IRB Application Instructions - Consent

Help Information

A. Consent Options

  • Approval of a consent form and process means that as part of your project, you will be providing the subjects with an opportunity to decide whether or not to participate in the research project.  This includes obtaining permission from parents, assent from children, or consent from a legally authorized representative to consent on behalf of an individual. If this option is selected, complete B.

  • Waiver of consent means that subjects will be involved in the research project without the consent (prospective agreement) to participate. If this option is selected, complete C.

  • Approval of a consent form and process and waiver of consent means that your project involves both; this may occur for projects that have multiple phases or components. If this option is selected, complete B and C.

B1. Consent Form Description

  • Informed consent is a process, not just a form and the consent procedure should be an opportunity for subjects to make a fully informed decision whether or not to participate in the research. Fully describe the process that you will use for obtaining consent, including identification of who will be obtaining consent.

  • Consent templates are highly recommended; visit hrpp.msu.edu for templates

  • See HRPP Manual Sections 6-4, Informed Consent and 12-4, Consent Form Guidelines for guidance on developing a consent process and form.

  • If your project will involve children, see HRPP Manual Section 6-4-C, Parental Permission and Child Assent, for guidance.

  • If your research will involve individuals with diminished capacity, see HRPP Manual Section 6-8-D, Individuals with Diminished Capacity for guidance on requirements and legally authorized representatives.

  • If your project involves obtaining consent from a legally authorized representative, please explain the process, including how you will determine whether an individual is a legally authorized representation

  • Submit as an attachment the consent document or script, parental permission form, or child assent

B2. Signature on Consent Document

  • There are certain criterion under which the requirements to obtain a signature may be waived.

    • 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.

    • The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from breach of confidentiality.

  • While consent will be obtained, the subject does not need to sign the consent form. This commonly occurs through online surveys (e.g. a statement like “you indicate your voluntary consent to begin this research by beginning the survey, clicking a button, etc.” is typically incorporated rather than a signature) or telephone interviews.

  • See HRPP Manual Sections 6-4-A, Documentation of Informed Consent and 6-4-D, Waiver of Documentation of Informed Consent for requirements

C. Waiver of Consent

  • A waiver of consent means that subjects will not prospectively be asked permission to participate in the research project

  • Examples of requests for waiver of consent include when the project involves incomplete disclosure or deception or analysis of existing records where it would be impracticable to obtain consent

  • An IRB may waive the requirements for consent only if the following criterion are met:

    • the research involves no more than minimal risk to the subjects; and

    • the waiver or alteration will not adversely affect the rights and welfare of the subjects; and

    • the research could not practicably be carried out without the waiver or alteration; and

    • whenever appropriate, the subjects will be provided with additional pertinent information after participation.

  • See HRPP Manual Section 6-4-B, Waiver or Alteration of Informed Consent for requirements

Helpful HRPP Manual Sections

Question Number

  • Initial Application (Expedited and Full Board) - Question 24