Patients' participate in clinical studies exclusively of their volition. Patients reserve the right to refuse to participate in a study, or to stop participating at any stage of a given study. The patients' medical rights will not be undermined in any way should they decide to end their participation in the study, and they will continue to receive optimal care at all times.
What is a Clinical (Medical) Trial (Study)? (Under the Ministry of Health Protocol, 2016).
A. Making use of a medicine, radiation, or chemical substance, radiological or paramedical, in opposition to the approval given for this use under legislation; or when this use is not standard practice in Israel for the needs they are used for; or it has not been tested yet in Israel, and it affects or is meant to affect the health, body, or mental state of a person or fetus, including the genetic system.
B. Performing any procedure, action, or test on a human being that is not standard practice, which is not generally performed in the professional or medical practice.
The goals of clinical trials on human beings, as defined by the Helsinki Convention, are: to improve treatment, diagnosis, and prevention of illnesses, and to contribute to an understanding of the etiology and prognosis of illnesses.
Genetic trial/genetic study. A study where a biological sample is taken and DNA is extracted for the purposes of receiving genetic information, in conformance with the Genetic Information Law.
Non-intervention clinical trial. A study in which, during the course of the treatment administered to participants in the trial, data on the treatment and its results are collected. This, provided that the treatment plan is standard for the participant's state, and is administered as per the decision of the caregiver, and when the trial plan does not change the standard treatment or the follow-up on the patient's state, or influences it.
A Clinical study without a trial product. One of the following: a clinical trial involving a new procedure (that is not standard in professional or medical practice, and does not involve use of a trial product); when blood and/or biological samples are taken; involving questionnaires
C. What is a Helsinki Committee? (Under the Ministry of Health Protocol, 2016)
The Helsinki committee of a hospital or of a medical institution is an independent committee whose legal composition, appointment methods, and number are defined by regulations. Its purpose is to safeguard the rights, safety, and wellbeing of participants recruited for clinical trials, among other things, by examination and approval of the clinical trial protocol and the informed consent form. The committee's role is also to regularly monitor the trial process, including the changes in protocol and on the informed consent form, and to monitor the clinical trial in general. The Helsinki committee can act in the place of a Helsinki sub-committee to approve studies, data, and questionnaires.
Should an investigator wish to receive approval to perform a clinical trial on humans, they must first:
·Receive training in running and performing medical studies under the Good Clinical Practice (GCP) protocol.
·Submit a study proposal and all additional documents associated with the study required to receive approval by the institutions' Helsinki committee.
Good Clinical Practice (GCP): Work methods and methodologies meant to ensure the wellbeing and rights of participants in trials and the quality of the data collected during the trial.
Informed Consent Form
No clinical trial will be performed in which human beings are involved without first receiving the informed consent of the person participating in the clinical trial. After patients are provided with an appropriate verbal explanation by the investigator, and they have read the informed consent form, understand the essence of the trial and their role in it, will consent be provided in writing on the informed consent form to be approved by the Helsinki committee for the trial. The informed consent form will be signed and dated by the participant, and signed and dated at the same time by the investigator. A copy of the signed form will be provided to the participant.
The informed consent form is composed of an unchanging segment that anchors the rights of the participants, and a varying segment that includes an abstract of the information about the clinical trial, as provided to the patient.
The informed consent form includes information on the following topics:
·Goals of the study.
·Approximate number of participants in the trial.
·The expected period of participation in the trial.
·Methods used in the study, including a description of the study product and of the various procedures during the course of the trial, with a clear differentiation between the trial procedures and those that are standard medical practice.
·Expected advantages for participants or others as a result of the trial.
·Known risks and/or discomfort that can be foreseen for participants in the study.
·Circumstances in which the participation in the clinical trial may be halted at the decision of the investigator or the trial's initiator.
·An explanation to the participant about alternative treatments, about their advantages and disadvantages, if any such exist.
·A contact person who can be turned to for additional questions or clarifications associated with the study or regarding medical issues that may arise during the course of the study.
·Compensation (if such exists) to the patient, including reimbursement of travel expenses.
·Nondisclosure of personal medical information.
Patients' participate in medical studies exclusively of their volition. Patients reserve the right to refuse to participate in a study, or to stop participating at any stage of a given study. The patients' medical rights will not be undermined in any way should they decide to end their participation in the study, and they will continue to receive optimal care at all times.
Upon signing the consent form, the patient approves that the initiator of the trial, the institution's Helsinki committee, the motoring organization in the medical institution, and to the Ministry of Health all have direct access to the patient's medical file to verify the trial methods and clinical data.
After signing the consent form, patients receive a copy of the signed form and may study it at any time.
By signing the consent form, patients agree that information about their participation in the study will be transferred to their personal practitioner in the HMO they belong to.
Trial participants are called for check-ups by the doctor presiding over the study, according to the study protocol requirements, in addition to the regular treatment.
Insurance
In all instances of participation in medical studies, participants are insured by the company or medical institution initiating the study.
Participation by vulnerable sectors in studies, including "children, prisoners, pregnant women, individuals with mental disabilities, uneducated or financially disadvantaged individuals, those with a limited ability to make educated or voluntary decisions to participate in a study, members of the hospital staff and other subordinates to the principal investigator or one of the deputy principal investigators, who may be at risk of coercion or unfair influence" requires special approval by the Helsinki committee. And this is only when the study is crucial to the advancement of this sector and cannot be conducted using another sector in its place.
Information about Clinical Trials at the Poriya Medical Center, in Other Places in Israel, and Around the World
1. Patients can contact their specialist directly and ask if there currently is a clinical trial that may be appropriate for them to participate in.
2. Information about clinical trials performed at the Baruch Padeh Medical Center, Poriya, which are recruiting participants, are posted on our website under: Studies recruiting participants.
3. A list of clinical trials can be found on the international NIH(National Institutes of Health) database. On this site it is possible to find out which clinical trials are being conducted on any given subject in any place around the world.