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. Have a research question about COVID-19? Submit it here and get a response within one business day.
- Ensure that adequate study staff and resources are available before you start the study.
- Confirm that investigational product and clinical supplies will continue to be accessible throughout the study.
- Consider delaying enrollment if study procedures may be impacted by the pandemic or submit a protocol modification to the IRB to change the procedures.
Note: Screening questions relating to COVID-19 are not considered research questions unless you will be collecting data on COVID-19.
Sterling initially published guidance based on the assumption that changes made to the protocol due to the pandemic would be short-term. We are revising our instructions on reporting protocol changes now that it is apparent that research may be impacted for some time into the future or permanently.
If you are changing the conduct of the protocol permanently or for an indefinite time, please submit an amendment. This can be done in a reasonable time frame after initiating any changes required to eliminate immediate hazards to participant safety. Please note that most temporary changes are likely to continue for an indefinite time and should be submitted as a study amendment.
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 study participants were impacted and how those study participants were impacted.
If there is a change in the administration or shipping of a study drug, in most cases, this will need to be reported to the IRB since in-hospital/office/clinic monitoring will not be available to participants at their homes.
At continuing review, we are asking investigators to confirm that:
- Any changes to procedures in response to the pandemic (e.g., changing from in-person visits to remote visits, obtaining consent remotely) have been documented and communicated to the sponsor.
- Any changes made to the conduct of the study that will be in place indefinitely have been submitted to the IRB for review as an amendment to the study or administrative letter.
- Any changes made to the study that are minor, temporary, and do not increase the risk of harm to participants or adversely impact the data have been documented as minor deviations.
- Any changes made to the study that are major deviations (including changes in administration of study drug) have been submitted to the IRB for review.
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 nonsignificant deviations, please refer to Sterling IRB’s Handbook.
Any change implemented to manage study conduct during disruption of the study as a result of COVID-19 control measures must be documented per FDA.
- A listing of all participants affected by the COVID-19 related study disruption must be documented. This documentation should include unique participant number identifier, investigational site, and a description of how the individual’s participation was altered.
- 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 nontherapeutic 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.
Sterling IRB recommends that participants be advised of changes in study visits by letter or other form of communication. Reconsent 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.
Please note that if you do elect to reconsent your research participants, the new/revised consent document must be submitted for IRB review and approval.
If home visits are substituted for in-office study visits, the following change in risks should be considered:
- Will the study staff be wearing personal protective equipment (PPE)?
- What other safety protocols are needed to protect a participant from exposure when inviting study staff into their home?
- How will the health status of the study staff going into the home be evaluated prior to entering the participant’s home?
Remote visits via telephone, telemedicine, Skype, Facetime, or other appropriate virtual communication may be substituted for a visit to an office, hospital, or clinic without prior review by the IRB. A substitution of a remote visit would not be a protocol deviation if it does not increase harm to participants and would not need to be reported to the IRB. If there is a harm to participants from not going to an in-office visit, the study team should take whatever steps are appropriate and necessary to mitigate that harm and report those actions, in as reasonable a time frame as possible, to the IRB. If remote visits will continue for an indefinite period, a study amendment should be submitted.
Screening questions relating to COVID-19 are not considered research questions unless you will be collecting data on COVID-19.
If the changes to the study involve study-specific testing for respiratory symptoms and clarification regarding cost of the PCP visit and testing, they do not alter the fundamental consent to the study. No new consent to participate in the study is required. Such changes can be provided to the participants by way of a letter or other documented means of communication. If these changes may continue for an indefinite period of time, they should be submitted as a study amendment.
If participants are not able to come to the site for drug dispensation, study drugs may be shipped to participants provided that:
- It does not increase the risk of harm (e.g., it would not increase the risk of harm if participants are taking drugs orally, but if drugs are normally injected by staff at the study site, it would increase the risk to ship the drug directly to the participant for self-administration)
- FDA and sponsor drug accountability requirements, state law, and pharmacy requirements allow for shipment (e.g., sponsors should be consulted about shipping investigational products).
