What is the Dental Registry and DNA Repository?
The Dental Registry and DNA Repository (hereafter referred to as the DRDR) is a project being initiated at the University of Pittsburgh School of Dental Medicine. This project will seek to obtain DNA samples from patients seeking treatment at the University of Pittsburgh School of Dental Medicine in order to better understand, diagnose, and treat various dental conditions and diseases. To our knowledge, this is the only project in the world that will keep a comprehensive set of dental phenotypes linked to DNA samples. The DRDR will serve as a one-source provider of clinical data linked to DNA samples for educational and research purposes.
You may be asked to participate in the DRDR if you are, or will be, undergoing treatment at the School of Dental Medicine.
Why is the DRDR important and how will my participation help?
Our understanding of the nature of any disease determines how we diagnose it; and, in turn, how we treat it. This general principle applies to dental specific diseases, as well as all other diseases. Your participation in this project may help researchers to find innovative procedures and potentially effective new methods of treatment. The general principle is that, the more information that researchers can discover, the better they can treat disease.
How does it work, and in what way will my DNA sample be used?
If you decide to participate in the DRDR, a sample of your saliva will be collected by spitting into a collection container. The sample will be placed in a bank, which will later be used by researchers to discover treatments for various dental disease and conditions.
Who will benefit?
Although you will receive no direct benefit for participating and including your saliva sample in the DRDR, you may gain the satisfaction of knowing that your participation can potentially help to better treat a variety of dental diseases, some of which may or may not pertain to you. The availability of such DNA samples for research use is very important to the future development of new treatments, and therefore you will be playing an invaluable role by participating in the DRDR.
Will I be paid?
No, there is no financial compensation for participating in the DRDR.
How much time does it take?
It may take up to 30 minutes to spit the ideal amount of saliva needed. However, most people take only about 10 minutes. You can easily participate in the DRDR on the same day that you already have an appointment scheduled with the School of Dental Medicine. Many patients participate during wait time.
What are the requirements for participation?
If you are a seeking treatment at the University of Pittsburgh School of Dental Medicine you are eligible to participate in the DRDR.
Can my child participate in the DRDR?
Yes. Because certain dental diseases and conditions can only be found in children, or are more prevalent during childhood, children of all ages can participate in the DRDR. In fact, it is very important to include children in this project in order to learn to better treat such conditions and diseases that are specific to children. Dr. Vieira, the principal investigator for the DRDR, is a pediatric dentist specially trained to work with children. The professionals inviting your children to participate in the study are also highly trained individuals in dentistry for children.
Who will have access to my personal information?
If you agree to participate in the DRDR, your past, current, and future medical record information will be placed into the Research Registry. Your medical records and your sample will be stored in the DRDR in such a manner whereby it will be possible only for individuals responsible for the DRDR to connect your identity with your sample.
The researchers who actually use the samples for research will not have knowledge of your identity. Great lengths will be taken (in the form of a Data and Safety Monitoring Plan), in order to ensure that your privacy is protected at all times. Jacqueline Noel, the study coordinator and honest broker, takes measures to ensure complete compliance with current HIPAA regulations and IRB policies and procedures.
Who will have access to my DNA? Can it be sold?
When investigators receive the DNA samples for research, the samples will already have been de-identified to include no identifiable information connecting you with your sample. Investigators cannot sell DNA samples. It is strictly prohibited to use DNA samples for any unethical measure. The DRDR staff ensures that important ethical procedures are being followed at all times.
Can I withdraw my participation at a later date?
Yes. If at any point you decide that you no longer wish to participate in the DRDR, you have the right to withdraw. If you decide to withdraw, you should send a dated letter to the individual listed in the consent form, Dr. Vieira. When the letter is received, your information will be completely deleted from the DRDR, and your DNA sample will be destroyed.
Will I find out the results of the study?
Because it will not be possible to connect your identity with your saliva sample when the sample is being used for research, it will also not be possible to inform you of the results of such research. However, any research or finding resulting from the use of the resources from the DRDR will be made available so that the dental and medical communities can be aware of such innovative developments. You can also browse the Vieira Lab newsletter found on this website in order to receive constant updates on the progress of the DRDR.
Will I be contacted again after I submit my sample?
You can elect whether or not you wish to be contacted at a later date in order to be invited into a specific research study, which may or may not include monetary compensation for your time/participation. You will not receive phone calls asking if you would like to participate in such future studies; you will be recontacted via letter only.
What is a clinical trial?
A clinical trial is a controlled study involving human subjects, designed to evaluate prospectively the safety and effectiveness of a drug or device. Clinical trials serve in showing us what works and what does not work in medicine. They provide means for researchers to decide what is safe and effective in treating diseases.
What is a human subject?
“Human subject” is the term used to describe any person participating in any clinical research trial.
What is research?
Research is defined as a “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Research helps to better diagnose and treat various disease and conditions.
What is a protocol?
A protocol is the researcher's formal plan for a scientific experiment or treatment. All protocols involving human subjects must be IRB (Institutional Review Board) approved.
What is a consent form?
A consent form is an important document that describes the researcher's purpose and methods in the research project. You should carefully read the consent form, and ask any questions that you may have about the project. Should you have additional questions at any point in the future regarding the project, you have the right to discuss them with the principal investigator.
What is informed consent?
Informed consent means “knowing consent.” It is the exercise of a free power of choice without force or coercion. In other words, this means that you understand the project, and that you willingly decide to participate. No one is permitted to force you into participating.
What is an investigator?
An investigator, or researcher, is the clinician or scientist responsible for conducting the study. The principal investigator for the DRDR is Dr. Vieira.
What does minimal risk mean?
Minimal risk is a term that you will see in the consent form used to participate in the study. Risk is defined as minimal where the probability and magnitude of harm or discomfort anticipated in research project are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. In short, this means that this study has been classified in the lowest category possible for causing harm or bad effects to you.