The novel coronavirus (COVID-19) has brought about many challenges for clinical trial study sites and subjects.
Because of these challenges, sites may encounter difficulties in obtaining informed consent, maintaining subject safety and adhering to protocol-mandated visits or follow-up procedures.
To allow commitment to the study during this worldwide pandemic, study sites and subjects should consider the following options.
Alternatives For Obtaining Informed Consent
Clinical researchers have several alternatives for obtaining informed consent during this time. Here are a few options.
Mailing Or Emailing Informed Consent Forms
A consent form could either be mailed or emailed to a potential study subject for them to review, sign and date and return to the site. Should the study subject have any questions, the investigator or a designee can address their concerns in a follow-up phone conversation.
Reading Informed Consent Forms
The entire consent form could be read to the study subject by the Investigator and/or designee over the phone, in which the study subject expresses understanding of the nature of the procedure, the risks, the benefits and is given the opportunity to ask and have questions answered. The study subject could then give verbal agreement for the procedure.
Obtaining Informed Consent From A Subject With COVID-19
For studies in which the study subject is in isolation for COVID-19 and the infection control policy would prevent the site from removing the consent document from their hospital room, the following similar options would satisfy documentation of 21 CFR 50.27(a):
- Electronic methods of obtaining informed consent
- Having the consent form provided to the study subject by a health care worker who has entered the room and either communicates directly or by phone with an impartial witness, if electronic methods are not feasible
If the signed consent form cannot be collected from the study subject’s location, the FDA Guidance considers the following acceptable:
- Attestations by the witness and the investigator confirming the study subject agreed to participate and signed the consent form
- A photograph of the consent form with an attestation by the person entering the photograph into the study records that includes how the photo was obtained and a statement that it is indeed a photo of the consent form signed by the study subject.
Maintaining Safety and Protocol Compliance
First and foremost, ensuring the safety of study subjects is paramount. The protection of a study subject’s safety, welfare and rights may be best served by either continuing in the study or by discontinuing the administration or use of the investigational product or even participation in the study. Should the study continue according to the Sponsor, Investigator and Institutional Review Board/Independent Ethics Committee (IRB/IEC), the following are options that can be considered for maintaining subject safety and protocol compliance:
If a follow-up procedure involves a physical assessment in which the site needs to visually see the subject, perhaps the site completes this via a video call with the subject.
For an otherwise simple follow-up such as assessment of pain, work status, satisfaction of the procedure or current medication, the site may look to complete a follow-up phone call.
Some Electronic Data Capture (EDC) systems may allow for subjects to complete follow-up questionnaires directly into the system, which can be extremely beneficial for eliminating the need of scheduling a specific time to complete the assessments.
If any of the options mentioned above are selected as an alternative approach during COVID-19, the site’s next highest priority will be documenting. Some key items to document and file in the study subject’s chart during the consent process include the personnel involved, confirmation from an impartial witness that all questions have been answered and an attestation from both the study subject and Investigator that confirms the study subject was willing and able to participate in the study. Additionally, key items to document during follow-up procedures include how the follow-up was performed and if the “visit” was missed that led to data not being obtained, specific information that explains the basis of the missing data, including again the relationship to COVID-19.
Please note, IRB/IEC, sponsor and FDA approval may be required prior to implementing any of the options above.
Have you or your site experienced any of the above scenarios? Are there other processes that you have found helpful? Or have any of these presented you with additional challenges?