1. Informed Consent Waivers IRB Health Sciences & Behavioral Sciences University of Michigan 2009-2010 6/26/20091

2. Goals of this audiocast Provide an overview of the informed consent waivers permitted by the federal regulations governing research with human subjects (45 CFR 46.116, 46.117). Describe the situations in which these waivers would be appropriate 6/26/20092

3. Waiver of documentation of informed consent The default is always signed informed consent (also called “comprehensive written informed consent”) Regulations permit the omission of the subject’s signature, called a waiver of documentation of informed consent 6/26/20093

4. Waiver of documentation of informed consent According to 45 CFR 46.117, an IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either: 1. That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality, OR 6/26/20094

5. Waiver of documentation of informed consent 2. That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. 6/26/20095

6. Examples of situations in which a waiver of documentation of informed consent is appropriate A web-based survey A telephone survey that presents no more than minimal risk A paper-and-pencil survey that is anonymous Request a waiver of documentation of informed consent in 10.1, and complete 10-4 in the eResearch application. 6/26/20096

7. Waiver of informed consent According to 45 CFR 46.116, an IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent…or waive the requirements to obtain informed consent provided the IRB finds and documents that: 6/26/20097

8. Waiver of informed consent All four conditions must be met: 1. The research involves no more than minimal risk to the subjects; 2. The waiver or alteration will not adversely affect the rights and welfare of the subjects; 3. The research could not practicably be carried out without the waiver or alteration; AND 4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation. 6/26/20098

9. Examples of situations in which a waiver of informed consent is appropriate Secondary analysis of existing datasets Medical or dental chart abstraction Public observation Request a waiver of informed consent in 10.1, and complete Section 10-3 of the eResearch application. 6/26/20099

10. Resources IRB Health Sciences & Behavioral Sciences irbhsbs@umich.edu 936-0933 www.research.umich.edu/irb/index.html eResearch www.eresearch.umich.edu HELP features, tutorial, Sandbox in eResearch Informed consent templates & samples www.research.umich.edu/irb/Consent/consent.html Office for Human Research Protections (OHRP) www.hhs.gov/ohrp 10 6/26/2009