What is Informed Consent?
Informed consent is the process of learning the key facts about a research study before you decide whether or not to volunteer. Your agreement to volunteer should be based upon knowing what will take place in the research study and how it might affect you. Informed consent begins when the research staff explains the facts to you about the research study.
For minors, Parental Permission (rather than Consent) and Assent are required unless specifically waived by the IRB.
Required sections of the Consent Form :
1. Purpose and Overview
A statement that the study involves research, an explanation of the purposes and the expected duration of the subject's participation, and a description of the procedures, noting any procedures which are experimental.
A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject would otherwise be entitled.
3. Alternative Treatments/Alternatives to Participation
Disclosure of appropriate alternative procedures or courses of treatment.
A brief description of study procedures.
5. Risks and Inconveniences
A description of reasonably foreseeable risks or discomforts.
A description of benefits to the subject or others that may reasonably be expected.
A statement of the degree to which confidentiality of records identifying the subject will be maintained.
8. Study Compensation
A description of compensation provided for time, effort, and reimbursement of transportation costs, if any.
9. In Case of Injury
A statement about our institution's policy with regard to compensation and payment for treatment of research-related injuries.
Who to contact for answers to questions about the research, about research about research subjects' rights, and about research-related injury.
11. Documentation of Consent
Documentation of Consent: Attestation of voluntary participation (i.e., informed consent). Please note that the requirement to obtain informed consent can be altered or waived under certain conditions.