Documentation of Consent & Process

Once a fully executed (signed and dated by all parties) informed consent form is obtained, a copy of the entire document must be given to the participant. The participant will need a full copy of the informed consent for his/her records to reference study schedules, procedures, risks, objectives, etc. over the course of the study.

• The entire original document must be retained by the researcher. It is suggested to maintain the original in a subject specific research binder/file rather than file the original with hospital or outpatient medical records.
• Documentation of the informed consent process is optional (for most studies) and may be placed in the subject’s research record or clinical records in addition to a copy of the fully executed consent form. Note: Some sponsors require documentation of informed consent discussion. A templated form for these instances is available on the IRB forms web page.
  

  Example of a note to the research record which documents the informed consent process:

  03/30/2007 @ 3:30pm: Ppt seen in GI clinic today. Reviewed the consent form; specifically explained the purpose of the study, risks and benefits, expected duration of participation, the number of visits per year, weekly diaries, confidentiality, right to withdraw at any time and emergency contact information. Ppt given time to review consent form and ask questions prior to signing.

  All questions were answered.

  Ppt signed/dated consent form and was given a copy for her records. She will start research screening procedures on 04/05/2007. -Judith Smith, MD