- Any changes to the protocol to allow drug shipment should be documented in writing (a letter as an amendment is sufficient) and submitted to the IRB.
- Some study drugs may be administered using home nursing or alternative sites by trained, but non-study, personnel. Sterling recommends that you consult the FDA review divisions on plans for alternative administration of the study drug.
For further guidance regarding the administration of investigational product, please refer to the FDA Guidance regarding the Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic.
Methods of obtaining informed consent other than a face-to-face consent interview may still be acceptable if those methods allow for an adequate exchange of information and documentation, and a method to ensure that the signer of the consent form is the person who plans to enroll as a participant in the clinical investigation, or is the legally authorized representative (LAR) of the trial participant. For example, the consent form may be sent to the trial participant or their LAR by facsimile or email, and the consent interview may then be conducted by telephone when the participant or their LAR can read the consent form during the discussion. After the consent discussion, the participant or their LAR can sign and date the consent form. Options for returning the document to the clinical investigator may include facsimile, a photographic image sent through electronic means, scanning the consent form and returning it through a secure email account, or posting it to a secure internet address, especially if there are concerns about having the participant mail a potentially contaminated consent document. Alternatively, the participant may bring the signed and dated consent form to his/her next visit to the clinical site, or mail it to the clinical investigator. The case history for each participant must document that informed consent was obtained prior to participation in the trial. In addition, the person signing the consent form must receive a copy of the consent form. Although FDA regulations do not require the trial participant’s copy to be a signed copy, FDA recommends that a copy of the signed consent form be provided. The participant or their LAR must sign and date the informed consent form before the investigator may conduct any study-related procedures involving the participant.
Where it is not feasible for investigators to receive the signed consent form prior to beginning study-related procedures, the investigators should have the prospective trial participant or legally authorized representative confirm verbally during the consent interview that the participant or legally authorized representative has signed and dated the form.
The remote consenting approach must be reviewed and approved by Sterling IRB as required by FDA regulations.
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:
- The method used for communication with the prospective research participant and the specific means by which the prospective research participant communicated agreement to take part in the study should be documented.
- An impartial witness should be present (physically or by phone or video conference) during the entire consent process.
When individuals cannot print and sign a paper copy of the consent form provided by the investigator or person obtaining consent, they cannot electronically sign the consent form, and providing a paper copy of the consent form via mail/courier is not feasible within the time frame for enrollment into the research study, the investigator may consider using the following alternative process to satisfy FDA requirements for obtaining and documenting informed consent:
- The investigator/designee provides the prospective participant (or LAR) with an electronic version of the ICF.
- The investigator/designee arranges a telephone call or videoconference call with the prospective participant (or LAR), the investigator/designee, a witness who is not otherwise connected with the research study, and additional participants requested by the prospective participant (e.g., next of kin). Instead of having a witness present, a recording of the conversation can be made.
- To ensure the prospective participant (or LAR) is approached in a consistent fashion, a standard process should be used that will accomplish the following:
- Identification of who is on the call
- Review of the consent form with the prospective participant (or LAR) by the investigator/designee
- Any questions the prospective participant (or LAR) may have are answered by the investigator/designee
- Verbal confirmation by the participant (or LAR) that they signed and dated a blank piece of paper with a written statement that they voluntarily agree to participate in the protocol, noting both the protocol “number” and brief protocol title
- After signing and dating the newly created document, the study participant (or LAR) sends a photograph of the signed and dated statement by fax, text message, or email to the investigator/designee, or returns the document to the investigator by mail at a later date or at a future study visit that might occur in person.
- When using a witness, documentation in the study record includes a signed and dated attestation by the witness who participated on the call that the participant confirmed their agreement to participate in the study and signed the document referenced above.
