Informed Consent Guidelines

The purpose of the informed consent process is to give potential participants sufficient information in order to make a reasoned decision about whether they would like to participate in your study. A good informed consent statement should be clear and concise, directed at the potential participant, and consist of language that the potential participant can easily understand.

Here are some key elements that should be present in your consent statement, regardless of whether it is delivered orally, displayed online as the first page of an internet survey, or provided in the form of a physical Informed Consent document that the participant signs:

  • An explicit statement letting them know that they are being asked to participate in research.
  • An explicit statement that their participation is voluntary, and that they will not incur any penalties or lose any privileges if they decide they do not want to participate.
  • A very brief description of what you are studying, and what they will be asked to do in the course of your study. This can be vague, but may not be intentionally misleading. Your description should include an estimate of how much time the study will take. If their participation in the study will not be complete in a single sitting (for instance, if they will need to complete a follow-up survey) this should be made clear as well.
  • A fair and complete description of the potential risks and costs they might incur by taking part in your study, as well as any benefits they may receive directly through their participation. Note that benefits of participation and compensation for participation are separate items.
  • A clear and complete explanation of whether compensation will be offered, and (if so) the details of this compensation, and how it will be administered.
  • For studies requiring repeated or ongoing contact with participants, a statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.
  • An accurate and clear description of how their data will be handled. For instance, will you be collecting data completely anonymously (this means that none of the participants’ data could be linked back to their individual identity, even by you and/or other members of your research team). If not anonymous, how will you protect the confidentiality of their data?
  • An explicit statement letting the participant know either that:
    • Their data may be saved, with the personally identifying information stripped, and that this data might then either be used in a future study or shared with other researchers who might use the information [Include this statement if there is any possibility that this may be done.]
      OR
      Their de-identified data will NOT be stored for use in future studies or shared with other researchers. [Include this statement only if you can guarantee that there will be no storage of this data for later use or distribution.]
  • An explicit statement that they may withdraw from the study at any time at no penalty, and/or decline to answer any questions they are uncomfortable answering. If applicable, you should be clear about how you will handle compensation for participants who withdraw early (standard practice is partial compensation commensurate with amount of time spent).
  • Contact information for the lead investigator on the study and a statement about whom the participant can contact with questions about the study (including contact info, if this person is not the lead investigator).
  • A statement directing them to the UW-Superior IRB email address, which they can contact if they have questions about their treatment as a participant in the study.
  • An explicit statement that provides them an opportunity to accept or decline participation in the study. Depending on your study format, the participant can respond orally, affirm by clicking “continue” on the survey, or sign the consent form as indications of their consent.

Your informed consent statement may not include any “exculpatory language” – that is, any language through which the participant / legal representative waives, or appears to waive, any rights or release the investigator (or research sponsor, or institution) from liability for negligence.

Please note: in rare circumstances, a waiver of the informed consent process may be granted by the IRB. This is *not* the same as requesting to waive the physical, signed document, and is only permitted when the research would be impossible to conduct without the waiver.