Participant Consent Form (echo): babyPHONO study

Statement 1

I confirm that I have read the relevant participant information sheet [PIS_babyPHONO_ECHO_v2.0] for the above study. I have had the opportunity to consider the information, ask questions and have had these answered satisfactorily.

Statement 2

I understand that taking part in this study will involve:

a) The recording of my child’s heart sounds using a digital stethoscope

b) The recording of my child’s heart rate, respiratory rate, and blood oxygen levels

c) The completion of a short paper survey paper after (a) and (b) above

d) The storing of pseudonymised images from my baby’s echocardiogram for purposes of research analysis (pseudonymised means their personal details like name and date of birth will be removed)

e) (a), (b), (c) and (d) above repeated if my child has a repeat echocardiogram before 3 months of age

f) A follow-up telephone call after my child is 1 year of age to check if my child has been diagnosed with any heart conditions. This call will likely take less than 20 minutes.

Statement 3

I understand that participation of my child is voluntary and that I am free to withdraw my child at any time without giving any reason, without my medical care or legal rights being affected.

Statement 4

I understand that by choosing to participate as a volunteer in this research, this does not create a legally binding agreement nor is it intended to create an employment relationship with the University of Sheffield

Statement 5

If I decide to withdraw my child from the study, I understand no further data will be collected. I understand that the research team can withdraw my data from the study, unless it has already been aggregated, shared or published in which case it will not be possible to withdraw my data.

Statement 6

I understand that identifiable data (such as name) and relevant sections of my child’s medical notes and/or data collected during the study may be reviewed by responsible individuals from the research team, the Sponsor (the University of Sheffield), the NHS Trust, or from regulatory authorities. I give permission for these individuals to have access to my child’s records. The purpose of this access will be to establish the age of the baby (in hours) at each assessment, and to download images from echocardiogram scans from hospital systems after they’ve taken place.

Statement 7

I understand and agree that anonymised data about my child may be used in publications, reports, presentations, web pages, and other research outputs. I understand that this anonymised and aggregated data will be available indefinitely, but that my child will not be identifiable in these outputs.

Statement 8

OPTIONAL: I understand and agree for my child’s individual pseudonymised information to be made available to other researchers, third parties or commercial parties on request for answering future research questions or the development or testing of healthcare technologies. You may still take part in the study if you do not consent for this type of data sharing (in this case please initial the box beneath the column ‘no’).

Statement 9

I understand researchers or those at other organisations allowed by the research team to use the data will never know the identity of me or my baby, and no published research will ever reveal my identity.

Statement 10

I understand that the heart sound recordings obtained from my child during this study are not being used to monitor their health, and will not give them any medical benefit. The recording of heart sounds will not change the medical advice or tests that are offered.

Statement 11

I understand that heart sound recordings obtained with the Eko CORE digital stethoscope are stored on a computer server in the United States prior to download onto NHS computers.

Statement 12

I understand that clinicians involved in the study are informed not to enter patient identifiable data into the digital stethoscope application. Only the research study identifier will be entered into the stethoscope application. If a clinician taking part in the study accidentally enters any patient identifiable data into the application, that data will be deleted when the heart sound recordings are downloaded onto NHS computers.

Statement 13

I understand that participation within this study does not alter any of the treatment or follow-up recommended for my child.

Statement 14

I understand that records relating to my child will be kept confidential. No information will be released or printed that would identify my child without my permission unless required for hospital or research governance purposes.

Statement 15

I understand and agree that the research team will securely store my identifiable details to contact me in future regarding this study (e.g. telephone/text/email) for up to 12 months after the end of the study. Identifiable details, including a copy of the consent form, will be available only to the research team, other than for purposes of monitoring and audit.

Statement 16

I agree to be contacted for a telephone interview about my child’s health after 1 year of age

Statement 16

OPTIONAL: I agree to be emailed by the study team with updates about the studies progress and results. I will be able to opt out of these e-mails at any time.

Statement 18

I agree for my child to take part in the above study