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Informed Consent Guidelines

U-M HRPP Informed Consent Information

See the Operations Manual, Part 3, Section III, 4 d.

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.

Contact the IRB Office for more information.

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).  

Exempt Research

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

Reading level

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.

Writing tips

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.

Documentation Formating

  • 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.  

References and Resources

Informed Consent Templates

  • Informed Consent Template - General

    (Word) Blank template with required informed consent elements represented as section headers; includes instructions and recommended language.  Modify this template to draft a project-specific informed consent document for your study for IRB review and approval.

  • Informed Consent Template - Clinical

    (Word) Template to modify for clinical research studies to be reviewed by IRB-HSBS

  • Informed Consent Template - Exempt

    (Word) Template to modify for exempt human subject studies that outlines the details of the research, and the benefits/risks to the subject.

  • Informed Consent Flyer - Template

    (Word) General outline to create and post a flyer seeking participation in a human subjects study.  Includes instructions.

Informed Consent Guidance

  • Informed Consent Elements & Suggested Language

    PDF Outline of the federally required elements (e.g., description of subject involvement) that an informed consent doucment must include.  Includes suggested language and/or additional instructions.

  • Making Changes to Your Consent Document

    PDF.  Instructions to update an approved informed consent document and upload both "clean" and "track change" versions in eResearch Regulatory Management for IRB review.

Sample Consent - Project Consideration

  • Exempt Protocol - No Signature Sample

    (Word) Sample language for an informed consent document for an exempt study where a signature is not required to consent to participate

  • Exempt Protocol - Signature Sample

    (Word) Sample of informed consent language including a signature line to use for exempt studies where a signature is collected.

  • Focus Group Sample

    Word.  Last updated: November 2014

  • Interview Project Sample

    (Word) Sample of the elements, procedures, and language used in an informed consent document for an interview. (Last modified, 2010)

  • Online Survey Sample

    (Word).  Sample language for informed consent documentation for a human subjects study that includes a computer-based or computer-delivered survey.

  • Letter of Cooperation Samples

    (Word) Two sample letters for site approval cooperation between U-M and other institutions, organizations, etc.  Letters of cooperation must be on U-M letterhead and signed by an appropriate official.  These letters are uploaded into the Performance Site section of the eResearch IRB application.

Sample Consent - Subject Consideration

  • Parent Permission Letter Sample

    (Word).  Sample of informed consent permission letter addressed to the parents of a child being recruited for participation in a human subjects study.  

  • Teenager Assent Sample

    (Word).  Example of consent form assent language for use when children ages 13-17 are participants in a human subjects study.

  • Child Assent Sample

    (Word) Sample language for obtaining consent from children ages 7-13.  Must be accompanied by a Parent Permission letter or consent form.

Questions?

IRB-Health Sciences and Behavioral Sciences (IRB-HSBS)

Phone: (734) 936-0933
Fax: (734) 936-1852
irbhsbs@umich.edu