IRBMED FAQs: Research During COVID-19

 

Updated July 1, 2020 

 

IRBMED Questions Related to Research Reactivation

Are study teams required to submit approval from a Reactivation Committee to IRBMED and if so, how?

Yes, this approval from the Reactivation Committee should be submitted to IRBMED. Once the study team obtains the approval, submit this notification to IRBMED via the Post Correspondence activity (in eResearch main study workspace) by selecting “IRBMED” as a recipient. This activity allows for uploading of documents. Notification of the Reactivation approval should not be uploaded into the IRB application itself.

The research Reactivation Request and Amendments to IRB application can be submitted at the same time. However, research should not be reactivated until both IRBMED and Reactivation Committee approvals are obtained.

If my study does not qualify for activation as a Tier 0 or Tier 1 study, can I submit an amendment in advance to prepare for Tier 2 Activation?

IRB amendments can be submitted now to prepare for reactivation under Tier 2.

If my study has continued during this pause, what am I required to do now?

If it was conducted fully remotely and will remain fully remote, there is no need to apply through the reactivation process. If it involves direct contact with participants and/or the study team members to come on site it should go through the reactivation process per the UMOR Reactivation procedures.

When should screening and testing procedures for COVID-19 be added to the study protocol?

If screening (questions about health and/or a temperature check) for COVID-19 is performed before individuals can enter the facility – then no.

If testing and knowing the outcome of the testing is part of the eligibility criteria – then yes. For example, if a participant must never have tested positive in order to participate in the study, then it must be added to the study protocol.

Can a consent process or study procedure occur at the same time as a clinic visit?

Yes, this can be done. It is preferable to conduct study consenting procedures remotely, but if that is not possible, it can be conducted in-clinic using the safe-study guidelines on the UMOR website. If a study procedure can be conducted at the same time as a clinic visit it is preferred as it reduces the number of additional visits to the facility required by the participant – thus reducing the incremental risk to participants.

What Personal Protective Equipment (PPE), if any, will be supplied to Research Coordinators who will be asked to spend extended periods of time with a participant in close quarters? Who will provide the PPE?

Study team members are responsible for wearing PPE to protect themselves. The PI or other unit director is responsible for ensuring the proper safety equipment is available in your work area per institutional practice and the requirements of the study activities. They are responsible to be sure everyone understands how to properly use it. 

1.In Michigan Medicine facilities, all individuals entering the facilities are provided with a disposable mask which is not allowed to be reused.
2.In study locations outside Michigan Medicine facilities, cloth masks are acceptable. Refer to EHS Face Covering Usage for COVID-19.

Also, all study team personnel are required to take the

Human Research During COVID-19 Training Module

Who is responsible for making sure masks are available for participants?

Use of face coverings must adhere to local public health guidance of the study location.

1.In Michigan Medicine facilities, all individuals entering the facilities are provided with a disposable mask which is not allowed to be reused.
2.In study locations outside Michigan Medicine facilities, cloth masks are acceptable. Refer to EHS Face Covering Usage for COVID-19.

And see the UMOR website section on Safe Research Plans

Who will provide cleaning supplies for the spaces associated with our behavioral clinical trial? I am unsure if we can purchase these items using grant money, but also am not clear if my department will provide them.

The PI or other unit director is responsible for ensuring the proper safety equipment is available in your work area per institutional practice and the requirements of the study activities.

And see the UMOR website section on Safe Research Plans

Some studies were not paused because they were exempt, not "patient facing" or were able to continue virtually. Are those studies we should add to the tiered-start forms we are completing?

Per UMOR’s Guiding Principles for human research during COVID-19

The reactivation requirements do not apply to studies that are and will remain fully remote or do not involve direct contact with human participants, such as data analysis studies that can be conducted remotely.

But, existing and new studies that must complete the Human Research Activation procedure and apply to the Reactivation Committee if seeking to initiate face-to-face interactions with participants, return to U-M facilities, or a return to contact among staff members in any setting.  Every study involving contact with human participants must go through the Human Research Activation Procedures and develop a COVID-19 Safety Plan.

Studies that were modified in order to continue virtually (remotely) should continue in that manner unless activation of in-person activities are necessary and approved by the Reactivation Committee.

Who will be responsible for screening participants entering the building especially when we have very limited staff. How are research projects with very limited budgets expected to afford the increase in PPE costs for staff and patients?

All visitors will be screened upon arrival at any of our hospitals or health centers. Visitors to the hospitals and health centers may bring their own mask or face covering from home, or masks are available at each entrance if they do not have one.

Study teams are responsible for screen participants and any individual(s) accompanying the study participant prior to the start of the study visit (e.g., parent, partner, spouse, child) for a COVID-19  diagnosis and, using current questions from the U-M Daily Health Screen. Ideally this COVID health screen is done 1-3 days BEFORE the scheduled study visit AND at the time of the study visit. Note the UM Daily screen is for employees and UM affiliates only-- as the responses direct people to call OHS. Thus researchers/ studies can refer to these questions for the most current health screen questions but should not direct study participants to the site.

