University of Washington
Consent Form for
“Forced Cough/Non-Cough Sounds Collection for Cough Detection Algorithm"
RESEARCHER’S STATEMENT
We are asking you or your child to participate in a research study. The purpose of this consent form is to give you information about the study. This information will help you decide whether to take part in the study or allow your child to take part in the study.
Please read the form carefully. Once you have completed reading the form, you can decide whether to participate or allow your child to participate. You (or your child) may refuse to participate or withdraw from this study at any time without penalty or loss of benefits to which you or your child are otherwise entitled.
PURPOSE AND BENEFITS
The purpose of the project is to collect audio samples of both cough and non-cough sounds to improve an algorithm that can automatically identify coughs from an audio recording. Since a patient’s cough pattern and type of cough are indicators of a patient’s lung health, accurate cough counting improves our ability to monitor a patient’s pulmonary health. You or your child will not directly benefit from taking part in this research study.
PROCEDURES
We ask that this study is performed in a quiet environment to eliminate any potential background noise.
If you are the parent of a minor, we also ask you to assist your child in completing the study if they need help during any portion.
The study participant will first be asked to complete a study questionnaire which will include basic demographics and health questions.
Next, the study participant will record 20-25 samples of forced (or voluntary) coughs. After completing the forced coughs, the study participant will have the option of exiting the survey. If the study participant wishes to continue with the study, he or she will record 5-10 samples of speech, throat clears, and laughter.
The questionnaire results and audio recordings collected during the study will be downloaded from the survey software by the research team from and stored in our secure database. The study participant will not receive any data collection results from this study.
BENEFITS OF THE STUDY
No individual benefits are expected for subjects who participate in this study.
RISK, STRESS OR DISCOMFORT
The recorded audio may contain sounds that the study participant does not want shared, which presents a privacy risk. Please see the privacy information section below for additional information.
While recording sounds for the study, the study participant may feel discomforts such as being tired, breathless, hoarse, or otherwise uncomfortable. To account for this potential discomfort, the study participant will be permitted to take as much time as needed between recording sounds. Furthermore, the study participant may end any section early and continue to the next task. We also recommend having water available during the study to help alleviate any discomfort.
Because the study involves producing sounds like a cough, there is a risk of spreading germs. To reduce this risk, we will ask the study participant to produce the sounds away from other humans and disinfect the recording device and nearby surfaces when the study is complete.
PRIVACY INFORMATION
Taking part in this study is voluntary and the study participant may stop at any time. Information about the study participant and all audio recordings are confidential.
The researchers will manage annotation of the audio recordings. Annotation will include tasks like listening to the audio recording, verifying the type of sound in the recording, and adding labels that correspond to the start and end points of certain audio portions. This data will be used by our research team to develop and improve the cough algorithm.
The recordings and their annotations may be shared with other researchers for future use in developing audio health sensing algorithms (see next section). Any sharing of data will be managed by the research team.
Government or university staff sometimes review studies such as this one to make sure they are being done safely and legally. If a review of this study takes place, the study participant’s records may be examined. The reviewers will protect the study participant’s privacy. The study records will not be used to put the study participant at legal risk of harm.
The study team may want to contact the study participant about taking part in additional data collection sessions for this study or future related studies. The study participant is not obligated to participate in any of these future studies.
USING DATA IN FUTURE RESEARCH
The information that we obtain from the study participant might be used for future studies. We may remove anything that might identify the study participant from the information. If we do so, that information may then be used for future research studies or given to another investigator without getting additional permission from the study participant. It is also possible that in the future we may want to use or share study information that might identify the study participant. If we do, a review board will decide whether we need to get additional permission from the study participant.
CONTACT
If you have questions about the study or feel you have been harmed by it, you may contact the research team at [email protected].
If you have questions about your rights as a research subject, you can call the University of Washington Human Subjects Division at (206) 543-0098. We will give you a copy of this form for your records.