Title of Research Study: The Great Minnesota Earwax Study
Investigator Team Contact Information: Dr. Meredith Adams
For questions about the research study, research results, or other concerns, call the study team at:
Investigator Name: Dr. Meredith Adams Investigator Departmental Affiliation: Otolaryngology Phone Number: 612-626-0912 Email Address: meadams@umn.edu | Research Team Contact Information: ENT Clinical Research Manager: Ali Stockness, MPH Phone Number: 612-626-3018 Email Address: entstudy@umn.edu |
Supported By: This research is supported by Lions International Hearing Foundation.
Key Information About This Research Study
The following is a short summary to help you decide whether or not to be a part of this research study. More detailed information is listed later on in this form.
What should I know about a research study?
● Someone will explain this research study to you.
● Whether or not you take part is up to you.
● You can choose not to take part.
● Your decision will not be held against you.
● You can ask all the questions you want before you decide.
Why is this research being done?
We want to understand:
1. What bacteria naturally live inside a healthy ear
2. If having earwax changes the bacteria that naturally live in your ear
3. How the bacteria present may change with different health conditions
We are doing this study because we want to identify the bacteria that naturally live in the ear canal, and learn how this may change with different health conditions. We will use the information to design new ways to promote healthy ears and to treat infections
How long will the research last?
We expect that you will spend 15 minutes or less in this research study.
What will I need to do to participate?
You will be asked to complete a questionnaire and have photos taken of your ear canals, and a swab sample of one ear canal. We do not ask for your name or any other identifying information. The questionnaire asks about your demographics, health history, and ear cleaning habits. The tip of a sterile swab will be inserted into the outer part of your ear canal and swirled for 30 seconds to take a sample of your ear canal bacteria. The tip of a handheld camera (video otoscope) will be placed just inside the ear canal opening, to photograph earwax in each ear.
Is there any way that being in this study could be bad for me?
There are no significant risks associated with the questionnaire that asks about your demographics, health history, and ear cleaning habits. There may be mild discomfort answering questions as information gathered may be about specific life circumstances that may cause temporary distress.
When collecting the ear canal swab sample, you may experience some discomfort as the swab is gently inserted into the ear canal to collect the sample. In rare cases, if the swab were to go further into the ear canal than intended, it could injure your ear drum. To minimize this risk, the trained study team member with a medical background, who routinely does ear examinations and is delegated by the PI, will collect the sample.
During the video-otoscope exam, just as when you get your ear examined at the doctor’s office, you could have temporary discomfort when the video-otoscope is used to photograph your ear canal. In rare cases, if the tip of the otoscope went farther into your ear canal than intended, it could scratch the skin or injure your ear drum. To minimize this risk, a study physician who routinely does ear examinations will take the photo and we will ask you to sit down and hold your head still during the photo.
Will being in this study help me in any way?
There are no benefits to you from your taking part in this research. We cannot promise any benefits to others from your taking part in this research. However, possible benefits to others include the advancement of medical knowledge related to ear hygiene and natural bacteria of the ear.
What happens if I do not want to be in this research?
There are no known alternatives, other than deciding not to participate in this research study.
Detailed Information About This Research Study
The following is more detailed information about this study in addition to the information listed above.
How many people will be studied?
We expect up to 1,000 people will be in this research study.
What happens if I say “Yes, I want to be in this research”?
You will first be asked to complete a questionnaire about your demographics, health history, and ear cleaning habits.
- The questionnaire will take less than 10 minutes to complete.
After the survey, the study personnel will use a sterile swab to take a sample of the bacteria at the entrance of the ear canal. We will then use a video-otoscope to photograph each of your ear canals.
The video-otoscope is a small handheld camera designed for people to use at home to examine their own ears. You will be seated in a chair. We will ask you to hold your head still. We may use a little speculum (plastic funnel) to hold your ear canal skin open. A study doctor will place the tip of the camera just inside your ear canal to take a photo.
- The ear canal swab and video-otoscope image capture will take less than 5 minutes to complete
Where will the study take place?
Research will take place in the MN state and county fair setting.
Will it cost me anything to participate in this research study?
Taking part in this research study will not lead to any costs to you.
What happens to the information collected for the research?
Efforts will be made to limit the use and disclosure of your personal information, including research study and medical records, to people who have a need to review this information. We cannot promise complete confidentiality. Organizations that may inspect and copy your information include the Institutional Review Board (IRB), the committee that provides ethical and regulatory oversight of research, and other representatives of this institution, including those that have responsibilities for monitoring or ensuring compliance (such as the Quality Assurance Program of the Human Research Protection Program (HRPP)).
Will I receive research test results?
No results will be shared with you. The photo of your ear canal is not a clinical exam of the ear and cannot be used to make clinical judgments.
What will be done with my data when this study is over?
We may use data for future research. Your data will not be shared with researchers/institutions outside of University of Minnesota. We will not ask for your consent before using data in the future. There will be no identifiers in your data, which means that nobody who works with the data for future research will know who you are. Therefore, you will not receive any results or financial benefit from future research done on your data.
Whom do I contact if I have questions, concerns or feedback about my experience?
This research has been reviewed and approved by an IRB within the Human Research Protections Program (HRPP). To share feedback privately with the HRPP about your research experience, call the Research Participants’ Advocate Line at 612-625-1650 (Toll Free: 1-888-224-8636) or go to z.umn.edu/participants. You are encouraged to contact the HRPP if:
- Your questions, concerns, or complaints are not being answered by the research team.
- You cannot reach the research team.
- You want to talk to someone besides the research team.
- You have questions about your rights as a research participant.
- You want to get information or provide input about this research.
Will I have a chance to provide feedback after the study is over?
The HRPP may ask you to complete a survey that asks about your experience as a research participant. You do not have to complete the survey if you do not want to. If you do choose to complete the survey, your responses will be anonymous.
If you are not asked to complete a survey, but you would like to share feedback, please contact the study team or the HRPP. See the “Investigator Contact Information” of this form for study team contact information and “Whom do I contact if I have questions, concerns or feedback about my experience?” of this form for HRPP contact information.
Can I be removed from the research?
The person in charge of the research study or the sponsor can remove you from the research study without your approval. Possible reasons for removal include if you do not follow study rules or if the study is stopped.
What happens if I am injured while participating in this research?
In the event that this research activity results in an injury, treatment will be available, including first aid, emergency treatment and follow-up care as needed. Care for such injuries will be billed in the ordinary manner, to you or your insurance company. If you think that you have suffered a research related injury let the study physician know right away.
Will I be compensated for my participation?
If you agree to take part in this research study, you will receive a University of Minnesota drawstring backpack for your time and effort.