Informed Consent

The consent process has three components: information (disclosure of relevant details), comprehension (participant understands what is being asked), and voluntariness (no coercion or undue influence). Required elements include: a statement that the study involves research, explanation of purpose and procedures, description of foreseeable risks and discomforts, description of expected benefits, disclosure of alternatives, explanation of confidentiality measures, compensation and treatment for injury (if applicable), contact information for questions, and a statement that participation is voluntary with the right to withdraw at any time without penalty. Assent is used for children (typically ages 7-17) who cannot legally consent but can express willingness to participate; their parent/guardian provides consent while the child provides assent. Consent waivers may be approved by the IRB when: the research poses no more than minimal risk, the waiver will not adversely affect participants' rights, the research could not practicably be carried out without the waiver, and participants will be provided additional pertinent information afterward when appropriate. Common waiver situations include large-scale retrospective data studies and emergency research.