March 12, 2020

Human subject research in the time of Coronavirus (COVID-19)

Please continue to watch this space, as conditions related to the spread of coronavirus seem to change at least hourly.

Last updated 6/3/20  4:45 pm with a link to updated TRI/institutional guidance about research during Covid-19. 

Q. Will the IRB office remain open?

A. Yes. However, we plan to work from home, so we ask for your help in keeping the lines of communication open. You can always reach us via email.  If you call our main number and no one answers, please leave a voicemail. We will check voicemails frequently. Also, we plan to continue holding our convened meetings as agenda items warrant, although we may switch to a videoconference or conference call format, as conditions warrant.

Q. Will the IRB review research related to the Covid-19 situation?

A. Yes. The IRB will do what it can to get these projects approved quickly. Note that IRB approval is only one part of the approval process — and it’s the final step. The reviews and approval that occur prior to IRB review are outside the IRB’s purview.

Q. Should research studies involving direct subject interaction continue at this time?

A. The IRB can offer no overall guidance on this question at this time. We feel the PIs and clinicians involved in the research are best qualified to determine whether their studies can safely continue as is, continue with modifications, or if they should be halted until things return to something resembling normal. Note that specific study sponsors, divisions, departments, or clinical areas may provide more specific guidance regarding the continuation of research, and affected researchers should follow that guidance.  In the absence of any area-specific guidance, PIs and clinicians are encouraged to make whatever decision maximizes the safety of both the research subjects and the study team, as always. Some considerations to keep in mind as you make the decision whether or not to continue include:

  • Some parts of the UAMS campus have established access restrictions that may make it difficult for some study participants to access they study site, particularly if they usually have someone accompanying them for visits.
  • Research staff or care resources may need to be redirected to patient care.
  • Some studies lend themselves to virtual participant encounters better than others do.
  • Some interventional studies may potentially have direct benefit for participants and/or halting study interactions may increase risks for participants.
  • Research sponsors or external IRBs, if you are relying on an external IRB, may have different requirements for halting studies at this time.

In addition, Arkansas Children’s Research Institute and the UAMS Translational Research Institute have issued separate guidance pertaining to research in which they are involved. Please click on the links for more information. The Food and Drug Administration (FDA) has also broken all kinds of speed records in releasing guidances relating to the products it regulates and their use during the Covid-19 emergency, including a guidance on the conduct of clinical trials during the pandemic. The federal Office for Human Research Protections also released guidance April 9th pertaining to studies subject to the Common Rule.

Q. Will the IRB allow flexibility in obtaining and documenting informed consent, since in-person interactions may increase risk?

A. The UAMS IRB always encourages flexibility and creative thinking in the informed consent process, and current conditions are good motivation to think about different ways of obtaining and documenting informed consent. Would your study qualify for a waiver of documentation of consent? If so, getting consent by phone may be appropriate, and eliminate the need for an in-person contact that may increase risk. Can you email the participant the consent form and then have a phone discussion? If consent forms are emailed, will everybody be able to print it, sign it, and rescan it to email it back? Or should you consider a typed signature or a return email indicating willingness to participate an alternative form of documentation? Depending on the type of study, any of these options may be approvable. Like any other consent process, these alternative consent processes should be approved by the IRB before being implemented, if possible. If you need to revise your consent process right away in an ongoing study to eliminate an apparent immediate risk to subjects, you can do so, but please submit a protocol amendment describing the change ASAP.

Q. Are there additional things I should consider when documenting consent processes during the Covid-19 pandemic?

A. Yes. See this blog item about documenting atypical consent processes. While this is useful information for documenting any consent process, it is particularly applicable to consent processes that are not the usual “discuss directly with the subject in person and have the person sign” way of obtaining and documenting consent.

Q. Will the IRB ask me to address Covid-19 adaptations in my current new submissions, continuing reviews, and modifications?

A. Yes. If your study involves direct subject contact, please address whether you will make any changes to promote subject and staff safety during the Covid-19 pandemic.

Q. What do I need to do if I want to continue collecting data and interacting with human subjects while the Covid-19 situation is still unfolding?

A. Consider revising your protocol to allow data collection and interaction without in-person subject contact. For example, if people are coming in for interviews that you could do by phone or videoconference, such as Skype, consider using one of these alternative contact methods. Also revise your current protocol to work from home or to allow greater flexibility in scheduling in-person follow-ups, if appropriate. If you must continue to have study visits and these visits cannot be done remotely, please be sure you are familiar with and follow any appropriate clinical area or institution policies regarding these in-person contacts.

See also our separate blog item about obtaining informed consent while this pandemic continues.

Q. These are unusual times. Do I still need to submit a formal protocol modification and have it approved before implementing protocol changes related to using alternative methods to contact subjects?

A. Sort of. We are taking the stance this is one of those vanishingly rare protocol changes that eliminates an apparent immediate hazard to subjects, and therefore can be implemented immediately if you are unable to get IRB approval first. So go ahead and implement changes that reduce interpersonal contact, but please submit a protocol modification describing this change as soon as possible. When you submit the modification, please indicate whether it has already been implemented and, if so, the number of subjects to which it has already been applied. Including this information will meet the regulatory requirement of reporting this prior implementation to the IRB.

Q. How can I get these modifications approved quickly?

A. The IRB office is prepared to review modifications as they come in to see which are changes that need to be approved quickly to minimize disruptions to ongoing research. Here are some tips to help speed approval:

  • Review your protocol closely to see if it indeed requires modification. For example, if the protocol says you will contact subjects by phone and all calls will be made from a private room, that language is general enough to allow calling from home, assuming your study staff can create a private space at home from which to call. However, if you specified that calls will be made from an office in a particular on-campus building, you will need to revise the protocol to allow staff to make calls from home.
  • If a protocol modification is required, make the change general enough such that you don’t need to remodify the protocol once conditions change such that you can return to your original plan. Example: Instead of holding in-person interviews, you’re switching to Skype for now. Revise the protocol to allow your team to do interviews either in person or by Skype, as conditions may warrant. Don’t say that you’ll be switching entirely to Skype if you may revert to in-person interviews in the future.
  • Make any protocol amendments specific to the changing conditions right now. The IRB office can process a simple amendment related only to the method of subject contact fairly quickly. Adding more substantive protocol changes requiring the IRB to consider whether study’s risk/benefit ratio has changed will slow approvals.
  • Note in the modification form that the change is being made to adapt to coronavirus-related conditions. This language will help the IRB office identify these modifications and process them quickly.

Q.  What do I need to do if I want to put my study on hold because I think it would be safer to do so?

A.  You can go ahead and stop your study before notifying the IRB of the change, since you are eliminating an apparent immediate risk. However, please submit a modification to the IRB indicating that the study is on hold for Covid-19-related reasons. Include a description of any steps you will take to ensure the study can be held safely. Also indicate if you plan to reopen the study in the future. If the situation is such that you have no choice but to close the study, please submit a closure form, also including a description of any steps you will take to ensure any subject participation wraps up safely.

Q.  My study is being reviewed by an external IRB. What should I do?

A.  Consult the external IRB for specific guidance, keeping in mind any site-specific requirements or resource constraints that may impede the ability to carry out research at this time.

Q. Why should studies be “held” or “closed” rather than “suspended” or “terminated”?

A. Because suspensions and terminations need to be reported to federal oversight agencies in some cases, whereas holds and closures do not.