If the participant has a recent COVID-19 diagnosis with the exception of studies related to COVID specifically, or does not pass the U-M Health Screen questions, the study visit must be rescheduled. If the individuals accompanying the participant to the study visit have a recent COVID-19 diagnosis or do not pass the U-M Health Screen, the individuals may not accompany the participant to the study visit, or the study visit must be rescheduled. Study participants and those accompanying them who have a recent diagnosis of COVID-19 or do not pass the U-M Health Screen should not follow the next steps provided by U-M Daily Health Screen because these pathways are specific to U-M personnel.  Instead, these individuals should be encouraged to seek guidance from their health care provider about COVID-19 related concerns.

See the UMOR section on Safe Research Plans

Additionally, UM Environmental Health & Safety has published Re-engagement Resources online.

Sponsors keep requesting information about when they will be allowed back on site for monitoring, site visits, etc. Is there an estimated date that these types of visits may occur?

Study monitor in-person visits

  • Monitor visits should be converted to remote to the fullest extent possible.
  • If in-person monitor visits are needed e.g. for site inspection, MI Governor and Michigan Medicine visitor policies must apply.

Are there any special limitations being placed for bringing together small groups of research participants--group size, food, masking, etc.?

It depends on the activation Tier of the study, the parameters associated with the Tier, and approval by the Reactivation Committee. If a study includes interactions that affect social distancing and use of PPE, this will impact the incremental risk of COVID community transmission and activation Tier assignment.

Which system should I use for e-consent – REDCap or SignNow? What are their differences, etc.”

SignNow is both HIPAA and FDA 21 CFR Part 11 compliant and available for use by UM personnel and students.

The UM REDCap environment is not FDA 21 CFR Part 11 compliant and would not be recommended for use with FDA-regulated research.

Other electronic informed consent platforms may be appropriate. However, if FDA-regulated, the study team will need to provide a vendor statement that the system is FDA 21 CFR 11 compliant. If HIPAA Authorization will be obtained electronically, there should be a vendor statement that the system is HIPAA compliant.

Is it safe to go into participant's homes?

Determining which activities are safe would depend upon the Tier assignment and review process which is not something IRBMED can address.

However, a study must be reactivated under the formal reactivation process before in person activities can take place.

Do Biorepository applications associated with other active projects need to be "reactivated" too? Do they need a "reactivation" survey if the project that it is associated with it has already had a reactivation survey submitted by the PI?

Per UMOR Human research activation procedures:

The reactivation requirements apply to those studies seeking to initiate face-to-face interactions with participants, return to U-M facilities, or a return to contact among staff members in any setting.

Please also see “Can biospecimen collection for research continue if my human research study is not yet activated?” on the UMOR website under, Research Involving Human Subjects.

We made protocol changes to work remotely via an ORIO & plan to continue to do so, despite having a tier 2 study. Will we need to submit a "permanent" change to our protocol, even if changes would not remain in effect if we return to the office full-time?

An Amendment should be submitted in eResearch for study-wide or permanent changes.

Reporting changes via ORIOs is designated for temporary changes that will generally impact one or two subjects. An ORIO approval for a temporary change will become void after it has been implemented and/or completed. For example: if an ORIO was submitted to have remote study procedures for 2 subjects, the ORIO approval will become void after the 2 subjects completed the remote procedures. This ORIO approval will not be applicable to other subjects or other study procedures.

IRBMED strongly encourages the study teams to prepare contingency plans due to COVID-19. These contingency plans should help the study team for continuity of operations in light of COVID-19 and be submitted to IRBMED via Amendments.

Is an amendment necessary if I wish to change the mode of data collection for my exempt study?

Per UMOR FAQs for research involving human subjects, (March 18, 2:55 pm), amendments to change from person-to-person to phone or electronic data collection are not required. Do not submit amendments for these studies.

General Questions from C3RG Seminar on June 30, 2020

Are dental studies considered High risk due to the participant not using PPE when working in the mouth?

Review the UMOR guidance and risk/tier classifications at https://research.umich.edu/covid-19/research-reengagement 

If a protocol is designed to allow patients >65 yo, etc. and possible COVID+, recruiting / performed inpatient - is this high risk?

Review the UMOR guidance and risk/tier classifications at https://research.umich.edu/covid-19/research-reengagement 

Will we have to complete additional reactivation applications for the same study for activities that fall under a higher tier?

Contact UMOR for guidance on risk/tier classification at human-research-activation@umich.edu.

I have a few projects that used Qualtrics (and were IRB approved) as the method for signing consent forms. Is this still okay?

Qualtrics is HIPAA compliant but not compliant with FDA 21 CFR 11. Therefore, Qualtrics should not be used for FDA-regulated studies

Is Rachel Upjohn Building considered to be Michigan Medicine, for research participants coming to this building for testing?

