1. I hereby declare I consent to participate in the clinical trial, as described in this document.
2. I have received adequate information about the clinical trials, and have had sufficient time to ask questions, to consider and to reconsider.
3. I understand the subject of the clinical trial is a screening test for COVID-19, using an investigational molecular saliva test.
4. I understand that for the purpose of the test, I will give a saliva sample, by spitting into a dedicated plastic test tube, which I will provide to the researcher or place at the collecting point of the experiment in the Technion. It is also possible that I will be offered to perform the processing myself at stations around the campus.
a. I understand that the saliva sample will undergo a molecular SARS-CoV-2 detection test that was developed Rapid Diagnostic Co. (product “Naor”), and which has not yet been approved by the Ministry of Health.
b. I understand that, the results will be made available to me through an online interface.
c. I understand that the purpose of the test is not to verify my clinical status, but in order to test the broad usability and effectiveness of the “Naor test”. Nonetheless, I will be able to receive information from the coded result I receive, if I choose to do so.
5. I hereby declare:
a. I give my consent that if I am asked to do so, even if the result of the Naor test will be negative, I will undergo a laboratory PCR test, and share the result with the Technion through a code that will be provided to me for the purpose. Both the PCR test and reporting its results will be voluntary.
b. I am aware that even though so far, the false positive rate of the test has been close to 0%, a positive test result does not necessarily mean I carry the SARS-CoV-2 Coronavirus. Nonetheless, in the case of a positive result, I will voluntarily undergo a recognised laboratory test (PCR) on the same day or the day after, for fear that I carry a contagious virus. In addition, I will voluntarily and of my own free will go into self-isolation until I receive the test results. I am aware that the Naor test results are not definitive, and even if I received a positive result, only a Ministry of Health-approved PCR test will decide if I am positive or not. [duplicative]
c. I understand that a negative result of the Naor test does not constitute confirmation that I do not carry the Coronavirus or that I am not infectious (the false negative rate at the moment is ~20% in general, and ~10% for cases with high viral load) and in any case I must act in accordance with the law and with the care necessitated by the COVID-19 epidemic. In addition, I am aware that the test is in a trial stage, and no result can be treated as diagnosis.
d. I am aware that the results of the study are for research purposes only, and cannot be used for clinical purposes.
6. I am aware that the primary investigator, Dr. Naama Geva-Zatorsky, received an approval from the Technion Management to carry out the experiment, as stipulated in the Public Health Regulations (Medical Experiments on Humans, 1980), hereinafter the experiment.
7. I am free to choose not to participate in the experiment, or to stop my participation at any time, by an electronic notification in the system, or by notifying Anna Shreder, or another person on her behalf (see section 12).
8. In the case of filling a form – I may choose not to answer some of the questions or all of them. In any case, there will be no questions that would allow my identification.
9. I am assured that my personal identity will be kept confidential by all those involved in the study and will not be published in any publication including scientific publications.
10. At the time of signing the informed consent, a user code will be assigned to each volunteer. The volunteer's personal details will be kept separate from the online results system for the purpose of information security, and the researchers will not have access to the names of the volunteers.
11. I am guaranteed that any questions I might raise will be willingly answered, and I will have the opportunity to consult another party regarding a decision to participate in the experiment and/or continue it.
12. For any problems with regards to the experiment, I will be able to contact Anna Shreder by phone: 04-8295153 or by mail: email@example.com
13. I declare that I was provided with detailed information about the experiment, including its background, goals, methods, duration, the benefits expected to the participant if any, and the risks or inconveniences involved in the experiment.
14. I give the Technion permission to use my data for research purposes by Technion researchers as defined by the primary investigator, after it has been anonymised.
15. I hereby declare that my consent is given of my own free will and that I have understood everything said above. In addition, I have received a copy of this informed consent form, lawfully signed and dated.
16. By signing this informed consent form, I give the institutional ethics committee and the Ministry of Health permission to directly access the information relevant to the experiment for the purpose of verifying the experiment methods and data. This access to my information will be performed while maintaining confidentiality, in accordance with the laws and procedures of confidentiality.
The Principal Investigator:
Dr Naama Geva-Zatorsky, firstname.lastname@example.org