resumption permission from their dean or the vice president for research.

If resumption permission is received, PIs must then submit the approved Resumption Request form to the HRPP/IRB via a project revision. See the Post Approval webpage for instructions on submitting the project revision form, and see project revision guidance for further instructions related to iRIS.

If the PI could not check all seven safety criteria boxes in section 4 of the Resumption Request form, only then must the PI submit revised documents that include the safety procedures proposed for the study.

Requirements for conducting face-to-face research activities

• Researchers must 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.”
• Whenever possible, on-site visits should be limited for populations the Centers for Disease Control (CDC) identifies as higher risk of severe illness from COVID-19  (e.g. older participants, those with cardiovascular disease or diabetes).
• Study activities must be performed while maintaining at least 6 feet of physical distance at all times. If person-to-person contact is required (e.g. activities involving blood samples, muscle biopsies or the placing of sensors on participants), use of personal protective equipment (PPE) is required for both the participant and the investigators, and CDC guidance regarding its use must be followed: https://www.cdc.gov/coronavirus/2019-ncov/hcp/using-ppe.html
• Researchers must provide PPE to each research subject when at least 6 feet of distance cannot be guaranteed for the duration of the study visit.
• Strict cleaning protocols must be followed for all shared surfaces, equipment, and devices (e.g. simulators, wearing devices like glasses or goggles, keyboards, pens) following guidance from Environmental Health and Safety (EHS): https://ehs.oregonstate.edu/coronavirus
• Existing safety procedures (e.g., lab safety protocols) must be maintained or exceeded.
• Researchers must coordinate activities in adjacent and shared spaces to enable appropriate physical distancing (≥ 6 feet). These actions may involve coordinating with OSU employees and students throughout a building or with external institutions, as in the case of shared buildings such as the Portland Center or the Robertson Life Science Building on OHSU’s campus.
• Activities should be completed efficiently to minimize time spent in contact with the participant. Visits should be ended immediately if a participant becomes uncomfortable with the interaction.
• Researchers must have a plan to quickly stop or ramp down all research activities if restrictions are implemented by the state of Oregon or the university. During Stage 1, activities may have to ramp down within two days. During Stage 2, activities may have to ramp down within seven days. Do not plan to resume activities that cannot adhere to these requirements.
• The research plan must be in compliance with current orders from the relevant local authorities governing the site of the research activities (e.g., city, county, state, federal, sovereign nation, international government body). 

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.

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

Effective March 21, 2020, in-person study interactions were required to cease, unless those in-person interactions will have a direct therapeutic benefit to the subjects and are essential for their health and safety. Because of the global pandemic, this directive applies to research conducted by OSU researchers at any site in the U.S. or abroad.

If in-person study activities are required for studies related to COVID-19 or for safety monitoring related to other life threatening conditions, contact the HRPP Office immediately to discuss feasibility.

All other in-person interactions with study subjects are considered “non-critical” and are cancelled until resumption permission is received and any necessary study revisions are approved by the IRB.

The Vice President for Research, in collaboration with the IRB Chair, will make any necessary determinations as to whether particular in-person study interactions are critical.

Critical in-person study interactions are those that have a direct, therapeutic benefit to the participants and are essential for health and safety. Therapeutic benefit here refers to the effect obtained because of treatment provided as part of the research protocol that benefits the individual participant. Eventual benefit to society is not considered “critical” in this context.

Non-critical in-person studies include:

• Therapeutic studies for conditions that are not life-threatening in the near-term
• Non-therapeutic interventional studies intended to improve health, but not for the treatment of a specific disease
• Observational studies
• Social, behavioral, and education research studies that are not critical to the health and safety of the participants

Any approved 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

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 may be approved with the condition that enrollment cannot begin unless activities can adhere to the current OSU stage requirements for allowable in-person activities. If activities cannot meet the requirements for the current stage, enrollment cannot begin until after the restrictions are lifted. Study applications should be clear about conditions under which activities will stop. Please also see the “Process for resuming face-to-face research” section for instructions on how to seek permission for resuming face-to-face research, as resumption permission will also be needed for new applications.

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
• Working Remotely
• Additional Information

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

• Keep Working, Oregon State University Information and Technology
• Baseline Standards of Care, Oregon State University Information and Technology Office of Information Security

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.

Until further notice, human biological samples collected at external sites should not be sent to OSU for processing, analysis, and storage. If samples are still being collected at this time, they should be stored at the originating site for later shipment to OSU.

Researchers receiving samples to assist with current clinical treatment decisions for a life threatening condition, or as part of an approved COVID-19 protocol, may continue to receive samples if they have received the necessary approval from OSU Environmental Health and Safety.