Telephone Script for Parental Consents



Telephone Script for ConsentGetting Started:About Phone Consent and Audio Recordings: For those researchers where DocuSign may not be an option. If written consent is required, this process can occur over the phone, or by other means such as videoconferencing, and should include recording to document the consent process. Whether by phone or video conference, it may also be appropriate for FDA-regulated research to include a witness in the process. Remember that all expectations of informed consent documentation still apply (45 CFR 46.117 and 21 CFR 50.27), in particular, please be sure to provide a copy of the consent to the subject to keep either by mail, email or fax. Important!FDA Regulated Research: Please review the updated FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, especially FAQ 10, which addresses cases where signed consent may not be collected from the subject for the study file.Recruitment Tips: Before contacting potential subjects, the study team should address the following.Develop a plan to maintain the potential subject’s privacy.What will happen when someone other than the potential subject answers the phone? Be mindful of privacy considerations (i.e., do not disclose any private information – such as a patient diagnosis). Limit phone contact / messages to no more than 5 attempts.Only those listed on the IRB approved protocol as able to be involved in and then finalize informed consent should be involved in this process (this could mean that more than one study team member is involved – one to explain the consent, and another to facilitate understanding of the consent process and finalize/ confirm consent).Study team member/s contacting the potential subject must be knowledgeable and able to answer questions related to the screening and the main study. Whenever feasible, the potential subject should be provided with a copy of the written consent form (via email, fax, or mail) prior to the phone consent discussion. When the consent is not provided in advance, the entire consent should be read over the phone to the potential subject. In either case, ask open-ended questions to confirm comprehension.The Office of Research recommends that if electronic consent is not feasible, and the potential subject declines both the inclusion of an impartial witness and the use of an audio/ videoconference to document the consent process for FDA regulated research, the research team discontinue the consent discussion at that time. If recording: Do NOT begin recording the conversation until you have received approval from the potential subject to do so.Script for Consent: Please use the following script when introducing yourself and the study. Introduction: “Hi, my name is __________ from UC Irvine. I am calling to speak with ________. Is this he/she?If the answer is yes: “Great! Do you have a few minutes to discuss a research project that you may be interested in participating?”If yes: Confirm their identity and continue with the script below.If no: Ask if there is a more convenient time to call back.If the answer is no: “Is he/she available to speak with me?”If yes: Wait for the potential subject to come on the line, confirm their identity, and then continue with the script below.If no: Ask if there is a more convenient time to call back.“We are conducting a research study looking <describe the study>. We are interested in conducting an <describe the study procedures (i.e., survey, questionnaire, obtaining clinical data, a clinical trial, etc.)> which will take approximately <describe the time commitment>. Are you interested in participating in this research?”If yes: “In order for you to participate, I need to obtain your informed consent. To do this, I can either send you the consent form and then you can call us after you have received it; OR, I can read the consent form to you, obtain your consent today, and send you a copy of the consent form afterwards. Do you prefer to receive the consent form prior to the consenting process, or can it be sent afterwards?”If the potential subject prefers to receive the consent after providing their consent: “I will be sure to send you a copy of the consent form after our discussion. Do you prefer that it be sent via email, mail, or fax?” (Continue with script below)If the potential subject prefers to receive the consent prior to the consenting process: “No problem. How would you like me to send you a copy; do you prefer email, mail, or fax? After you have received the consent form and when you have time to finish the consent process, please contact a member of the study team listed at the top of the document.” Continue with script below after the potential subject has received the consent form and calls the study team.If the answer is no: “Thank you for your time. If at any point you have questions or would like additional information, please feel free to contact me at <phone number>. Goodbye.”“Only if you agree, I would like to record my reading of the consent form to you and then record your response if you agree to participate. This audio or video recording is only for record keeping purposes and will be maintained in confidence by the research team, the study sponsor, as applicable, the UCI IRB and any other IRB of record responsible for overseeing the study. In addition, I may also ask a third party to be included on the call as an impartial witness to the conversation. Do I have your permission to ask an impartial witness to join the conference? Do I have your permission to audio record our discussion? FDA Regulated Research: If no to witness and recording (STOP – Do not continue with consent)Non-FDA Regulated Research: If no to witness and recording (do no record, do not obtain witness) “Okay, I will not record our conversation and I will make a note in our study records to document your consent if you decide to provide it. I will now read you the consent form.” (Continue script below)Non-FDA Regulated Research: If yes to witness and recording (conference in witness and start recording): “I have added in an impartial witness on our call. I now have the voice recorder turned on and will read you the consent form.” (Continue script below) “Please feel free to stop me at any time to ask questions”. [Begin reading from the consent form. Pause after each section and inquire with the potential subject (using open ended questions) to assess their understanding of what was read to them. After this process is complete, continue with script.]“Do you have any questions?” (Answer any questions, and before proceeding, confirm that the potential subject has no further questions.) “Just so I’m sure that I accurately document this call and have all the information correct, could you please state your name and the date. I will make sure to document this (note: even if no voice recording, documentation of the entire consent process is important!!). Thank you for your time. If at any point you have questions or would like additional information, please feel free to contact me at <phone number>. Goodbye.” ................
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