Informed Consent Form

Measurement of Speech-Evoked Potentials in Normal Hearing Participants

You are invited to participate in this study. This informed consent form is to make sure that you understand the purpose of this study and the nature of your involvement. The research project is being conducted by Dr. Hilmi Dajani, Full Professor at the School of Electrical Engineering and Computer Science (613-562-5800, ext. 6217; hdajani@eecs.uottawa.ca). Data from this study may be used by Ms. Maryam Karimi Boroujeni (mkari052@uottawa.ca), for her thesis projects, or by her thesis co-supervisor Dr. Christian Giguère, Full Professor at the School of Rehabilitation Sciences (613 562-5800 ext. 4649; cgiguere@uottawa.ca).

Purpose of the study: The purpose of this study is to investigate the brain’s electrical response to speech stimuli. This electrical signal, called the auditory-evoked potential, allows clinicians to diagnose hearing problems and find their origin in the brain. The sounds that clinicians most commonly use for this test are brief clicks or other artificial sounds. These types of sounds do not provide sufficient information to assess the ability to hear speech. As a result, we are interested in developing tests that record the brain's electrical response to speech, or the Speech-Evoked Potential, with a diverse set of speech samples and in different acoustic environments. The knowledge gained is expected to help in the development of better diagnostic tests of hearing loss and tools for evaluating hearing aids.

Procedure: The study is performed in the Audiology Laboratory, 1st floor, Roger-Guindon Hall, 451 Smyth Rd., Ottawa, ON K1H 8M5. Data is collected on a single day and the entire session lasts about two hours.

The following is the step by step procedure that will be followed:
1. The participant’s ears will first be examined using an otoscope, which is a device that shines a beam of light to help visualize and examine the condition of the ear canal and eardrum.
2. The hearing of the participant will be tested with pure tones at 500, 1000, 2000 and 4000 cycles per second. We will provide the participant with the result of this test. Those who are not found eligible following the hearing test will be excluded.
3. Participants will be asked to sit in a comfortable chair inside a sound-proof room, and will be asked to minimize movement during the recordings.
4. The vertex (at centre of the top of the scalp) or the centre of the forehead, and earlobes will be cleaned with a mild abrasive cream that prepares the skin for attaching electrodes with minimal discomfort and irritation. Then, an electrode filled with conductive gel will be placed on the vertex or centre of forehead, and two other electrodes will be placed on the earlobes to measure the brain’s response to sounds. Foam earphones will be inserted into the participant’s ear canals. The earphones will deliver the sound at a level calibrated at less than or equal to 85 decibels (SPL or Sound Pressure Level). This level is well within the acceptable safe range for sounds, and well below Canadian occupational exposure limits.
Participant description: Adults with normal hearing and without any external or middle ear disease will be included.

Risks to participating: There is no danger or risk to health associated with this study. All procedures have been pre-tested and they have been used routinely for many years in hospitals, clinics, and laboratories.

Withdrawing from the study: Your participation in this study is voluntary. You may withdraw from the study at any time, by verbally informing any of the investigators, even after signing this form, or even after data collection has ended. There will be no consequences following this action, and withdrawing from the study will have no bearing on the participants’ relationship with the researchers. Moreover, the collected data will be deleted.

Compensation: You will receive $20 for participating in the study. Participants will still receive the compensation should they choose to withdraw from the study.

Confidentiality: Any information about you collected during this study will be kept strictly confidential. Your name will not be associated with the collected data in any way. While the results will appear in students’ dissertations and may also be published, you will not be identified.

The data collection is conducted by Dr. Dajani, Dr. Giguère, or their graduate student. The records will be kept on computer files. The files will be password-protected. Only Dr. Dajani, Dr. Giguère, and their graduate student will have access to the data.

The data will be kept in Dr. Dajani’s office when not in use and will be conserved for 10 years, after which the computer files will be deleted, and the consent forms will be shredded.

Benefits of the Study: Hearing impairment is an important public health problem. This study will help develop better technologies to measure hearing loss.
Funding Source: Funding for this study is provided by the Natural Sciences and Engineering Research Council of Canada (NSERC)

In closing: With your participation, you will be given a copy of this consent form. You may ask questions at any time, even after signing this consent form.
If you have any questions about this study, you may contact Dr. Dajani, Dr. Giguère, or Ms. Karimi Boroujeni (contact information provided in first paragraph of this form).

If you have any concerns with regards to the ethical conduct of the study, you may contact the Protocol Officer for Ethics in Research, University of Ottawa, Tabaret Hall, 550 Cumberland Street, Room 159, Ottawa, ON K1N 6N5, tel.: 613-562-5841, email: ethics@uottawa.ca.

Signatures: I have read the above description of the study and understand the conditions of participation. My signature indicates that I agree to participate in the study.

Name of the participant (please print):

Participant’s signature:

Date:

Researcher's signature:

Date: