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:
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 email@example.com, and a coordinator will respond via email as soon as possible. Messages sent to firstname.lastname@example.org 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 email@example.com 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.
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.
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.
The information in this guidance outlines privacy and confidentiality considerations for working remotely (e.g., telecommuting) on human subjects research.
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.
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.
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.