COVID-19: Impact on Human Subjects Research

See Communicating with Research Subjects Remotely - added 4/13/2020

FAQs below updated 4/11/2020; 10:40am

The following FAQs pertain to the human subjects research pause addressed in the memos issued to IRB protocol principal investigators on March 6, 2020 (CUIMC) and March 11, 2020 (Morningside) by the IRB, as well as human subjects research affected by the research ramp-down, effective March 19, 2020.

On-going trials that involve in-person contact with study participants, and offer the prospect of direct potential benefit to participants may continue for enrolled subjects, if the IRB has so determined. Non-trial research done wholly in the hospital or other clinical settings, that was previously allowed to continue because it did not involve participants coming to additional visits, are now halted. Studies that do not involve in-person contact with study participants may also continue.

No, with the exception of trials directly related to COVID-19, subject to the approval of the Executive Vice President for Health Sciences.

No. New enrollment in all clinical trials must cease, if any study procedures involve in-person contact with study participants.

Yes, the Research Pharmacy and the Infusion Suite will remain open.

Clinical laboratories in NYP and the Department of Pathology will continue to operate. Research laboratories that process specimens or perform assays or tests for ongoing clinical trials may be considered essential. To continue such activities, an exception should be requested to the IRB including the IRB protocol number and project title, the critical importance of the laboratory activity to the protocol, and the number of tests or specimens predicted per week.

Yes. The IRB and the sponsor should be informed and the fact that a visit is done in this way should be noted in the study documentation. A modification to your protocol does not need to be submitted until the time of your next renewal or modification that is being submitted for other changes, however, the IRB must be notified of the change by email to irboffice@columbia.edu.

The study team should first assess whether a visit can be conducted in an alternative method (e.g., phone contact, virtual visit, alternative location for assessment, including local labs or imaging centers).  If an alternative method is not possible, and the study participant must be seen on-site, the study team should adhere to the following guidance:

  • Participants should be called prior to their scheduled visit and screened on the phone for new onset (in last 7 days) of symptoms of possible COVID-19 (fever >=100.4, cough, shortness of breath, and/or sore throat) that cannot be attributed to an underlying or previously recognized condition. If any symptoms are present, advise the participant not to come in and to contact their provider/health facility; the visit should be rescheduled, if possible. If the screen is negative, and participant wishes to proceed with a visit, they are invited to come to the research site.
  • When a participant arrives at the research site, the research staff should re-ask the screening questions (ideally outside or away from other participants in the waiting area). If the screen is positive, the participant should be advised to contact their provider/health facility, and reminded about contact and droplet precautions. If negative, they can be allowed into the research site. Staff screening a research participant in person should keep at least six feet apart.
  • Study visits should be staggered so there is no congregation of participants at the research site and to maintain 6 feet of separation between participants.
  • Participants should be advised that if they experience a new onset of symptoms described above, they need to contact their provider/health care facility and call the research team to inform them.

Given the current COVID-19 coronavirus outbreak, and the real or perceived risk of exposure, the risk/benefit ratio for research participation has been reassessed for each protocol. Ethical principles of research and federal regulations for the protection of human research participants require an acceptable risk/benefit ratio. The PI for each study has been notified of the outcome of this assessment, and advised whether study procedures involving in-person contact with study participants must pause, or can continue.  If the IRB has received notification that study procedures have been modified to avoid in-person contact with study participants, this has been acknowledged.

Studies for which there is little to no prospect of direct benefit to participants 

Study procedures involving in-person contact with participants must be paused, effective immediately or as soon as can be implemented. Procedures such as telephone contact or monitoring or remote data collection if part of such studies may continue. 

Studies for which there is direct benefit to participants 

These studies may continue, if the IRB has so determined. To the extent possible, study activities that can be done remotely by telephone or electronically should be done in this way.

Note that COVID-19 studies may involve in-person contact if approved by the IRB.

These should be paused, or modified to remove in-person contact (by anyone) with study subjects. The IRB should be notified via an email to irboffice@columbia.edu that there is a change.

Yes. Sponsored Projects Administration (SPA) has issued an initial institutional notification to NIH and other major sponsors. After the IRB makes specific protocol determinations, they will be providing SPA with information concerning those protocols that will require a pause and follow-up communications will be sent by SPA for all impacted grants. SPA will notify each Pl prior to issuing a follow-up notification to a sponsor. All communication to external sponsors must be issued from SPA. For questions concerning your NIH- and other government or foundation sponsored studies, please contact your SPA Project Officer; for your industry-sponsored studies, please contact the CTO at ctosubmission@columbia.edu.

All study-related activities that are not affected by a pause can continue to be charged as normal. However, current prior approval requirements remain in effect if a PD/PI is absent from a project of 3 months or more. See Allowable Costs FAQs for more information.

Yes. If your study is impacted, your SPA Project Officer will provide you with guidance on how and where this should be included in your progress report (i.e., in Section F.2 of a NIH RPPR). about what information should be included.

