210601P - INFORMED CONSENT

Presentation prepared by Dr Omar Hasan Kasule Sr MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Professor of Epidemiology and Bioethics King Fahad Medical City.

 

2 COMPONENTS OF INFORMED CONSENT

• Process of disclosure of all information in layman's language about the trial and giving the participant time to ask questions and also think about the information
• Process of signing the consent form by the participant and the investigator with proper date and time

 

REQUIRED ELEMENTS OF THE CONSENT DOCUMENT - 1

• A statement that the study involves research.
• An explanation of the purposes of the research.
• The expected duration of the subject’s participation.
• A description of the procedures to be followed.
• Identification of any procedures that 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 that may reasonably be expected from the research.

 

REQUIRED ELEMENTS OF THE CONSENT DOCUMENT - 2

• A statement that the study involves research.
• An explanation of the purposes of the research.
• The expected duration of the subject’s participation.
• A description of the procedures to be followed.
• Identification of any procedures that 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 that may reasonably be expected from the research.

 

ADDITIONAL ELEMENTS

• 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.
• Any additional costs to the subject that may result from participation in the research.
• 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.

 

THE INFORMED CONSENT DOCUMENT

• IRB must approve the informed consent documents. The original has the IRB stamp and copies given to the participant are made from the stamped template
• Informed consent is not a one-time procedure. It involves explaining, answering questions, and giving the participant time to think and consult the family
• The participant is given a copy of the proposed consent to take and read at home. The participant also is given a copy of the signed consent to keep.
• The document must be signed and dated by both the participant and the person taking the consent
• The document must be written in ordinary language understood by the participant
• When new safety information becomes available the consent document is revised abd the participant is reconsented

 

INFORMED CONSENT PROCESS

• The Principal Investigator (PI) has ultimate responsibility to obtain consent but may delegate this to a qualified individual but must still counter sign on the form
• The PI discloses details of the trial such as risks, benefits to the participant or the participant’s legal
• The PI allows the participant to ask questions
• The participant signs and dates the informed consent document and is given a copy to take home
• The participant can withdraw consent at any time without having to give a reason and suffers no penalty
• The PI documents the consent process in the study source documents: was the consent verbal or written? Was the participant competent to understand the purpose of the study, its procedures, its risks, and its requirements (visits, examinations, samples to be taken), when did the consent process start and end?, what were the participant’s questions and how were they answered?