What is an informed consent form?
The informed consent form is the document that participants must sign before participating in a clinical research study. The informed consent document should give specific information about the study that a potential participant is considering and should contain the following information:
- Name of the clinical research study and its purpose
- Statement that the study involves research
- Indication of how long the study will last
- Description of procedures that will be performed, and whether any of the procedures are investigational (part of the clinical trial)
- Description of possible risks or discomforts associated with the study and frequency of these risks occurring.
- Description of any benefits to the participant or to others, if any, that can be reasonably expected
- Description of possible alternatives, if any, to participation in the study that potential participant could consider
- Description of the level of confidentiality that will be applied to your private health information and who may have access the participant's records
- Description of responsibility for costs or expenses associated with participation in the study, including study-related injuries
- Contact information for questions concerning the study or a research-related injury (usually the clinical investigator), and questions concerning research participant rights (usually the IRB/REB)
- Statement that participation in the study is voluntary and that a choice not to participate, or to discontinue participation, will not result in any loss of benefits or penalty to you
- Other information the clinical investigator, the sponsor, and/or the IRB find necessary to better inform participants and assist in the decision-making process.
The informed consent form will also have a signature line or signature page. When the participant of his/her legally authorized representative sign the informed consent form he or she has legally consented to participate in the study. The participant is provided with a copy of the signed informed consent form for his/her personal records and to consult as a reference throughout the study.