Most federal sponsors allow for a one-time no cost extension for 12 months at the end of the project. Please discuss your specific project with your SPA Project Officer, who will provide guidance on the options available to you. For more information about prior approvals, go to _______.

Yes. The FDA will need to be notified. Contact Helen Kim and the IND/IDE Assistance Program (indhelp@cumc.columbia.edu) for specific guidance and information on the notification process.

If the study needs to be paused, the sponsor will need to be notified. Contact the Clinical Trials Office at ctosubmission@columbia.edu for the notification process.

No, for purposes of the pause, it is assumed that trials with investigational treatments, including drugs and devices, provide the potential for benefit and should continue, unless the IRB has determined otherwise.. However, no new subjects can be enrolled.

Yes. There is no increased risk to subjects relating to COVID-19.

Yes. There is no increased risk to subjects relating to COVID-19.

No. While the real or potential risk to participants of traveling to a research site, and aggregation at the site, are absent from home visits, there may still be real or apparent risk.

No. It is not necessary to submit a modification, however, the IRB must be notified of the change by email to irboffice@columbia.edu.

The wording and language may need to be specific to each study. The guidance is as follows:

Due to the potential or perceived risks of COVID-19, Columbia University has paused human subjects research studies involving direct subject contact that provide little or no potential benefit to subjects. These studies will be able to maintain telephone contact and remote data collection activities during this pause and may resume when the risk of COVID-19 has passed.

If a study is deemed to have potential benefit to individual subjects, the study may continue, if so determined by the IRB, unless there is concern that the risks from COVID-19 outweigh the potential benefits to subjects. Study-by-study guidance should be obtained from the IRB. Studies that are determined to not provide direct potential benefit to subjects must be paused. Investigators may present a risk/benefit analysis to the IRB that takes into account the prevalence of COVID-19 in the areas where the study is being conducted.

Yes. The same ethical issues relating to the changed risk/benefit ratio that apply study sites on a Columbia campus apply elsewhere.

For Columbia research sites, this guidance applies, whether physically at a Columbia campus, at a practice site, or elsewhere. The same rationale applies regarding the risks relating to COVID-19.

You should inform the study sponsor and/or the overall Pl of the study of the modified procedures and what documentation requirements will need to be modified (e.g., changes to CRFs, etc.).

The IRB needs to be notified at the time the change is implemented, by email to irboffice@columbia.edu.  You will also need to formally report the pause or change to the Columbia IRB at the time of your next submission (e.g., modification or renewal) or sooner if directed by the IRB.

You should inform the study sponsor and/or the overall Pl of the study of the modified procedures and what documentation requirements will need to be modified (e.g., changes to CRFs, etc.). You will also need to report the pause or change to the Columbia IRB at the time of your next submission (e.g., modification or renewal) or sooner if directed by the IRB.

Yes, as soon as feasible. The regulations allow implementation of a change to study procedures without prospective IRB approval when it is necessary to avoid imminent hazards to subjects. The IRB of Record will need to approve resumption of study procedures.

The IRB has drafted language that can and should be used in discussions, e.g., by email, telephone or online, with participants to explain why study procedures are being paused or modified to remove in-person study visits.

Participants of protocols where procedures will be modified to remote contact:

We value your participation in a research study conducted by Columbia University. To reduce the chance of spread of the virus that causes COVID-19, the University has decided to move as many research procedures as possible from in-person to phone or online contact.  Your study will change [in person interviews/questionnaires/follow up visits, etc.] to remote [interviews/questionnaires/follow up visits, etc] for now.  In-person study procedures will resume when it is safe to do so.

For more information about Coronavirus Disease, the Centers for Disease Control and Prevention provides updated information and useful information, visit https://www.cdc.gov/coronavirus/2019-ncov/index.html.” 

Participants of protocols where study procedures will be paused:

We value your participation in a research study conducted by Columbia University. The University has decided to pause study procedures that involve in-person contact for this study to reduce the chance of spread of the virus that causes COVID-19.  [If applicable, add: Study procedures that do not involve in-person visits will continue.]  In-person study procedures are expected to resume when it is safe to do so. We will contact you when that occurs.  

For more information about Coronavirus Disease, the Centers for Disease Control and Prevention provides updated information and useful information, visit https://www.cdc.gov/coronavirus/2019-ncov/index.html

Yes, new applications for non-COVID-19 related research can be submitted in Rascal and will be processed by HRPO staff and the IRB. Note, however, that new applications with a focus on COVID-19 will be given priority and thus the process and review of other new applications may be delayed as a result.

Yes, the IRB is functioning as usual at this time. HRPO staff will continue assessing each event submitted in Rascal and determine the priority for review. At this time review of Unanticipated problems (UPs) and all COVID-19 related research will be processed first over the following events:

  • Renewals for interventional studies or studies where subjects are on study drug (initial and resubmission)
  • Substantive modifications affecting risk (initial & resubmission)
  • Closures

The IRBs will continue to meet as per the IRB meeting schedule, however ad-hoc meetings to review COVID-19 related protocols are also scheduled as necessary to ensure rapid review of these protocols.

Guidance will be provided at a later date.