Frequently Asked Questions (FAQ)
At Therametric Technologies, Inc. (TTI), some of our studies require individuals who have a specific dental condition (certain oral health disease, missing tooth/teeth, etc.) while others enroll healthy people to participate. Prior to beginning a study, potential participants will be screened to ensure they meet all qualification requirements. Screening typically involves reviewing medical and dental records as well as receiving an oral exam from a licensed Dentist. If qualified and willing to paticipate, subjects will be followed closely by a team of dental experts for the duration of the study period.
Are the clinical studies confidential?
Your privacy is important to us! Protected Personal health Information (PPI), including information such as your name, DOB and address, will not be shared with any external party without your authorization. The Health Insurance Portability and Accountability Act (HIPAA) is used to help protect your PPI from being shared or used inappropriately. At TTI, we are committed to the responsibility of ensuring that your PPI is collected, used, disclosed and retained in compliance with applicable privacy regulations.
Can I stop my participation in the middle of a study?
Yes, you can choose to stop your participation in a study at any time.
What is an Informed Consent Document, and why do I have to read and sign it?
An Informed Consent Document (ICD) gives interested individuals information about a specific clinical research study, so they can make an informed decision to participate. The ICD outlines the study procedures, risks,and benefits of the research.
TTI staff in the Clinical Studies Division are responsible for making sure that every interested individual participates in an informed consent discussion after each has had adequate time to review the information contained in the ICD. This informed consent process ensures that interested individuals get answers to questions about the study and feel informed and comfortable about the nature of the study.
In order to participate, all interested individuals must voluntarily sign the reviewed ICD in the presence of a TTI staff member following the discussion.
Can I bring my children with me to study visits?
TTI requests that for your child’s safety, you make every measure to avoid bringing children with you to your study appointments.
I am a smoker. Can I participate in a study?
Some studies (but not all) allow individuals who smoke or use tobacco products to participate. Be sure to inform a TTI Staff member working in the Clinical Studies Division of your tobacco use so that they can review the entry requirements for the specific study you are interested in. Smoking is not allowed in the building or for the duration of the study visits at our clinic.
What are the benefits of participating in a research study?
There are many benefits to participation, including:
- Becoming active in your own oral health
- Helping others by contributing to dental research
- Gaining access to leading-edge dental treatments that are not yet available to the public
- Obtaining expert dental attention during the study
What is an IRB?
IRB stands for “Institutional Review Board.” An IRB is a group of individuals formally created under federal law to review, approve the initiation of, and to conduct periodic review of research studies involving human subjects. The primary responsibility of an IRB is to protect the safety and rights of study participants. An IRB protects the the rights and welfare of research participants by ensuring that:
Risks to study participants are minimized
Risks are reasonable in relation to potential benefits
The Informed Consent Document is accurate and complete in describing the study procedures, risks, and benefits
All study activities have been planned and are being conducted in an ethical manner
An IRB may approve, require changes in the study design, or disapprove the research study in order to help protect the rights and welfare of human subjects. Most clinical research studies involving human subjects cannot begin without a review board’s approval.
Will I be paid for my participation?
Most studies conducted at TTI offer financial reimbursement for time and travel. The amount of compensation depends on the number and length of visits and the complexity of the procedures you will be expected to perform at home and in the clinic.
How long will my study participation last?
The length of each study conducted at TTI varies and depends on the goal and design of the research. Specific details will be provided to uou before and during the informed consent meeting.
Does participating in a dental research study replace my visits to my family physician or dentist?
You should continue to see your family physician and dentist as you normally would. Clinical studies should not interfere with your normal health care and are not intended to replace any regular health or dental care visits. However, many dental studies we run will require you to refrain from having your teeth cleaned, receiving fluoride applications or having other types of preventative procedures performed on your teeth while participating in a study. Specific requirements for each study will be reviewed with you during the informed consent meeting. When participating in any study with TTI, it is required that you report all visits to your family physician or dentist, as well as medication changes as they occur.