Sterling IRB has prepared the following guidance to address your questions regarding the impact of COVID-19 on ongoing clinical trials. We will update this page as new information becomes available.
Changes in Research
Changes that impact the entire study and are permanent should be submitted to the IRB as an amendment. Changes may be submitted via a letter, memo or note to file pending a full study amendment. For sponsors with multiple studies affected by the same protocol change (e.g., use of telehealth for study visits) a single letter may be submitted to Sterling IRB as a “generic item.” While changes made to minimize or eliminate immediate safety hazards to participants may be implemented prior to IRB review and approval, we encourage you to contact Sterling IRB as early as possible when changes to the study are anticipated as a result of COVID-19. Temporary changes to the research protocol do not require notification to Sterling IRB unless:
- There is an increased risk of harm to participants; or
- The integrity of the data will be adversely impacted.
Only protocol deviations that meet Sterling IRB’s standard definition of a significant protocol deviation require reporting.
Please see Sterling IRB’s definition of a significant protocol deviation below:
Significant Deviation: A protocol deviation that affects the scientific design/integrity of the study; affects the rights, safety, or welfare of study subjects; changes the risk/benefit ratio; or violates an ethical principle.
Example: If individuals are not able to travel for an in-person visit because of concerns related to COVID-19, that is a minor deviation and does not need to be reported unless it impacts the risk to the participant.
For additional examples of significant and non-significant deviations, please refer to Sterling IRB’s Investigator Handbook.
- A halt or delay in enrollment does not require reporting to Sterling IRB, but it should be reported to the sponsor.
- A total suspension of a non-therapeutic trial does not require reporting to Sterling IRB, but it should be reported to the sponsor.
- A total suspension of a therapeutic trial should be reported to the IRB if participants are enrolled and may be at risk due to the discontinuance of study procedures. The report should include a plan for managing those risks. This suspension should also be reported to the sponsor.
Informed Consent / Notifying Participants of Changes to Study Visit Procedures
Sterling IRB recommends that participants be advised of changes in study visits by letter or other form of communication. Re-consent is not required, and the letter does not need to be submitted to the IRB. However, Sterling IRB will issue an acknowledgement of the communication if requested.
Electronic Informed Consent
- The research participant may receive the informed consent in person or via email, mail or fax, take a picture of the signed informed consent and send it to the study team.
- The clinical team may conduct the research consenting process if it is documented that they were educated in what the research involves so that they can knowledgeably consent someone to the research. This should be documented in the study records.
If a research participant is unable to physically sign the informed consent or if there is a request for a participant not to physically sign the informed consent, the following procedure should be followed pursuant to the FDA Guidance on Informed Consent:
- The method used for communication with the prospective subject and the specific means by which the prospective subject communicated agreement to participate in the study should be documented.
- An impartial witness should be present (physically or by phone or video conference) during the entire consent process.
A waiver of documentation of informed consent would not be required in this instance.
Changes from in-person monitoring to centralized or remote monitoring do not require submission to Sterling IRB.
HIPAA Compliance / Telemedicine
The Office of Civil Rights has issued a limited waiver of HIPAA sanctions due to Coronavirus. The Office of Civil Rights is encouraging health providers to serve patients wherever they are during this national public health emergency. This provision applies to the good faith provision of all telehealth services provided during the COVID-19 nationwide public health emergency, regardless of whether the service is directly related to the diagnosis or treatment related to COVID-19 health conditions.
Maintenance of Research Records
Sponsors and investigators must maintain required research records for a period of two years after the date the investigation is completed or terminated or the records are no longer required to support a marketing application, whichever date is later. An investigator or sponsor may withdraw from the responsibility to maintain records for the time required by transferring custody to another person who will accept responsibility for them. If an investigator or sponsor transfers custody of the records to another person, FDA must be notified within 10 working days after the transfer occurs.
At this time, there is limited guidance available regarding the temporary transfer of custody of research records due to COVID-19. Sterling IRB recommends that Sponsors and/or Investigators contact the appropriate FDA review division for further information pertaining to the requirement for FDA notification.
Changes/Updates to the Form FDA 1572
If investigational product will be administered at a participant’s home, the FDA Guidance, Frequently Asked Questions – Statement of Investigator (Form FDA 1572), notes that the subjects’ home addresses do not have to be listed on the 1572. Study records should reflect that the test article was administered at the subject’s home.
For further guidance regarding the administration of investigational product, please refer to the FDA Guidance that was issued on March 18, 2020 regarding the Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic.
New Research Protocols
- Ensure that you have adequate study staff and resources before you begin conducting the study.
- Consider delaying enrollment if your study procedures may be impacted by the pandemic, or submit a protocol modification to the IRB to change the procedures.
- Screening questions relating to COVID-19 are not considered research questions unless you will be collecting data on COVID-19.
IRB Notification of Study Holds, Suspensions or Terminations
Sterling IRB requires IRB notification of a study hold/suspension or termination imposed by the institution, sponsor/CRO, investigator, other reviewing IRB, other government agency, or other party. Sterling is waiving this requirement for 120 days (through July 30, 2020) during the COVID-19 pandemic, except where the institutional suspension or termination relates to noncompliance by an investigator or identification of safety issues impacting study participants.
Measures should be in place to ensure that research participants are properly informed of any suspensions/termination and that any procedures needed for participant follow-up are in place.
As indicated in the guidance published by the FDA regarding COVID-19, the implementation of alternative processes should be consistent with the protocol to the extent possible, and sponsors and clinical investigators should document the reason for any contingency measures implemented. Sponsors and clinical investigators should document how restrictions related to COVID-19 led to the changes in study conduct and duration of those changes and indicate which trial participants were impacted and how those trial participants were impacted.