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IRB Guidance for Investigators and Research Coordinators
UPDATED: October 21, 2020
What clinical research can resume accrual and/or research interventions?
All research activities, including those without direct subject benefit and with face to face (F2F) contact, may resume. This includes new subject accrual as well as research intervention subjects already enrolled. However, for research with F2F contact but no direct subject benefit, a safety plan must be first reviewed and approved by the Human Subject Research Safety Review Committee (HSRSRC). The form can be found at https://is.gd/HumanSubjectsSafetyPlan.
All research activities must follow restrictions and guidance imposed by the research site (for example, Nebraska Medicine, UNMC, UNO, CHMC and Bellevue Medical Center). This includes mask, visitor, and social distancing policies of that area.
Before new accrual begins or research activities resume, the investigator must obtain permission from the clinical area where the study is to be conducted. Permission must also be obtained from appropriate support cores (for example, CRC, MEG, research MRI) prior to re-initiating accrual of human subject participants.
Do I need to get approval from the IRB before resuming?
For studies without direct subject benefit, the HSRSRC will notify the IRB when they have approved the safety plan, and the IRB will, in turn, notify the investigator that the research may resume (and release the consent form if needed).
For studies with the prospect of direct benefit, no approval from the IRB, but you should send a message to the IRB through the RSS portal advising that that your study is restarting. You do not need to wait for acknowledgement or permission. If you cannot open the consent, you can message IRB or call an administrator to activate it.
If your protocol was approved by the IRB but not activated due to the institutional requirement, and you believe it is now eligible to start, you should contact the Office of Regulatory Affairs through the RSS message portal.
What about submitting new protocols?
The IRB will continue to review all protocols.
Protocols with F2F contact and no direct subject benefit will need to be reviewed and approved by the Human Subject Research Safety Review Committee (HSRSRC) (https://is.gd/HumanSubjectsSafetyPlan). All new submissions which involve F2F contact will complete section IV of the IRB application which involves COVID-19 infection precautions.
All research involving coronavirus or subjects with COVID-19 must be reviewed and approved by the COVID Research Pre-Review Panel, prior to review by the IRB. Please complete this form before submission.
Should I test subjects for SARS-CoV-2?
Testing of subjects should follow Nebraska Medicine and CHMC Guidelines, as well as requirements of the sponsor or protocol. You should also test subjects when such testing is important to the safety of the research staff.
In addition, you should consider testing if infection of a subject with SARS-CoV-2 might be a confounding factor in interpreting results of the research.
Should I test research personnel for SARS-CoV-2?
All employees must monitor themselves for COVID-19 symptoms, including new onset cough, fever, and other symptoms specified by the CDC. If having any symptoms, they should get tested and isolate from other research personnel or research subjects until testing is complete.
Can the process of consent be conducted by telephone, email or other remote techniques?
Yes, with some restrictions. Please see HRPP Policy 5.3 (Use of a Remote Consent Process)
Of note, the potential subject must have a copy (paper or electronic) of the consent form available to them prior to discussion with the investigator. Unless specifically approved by the IRB, the investigator must obtain a physical signature from the subject on a consent form. That consent form can then be mailed, faxed, or scanned back to the investigator. In some circumstances, a photo of the signed form may be acceptable if the form cannot be returned.
Can I use an electronic signature for the informed consent form?
E-signatures may be acceptable, if appropriately witnessed and/or obtained using certain technologies (like DocuSign or Global Protect). Contact the IRB for details.
There is an RSS E-consent module which is being beta tested, and will be available soon for research which is not Federally funded or not FDA regulated.
Use of this module for FDA regulated or federally funded research is being actively investigated.
If I want to make a change to a protocol in response to the coronavirus pandemic. Is an IRB Request for Change or Protocol Deviation request required?
Changes necessary to eliminate apparent immediate hazards to the subject may be made without prior approval of the IRB (per 45 CFR 46.108(a)(3)(iii), 21 CFR 56.108(a)(4) and HRPP Policy 2.4). The IRB expects that these modifications will be made with due consideration of the importance of subject safety evaluations, and, to the extent possible, of the effects on the scientific aims of the research.
Changes made to the study that are minor (such as to decrease number of study visits, or to give a “window” for a visit), temporary and do not increase the risk of harm to participants or adversely impact the data do not need to be reported to the IRB until the time of continuing review.
Any changes made to the study that are major (for example, changes in method or dose timing of agent administered, major changes in data collection which affect primary endpoints of the research) must be submitted as separate protocol deviations, and reviewed and approved before implementation. A deviation report may encompass multiple incidences of the same event.
Any changes made to the conduct of the study that will be in place indefinitely (that is, after the emergency has passed) must be submitted to the IRB for review as an amendment to the study, and reviewed and approved before implantation.
Before instituting changes in a protocol (other than changes necessary to eliminate apparent immediate hazards), the investigator should contact the sponsor with/through either Sponsored Programs Administration or UNeHealth. The sponsor’s approval should be obtained in writing before instituting the change and retained with study documents. The IRB does not require verification of the sponsor’s concurrence, however the document should be uploaded to RSS.
What about changes which have already been made to reduce risk?
During the COVID emergency the IRB has allowed investigators to implement procedures to minimize risk to subjects without modification to the IRB application or formal approval.
Changes made to the study that were minor (for example, institution of remote consent; changes in frequency, timing or location of research visits; flexibility in scheduling) do not need to be reported to the IRB until the time of continuing review. These changes should be reported within the Continuing Review form, in section I.3 (“If research activities have continued, describe any changes made to research procedures in response to the pandemic.”). These minor changes made due to the COVID pandemic should not be reported as a Single Patient Protocol Deviation or as Protocol non-compliance.
Further, as previous advised, the IRB expects all investigators that have made modifications to their research without specific IRB approval to either revert to the procedures described in the IRB-approved application OR to submit a formal Change Request to the IRB application and have IRB approval of the changes by January 1.
After January 1 any deviation from the IRB approved application will constitute non-compliance.
If possible, the Change Request should be submitted at the time of continuing review. If your study is not due for continuing review before January 1, or does not require continuing review, the Change Request should be submitted at your earliest convenience, but must be received and reviewed by January 1.
All other changes not intended to reduce risk require IRB approval before they can be implemented.
There is no investigator who is authorized to document informed consent available, can I add investigators to my protocol?
Yes. For the duration of the emergency, you can add investigators (including investigators authorized to document consent) by notifying the IRB through the RSS Message Portal or by email. No Request for Change in protocol is required. New investigators must be faculty, fellows, residents or employees of the organization, have completed CITI training, and be qualified by education, training, experience, credentialing and licensure (as applicable) to perform the specific responsibilities described in the protocol.
I paused enrollment of new subjects (or paused all research interventions). Must I still do a continuing review?
Yes. Federal regulations require re-review (continuing review) no less often that yearly. Therefore, CR must be submitted by the investigator and approved by 1 year after initial IRB approval, or the research approval will expire. The Office of Regulatory Affairs will send out reminders that CR is due starting two months prior to deadline. There will be some accommodations made for illness of research personnel (for example, allowing signature by someone other than the PI) on a case by case basis.