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.
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