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RESEARCH COMPLIANCE
HUMAN SUBJECTS
Developing a Consent Agreement
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An important aspect of human subject research is developing an appropriate consent form. It should be noted that the consent form is only a small part of an overall consent process.

A good consent form not only provides human subjects with detailed information about the research project, but also informs the University Human Subjects Review Committee (UHSRC) that the subjects’ interests are well protected by the researcher.

EMU provides a consent template, accessible through the Forms and Templates tool. The UHSRC strongly recommends that you consult and use this template when creating your consent form. Sample consent forms for different project types are available on this website. It is suggested that you use these sample consent forms as models if you choose not to use the template.

EMU policy and Federal Regulations require that consent forms contain the following information:
  • A statement that the study involves research, an explanation of the purpose of the research, a description of study procedures, information about the duration of a subject’s participation, and an indication of experimental study procedures

  • A description of potential risks to participation

  • A description of potential benefits from participation. Note that benefits are measurable improvements in physical or psychological health or quality of life. Compensation, course credit, and learning more about oneself from completing questionnaires are not benefits.

  • If applicable, an explanation of alternative procedures or treatments. If subjects are earning course credit for participation, alternative ways of earning this credit must be listed.

  • An explanation of the procedures in place to protect confidentiality. This includes whether data will be identifiable, coded, or anonymous, and how data will be stored and disseminated.

  • Contact information for the principal investigator. If the principal investigator is a student, the advisor’s contact information must also be provided.

  • The following sentence: "For information about your rights as a participant in research, you can contact the Eastern Michigan University Office of Research Compliance at 734-487-3090 or human.subjects@emich.edu."

  • A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.


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The following information must be in the consent form, as applicable:

  • For research involving greater than minimal risk or in which research-related injury is a risk, an explanation as to whether compensation will be offered for research-related injury and an explanation as to whether any medical treatments are available if injury occurs. If medical treatments are available, explain what the treatments consist of and how further information may be obtained.

  • A statement that there may be risks involved that are currently unforeseeable

  • An explanation of circumstances under which participation may be terminated without regard to the subject’s consent

  • Any costs to the subject that may result from participation

  • The consequences of a subject's decision to withdraw from the research and termination procedures

  • A statement that significant new findings developed during the course of the research which may affect the subject's willingness to continue participation will be provided

  • The number of subjects involved in the study

The consent form must be uploaded for review with the application package.
Please note that exculpatory language is not allowed and "I understand" language is not recommended.
If you have questions or would like assistance in developing a consent form, contact the Research Compliance Officer, Sonia Chawla, at 734-498-3090 or schawlaw@emich.edu.

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Content Posted 08/20/2014 | Design Posted 04/17/2012