Frequently Asked Questions Regarding COVID-19 And The CIRB
1. What if a participant cannot make their scheduled study visit?
If a participant at a site is unable to complete a required study related activity per the CIRB approved protocol due to COVID-19 or COVID-19 control measures, the investigator must assess whether this constitutes a minor protocol deviation or a major protocol deviation.
The protocol deviation should also be evaluated using the CIRB algorithm and definitions for Serious and/or Continuing Noncompliance (SCNC). Deviations determined to be SCNC must be reported to the CIRB by the site investigator per standard process.
Individual minor protocol deviations that are neither serious nor continuing are typically not reported to the CIRB. However, in the exceptional circumstance with the COVID-19 public health emergency, the CIRB will be reviewing all minor protocol deviations in a log submitted by the Study Chair at the time of continuing review (CR). Local sites should maintain a log of study-specific minor protocol deviations due to COVID-19 and COVID-19 control measures and submit them to the Study Chair through the organization leading the study (e.g., NCTN Group, NCORP Research Base, ETCTN Lead Protocol Organization) at the time of CR. The Lead Organization with the Study Chair will be responsible for submitting a comprehensive list of minor deviations to the CIRB at the time of CR. Please contact the organization leading the study for the template for the log. In some cases, the lead organization may be creating a case report form to help sites collect minor protocol deviations related to the COVID-19 public health emergency.
2. Should I report a minor protocol deviation related to COVID-19 to the CIRB?
As stated above, in the exceptional circumstance with COVID-19, minor protocol deviations that are identified as not SCNC but are related to COVID-19 will be reported at the time of continuing review (CR) to the CIRB. Local sites should maintain a log of study-specific minor protocol deviations due to COVID-19 or COVID-19 control measures and submit them to the Study Chair through the organization leading the study at the time of CR. The Lead Organization with the Study Chair will be responsible for submitting a comprehensive list of minor deviations to the CIRB at the time of CR. Please contact the organization leading the study (e.g., NCTN Group, NCORP Research Base, ETCTN Lead Protocol Organization) for the template for the log or the specific case report form that is being used to collect minor deviations due to COVID-19/COVID-19 control measures.
Protocol deviations which are considered potential Serious and/or Continuing Noncompliance should continue to be reported to the CIRB via the Unanticipated Problem and/or Serious or Continuing Noncompliance Reporting Worksheet.
3. How do I get more information on the CIRB’s standard processes regarding submission of non-compliance?
Please refer to these documents listed below for details on the CIRB’s processes.
REPORTING AUDIT FINDINGS provides instructions for reporting audit findings to the CIRB as potential Serious or Continuing Non-compliance (SCNC).
ALGORITHM TO ASSESS POTENTIAL NONCOMPLIANCE provides an algorithm to assess whether or not an incident is reportable to the CIRB as potential Serious or Continuing Non-compliance (SCNC).
COMPLETING THE UNANTICIPATED PROBLEM AND/OR NONCOMPLIANCE REPORTING WORKSHEET provides instructions for completing the Unanticipated Problem and/or the Noncompliance Reporting Worksheet.
4. Can the study procedures be modified by local sites to address the potential impacts COVID-19?
The regulations allow for modifications to be implemented prior to IRB approval only when it is necessary to eliminate apparent immediate hazards to the subject (§46.108 (a)(3)(iii) and 21 CFR 56.108(a)(4)). If this occurs, the event is considered a deviation from the CIRB approved protocol and should be evaluated. Minor protocol deviations that are neither serious nor continuing should be reported at time of continuing review as stated above. Deviations that meet the definition of SCNC must be reported to the CIRB by the site investigator per standard process.
5. Can participants be seen at another site or by a local healthcare provider?
Yes, the Principal Investigator (Responsible Investigator) may make arrangements for non-research staff (i.e., a Local Healthcare Provider) to provide certain study activities to provide continuity of care and follow-up study visits on an intermittent/short-term basis when a research participant cannot travel to the site location of the Principal Investigator.
Protocol required activities which may occur at the Local Healthcare Provider are outlined in CTEP’s memorandums dated 03/12/2020 and 03/23/2020 and are the following:
- Physical exam(s) and assessment of the patient’s vital signs, temperature, weight, performance status, and other standard assessments may be conducted by the Local Healthcare Provider. All clinical findings and information must be conveyed to the Responsible Investigator overseeing the patient’s care in the study. All decisions must continue to reside with the Responsible Investigator for the patient’s care within the study.
- Clinical laboratory tests may be performed by the Local Healthcare Provider/Local Laboratory with results sent to the Responsible Investigator.
- Blood collections necessary for patient assessment within the study that require evaluation in a central research laboratory may also be collected by the Local Healthcare Provider and shipped to the designated central laboratory under the Responsible Investigator’s oversight. The Responsible Investigator needs to ensure that the Local Healthcare Provider can make these collections depending on the protocol requirements.
- Standard parameters such as ECHO and radiologic imaging may be performed locally with results sent to the Responsible Investigator for review (report and image, if applicable).
- Drug therapy with non-investigational agents may be administered by the Local Healthcare Provider (this includes therapy on treatment arms that do not include investigational agents on IND studies) with appropriate reporting of study therapy administration data and adverse event information to the Responsible Investigator. Standard radiation therapy, surgery, and other interventions that do not require protocol-specified credentialing may also be performed by the Local Healthcare Provider with oversight by the Responsible Investigator.
