Investigators must obtain the legally effective informed consent of a research participant or the participant’s legally authorized representative (LAR). Consent must be obtained prior to the research activities and documented as approved by the Institutional Review Board (IRB).

The Consent Process. Informed consent is more than just a signature on a form, it is a process of information exchange that may include (in addition to reading and signing the informed consent document) subject recruitment materials, verbal instructions, question/answer sessions and measures of participant understanding. The informed consent process should ensure that all critical information about a study is completely disclosed, and that prospective subjects or their LAR adequately understand the research so that they can make informed choices. Thus, rather than an endpoint, the consent document should be the basis for a meaningful exchange between the investigator and the participant.

An effective informed consent process involves the following elements:

• Ensuring the investigator conducting the process is qualified and appropriately trained to explain the research and assess comprehension
• Conducting the process in a manner and location that ensures participant privacy
• Giving adequate information about the study in a language the potential participant can understand (6^th – 8^th reading level is recommended)
• Responding to the potential participant’s questions and or concerns
• Ensuring comprehension
• Documenting consent as approved by the IRB
• Providing a copy(ies) of the consent form to the participant
• Continuing to assess understanding and providing information as needed to the participant

Comprehension Questions. To aid in the evaluation of a participant’s understanding of the research activities, investigators conducting in-person procedures or the informed consent process through a virtual platform to should ask a series of comprehension questions. These are intended to encourage dialog between the investigator and participant and should not elicit a simple yes/no answer.

Example comprehension questions:

• What can you tell me the purpose of the study?
• What should you do if you want to leave before the study procedures are complete?
• What type of information will you be asked to provide today?

Foreign Language Consent Form. When the prospective participant population is anticipated to include individuals who do not speak or understand English, the consent documents must be translated to the appropriate language. The Principal Investigator (or Faculty Sponsor as applicable) of the study is responsible for ensuring the translation is performed by an individual qualified to do so and that the translated version of the consent form matches the English version.

Documentation of Consent. After the investigator confirms the participant understands the study and procedures, the agreement to enroll in the study must be documented as outlined in the IRB approved protocol. Typically, this involves obtaining the signature of the participant or their LAR. The investigator conducting the informed consent process must sign the consent form after the participant signs. The consent form should be dated by both the investigator and participant. A copy of the signed form shall be provided to the participant and the original version retained by the investigator in study records.

Waiver of Documentation. The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

1. That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research and the subject’s wishes will govern; or

• That 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 (e.g., drawing a blood sample, or asking shoppers in a mall about the ambient lighting or temperature).

Witnesses. Observation of the consent process by a witness is required in the following situations:

• When using the IRB-approved foreign language short form process for participants who do not speak English;
• When obtaining informed consent from a participant or their legally authorized representative who can understand and comprehend the language, but is physically unable to read, write, talk or is blind.
  • The individual providing informed consent must be competent and able to indicate approval or disapproval by other means.
  • The method by which the individual indicated consent must be noted on the consent form (blinking of eyes, raising arm, etc.).

The witness must be impartial, such as an adult who is not a member of the study team and who is not a family member of the participant.

The witness must sign and date the consent form attesting that:

• the requirements for informed consent have been satisfied; and
• that consent is voluntary and freely given without any element of force, fraud, deceit, duress, coercion, or undue influence.

Modifications. The IRB must review and approve any changes in the approved consent procedure, including updates to consent form language. IRB approval can be obtained by submitting a Modification request. Changes must be outlined and justified in the Modification request. No changes can put into practice until IRB approval is obtained and the IRB releases an updated version of the consent form stamped with the approval date.