mdi ConsultantsFDA Update – July 9, 2020
Updated Q&A Appendix for guidance Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency
This is some interesting information on problems companies had conducting clinical trials during this Pandemic Crisis.
The FDA made a recent update to the guidance document titled Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. The updated guidance clarifies two previous methods for obtaining informed consent from a hospitalized patient in isolation as well as including a new question and answer in regards obtaining informed consent from a prospective trial participant in certain circumstances. This includes where the enrollment timeframe is limited and the patient can receive a copy of informed consent document electronically but cannot sign it. The new update also clarifies recommendations on documenting details when using video conferencing for trial visits.
Q10. How do I obtain signed informed consent from a hospitalized patient who is in isolation when a COVID-19 infection control policy prevents us from entering the patient’s room to collect a signed informed consent form?
FDA regulations generally require that the informed consent of a trial participant (in this case a hospitalized patient) be documented by the use of a written consent document that typically includes the elements of informed consent, as described in 21 CFR 50.25, and that has been approved by the IRB and signed and dated by the trial participant or their legally authorized representative at the time of consent (21 CFR 50.27(a)). When feasible, we recommend a traditional method of obtaining and documenting informed consent using a signed paper copy of the consent form, or use of electronic informed consent. If neither of these approaches are possible, the following procedures would be considered to satisfy FDA’s informed consent documentation requirement.
Method 1: A photograph of the signed informed consent document can be transmitted to the trial staff
Method 2: A witness can attest to the signature, but a photograph of the signed informed consent document cannot be transmitted
Q11. How do I obtain informed consent from a patient unable to travel to a clinical trial site where electronic informed consent is not an option?
When investigators do not have electronic informed consent (eIC) capabilities, 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 of the trial participant. For example, the consent form may be sent to the trial participant or their legally authorized representative by facsimile or email, and the consent interview may then be conducted by telephone when the trial participant or their legally authorized representative can read the consent form during the discussion. After the consent discussion, the trial participant or their legally authorized representative can sign and date the consent form.
Q12. How can informed consent be obtained and documented from a prospective trial participant (or legally authorized representative) when they cannot print and sign a paper copy of the consent form provided electronically by the investigator/designee, they cannot electronically sign the informed 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 clinical trial?
Where a prospective trial participant (or legally authorized representative) is unable to print the informed consent document provided electronically by the investigator/designee, an electronic signature process is not available, and the prospective trial participant must meet time-sensitive eligibility criteria, the investigator may consider using alternative process to satisfy FDA requirements for obtaining and documenting informed consent.
All of the alternative approaches must be reviewed by the IRB overseeing the trial as required by FDA regulations.
Q20. We are instituting trial participant visits remotely through video conferencing. Are there recommendations regarding best practices?
With the increasing use of telemedicine in clinical practice, a number of resources may be available to provide recommendations on best practices. FDA does not endorse any particular telemedicine best practices. However, from an FDA regulatory perspective, important considerations for trial visits through video conferencing include:
- The investigator or study personnel who will conduct remote visits should be trained on how to conduct real-time video conferencing visits (e.g., training on the use of telemedicine for remote clinical trial visits).
- Procedures should be put in place to maintain a trial participant’s privacy, as would be done for a clinical visit.
- Both the investigator and the trial participant should confirm their respective identities with one another before engaging in a real-time video conference visit according to an identity verification plan developed by the sponsor.
To provide the same information that would be documented during a face-to-face visit, the date of a real-time video conference visit should be documented in the trial records—and if specified in the protocol, the time of the visit. Investigators should consider asking for the trial participant’s location during a video conference visit in case a medical emergency arises during the visit.
Having trouble running your clinical trials during these trying times, contact mdi at info@mdiconsultants.com to discuss various remedies, RE: clinical trial questions