Ethical, Legal, and Social Implications (ELSI)
It is important that parents are involved in the process of evaluating the potential benefits and harms of expanding newborn screening (NBS) panels, and that they participate in discussions about how the process can be improved. As NBS is changing so rapidly, the ScreenPlus team is very interested in hearing parents’ opinions about NBS, NBS-related research, and parental experience with ScreenPlus. During the e-consent process, parents will be asked if they would like to participate in ELSI studies.
- Parent(s) who agree to participate in the ELSI studies will be contacted by email when new surveys become available.
- Survey answers will be de-identified, meaning stored in a way that cannot be traced back to you.
- The first ELSI survey will be sent to parent(s) shortly after they consent to ScreenPlus. This survey will ask about the consent and education process. The information we learn will help make the process better for other parents.
- Overall, these surveys are designed to help us better understand parents’ expectations, satisfaction with, and concerns about newborn screening.
Qualitative (Interview) Study
At ScreenPlus, we want to better understand the impact of rare disorders on families.
- In the face of a challenging diagnosis or uncertain results, family members may experience strong emotions such as guilt, anger, sadness, fear, anxiety and depressed mood.
- We care deeply about the well-being of our participants, and that’s why ScreenPlus’ PI, Dr. Melissa Wasserstein, has partnered with bioethicist Dr. Aaron Goldenberg and qualitative researcher and rare disease advocate Dr. Maria Kefalas to better understand the challenges families may experience.
- We will ask families who receive a positive or uncertain ScreenPlus result to participate in a series of research interviews with us, but participation is entirely voluntary.
- These interviews with the ScreenPlus team will remain completely confidential and will not be shared with anyone outside of ScreenPlus.
- The ultimate goal of the qualitative study is to gain an understanding of the rare disorder journey, and how we can better help patients and families deal with the challenges of a rare disorder diagnosis.
- Please learn more information about how ScreenPlus provides support for families.