D. Interview Subject Consent Form

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Consent Form –Interviews on Embedded Research in Care Delivery Systems

PURPOSE: We invite you to serve an informant on Embedded Systems Research. Our discussion with you will help us better understand the current state of embedded research in your care delivery system. We will use the information you provide to help us to develop illustrative case examples of how systems conduct embedded research. Our research will describe diverse approaches to embedding research that addresses operational priorities. We will also explore some of the benefits and challenges associated with these approaches.

SPONSOR and RESEARCHERS: These interviews are part of an intramural research project conducted by Michael Harrison and Amanda Borsky, both staff members in the Center for Evidence and Practice Improvement at the Agency for Healthcare Research and Quality (AHRQ).

WHAT IS INVOLVED: Participation in this research is voluntary. Michael and/or Amanda will use an open-ended list of topics as a basis for the interview. We will ask about how operationally relevant research is organized and conducted within your delivery system; types of projects that have been conducted in the last couple of years; and challenges associated with these projects. The interview will last about an hour.

recording and Transcription: To be sure to capture what you tell us, we will audio record this interview and transcribe it. We will also take notes during the interview. We will not connect your name with anything that you say during the interview or any document summarizing the interview or our case analyses. If you do not feel comfortable with our recording the interview, we will not do so.

CONFIDENTIALITY: Your responses will be kept confidential to the extent permitted by law, including AHRQ’s confidentiality statement, 42USC 299c-3©. That statute requires that information collected or research by AHRQ that identifies individuals or establishments be used only for the purpose for which it was supplied, unless you consent to the use of the information for another purpose. The name of your organization will be included in the interview notes and transcriptions. However, neither your name, nor other personal identifiers will appear there. No one but the people involved in this research will ever see these documents or have access to the recordings. Our correspondence with you and other people we want to talk with will be kept completely separate from our notes, transcriptions, and recordings. There will be no links between any information we collected in order to contact you and arrange the interview and the interview documents and recordings.

RISKS: There are no foreseeable risks to participating in this study. The only cost to you is the time and effort to answer questions. You may skip topics or questions as you see fit. The information you give will be treated as confidential; no discussion participants will be identified by name in the reports.

BENEFITS: There are no direct benefits to you for participating in this study. However, you will be helping us and others understand how embedded research is currently conducted and the challenges that systems face in conducting this type of research.

QUESTIONS: For questions about the project, you may call Michael Harrison at 301 427 1434 or email him at Michael.Harrison@ahrq.hhs.gov.

I have read the consent form. My questions have been answered. My verbal consent interview means that I understand the information and I consent to participate in this study and, unless otherwise stated, give permission for interviews to be recorded. I also certify that I am 18 years of age or older.

This interview is authorized under 42 U.S.C. 299a. The confidentiality of your responses to this survey is protected by Sections 944(c) and 308(d) of the Public Health Service Act [42 U.S.C. 299c-3(c) and 42 U.S.C. 242m(d)].  Information that could identify you will not be disclosed unless you have consented to that disclosure. Public reporting burden for this collection of information is estimated to average 60 minutes per response, the estimated time required to complete the interview. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.  Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: AHRQ Reports Clearance Officer Attention: PRA, Paperwork Reduction Project (0935-XXXX) AHRQ, 5600 Fishers Lane, Room #07W42, Rockville, MD 20857.