The activities provided by the Local Healthcare Provider must be conducted under the oversight of the Principal Investigator in accordance with the protocol. In addition, processes must be in place to report all required information from the Local Healthcare Provided to the Principal Investigator.
6. When do I need to notify the CIRB if participants are seen by a Local Healthcare Provider?
The CIRB DOES require notification if a participant is being seen by a Local Healthcare Provider under the following circumstance:
- If a Local Healthcare Provider is providing standard of care treatment under the oversight of the Principal Investigator and the site is not a currently enrolled CIRB site.
Notification should be made by emailing email@example.com the following information:
- Study Number
- Name of Site
- Name of Site PI
- Name of Local Healthcare Provider
- A statement of what activities are being conducted by the Local Healthcare Provider
- A description of how reporting is being accomplished with the site PI
- Confirmation that there is no investigational treatment being provided by the Local Healthcare Provider.
7. When do I NOT need to notify the CIRB if participants are seen by a Local Healthcare Provider?
The CIRB DOES NOT require notification if participants are being seen by a Local Healthcare Provider under the following circumstance:
- If a participant is receiving protocol specific therapy at another CIRB approved site where the study is open
- Institutions that are not a research site but provide study-related medical services that are dictated by the protocol and would typically be performed as part of routine clinical monitoring and/or follow-up of participants enrolled at a study site by study investigators (e.g., medical history, physical examination, assessment of adverse events, blood test, chest X-ray, or CT scan) provided that ALL of the following conditions also are met:
a. the institution does not administer the study interventions being tested or evaluated under
b. the study-related medical services are typically provided by the institution for clinical purposes;
c. the institution does not enroll participants or obtain the informed consent of any subject for
participation in the research; and
d. when appropriate, investigators from an institution engaged in the research retain responsibility for:
i. overseeing protocol-related activities; AND
ii. ensuring appropriate arrangements are made for reporting protocol-related data
to investigators at an engaged institution, including the reporting of safety
monitoring data and adverse events as required under the IRB-approved protocol.
8. Can I utilize Remote Consent procedures at my site due to the COVID-19 public health emergency?
These procedures must be used for any Remote Consent process implemented in response to the COVID-19 public health emergency that requires signature including initial consent, addendum consent, etc.
Remote Consent procedures are defined as follows:
- The participant or their legally-authorized representative (LAR) receives a copy of the informed consent document (e.g., via mail, fax or email) in advance of discussion regarding the study. If mailed, two copies must be mailed so the participant or LAR is able to retain a copy for reference when their signed document is returned to the site and they are waiting to receive the final copy with all necessary signatures back from the site.
- The investigator or designee discusses the study with the potential participant either via telephone or video conferencing. The investigator/designee must have the same consent discussion via telephone/video conferencing that they would have had with the participant or LAR during an in-person meeting. The investigator/designee must also implement a method to ensure the identity of the participant or LAR (e.g., verification of state identification or other identifying documents or use of personal questions or visual methods).
- If the potential participant or LAR agrees to participation, they sign the consent form and return it to the investigator (e.g., via mail, fax or email). If postal mail is used, a pre-paid, self-addressed envelope should be provided to the participant or LAR to mail the signed consent form back to the investigator.
The inclusion of a witness in the Remote Consent Procedures is dictated by local institutional policy and must follow FDA and OHRP requirements. When a witness is required, the research record must document the witness’ name and that they were present for the informed consent process. The inclusion of the witness’ signature on the consent form is dictated by local institutional policy.
- Once the research team receives the signed informed consent document from the participant or LAR, the investigator/designee who conducted the consent process must sign and date the document using the current date. Under the signature line, the investigator/designee must document whether consent was obtained over the telephone or video conferencing, the date of the telephone/video conference, and the date the signed consent was received. For example, “Discussed with [participant or LAR name] via [telephone or videoconferencing] on [insert date] and received signed consent form on [insert date].” Include a brief reason for performing the informed consent discussion over the telephone/videoconferencing.
- If the site has an informed consent policy that requires the witness to sign the consent document, the witness signs the informed consent. If the site does not have an informed consent policy that requires the signature of the witness on the consent document, then the name of the witness along with the date of the original consenting phone call is recorded in the research records to document the participation of the witness.
- The date the investigator/designee signs the informed consent document, not the date the consent discussion with the participant or LAR took place, is the official date of informed consent for the participant on the trial.
- The final informed consent document must be filed in the designated investigator/site regulatory file location. A copy of the final informed consent document, signed by the participant or LAR, the investigator, and the witness (if applicable), must be sent back to the participant via email/scan, fax, or postal mail.
- No research activities related to the study can begin until all steps of the informed consent process are complete.
9. Can I utilize eSignature if allowed by my local institution?
eSignatures, as defined in CIRB SOP section 22.214.171.124, are permitted to be implemented immediately for remote consenting during the COVID-19 public health emergency.
10. Groups have begun issuing study-specific memos with instructions for minor deviations. Where do I find these memos and where do I direct questions about these memos?
The study-specific memos related to COVID-19 are posted by the LPO on the CTSU website in the Supplemental Documents tab. Questions related to the content of these memos should be directed to the LPOs. The CIRB acknowledgement memo is posted on the Amendment tab in the CIRB documents on the CTSU website.
Updated: September 29, 2022