IRB-HSBS COVID-19 Updates
Updated May 11, 2020
COVID-19 Restrictions on Face-to-Face Research Continue
On April 30, 2020, Lois Brako, Assistant Vice President for Research – Regulatory and Compliance Oversight, sent a notice to the research community confirming that restrictions on face-to-face research remain in effect until future notice. For more information about human subjects research under these restrictions, see the Research Involving Human Subjects FAQ on the UMOR COVID-19 Research Operations website.
Exempt Research – Collection of Sensitive Information via Online Surveys
With the need for investigators to conduct research via remote methods, the IRB has seen an increase in the number of exempt projects proposing online surveys that ask sensitive questions about mental health issues, personal relationships, intimate partner violence, and other sensitive topics. Even when data are collected anonymously, these surveys may present the potential for increased risk to participants. Suggestions for mitigation of these risks include:
- Advise participants to take survey in a private place and be sure to close out the browser when leaving the survey.
- Advise participants of the sensitive nature of questions in the consent information.
- For anonymous surveys that may collect information about suicidality or possible abuse, advise participants that you will not be able to reach out to them directly, but provide local (when feasible) and national hotline resources.
- Include information in the survey to prepare participants for difficult questions, remind them that any question can be skipped, or provide resources in the survey for participants whose responses suggest a need for support.
Another area of concern involves surveys that ask questions that may promote xenophobic attitudes, even when the investigator’s purpose is to study and dissuade such attitudes. Investigators are reminded to be sensitive to these issues when designing their research. The IRB has developed a brief Best Practices document to assist investigators. See the Cultural Sensitivities and Surveys link on the IRB-HSBS Guidance website for more information. This document also provides information about the survey design consulting services offered by the Survey Research Organization of the Institute for Social Research at no cost to faculty, staff, or students.
As part of its review of exempt projects, the IRB may ask to review and revise your consent information or online survey instrument to address these concerns.
Updated April 2, 2020
New eResearch Questions
On Thursday, April 9, the eResearch Regulatory Management System was updated to include questions regarding COVID-19. This will allow the IRBs to track new and amended projects involving the study of COVID-19 as well as amendments that are submitted to change the mode of data collection in response to the restrictions placed on face-to-face research. New required questions will appear in the HUM (new applications), the Amendment Coversheet, and the AE/ORIO report.
UPDATE: IRB-HSBS Review and COVID-19 Research Prioritization Committee Process
Investigators can now submit the COVID-related Research Prioritization Form either before or concurrent with the submission of the IRB application. Our experience has shown that the IRB-HSBS may be able to complete its review of a project before the prioritization process is complete. Consequently, investigators may now conduct research activities that do not involve face-to-face interactions with human subjects as soon they receive an approval or an exempt/not regulated determination from the IRB. Once they receive notice from the prioritization committee, investigators should still upload a copy of that notice to their IRB application via a posted correspondence.
Exempt and Not Regulated System-Generated Determinations
System-generated exempt and not regulated functions in eResearch are not available to investigators during the period of restriction on face-to-face research interactions. Exempt and Not Regulated applications must be submitted to the IRB for review.
Zoom for Health
Zoom for Health, a more secure version of Zoom that can be used with Protected Health Information, is now available for research use at U-M. All Michigan Medicine affiliates and affiliates of the School of Dentistry, College of Pharmacy, and School of Nursing, are automatically directed to Zoom for Health when they log in to Zoom. Other members of the U-M community who need to use Zoom for Health for sensitive research can request it at this opt-in website. See the ITS Safe Computing Sensitive Data Guide for additional information.
Projects Registered on ClinicalTrials.gov
Responsible Parties should update the Overall Study Status of their ClinicalTrials.gov record to reflect any pauses in research activity due to COVID-19. Please see UMOR guidance regarding suggested status changes based on study activity (PDF). If you have questions, please email Kate Sasamoto at [email protected].
Working with the IRB-HSBS Staff
The entire IRB-HSBS staff is working remotely at this time. Our business hours have not changed, and we are committed to responding to your telephone calls, email messages, and eResearch posted correspondences on a timely basis. If you have not received a response within 24 hours (M-F), please contact the general IRB-HSBS email address ([email protected]), or leave a message on the IRB-HSBS main phone line at 734-936-0933. These are monitored throughout the business day and on the weekend.
IRB Operations
The IRB-HSBS team is committed to supporting our research community on the Ann Arbor, Dearborn, and Flint campuses during the COVID-19 emergency. The IRB-HSBS is open and fully operational with most staff working remotely to “flatten the curve.” IRB meetings, when necessary, will be held by videoconference. As always, your IRB staff liaison is available to answer questions via email (best) or phone. You can also contact us with general questions at [email protected] or 734-936-0933. These are monitored throughout the business day and on the weekend. In the short term, IRB-on-the-Road and educational sessions have been cancelled, but will resume when it is safe to do so.
Restrictions on Human Subjects Research due to COVID-19
Interim Vice President for Research, Rebecca Cunningham, announced the institution’s mandatory restrictions on the conduct of person-to-person research with human participants on March 13, 2020 (PDF). The purpose of the policy is to protect participants, researchers, and our communities from the risk of infection from COVID-19.
What research must be paused?
All face-to-face research interactions or interventions with participants, including exempt and not regulated projects must pause, with limited exceptions. This includes studies conducted outside the University, at both domestic and international sites. See our COVID-19 guidance for exceptions to this policy.
What research activities can continue during the pause?
- Projects or research procedures that do not involve any direct person-to-person contact with participants, such as web or mail surveys or interviews conducted via telephone or video conferencing
- Data analysis
Strategies for continuing research during the pause
- Amend your study to convert face-to-face data collection or other procedure to a remote method described above
- Continue only those research procedures in an IRB-approved or exempted study that do not involve face-to-face interaction during the pause
IRB Review of COVID-19-Related Submissions
The IRB will prioritize the review of submissions related to COVID-19, including amendments to eliminate person-to-person contact, amendments to add COVID-19-related elements to the research, or new COVID-19 studies. See our COVID-19 guidance for specific instructions.
***AMENDMENTS TO EXEMPT STUDIES ARE NOT REQUIRED TO CHANGE THE MODE OF DATA COLLECTION – EXCEPT FOR PROJECTS COLLECTING SENSITIVE, IDENTIFIABLE DATA***
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