COMIRB Consent Form News: Investigator Signature and Witness Lines
COMIRB Jun 1, 2017
COMIRB no longer requires a signature line from the Principal Investigator or designated co-investigator on consent and assent forms. The regulations do not require that these lines be present. The “person obtaining consent” is still required to sign consent documents. Principal Investigators remain responsible for ensuring that only eligible subjects are enrolled in research.
If you currently utilize the Investigator signature line, please continue to gather this signature as indicated by your approved study documents. If you would like to update your consent documents, please submit an amendment with a Change Form through InfoEd to formally remove the Investigator signature line.
COMIRB template consent forms will be revised shortly to reflect this change.
COMIRB policy regarding the role of the witness during the consent process (COMIRB policy 14.10.1) has been revised. The witness was previously charged with attesting to the quality of the interpretation and the subjects’ understanding of the information provided. The witness role has been narrowed to verify that the oral consent process took place in the subject’s preferred language. You can find the revised COMIRB policy here.
If you currently utilize the Investigator signature line, please continue to gather this signature as indicated by your approved study documents. If you would like to update your consent documents, please submit an amendment with a Change Form through InfoEd to formally remove the Investigator signature line.
COMIRB template consent forms will be revised shortly to reflect this change.
COMIRB policy regarding the role of the witness during the consent process (COMIRB policy 14.10.1) has been revised. The witness was previously charged with attesting to the quality of the interpretation and the subjects’ understanding of the information provided. The witness role has been narrowed to verify that the oral consent process took place in the subject’s preferred language. You can find the revised COMIRB policy here.
