Key Information
You are invited to take part in a research study to complete the CLIA Certification process for the DNA lab test developed to detect and measure the level of genetic damage done to the OPRM1 gene due to repetitive opioid exposure. It is the duty of Providers who are involved in this medical research study to protect your life, health, dignity. You have the right to privacy, and confidentiality of personal information. Smith Genetics Research is sponsoring this research study working with EpiGendix Laboratory.
You will be asked to obtain a buccal swab sample (a scraping from inside your mouth off of your cheek) and send the sample in to us through the US Postal Service, regular mail.
Please read this form carefully. Take your time to ask the study staff as many questions about the study as you would like. After receiving this Informed Consent form in the mail, you are required to sign both and return one in the postage paid envelope provided along with your sample. This is the same envelope that you will use to return your sample. The envelope should already be addressed and already have the postage. If either the postage or the address is missing or if you have any other questions, please reach out to Dr. Doug Smith (980-201-1073).
The second copy of this Informed Consent is for you to sign and date and keep for your own records. This study will consist of 45 opioid dependent individuals submitting a sample for DNA methylation analysis. This DNA analysis will be used in a process known as CLIA Certification. The CLIA Certification process is how a new lab test becomes recognized as being accurate and reliable. The 45 samples from the opioid dependent people will be compared against DNA samples of people who have never taken the opioids. This is how new lab tests are developed.
Please know that your information and the sample that you are submitting WILL NOT be used in any way other than for this CLIA Certification process. Neither your personal information nor your DNA information nor your sample will be used in any other manner now or in the future.
There is no fee or charge for participating in this study. There is no fee or charge to you. There is no fee or charge to your health insurance provider.
Background and Purpose
You are being asked to participate in this research study because you have symptoms that suggest that you have already had damage done to your DNA by the opioids. The symptoms of this damage is a sickness that happens to you when you try to stop taking the opioids. The purpose of this research study is to:
• Prove DNA damage to your body due to the opioids.
Our findings may lead to results that will help physicians better treat patients in the future.
What is the OPRM1 Gene?
In your body you have something called “nerves”. You can think about these nerves being like the electrical wires in your house. These nerves have “switches” called “receptors”. You can think about these receptors being like the light switch on a wall. The OPRM1 gene is the gene that manufactures a receptor called the “opioid receptor”. This opioid receptor is where opioids bind and have their effect in the body. It is the OPRM1 gene that is being studied in this study. No other part of your DNA will be examined.
What is Methylation?
There are certain substances that can change your DNA. Some of these changes are considered a type of poisoning. Some of these poisonings are called “mutations”. A mutation is when the poisoning causes a change in the sequence of the DNA. Some of these changes are called “methylation”. A methylation happens when a methyl group is added to the covering of the DNA. This area under the methylation is then turned off or “silenced”. The opioids have been linked to methylation in the person taking them.
What is CLIA Certification?
CLIA stands for Clinical Laboratory Improvement Act. It was a law passed in 1988. This law set new and very high standards for a lab test to be used in the United States. By having very high standards, we can all be assured that the lab test we are using in our healthcare is a good and reliable lab test. The test we have built is a new lab test. In order to be used in the United States, this lab test must pass the CLIA Certification process. You are helping us with this process by supplying a DNA sample.
What Will Happen During the Study?
Your participation in this study will consist of:
• Approximately 15 minutes at home collecting the buccal swab (scrapping from inside your cheek) sample and sending it to us through the regular mail.
Screening:
Before the study-related test procedure is performed, you will have been asked to read, sign, and date these consent forms that were mailed to you. There are two copies. One copy is to be returned to us with your sample. The second copy is for your records.
Testing Process:
After completing the above, you will have your:
• Buccal swab (scrapping from inside your cheek) sample collected and sent to us through the mail. After your buccal swab sample has been mailed, your participation in the study is completed.
Expectations:
If you participate in this study, you will receive the results of your DNA test. The results will be given to you as a laboratory report. We would then ask that you schedule a time with Dr. Smith to review your results. Dr. Smith can be reached at 980-201-1073.
Risks of Study Procedures
There are no known side effects of giving a buccal sample. The main known risk of participating in this study is the possibility that your identity could be accidentally exposed. Every possible step is taken to prevent this from happening. But some risk will always remain. There is always the possibility that some unexpected or unforeseen risk could arise.
Alternatives to Participation
You do not have to participate in this study. This is completely your decision. If you do decide that you do not want to participate in this study, that is okay. If you do decide not to participate in this study there is no punishment or denial of care or any other negative consequence for not participating in this study.
Furthermore, if at any time you change your mind and wish to withdraw from this study, you can do so without any penalty or punishment.
New Findings
Any new important information that is discovered during the study and which may influence your willingness to continue participation in the study will be provided to you.
Benefits
You may benefit as a result of your participation in this study. There is, however, no guarantee that you will benefit from your participation in this study. Information learned from the study may help other people in the future. If the study is successful, you will receive a lab report about your DNA. We would like to schedule a time with you to review the results if this happens. Dr. Smith can be reached at 980-201-1073.
Compensation for Participation
There is no compensation for participating in this study.
Confidentiality
Your name, address, phone number and date of birth will be kept on a password protected database and will be linked only with a study identification number for this research. Records of your participation in this study will be held confidential. The Investigator, the sponsor or persons working on behalf of the sponsor, and under certain circumstances, the United States Food and Drug Administration (FDA) and the Institutional Review Board (IRB) will be able to inspect and copy confidential study-related records which identify you by number. If the results of this study are published or presented at meetings, you will not be identified.
To make sure that the health information collected in this study is accurate, it will need to be checked from time to time against your medical records. Some persons may need to see these records to monitor the research and verify the accuracy of the study data, including:
- a limited number of representatives from the study sponsor (namely its monitors and auditors),
- The research ethics review board – Pearl IRB (an independent ethics committee that reviewed the ethical aspects of this study to help protect the rights and welfare of study participants),
- government regulatory authorities including the US FDA and other regulatory agencies.
Your study records, including confidential information about you collected during the study, will be kept under lock and key.
While every effort will be made to protect the privacy of your information, absolute confidentiality cannot be guaranteed. This does not limit the duty of the researchers and others to protect your privacy.
By signing and dating the DNA TEST REGISTRATION form, you consent to the collection, access, use and disclosure of your information as described above.
Whom to Contact About This Study
During the study, if you experience any medical problems, suffer a research-related injury, or have questions, concerns or complaints about the study such as:
- Whom to contact in the case of a research-related injury or illness;
- Payment or compensation for being in the study, if any; .
- Your responsibilities as a research subject;
- Eligibility to participate in the study;
- The Investigator’s or study site’s decision to exclude you from participation;
- Results of tests and/or procedures;
Please contact the Investigator at the telephone number listed on the first page of this consent document.
If you seek emergency care, or hospitalization is required, alert the treating physician that you are participating in this research study.
An institutional review board (IRB) is an independent committee established to help protect the rights of research subjects. If you have any questions about your rights as a research subject, contact(Monday through Friday 9-5 EST/EDT): 317-602-6104
By mail:
Pearl IRB
29 East McCarty Street, Suite 100
Indianapolis, Indiana 46225