SoundSense: A Design and Development of Smart Stethoscope for Automated Detection of Abnormal Lung Sounds using Machine Learning Approach Informed Consent Form For pre-identified individuals who have wheezes, crackles, or normal lung sounds Name of Principal Investigator: Escal, Eloisa Marie D Name of Department/Office/Institution: Name of Sponsor/Source of Funding: N/A Name of Research Project: A Design and Development of Smart Stethoscope for ‘Automated Detection of Abnormal Lung Sounds using Machine Learning Approach PURPOSE OF THE STUDY You are being invited to take part in a research study. Before you decide to participate in this study, it is important that you understand why the research is being done and what your Participation will involve. Please read the following information carefully and feel free to ask the researcher if there is anything that is not clear or if you need more information, ‘The purpose of this study is to evaluate the performance and accuracy of our smart stethoscope and its embedded machine-learning model for the automated detection of ‘abnormal lung sounds. Your participation in this study is voluntary and crucial to help us understand how well this device recognizes and distinguishes these particular sounds. As an Individual with pre identified wheezes, crackles, or normal lung sounds, your participation will help us gauge the accuracy and performance of the device. STUDY PROCEDURES As a participant, you will be asked to participate in the following procedures: ‘+ Participant Pre-Identification: Your inclusion as a participant in this study involves prior identification by a qualified healthcare professional with expertise in auscultation. They will identify individuals exhibiting specific lung sounds: wheezes, crackles, or normat lung sounds, deemed essential for the research study. + Auscultation and Lung Sound Recording Session: You will undergo an auscultation session using the SoundSense smart stethoscope device. This process involves, recording your lung sounds and analyzing them using the embedded machine- learning algorithm + Data Collection for Research Purposes: The collected data from your auscultation session and audio from the recording session will be used solely for research Purposes, contributing to the improvement of the machine learning model's accuracy.* Frolect Testing: Your participation wil involve engaging in project testing, which includes the classification of lung sounds into categories such as normal, whieezes, ot Crackles using the machine learning mode. It is important to note that the results obtained may be inaccurate or preliminary. This testing is part of the ongoing development process to enhance the device's accuracy. The results should not be Considered as a definitive diagnosis or a replacement for professional medical advice. DURATION ‘Your involvement in this research study will last for approximately 20 to 40 minutes. This includes the time required for the auscultation and lung sound recording session, data collection, and participation in the project testing, VOLUNTARY PARTICIPATION ‘Your participation in this study is voluntary. It is up to you whether or not you decide to Participate. If you decide to participate, you will be asked to sign this consent form. After you sign this consent form, you are still free to withdraw at any time and without giving a reason. Withdrawing from this study will not affect the relationship you have, if any, with the researcher. If you withdraw from the study before data collection is completed, your data will be destroyed. It's important to note that if you choose to withdraw from the study before project testing is completed, all recordings of lung sound classification and any associated data will be promptly destroyed. Your participation and the data collected are entirely confidential and will only be used for the purposes of this project. RISKS Participation in the recording process using the smart stethoscope might cause slight discomfort or inconvenience. However, this discomfort is expected to be minimal and non- invasive. During the testing phase of machine learning models, there might be instances where the classification of lung sounds is not entirely accurate. However, it's important to note that these classifications will be conducted under the supervision of medical professionals who are experts in auscultation. Their exper the accuracy of sound classification. @ will contribute to enhancing BENEFITS Your participation will aid in the development of a smart stethoscope capable of automatically detecting abnormal lung sounds. Your participation will also contribute valuable data that will assist researchers in refining machine learning algorithms for the classification of lung sounds CONFIDENTIALITYAll information collected during thi this study will be kept confidential. Your iden protected, and the data obtained will be used solely for research purposes. No Per identifiable information will be shared without your explicit consent, CONTACT INFORMATION ‘This study was approved by the Research Ethics Review Committee of DE UA SAL questions at any time about this study, or if you experience any non-normative sens participation, you may contact the researcher whase contact information i onthe first page. You Tove any questions regarding your rights or treatment as 2 research participant o If problems arise A your participation which you donot feel you can discuss wth the Principal Investigator, lease fe! fe to send an email to rmco-rer@dlsl.edu.ph. PA. f you have any ‘CONSENT (This section is mandatory] Ihave read the provided information, or it has been read to me. 1 have had the opportunity to tk questions about it and any questions | have been asked have been ‘answered to my aaa ieee understand that | will be given a copy of this form, and the researcher will keep rather copy on file. consent voluntarily to be a participant in this study printName ofPartiipant Emerd fie bir arZ Signature of Participant Dae 19 ob 2. 4¥ /month yes (this section is mandatory] Print Name of Researcher Bea\ posa None F ‘Signature of Researcher Sede Date Sali |2024 Day/month/year (This section is optional] Print Name of Impartial Witness Signature of Impartial Witness Date Day/month/year (ifthe participant is illiterate! have witnessed the accurate reading ofthe consent form tothe potenti participant, and the eeividual has had the opportunity to ask questions. ! confirm that the individual has given consent freely. Print name of witness Signature of witness Date Day/month/year eae eenuitneas mustsign (i possible, this person should be selected by the participantand ‘should have no connection to the research tearm).All information collected during this study will be poe 18 this study will be Ind the data obtained will be used formation willbe shared without y kept confidential. Your identity will be Solely for research purposes. No personally ur explicit consent. dio not feel you can discuss withthe Principal investigator, please feel free CONSENT (This section is mandatory) [have read the provided information, or it has been read to me. have had the opportunity to ask questions about it and any questions I have been asked have been answered to my satisfaction. | understand that Iwill be given a copy of this form, and the researcher will keep another copy on file. | consent voluntarily to be a participant in this study. A PrintName ofParticipant bf reyes Signature of Participant Gusta Date 4 Jey Jog Day /month/year (This secton is mandatory} Print Name of Researcher Fecal Elaige, MORE Signature of Researcher i Date Os [ot feces Day/month/year (This section is optional) Print Name of Impartial Witness Signature of Impartial Witness Date Day/month/year (ifthe participant isititerate 1 ave witessed the accurate reading ofthe consent frm tothe potential participant Individual has had the opportunity task questions: confirm thatthe Inada has given consent reel. Print name of witness Signature of witness Date 2 /month/year [ Lalterte witness must sign i possible this person should be selected by the paripantand