Informed Consent Process

It is the policy of Western Michigan University that all research involving human subjects will be reviewed by the Institutional Review Board. The involvement of human subjects in research is not permitted until the IRB has reviewed and approved the research protocol. This means that no contact with subjects—including recruitment and obtaining consent—can be initiated until the research has been approved, although researchers may contact organizations from which subjects will be recruited.

Furthermore, unless the consent process has been specifically waived by the IRB, no subjects may be included in research unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative.

A consent document should have three parts: beginning, middle and end.

Beginning

  • Who is doing the experiment.
  • The nature, purpose and duration of the experiment, including the fact that the procedure is experimental.
  • The uses to be made of the data.

Middle

  • The methods to be employed.
  • The hazards, inconveniences and risks the subjects will undergo, as far as they are known.
  • The availability of compensation and treatment, if injured.
  • The benefits that might be expected.
  • Disclosure of alternate procedures the subject may choose if the experiment is therapeutically related.
  • The conditions of participation, if any.

End

  • A statement that the data are confidential and a description of the procedures to be employed in maintaining confidentiality.
  • The fact that the subject is at liberty to withdraw his/her consent prior to the experiment, discontinue participation in the experiment at any time, or refuse to answer any questions, without prejudice.
  • An offer to answer any questions as well as instructions as to how to contact the researcher, the IRB and the vice president for research, should questions arise later.
  • A place for the date of signing and for the signature of the subject (and witness, is required).

Note: There can be no exculpatory language anywhere in the form.

Administering the consent document

  • Pass out two forms—one for subjects to sign and return to you and one for them to keep for their records.
  • Read the form aloud as the subjects read it to themselves.
  • After reading it aloud, summarize what is stated on the form.
  • Allow time for questions.
  • Schedule a break to allow subjects time to consider whether or not they want to participate.

Samples

The following information and sample documents are provided to help researchers develop consent and assent documents customized to the design of the individual research project. If departmental letterhead is used, the header “Western Michigan University” and the department name may by omitted.

These samples contain all of the elements found in the document development checklist.

Additional resources

Contact

Julia Mays
(269) 387-8293
Associate Director of Compliance