Consent for Participation in the COVID-19 Pregnancy Impact Study
Introduction
Thank you for considering participation in the COVID-19 Pregnancy Impact Study, a vital component of the Mother Child Pairings Initiative. This section outlines the study's purpose, what your participation entails, how we ensure your privacy, and your rights. Please review this information thoroughly and feel free to ask any questions before consenting to participate.
Study Purpose
This study aims to explore the potential long-term effects of COVID-19 vaccination and infection during pregnancy on fetal development and pregnancy outcomes. Our partnership with a leading nationwide clinical laboratory group enables us to conduct thorough assessments focusing on the presence of random DNA insertions, which may shed light on negative pregnancy outcomes and their links to COVID-19.
Participation Details
You will be provided with a complimentary buccal swab kit for easy and safe collection of DNA samples from both you and your child. The process involves a gentle wipe of the inner cheek and is entirely non-invasive. Participation does not require financial commitment or provide financial incentives.
Confidentiality and Privacy
We uphold the highest standards of privacy and confidentiality. All collected samples and information will be securely handled, anonymized, and not shared with medical providers or included in medical records, in strict compliance with HIPAA guidelines. Only aggregated data will be published.
Risks and Benefits
While there are minimal risks associated with buccal swab sample collection, understanding potential discomforts is essential. The study does not offer direct benefits to participants. However, your participation is crucial in advancing our understanding of COVID-19's impact on pregnancy and child health, potentially benefiting future generations.
Voluntary Participation
Your involvement is completely voluntary. You may decline or withdraw at any stage without penalty or loss of benefits. If insertional events are detected, a certified genetic counselor will discuss these findings and possible next steps with you.
Consent
By signing below, you confirm your understanding of the study's scope, your participation's voluntary nature, and the handling of your information. You agree to participate under these conditions, recognizing the importance of this research in advancing public health knowledge.