COVID-19 patients are hospitalized and thus they fall in category of vulnerable population. Thus as per guidelines audio- video consent should be taken from them. But it is observed that only written informed consent is being taken.. please share your views regarding it.
May be done provided proper maintaining record of audio visual consent.
The French regulations require us to sign a written consent for participation in a research study, if the person is able to do so.
About the written consent, we take precautions with the packaging of this document and a storage period to eliminate any risk of contamination.
Yes audio video consent should be taken before the clinical trial.
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency Guidance for Industry, Investigators, and Institutional Review Boards revised 11-May-2020 is a good starting point. https://www.fda.gov/media/136238/download
Specifically, Question 10: "How do I obtain signed informed consent from a 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 be documented by the use of a written consent form that has been approved by the IRB and signed and dated by the subject or the subject’s legally authorized representative at the time of consent (21 CFR 50.27(a)). In light of COVID-19 infection control measures, the following procedure would satisfy documentation of this requirement if the patient signing the informed consent is in COVID-19 isolation.
• If the technology is available, electronic methods of obtaining informed consent should be considered.
When it is not possible to obtain informed consent electronically, the sponsor should consider taking the following steps:
1. An unsigned consent form is provided to the patient by a heath care worker who has entered the room
2. If direct communication with the patient in isolation is not feasible or safe, the investigator (or their designee) obtains the patient’s phone number and arranges a three-way call or video conference with the patient, an impartial witness and, if desired and feasible, additional participants requested by the patient (e.g., next of kin)
3. To ensure that patients are approached in a consistent fashion, a standard process should be used that will accomplish the following:
o Identification of who is on the call
o Review of the informed consent with the patient by the investigator (or their designee) and response to any questions the patient may have
o Confirmation by the witness that the patient’s questions have been answered
o Confirmation by the investigator that the patient is willing to participate in the trial and sign the informed consent document while the witness is listening on the phone
o Verbal confirmation by the patient that they would like to participate in the trial and that they have signed and dated the informed consent document that is in their possession
If the signed informed consent document cannot be collected from the patient’s location and included in the study records, FDA considers the following two options acceptable to provide documentation that the patient signed the informed consent document:
• A dated attestation by the witness who participated in the call and by the investigator that the patient confirmed that they agreed to participate in the study and signed the informed consent.
OR
• A photograph of the informed consent document with attestation by the person entering the photograph into the study record that states how that photograph was obtained and that it is a photograph of the informed consent signed by the patient.
A copy of the informed consent document signed by the investigator and witness should be placed in the patient’s trial source documents, with a notation by the investigator of how the consent was obtained (e.g., telephone call). The trial record at the investigational site should document how it was confirmed that the patient signed the consent form (i.e., either using attestation by the witness and investigator or the photograph of the signed consent). The note should include a statement of why the informed consent document signed by the patient was not retained (e.g., due to potential contamination of the document by infectious material).
If the patient is unable to provide informed consent and there is a legally authorized representative, investigators must obtain written consent from the participant’s legally authorized representative in accordance with 21 CFR 50.27(a)."
I did not understand why they are sensitive in terms of getting written consent
Yes It is also important to inform about consequences of the treatment to let informed the patient..
Coskun Yorulmaz obtaining informed consent from clinical research participants is a fundamental human right that goes back to the findings from the Nuremburg Trials, which lead to the Nuremburg Code and thence the eventual establishment of the Declaration of Helsinki.
a proper explanation to the participants of the components of the clinical trial is essential.
AV recording is mandatory in India for any new chemical entity. As per the new directives G. S. R. 611 (E) it is mandatory only in cases of 1) Vulnerable Populations 2) New Chemical Entities. So, this will be decided on the basis of above mentioned two categories.
All hospitalized patients due to COVID are not vulnerable population. AV consent is required only in case if the drug being tested is NCE and the admitted patient complies the criteria for vulnerability. Hence, requirement for AV consent will be on case to case basis.
Dear researchers I searching for data, support, and explanations for the dramatic worst mortality data of Lombardia (N. Italy) in the first pandemic phase. Thanks for possible aid.
https://www.researchgate.net/post/The_novel_Coronavirus_in_N_Italy_Lombardia_COVID19_2019nCoV_SARSCoV2_shows_a_fatality_rate_compatible_with_SARS-MERS_Why
Linked pre-print papers: https://www.researchgate.net/publication/341325862
Stay safe --sv--