In the struggle against Covid-19, medical research constitutes an essential tool in finding new treatments and developing vaccines. In order to promote medical research in times of social distancing and to minimize unnecessary contact, the Ministry of Health (MOH) recently published a procedure concerning digitization of the informed consent process (hereinafter: the procedure).
This procedure follows guidance that the MOH published earlier this year concerning medical research in times of Covid-19. In this guidance the MOH enabled, for the meantime, transfer of the experimental drug directly to the subject’s home and treatment of a subject in his/her own house, including monitoring the subject's indexes from afar when medically appropriate (for example, MOH’s letter from March 2020 concerning the conduct of medical research amidst Covid-19). This is the first procedure which fully and formally addresses the digitization of the informed consent process.
The procedure applies to subjects of clinical trials who are adults and are competent to provide consent.
The procedure determines the principles governing informed consent, as follows:
The Helsinki Committee is responsible for examining the informed consent process, including the means chosen for signing the informed consent form. It is also responsible for ensuring that the informed consent process is appropriately adapted to the different subjects, and that the investigators undergo proper training.
The investigator is responsible for fulfilling the informed consent process requirements. The investigator is required to provide explanations appropriate to the subjects, to specify how the explantation has been provided digitally in the informed consent form, and to verify that the subject understands the explanations. The subject must be able to ask questions during the informed consent process.
The procedure explains that the purpose of the signature requirement on an informed consent form is to ensure free and willing consent, to verify the subject’s identity, to record his/her consent, the time of consent and to serve as evidence that the form was not altered following the subject's signature.
Accordingly, the procedure enables the digital signing of an informed consent form, according to the Digital Signature Law, and in accordance with certain conditions detailed in the procedure. The procedure further details different measures of identification, grading them by strength of identification.
The procedure requires that the use of digital means in obtaining informed consent will be subject to risk management analysis. As the risks of clinical trials are greater, the safety measures to ensure informed consent should be more meaningful. For example, in a clinical trial that involves high risk, meaningful means, that the investigators are required to make sure the subject understands the information (e.g. by asking him/her questions to verify understanding). Also, when risks are greater, the means to verify the identification of the subject should be more demanding.
The procedure requires implementing data protection safeguards according to the Privacy Act and sets other requirements, such as non-disclosure of subjects’ identity to the clincial trial's sponsor.
Receiving informed consent for research through digital means is not the ideal way to obtain consent. However, when this is necessary, the procedure outlines the relevant requirements.
The information in this update is based on the MOH procedure in Hebrew, which can be found here.
This update is informative only and should not be treated as legal advice or legal opinion.