Welcome to our “Q & A with QA” posting created by the Quality Assurance team. We believe all questions are important and if one individual has a question about something, then it’s likely others may have as well, or will at some point. We hope these blog posts will provide insight into common questions asked by study teams so that everyone can be included in the conversations. Of note, the questions we post are paraphrased and not taken directly from any one individual.
|We utilize the short form consent process frequently and understand that a witness needs to be present. We often use the interpreter as the witness. Can you explain the witness’s responsibility and what their signature represents?
|The responsibility of a witness is to be present during the entire consenting discussion and to provide a signature on both the short form and the summary form of the consent. The witness signature is attesting that an oral presentation took place with the participant, whether done in person or remotely.
A witness signature is an FDA requirement and is integrated in the SCI SOP. Per SU IRB, it is best practice to have the witness comprehend both English and the language of the participant, but not a requirement.
It’s acceptable to have the interpreter also act as the witness, but it’s important to ask the interpreter ahead of time if they are willing to also act as witness. In these situations, the interpreter would need to provide a signature on both the short form and summary form. If they are not willing to sign, then you must identify someone else willing to act as witness and provide their signature. This could be study staff, a family member, or someone else (except the person obtaining consent).
Finally, please remember the consent documentation needs to include that short form consenting process was used and who acted as the interpreter and witness.
SCI Consenting Research Participants and Legally Authorized Representatives SOP
4.12. Witness – A person who attests to the oral presentation and process of informed consent. The witness maybe the interpreter (including the hospital interpreter), study staff, a family member, or another person, but cannot also be the POC.5.3.4. A witness must be present during the entire consent process.188.8.131.52. If the interpreter serves as a witness, secure agreement before the consent conference that they will sign the documents as the witness (see 5.3.6).
SCI-CTO Consenting a Non-English Speaking Adult Patient
Section 5. Identify a witness to observe the consent process. …Before starting consent process verify if interpreter will serve as witness – if not, you will need another person to be the witness. You do not have consent without the witness signature.
21 CFR 50.27 Documentation of informed consent (b)(2)
A short form written consent document stating that the elements of informed consent required by 50.25 (elements of informed consent) have been presented orally to the subject or the subject’s legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining the consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative in addition to a copy of the short form.
FDA Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/informed-consent
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