Information Sheet for Participants (Patients & ELSI Experts)

Thank you your interest in this project. This sheet provides more information about the study to help you decide whether you desire to participate. Before you participate in this study, we will review this information with you and ask you to sign an informed consent form. We will send the informed consent form to you ahead of our meeting for your review. If you decide not to participate, there will be no disadvantage to you and we thank you for considering our request.

What are the research aims?

This research study will explore the design requirements to minimize the identity disclosure via controlled information disclosure and quantifying and communicating the remaining privacy risk. We would like to learn more about the perceptions of the privacy preserving interactive record linkage (PPIRL) framework for patient-centered comparative effectiveness research that requires record linkage. The researchers will solicit input and consensus from and among patients and stakeholders to collaboratively write the following template documents for PPIRL: 1) a privacy statement, 2) an institutional review board (IRB) application, and 3) a data use agreement (DUA). Additionally, the researchers will solicit any suggestions participants may have to improve current mechanisms based on their experiences with current practices (i.e., full disclosure to a trusted party), social norms of expectations, as well as any perceived privacy issues.

In big data integration projects, it is impracticable to obtain explicit informed consent in the traditional sense. Therefore, findings from this study will have important implications for how privacy is achieved in research that involves record linkage (RL).

Who is being invited to participate?

This research study will involve two main groups of participants:

1) IRB, legal, and bioethics experts, who we will collectively refer to as Ethical, Legal and Social Implications (ELSI) experts.

2) Patients and caregivers who are interested in participating in this study.

Participants must be 18 years of age or older and speak English.

Who is conducting the research?

The study is being conducted by two academic researchers, with funding from the Patient-Centered Outcomes Research Institute (PCORI), a non-profit organization that funds research in order to help patients and those who care for them make better-informed decisions about their healthcare choices. Dr. Hye-Chung Kum is an associate professor at Texas A&M University and is cross-trained in computer science and social work. Dr. Kum holds expertise in data science and data mining in support of accurate evidence-based decisions for policy, management, legislation, evaluation and research. Dr. Alva O. Ferdinand is an assistant professor at Texas A&M University and is cross-trained in public health (DrPH) and law (JD) with expertise in using large secondary data sources for population-level research. Drs. Kum and Ferdinand will be joined by Professor Cason Schmit, who is also an assistant professor at Texas A&M University and the HIPAA compliance officer at the university’s School of Public Health. The research team consists of avid researchers and experts in the role of law and data in health systems. You can read more about their work at the web addresses listed below:

What will participants be asked to do?

Should you agree to take part in this project, you will be participating in a nominal group technique (NGT) session with Professors Kum, Ferdinand, and Schmit, which will be held through an online forum (e.g., conference call). The session will last approximately 120 minutes. There are no right or wrong answers to any questions. We are interested in your views and experiences. The session will be audio recorded. You will be asked about your opinions regarding the PPIRL framework, as well as any experiences related to perceived privacy issues. You are free to skip any questions you do not wish to answer or to leave the research session at any time.

Who will see my interview responses?

Session recordings will be transcribed, but no identifying information such as your name will be included in the transcript. After the transcript is finished, we will delete the audio recording. The results of the study will be published, but information will be aggregated. Your responses will not be shared with anyone else. We also will not share information about who participated in the study.

Will I be compensated for participating?

Yes. Participants will be compensated with a small gift certificate upon completion of the qualitative session and will be entered into a raffle with an opportunity to obtain a higher-value gift certificate.

What if I have further questions or want to participate?

We would be delighted to tell you more about the study. The contact information for the research team is listed below. A member of the research team will follow up with you in a few days’ time with a reply.

This study has been approved by the Texas A&M University Institutional Review Board, which is charged with protecting the welfare of participants in human research. Should you wish to speak with them, you can call 979-458-4067 or toll free at 1-855-795-8636.

Thank you for your consideration! We look forward to meeting you!