The purpose of this study is to learn from you about how to better educate patients about newborn screening and the storage and use of leftover newborn screening bloodspots. We are not asking any personal questions. We will ask these questions in a group setting called a focus group. We hope that hearing what other people say may help increase ideas for how to improve education.
More details about what we will ask you during the focus group, benefits and risks are described below in the “Study Procedure” section.
Ask us if there is anything that is not clear or if you would like more information. Take time to read the information below and to decide if you would like to participate in this study.
- What will you be asked to do?
You will be asked to take part in a focus group. The focus group will last about 1.5 hours. Questions will be asked about newborn screening, the state-based Michigan Biotrust, consent information, and the most important points parents need to know about these topics. We will audio record the session to ensure accuracy of the conversation. All audio recordings will be deleted within 2 weeks of the transcription.
You may refuse to participate or discontinue participation without penalty or loss of benefits.
- What are the risks?
The risks of this study are minimal. You may feel upset thinking about or talking about personal information related to newborn screening and leftover bloodspots from newborn screening. These risks are similar to those you experience when discussing personal information with others. If you feel upset from this experience you can tell the researcher and he/she will tell you about resources available to help.
- What are the benefits?
There are no direct benefits for joining these focus groups. However, we hope the information we get from this study will help us, and others, to improve the consent process for the storage and use of leftover newborn screening bloodspots in the future.
Another potential, but unlikely, risk is a breach of confidentiality. Many steps have been taken by the research team to make sure that the confidentiality of all data collected are protected. All study data will be stored on secure servers and password-protected hard drives. Any identifying information (e.g., names) will be removed from our focus group transcripts and replaced with a code. A list linking the code and any identifiable information will be kept separate from the research data. All data collected will be identified only by that code (not by your name). As a result, no one outside of the research team will know who answered which question. Data obtained in this study will not be used in future research.
Other People to Contact
If you have questions, complaints or concerns about this study, you can contact Erin Rothwell, a Professor at the University of Utah at firstname.lastname@example.org or Aaron Goldenberg, Professor at Case Western Reserve University at email@example.com. If you feel you have been harmed as a result of participation, please contact Erin Johnson, PhD at firstname.lastname@example.org who may be reached during the hours of 8:00 am to 5:00 pm, Monday through Friday.
Institutional Review Board: Contact the University of Utah Institutional Review Board (IRB) if you have questions regarding your rights as a research participant. Also, contact the IRB if you have questions, complaints or concerns which you do not feel you can discuss with the investigator. The University of Utah IRB may be reached by phone at (801) 581-3655 or by e-mail at email@example.com.
Research Participant Advocate: You may also contact the Research Participant Advocate (RPA) by phone at (801) 581-3803 or by email at firstname.lastname@example.org.
COSTS AND COMPENSATION TO PARTICIPANTS
There are no costs related to participating in this study. You will receive compensation at the completion of the focus group.