- If a recording is used instead of a witness, documentation in the study record should include the recording of the conference call.
- After the signed and dated document is received by study staff, it should be attached to a copy of the consent form that was reviewed with the study participant (or LAR) and kept in the study record.
- The investigator/designee should prepare a note to file, explaining the circumstances of why informed consent was obtained through an alternative method.
This alternative approach must be reviewed and approved by Sterling IRB as required by FDA regulations.
Disclosures to Prevent a Serious and Imminent Threat: Health care providers may share patient information with anyone as necessary to prevent or lessen a serious and imminent threat to the health and safety of a person or the public – consistent with applicable law (such as state statutes, regulations, or case law) and the provider’s standards of ethical conduct. Thus, providers may disclose a patient’s health information to anyone who is in a position to prevent or lessen the serious and imminent threat, including family, friends, caregivers, and law enforcement without a patient’s permission. HIPAA expressly defers to the professional judgment of health professionals in making determinations about the nature and severity of the threat to health and safety. For more information, see 45 CFR 164.512(j).
Disclosures to Family, Friends, and Others Involved in an Individual’s Care and for Notification: The covered entity should get verbal permission from individuals or otherwise be able to reasonably infer that the patient does not object, when possible. If the individual is incapacitated or not available, covered entities may share information for these purposes if, in their professional judgment, doing so is in the patient’s best interest.
Changes from in-person monitoring to centralized or remote monitoring do not require submission to Sterling IRB.
FDA recognizes that monitors may not be able to access the research sites for on-site visits in a timely manner during the COVID-19 pandemic. Sponsors should work to find alternative approaches to maintain research participant safety and clinical trial data quality and integrity, such as enhanced central monitoring, telephone contact with the sites to review study procedures, research participant status and study progress, or remote monitoring of individual enrolled research participants, where appropriate and feasible. FDA recognizes that delays in on-site monitoring may result in delayed identification of GCP noncompliance (including major protocol deviations) at the clinical trial site(s) (including protocol deviations not due to the impact of COVID-19). Sponsors should carefully document situations where monitors were unable to access, or had to delay, monitoring of a clinical site.
Sponsors/monitors should also include in their documentation of protocol deviations or other GCP noncompliance issues identified at research sites whether delayed identification was due to postponed monitoring. FDA recognizes that unique situations at research sites will occur due to COVID-19 control measures and will consider these circumstances when evaluating inspectional observations.
The Office of Civil Rights (OCR) has published the Bulletin: HIPAA Privacy and Novel Coronavirus advising covered entities of further flexibilities available to them as well as obligations that remain in effect under HIPAA as they respond to crises or emergencies.
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.
Telemedicine is an acceptable option where it can adequately replace an in-person physical examination.
For the purpose of HIPAA, the HHS Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency waives penalties for noncompliance with HIPAA. OCR will exercise its enforcement discretion and will not impose penalties for noncompliance with the regulatory requirements under the HIPAA Rules against covered healthcare providers in connection with the good faith provision of telehealth during the COVID-19 nationwide public health emergency. This notification is effective immediately.
HIPAA Compliance and Telemedicine Application Vendors
The OCR guidance Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency identifies the following popular video chat applications that may be used to help provide telehealth visits during the COVID-19 public health emergency:
- Apple FaceTime
- Facebook Messenger video chat
- Google Hangouts video
Providers are encouraged to notify patients that these third-party applications potentially introduce privacy risks. Providers should enable all available encryption and privacy modes when using such applications.
Vendors that represent that they provide HIPAA-compliant video communication products and that they will enter into a HIPAA business associate agreement (BAA) include:
- Skype for Business
- Zoom for Healthcare
- Google G Suite Hangouts Meet
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.
Currently, 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.
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 regarding the Conduct of Clinical Trials of Medical Products during the COVID-19 Public Health Emergency.
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 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. However, Sterling IRB will issue an acknowledgement of this communication, if requested.
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.