Instructions for New IRB Application Instructions for Appendix

Instructions for New IRB Application Instructions for Appendix 2 Alterations to the Consent Process 1

Appendix 2 of New Application The IRB’s expectation is that written informed consent will be obtained from all research subjects. Under limited circumstances, the IRB may agree that it is appropriate to allow other methods of informed consent, or to waive the requirement for informed consent completely. –Surrogate Consent (obtaining consent from someone other than the research subject– Section A –Waiver of Consent (no consent is obtained) Section B –Waiver of Consent Form (written consent is not obtained) – Section C 2

Appendix 2 of New Application Surrogate Consent – Section A A. SURROGATE CONSENT • In a very limited number of cases involving research subjects who cannot provide informed consent for themselves, the IRB may determine that it is appropriate to allow someone else such as a close family member, to grant permission for the subject to be enrolled (such as patients who are sedated or are mentally impaired). This method is known as surrogate consent. • If written informed consent will be obtained from authorized representatives of the research participant, please complete questions 1 -2 and also Section D of Appendix 1, Vulnerable Subjects • Describe the circumstances by which consent will be obtained from someone other than the research subject (Who, When, Where, How) 3

Appendix 2 of New Application waiver of Consent Process – Section B B. WAIVER OF CONSENT PROCESS • Complete this section if you are requesting a complete waiver of informed consent. This means that you will not ask subjects whether or not they want to participate in the research. In most cases, the requirement for informed consent is only waived for retrospective chart reviews. • In order for the IRB to waive the requirement for informed consent, the research must not present more than minimal risk and cannot adversely affect the rights and welfare of the subjects. • Explain why you cannot obtain informed consent from research subjects • Describe how you will protect the confidentiality of identifiable data that is collected for this research 4

Appendix 2 of New Application Waiver of Written Consent Form – Section C C. WAIVER OF WRITTEN CONSENT FORM (but no waiver of consent process) • Complete this section if you will ask subjects to participate in the research, but will not ask them to sign a consent form. • Waiver of written consent is appropriate if the research will not include any identifiable information (such as anonymous surveys) • Written consent cannot be waived if the research presents greater than minimal risk • Just because a written consent form will not be used does not imply that subjects should not be informed about the study. An informational cover sheet can be attached to surveys to provide all of the required elements of consent and scripts can be used when conducting telephone interviews/screens. 5