IRB FAQ Informed Consent


What is informed consent?

This means that subjects understand the important implication of the decision to participate in research and they actively agree to such participation.

What elements should be included in the consent form?

Please see the consent templates: http://www.kent.edu/research/researchsafetyandcompliance/irb/forms.cfm

Are sample consent forms available?

Sample consent forms, parental consent forms, audio video forms and web based study forms are available at: http://www.kent.edu/research/researchsafetyandcompliance/irb/forms.cfm

Under what conditions may the requirement for written documentation of informed consent -such as a signature on a consent form - be waived?

The IRB may waive the requirement for written documentation of informed consent-per 45CFR46- if it finds and documents either of the following:
  • Signed consent is the only record linking the subject to the research and the greatest risk of the research is a breach of confidentiality. 
  • The research presents no more than minimal risk and involves procedures for which consent wouldn't normally be obtained, it is often advisable to present subjects with an information sheet or letter that contains the elements of informed consent, for their future reference.

    • Do I have to use copies of the stamped consent documents to recruit and or enroll subjects?

    Yes. All consent and assent documents need to include the KSU IRB approval stamp. In some cases involving minimal risk research, the IRB may waive the consent requirements. Requests for waiver of consent must be made in writing and include a justification. Decisions are made on a case by case basis.

    The KSU IRB does not stamp level I protocols.

    What is assent?

    Assent is a child's affirmative agreement to participate in research - 45CFR46

    Under what conditions can parts of consent be waived?

    • the research involves no more than minimal risk
    • the waiver or alteration will not adversely affect the rights and welfare of the subjects
    • the research could not practicably be carried out without the waiver or alteration
    • whenever appropriate, the subjects will be provided with additional pertinent information after participation
    • the informed consent requirement in this policy are intended to preempt and applicable federal, state, or local laws which require additional information to be disclosed in order for informed consent to be legally effective
    • nothing in this policy is intended to limit the authority of a physical to provide emergency medical care, to the extent the physician is permitted to do so under applicable federal, state or local law.

    If I am enrolling non-English speaking subjects into my study, do I need to have my consent forms translated into a language they can read and understand?

    Yes. You should always include a copy of the translated consent form with your application materials. In addition, you need to provide the details about who translated the consent form and information about their qualifications as a translator.
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