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Clinician Consent Form: babyPHONO study

Sheffield Teaching Hospitals NHS Foundation Trust University of Sheffield babyPHONO

This web page is for clinician participants to read only. The consent form must be completed on paper prior to participating in the study. You cannot enter any information into the boxes on this webpage.

Download a PDF of this form to print.

Study Title: Digital recordings of heart sounds in babies during the Newborn Infant Physical Examination

Short title: The babyPHONO study

Chief Investigator: Dr. Neil Lawrence

Principal Investigator: Dr. Simon Clark

If you wish to take part in ‘The babyPHONO study’, please read the clinician participant information sheet (PIS_babyPHONO_clinician_v2.0). Please write your initials next to each statement in the right-hand column below ‘yes’ if you agree or below ‘no’ if you do not agree, and sign and date the form at the end.

Consent statementYour initials

Statement 1

I confirm that I have read the clinician participant information sheet [PIS_babyPHONO_clinician_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) Me recording the heart sounds of babies using a digital stethoscope during the newborn infant physical examination.

b) The completion of a short survey after I have recorded the heart sounds of approximately ten babies (a minimum of five). I will provide my telephone number and email address to enable the research team to send me the survey.

E-mail: _______________________________

Phone number: _________________________

Statement 3

OPTIONAL: I understand that after recording the heart sounds of approximately ten babies I will be invited to attend a short interview with a research study team member that will last less than 30 minutes, to understand my experience of recording the heart sounds during the newborn infant physical examination. I can decide whether to take part in this at this time and will be asked for separate consent at the start of this interview

Statement 4

OPTIONAL: I understand that if I take part in an interview, the interview will be recorded via Microsoft teams. Following the recording, a member of the research team will pseudonymise the transcript from the interview, after which the recording will be deleted.

Statement 5

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 6

I understand that participation is voluntary and that I am free to withdraw at any time without giving any reason, without any impact upon my employment. If I am considering withdrawing from the study I can discuss the details of this with a member of the research study team.

Statement 7

If I withdraw from the research, I understand the research team will stop collecting my data, but that any data pertaining to participants that has already been collected (i.e. the heart sounds I have recorded) will remain within the research study file and will not be deleted. 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 8

I understand and agree that pseudonymised data from my survey or interview (if I have participated in an interview) may be used in publications, reports, presentations, web pages, and other research outputs. I understand that this pseudonymised and aggregated data will be available indefinitely. Pseudonymised means all personal details such as my name will be removed, to make it unlikely that I could be reidentified from the data shared.

Statement 9

I understand and agree that pseudonymised information from surveys or interviews that I take part in may 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, provided they agree to preserve the integrity of the data as per the description in this form.

Statement 10

I agree to this consent form and other data collected as part of this research study to be kept at Jessops Wing Hospital, Sheffield, UK for 6-12 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 11

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

Statement 12

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. If you do not want study updates, the e-mail you provide above will only be used to send you the survey.

Statement 13

I agree to take part in the above study

Participant and consent details

Consent form carer (clinician); babyPHONO study; STH23333; Version 2.0 Date 08/03/2026 IRAS ID: 358145