CONSENT TO PARTICIPATE IN A RESEARCH STUDY
The Biological Information & Genomics (BIG) Study Biorepository and Community Registry
You are being asked to contribute a blood and urine sample and clinical information to the BIG Study Biorepository and Community Registry because you live in Convenient County, NC and are over 18 years of age. These types of studies include only people who choose to take part. The nature of the study, risks, inconveniences, discomforts, and other important information about the study are listed below.
Dr. Edward Suarez from Bigstate University will run the study. It is funded by the BIG Institute. This Institute provides grant money to Bigstate University to pay expenses for the study, including the salaries for the research staff. The researchers involved with this study will seek additional funding over time to pay the expenses involved in continuing to enroll new subjects and to study the biospecimens and information collected during the study.
It is your choice to take part in this study or not. This consent form gives information to help you decide. Please read it carefully and take all the time you need to make your choice. Be sure to ask us as many questions as you want. We urge you to talk with your family, friends, and doctor before making your choice.
Everyone who takes part in research should know that
· Research is meant to gain knowledge that may help in solving problems. Research subjects may or may not benefit from being in a study. Being in a study may also involve some risks.
· Being in a research study is completely voluntary. You can choose not to join a study. If you choose to join a study, you can quit at any time.
· No matter what decision you make about being in a study, now or in the future, it will not affect your medical care.
WHO WILL BE MY DOCTOR ON THIS STUDY?
If you decide to join this study, Dr. Edward Suarez from Bigstate University will be your doctor for the study. No medical care will be provided by this study.
WHY IS THIS STUDY BEING DONE?
Medical researchers are trying to learn more about cancer, heart disease, diabetes, and other health problems. Much of this research is done using health information along with blood and urine. Researchers often study blood, urine and information from people who have health problems and from people who do not.
WHAT IS THE PURPOSE OF THIS PROJECT?
The purpose of this project is to collect and store blood and urine samples and health information. Researchers can then study the stored materials. Through such studies, they hope to find new ways to detect, treat, and maybe even prevent or cure health problems. Some of these studies may be about how genes affect health, or how genes affect response to treatment. (Genes, which are made up of DNA, have all the information needed to build and operate a human body.) DNA contains information needed to construct and operate a human body. The genetic material, in combination with other medical, nonmedical, and social information and blood and urine tests, will be available to researchers studying genetic and other factors that contribute to or cause many different health problems. Some of the studies may lead to new products, such as drugs or tests for diseases. The study is expected to last at least five years and we plan to enroll 50,000 individuals in your community.
A “biorepository” is a collection of stored biospecimens and information. This collection is called the BIG Study Community Registry and Biorepository (or just the “Biorepository” in the rest of this form). The directors of the Biorepository are Dr. Edward Suarez and Dr. James Watson in Convenient County, NC.
The “BIG Study” is a general name that refers to the Community Registry and Biorepository; studies that are done with the biospecimens and information stored in the Community Registry and Biorepository; and studies that are done with the people who give biospecimens and information for the Community Registry and Biorepository.
WHAT IS INVOLVED?
If you agree to join the BIG Study, you will be asked to sign this consent form. We will give you a signed copy of the consent form to keep.
Here is what will happen next:
We will ask for some information about you, your life, and your health.
First, we will ask you to fill out a BIG Study Participant Registry Questionnaire. This questionnaire asks for some basic information, like your name, age, racial or ethnic group, and health history. We will contact you no more than once a year to update this information. This will happen for as long as your information is stored in the Biorepository.
Second, if you agree, we will get some information from your medical record. Examples include information about your health problems, lab results, medical procedures, images (such as X-rays), and medicines. This is because future researchers need to know if you have any health problems. They may also need to know about any treatments you have had and how well the treatments worked. If you agree, we will use your medical record from time to time to update this information. This will happen for as long as your information is stored in the Biorepository.
Third, we will ask you to fill out three surveys. One survey asks about your understanding of the role of genes in health and illness, and your views about genetic research.. A second survey collects additional demographic information about you, including your education, where you live and work, your social networks, and your daily activities. The third survey asks about your feelings, your views about life, your relationships, and your lifestyle. Each of these surveys will be repeated no more than once a year to update the information.
Fourth, we will collect research data from any future BIG studies you decide to join.
Fifth, we will collect publicly available information about you from other medical and non-medical databases (for example, Department of Motor Vehicles, Social Security Administration, Medicare, Medicaid, Employment Security, Veterans Administration, etc.) and link it with the other information we have collected and stored.
We will take your vital signs and get a blood and urine sample from you.
We will measure your blood pressure, pulse and waist circumference. We will draw 50 ml (about 3 tablespoons) of blood from a vein in your arm by needle stick and collect about 20 ml of urine. We will also take a sample of cells from the inside of your cheek (by swa
ing the inside of your cheek with a Q-tip) to get your DNA, and we will take a sample of your saliva (by asking you to chew on a small piece of cotton) to measure your salivary cortisol level (a measure of stress).
We will store your biospecimens and information in the Biorepository.
We will keep your blood, urine and information in the Biorepository along with those from all the other people who join the BIG Study. There is no limit on the length of time we will keep your blood, urine and information. We will keep them as long as they are useful, unless you decide to quit the study or we close the Biorepository.
We will let researchers use the materials stored in the Biorepository for approved studies.
Researchers can apply to study the biospecimens and information stored in the Biorepository. A BIG Study research committee will review each application. An ethics review will also be done. This kind of review is to make sure that risks are minimized and that the rights and welfare of people who take part in research are protected.
If a study is approved, a part of your blood or urine and some information about your health might be distributed to the researchers, along with biospecimens and information from many other people. We will not give researchers your name or any other information that could identify you without your permission.
Materials stored in the Biorepository will be used mainly by researchers at Bigstate University. Researchers from other universities, the government, and drug- or health-related companies may also apply to study them.
Researchers may contact you in the future with offers to join other research studies.
We will not notify you every time your biospecimens and information are used in a study. However, some researchers might apply to do a study for which they would need to contact you. For example, they might want to ask you to fill out a survey, do a phone interview, or be seen by a researcher or doctor.
If a study like this is approved, the researcher will contact you to tell you more about the study. There will be a new consent process just for that study. You can decide then to join the new study or not.
We will make sure researchers do not contact you about more than four studies like this per year.
Some of your genetic and health information may be placed in Internet databases.
In order to speed research, it is often helpful for researchers to share the genetic information they get from studying blood and urine specimens. Other researchers can then compare that information to the genetic information from people in other studies. By sharing information, researchers can learn even more about human health and disease.
Some of your genetic and health information may be released into one or more scientific databases that can be accessed on the Internet. There are many scientific databases where your information may go. Some are kept by Bigstate University, some are kept by the National Institutes of Health, and some are kept by private companies. Some of these databases can be used by the public. Others are restricted and can only be used by approved researchers.
Your name and other information that could identify you will never be released into an Internet database. Nobody will know just from looking at a database that the information belongs to you.
WHAT ARE THE POSSIBLE RISKS?
Physical Risks. Like any other time you have blood drawn, you may feel
ief pain or have some
uising from the needle. Infection, excess bleeding, clotting or fainting is also possible, but unlikely.
Privacy Risks. There is a risk that someone could get access to the data we have stored about you. If those data suggested something serious about your health, it could be misused. For example, it could be used to make it harder for you to get or keep a job or insurance. There are laws against this kind of misuse, but they may not give full protection. We believe the chance of these things ever happening is very small,