General Requirements for Informed Consent
No Investigator may involve a human being as a subject in research covered by this policy unless the Investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative.
An Investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.
The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the Investigator, the sponsor, Weizmann or its agents from liability for negligence.
Basic elements of informed consent
In seeking informed consent the following information shall be provided to each subject, as applicable:
A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
A description of any reasonably foreseeable risks or discomforts to the subject;
A description of any benefits to the subject or to others which may reasonably be expected from the research;
A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and
A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
Additional elements of informed consent
When appropriate, one or more of the following elements of information shall also be provided to each subject:
A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
Anticipated circumstances under which the subject's participation may be terminated by the Investigator without regard to the subject's consent;
The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject;
The approximate number of subjects involved in the study.
Documentation of Informed Consent
Informed consent shall be documented by (i) usage of a written consent form that embodies the elements of informed consent required by section 7 above (ii) approved by the IRB.
A written consent document (i) shall be accompanied by comprehensive oral explanation by the Investigator. (ii) The Investigator shall give either the subject or the representative adequate opportunity to read it before it is signed. (iii) Document will be signed by the subject or the subject's legally authorized representative. (iv) A copy shall be given to the person signing the form.