Attachment C – Field Test Oral Consent Form – Tier 1

Date:

Principal Investigator:

Application No.:

ORAL CONSENT SCRIPT

Protocol Title: Safety Program in Perinatal Care (SPPC)-II/Demonstration Project

Greetings. I am <<Data Collector Name>> from Johns Hopkins University and would like to talk to you about your experience with the teamwork and communication training workshop this past month.

• We are interested in learning your opinion on the quality and utility of this training workshop.

• We are asking you to participate in this interview because you received this training. You do not have to participate, it is your choice. There will be no penalty if you decide not to join.

• If you agree to participate, I will ask you to answer several questions about the training. You may refuse to answer any of the questions during the interview or skip any questions that you do not wish to answer. The interview will take about 60 minutes.

• With your approval, this interview will be tape recorded for note taking purposes and to ensure that we capture all your feedback. You should know that:

  • You may request that the audio recording be stopped at any time;

  • If you agree to allow the audio recording and you change your mind at a later time, you may request that the recording be destroyed;

  • The audio recordings will be transcribed for the purposes of this research, but the full transcription will not be published. We may use specific sentences from the transcript when we present the results of this research, but your name will never be identified.

• You may get tired or bored when we are asking you questions. You do not have to answer any question you do not want to answer, and you may stop the interview at any time.

• There is the risk that information about your opinions may become known to people outside this study. Standard precautions will be taken to protect your data once it is collected. Confidentiality will be maintained utilizing computer systems that require passwords for access. Collected information will be stored in a password protected computer not available to anyone not directly involved in this study. All names or other personal information will be deleted from the transcribed interview in order to protect your confidentiality. Three years after completion of the analysis of data from these interviews, all audio recordings and transcribed interviews will be destroyed.

• You will not receive any payment or other direct benefits from participating in this interview. However, we will use your answers to our questions to understand experiences with the roll-out of the teamwork and communication training workshop for future participants.

• Do you have any questions? [Probe to assess the interviewee’s understanding.]

• You may contact Dr. Asad Latif, the Principal Investigator of this pilot study, about your questions or problems with this work. His contact information is provided below.

Telephone: 410-955-8978

Email: [email protected]

• If you have any questions about your rights as a participant, or if you think you have not been treated fairly, you may call the Johns Hopkins Institutional Review Board (IRB) at 410-955-3008.

• Would you like to participate in the interview?

• [If yes] May I begin?

• I will turn on the recorder now. Please say your first and last name and that you give me permission to record the interview.

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Oral Consent Script- March 2012, Version 3