What are the exceptions to informed consent requirements?
• The IRB may waive the requirement for written consent if the consent document is the only link between the subject and the research and the principal risk of harm would come from a breach of confidentiality. • The IRB may waive consent if: • The research involves no more than minimal risk to the subjects; • The waiver will not adversely affect the rights and welfare of the subjects; • The research could not practicably be carried out without the waiver; • If appropriate, the subjects will be provided with additional information after participation. • Consent may also be waived for some types of research regarding public service programs.
