Documentation of the Informed Consent Process

Documentation of the consenting process may occur in the progress notes of a clinic chart or medical record or in the study subject file created specifically for participation in the study.

"X" Item Comment-Suggestion
  Date informed consent obtained Document the time the informed consent was obtained if the consent was obtained the same day as other study-related activities.

Documentation of the time that the informed consent was obtained provides information regarding the sequence of activities.
  Study title Use the full or abbreviated title as documented in the initial IRB application. Inclusion of the IRB protocol number provides additional clarification.
  Indication for study participation Document why the individual is considered for inclusion in the study.
  Statement whether the individual meets all of the inclusion criteria and none of the exclusion criteria. If this statement cannot be made, the investigator must contact the sponsor and IRB for approval to proceed prior to the enrollment of the individual.
  Documentation regarding what information was presented and explained to the subject/legally authorized representative (LAR) and how it was presented. Information provided in order to obtain informed consent must include the required essential elements as well as the applicable additional elements as listed in the federal regulations unless there is IRB approval to waive or alter the informed consent.  The essential and additional elements of informed consent are listed in 45 CFR 46.116 and 21 CFR 50.25.

Include in the documentation if the informed consent process involved the use of a translator or witness and the relationship of the translator/witness.

Other suggested examples of information to include in the documentation are: 1) study subject was able to review the study information prior to the meeting, 2) use of tools such as a video or computer module to aid in the communication and comprehension of information.
  Documentation regarding how the subject’s/LAR’s questions and concerns were handled. Include in the documentation the nature of the subject’s/LAR’s questions and concerns and how those questions and concerns were addressed.
  Statement whether the subject/LAR appeared to understand the information presented Include in the documentation how the subject/LAR demonstrated his/her understanding of the information presented and how the level of understanding was assessed.

Examples of assessment include but are not limited to: 1) asking the individual to tell you in his/her own words what he/she understands his/her participation will encompass; 2) provide a post-consenting quiz for completion, review the responses with the individual, reinforce and correct information when appropriate; 3) ask a specific question such as “what is the purpose of the study?” or “what is a potential risk?”.
  Statement whether the subject/LAR agreed to participate in the study. Include in the documentation if one of the following events occurred: 1) The subject voluntarily gave his/her informed consent to participate; 2) The LAR granted permission for the subject to participate in the study and the subject assented.

If the subject was unable to consent or assent, include in the documentation why this occurred and the reason for continuation with enrollment into study.
  A copy of the completed and signed informed consent document was given to the subject/LAR. In accordance with MCW SOP 4.4.1(b).
  Signature of individual(s) obtaining the informed consent Only qualified individuals should conduct the informed consent process; that individual may be either an investigator or a research team member. The individual must be able to provide the information needed to make an informed decision, facilitate discussion regarding the study and address the individual’s questions and concerns.

The individual who obtained the informed consent should be the signatory for the documented process.