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U-M HRPP Informed Consent Information
The human subjects in your project must participate willingly, having been adequately informed about the research.
- If the human subjects are part of a vulnerable population (e.g., prisoners, cognitively impaired individuals, or children), special protections are required.
- If the human subjects are children, in most cases you must first obtain the permission of parents in addition to the consent of the children.
See the Waiver Guidelines for information about, and policies regarding, waivers for informed consent or informed consent documentation.
An informed consent document is typically used to provide subjects with the information they need to make a decision to volunteer for a research study. This information is most often presented subjects in the form of a written document, but may also be offered verbally by a member of the study team or in some other format understandable to the subject. Regulations and policy require that certain information be provided as part of the consent process.
Informed Consent Templates
For your convenience, IRB-HSBS recommends using one of U-M's informed consent templates (see Resources below) which have been developed to include the required documentation elements (per federal regulations 45 CFR 46, part 46.116), language, and formats. Use of the applicable template may facilitate IRB review. If you choose to create an informed consent document without using a template, you must ensure that all required elements are included. For assistance, see the Informed Consent Elements & Suggested Language guidelines provided by IRB-HSBS.
Sample informed consent documents
Sample informed consent documents provide an example for how to complete a blank template (or modify a sample document) for the types of research and procedures commonly reviewed by the IRB-HSBS. If you use a sample document as a starting point for your consent form, modify the sample language to accurately reflect the study activities. Sample documents are located in the Resources section below, including samples of alternate consent formats (e.g., flyer, letter of cooperation).
It is best practice to include an informed consent process or document for most exempt research. The IRB-HSBS reviews IRB applications for exempt research, per U-M policy (HRPP Operations Manual, Part 4, section VI), but not the informed consent documentation. In these cases, replace the IRB-HSBS contact information in the template footer with the following text:
The University of Michigan IRB Health Sciences and Behavioral Sciences has determined that this study is exempt from IRB oversight.
General Information & Tips
Informed consent documents should be written at a level appropriate to the subject population, generally at an 8th grade reading level. A best practice is to have a colleague or friend read the informed consent document for comprehension before submission with the IRB application. Always:
- Tailor the document to the subject population
- Avoid technical jargon or overly complex terms
- Use straightforward language that is understandable.
The informed consent document should succinctly describe the research as it has been presented in the IRB application.
- Present study details in the second (you) or third person (he/she). Avoid use of the first person (I).
- Include a statement of agreement at the conclusion of the informed consent document.
- Avoid inconsistency between the informed consent document and the IRB application.
- Remove "track changes" or inserted comments from the consent documentation prior to uploading the document into the IRB application for review, unless specifically requested to do so by the IRB-HSBS.
- Clearly name and date the informed consent document(s) for the study. Use a naming convention for multiple documents and/or revisions.