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Waiver of Documentation of Informed Consent

Researchers can request that a participant not be required to sign a consent form prior to participation. In order to waive the signature requirement, referred to as verbal consent, ONE OF THE FOLLOWING must be applicable to the study:

  1.  The only record linking a participant to the research is the consent from in studies where the principal risk is a breach of confidentiality.
  2. The research is minimal risk and only involves procedures for which consent is not normally sought.
  3.  Participants will be wary of signing documents from a cultural perspective.

To apply for a waiver of documentation of informed consent, a Request for the Documentation of Informed Consent form must be submitted with the protocol application.

Please Note:

  • A Participant Information Sheet must be provided to participants giving verbal consent. This is a brief written statement describing the research and contact information of the PI and IRB.

Waiver or Alteration of Elements of Informed Consent

In specific instances, any of the 8 elements of informed consent may be waived.  To do so, ALL of the four criteria below must be met:

  1. The research in its entirety involves no more than MINIMAL RISK to participants.
  2. The waiver or alteration will not adversely affect the rights or welfare of participants.
  3. The research could not practically be carried out without the waiver or alteration.
  4. Wherever appropriate, participants will be provided with additional pertinent information after participation.

To apply for the waiver or alteration, a Request for Waiver or Alteration of Elements of Informed Consent application must be submitted with the protocol application.

Please note:

  • A Waiver or Alteration of Elements of Informed Consent form is required for any study using deception.
  • Studies using deception must also include a debriefing form. 

Waiver of the Informed Consent Process

In rare cases, the entire consent process can be waived.  To waive the consent process altogether, ALL of the four criteria below must be met:

  1. The research in its entirety involves no more than MINIMAL RISK to participants.
  2. The waiver will not adversely affect the rights and welfare of participants.
  3. The research could not practically be carried out without the waiver.
  4. Whenever appropriate, participants will be provided with additional pertinent information after participation.

To apply for a waiver, a Request for Waiver of the Informed Consent Process must be submitted with the protocol application.


Translations of Study Documents

If translated forms are to be given to non-English speaking participants, those translated forms must be submitted to the SBER IRB Office along with a signed Certificate of Translation.  You can submit translations online here.

Please note:

  • Do not submit translations until the English version of the protocol has been approved.  This will ensure that the translated documents include any changes requested by the IRB Committee.
  • The person translating the study documents cannot be listed on the research protocol.