During Stages 1 & 2 of OSU’s resumption process, some face-to-face research related to previously approved activities with human subjects may resume if the study plan adheres to the requirements outlined in this guidance.
Please note that Stage 1 specifies that all research activities should be conducted remotely (without face-to-face contact) when possible.
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.
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.
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:
Any approved in-person interactions must strictly adhere to the requirements below to reduce exposure.
In the past 14 days have you:
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 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.
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.
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.