The Rachel Upjohn Building is part of Michigan Medicine.  Contact your department supervisor or administrator for additional information.

What if the study team is under the administration of a different university with less strict guidelines? Whose guidelines should they adhere to?

The UMOR guidelines apply to all approved re-engaged research activities, and all U-M employees entering and exiting those workspaces, regardless of their location. Per UMOR, “The U-M research re-engagement guidelines do not supersede any more stringent safety requirements applicable to a given research project, which must continue to be followed at all times.”  Given the minimal detail provided in this question, contact human-research-activation@umich.edu if you have additional questions.

One of new requirements it to gather contact information from everyone we interact with in research. Do we need/have IRB approval to gather this from people who do not consent to be in the study?

Generally, IRB approval is NOT required when the intent of contact tracing is for public health surveillance or monitoring purposes. However, IRB approval will be required if the study team has plans to utilize the collected contact information for research purposes. The UMOR website provides additional information and specific guidance regarding the contact tracing. This is listed as one of the responsibilities of the study teams as well as the subjects. Visit UMOR for details. 

eResearch Submission Specific Questions from C3RG Seminar on June 30, 2020

If the changes made during COVID were only temporary, will amendments still be required? ORIOs were submitted with a list of temporary changes stating that we will return to "normal" when it's safe to do so.

Amendments will be required if the study team is planning to convert temporary changes (that were approved via ORIOs) into study-wide permanent changes. For additional information, visit IRBMED guidance on time-sensitive modification at https://research.medicine.umich.edu/sites/default/files/res_irbmed_reporting_time_sensitive_changes_06.19.2020.pdf

If my study recruits women ages 18-100, do I need to do an amendment if I’m targeting only women under 65 during this COVID period of high risk?

An Amendment is NOT required when the targeted (or, to-be-enrolled) subject population is as part of the IRB approved subject population.  It would be helpful to indicate this information at the time of annual continuing review, as a note to IRBMED. 

Is the IRB requiring a continuity plan to be submitted as part of a research application for purposes of approval? If so, do you have a template that can be utilized? Or a list of items that should be addressed in the protocol?

IRBMED is not requiring a continuity plan at this time, however, we strongly recommend that the study teams develop contingency plans to support the continuity of operations for either ramp-up or ramp-down. IRBMED has outlined some general considerations for the study teams in preparing contingency plans. This guidance is available on the IRBMED site. Also, IRBMED is currently working on finalizing a template for this purpose, which will also be posted on IRBMED website.

https://research.medicine.umich.edu/our-units/institutional-review-boards-irbmed/irbmed-guidance-covid-19-study-specific-planning

A study was approved pre-ramp down but recruitment had not started, an amendment was submitted and approved to revert to fully remote study activities during ramp down, do we need to submit a re-activation checklist before we can start remote recruitment?

The Human Research Activation Procedure is not applicable when study activities are fully remote and will remain fully remote.

For completely remote studies, should we post correspondence in eResearch to inform IRB that a reactivation checklist will NOT be submitted?

It is not necessary to send a Post Correspondence for this purpose. Only when Activation Approval is required should it be sent to IRBMED via the Post Correspondence activity, on the main study workspace, by selecting IRBMED as a recipient.

Single IRB, Ceded and Multi-site Research related Questions from C3RG Seminar on June 30, 2020

For sIRB studies with UM as the IRB of record, are individual reactivation forms required for each site/institution? If so, how should reactivation forms be completed for participating sites?

In some instances, the UM study team/IRBMED may require that the entire research study be paused during any ramp-down. However, if the study is permitted to continue at all sites, each participating site is required to provide evidence that study reactivation is permitted at their institution under their local parameters.

If the study is ceded and the oversight IRB does not require amendments or re-activation, will we still need to get IRBMED approval? Can we submit a letter from the other IRB stating we can resume study activities when the PI feels it's safe to do so?

Prior to restarting the study at U-M, the study will be required to go through the UMOR Reactivation process per the details located at https://research.umich.edu/covid-19/research-reengagement. The Reactivation Approval letter should be uploaded as a Posted Correspondence in the eResearch ceding application.

We have a multisite study & IRBMED is the sIRB. A umbrella HUM is approved & a separate HUM is approved for UM data collection. We are almost ready to submit a multisite application. For the activation checklist, is this considered existing or new?

This would be considered a new study as the IRB had not reviewed and approved the full study application.

If a study that is regulated by a central IRB has received central approval for electronic consenting, what are the reporting requirements to IRBMED?

If these are new procedures not previously reported in the original ceding application, the study protocol and consent procedures should be updated in the ceding application via an amendment in eResearch. Due to the fact that ceded applications do not have a consent procedures question in section 10, please outline the consent procedures in section 1.8 by starting them as “***COVID Reactivation Consent procedures…”

Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)

2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.