Israeli healthcare and life sciences legal update | April 2020
The COVID-19 effects on Clinical Studies – Update
The Israeli Ministry of Health issued additional guidelines for the conduct of clinical studies during the COVID-19 pandemic
The Israeli Ministry of Health (the “MOH“) issued, on April 12, 2020, additional guidelines for sponsors, investigators, Helsinki Committees (the equivalent of IRB, or ethics committees) and medical institutions, with respect to the performance of clinical studies during the COVID-19 pandemic (See also our previous update). The matters below are the main issues addressed therein:
- New submissions for clinical studies may be performed by digital means and may be signed electronically.
- In non-interventional, prospective studies, minimization of human contact should be contemplated, to the extent possible, while keeping the performance of all the required actions by electronic means (e.g. informed consent procedure, patient monitoring).
- The informed consent procedure for study subjects who are in quarantine (and therefore are not arriving at the medical institution):
- If such consent is provided orally, the questions asked by the study subject and the answers provided must be documented.
- If a study subject provides its consent through a digital informed consent form, the study subject must respond in the form that its consent is provided after reading the form. The study subject should be provided with the opportunity to receive additional clarifications, to the extended requested by him/her, before the consent is given.
- The institutional Helsinki Committees may waive the informed consent requirement for studies performed using samples that were obtained for other clinical purposes (excluding studies which involve genetic information), provided that de-identification procedures with respect to the samples, have been performed by a qualified person within the medical institution.
- Safety reports shall continue to be performed according to the existing regulations. However, safety reports can be provided without filling out the designated form, provided that the report contains the clinical information needed (e.g. description of the event, study phase, medical history of the study subjects).
- Progress reports with respect to interventional studies and compassion treatments should be sent once every two weeks via email.
- Changes to the study’s documents resulting from the effects of the COVID-19 pandemic, as well as administrative or logistical changes will be addressed by the institutional Helsinki Committee in an expedited procedure. Substantial changes to the study’s documents, including changes arising from the investigational device/drug’s safety, which are not derived from the COVID-19 pandemic, are required to be examined in accordance with existing regulations.
The above does not constitute a legal opinion and is provided as a general update only. For additional information please contact your GKH attorney or one of the following Adv. Hili Cohen, partner and head of life sciences department (Hili@gkh-law.com) Adv. Tami Fishman, partner (Tamif@gkh-law.com), or Adv. Ofir Goldstein (Ofirg@Gkh-Law.Com).