Study Aims and Procedures
What is different (and similar) about this phase of the SSDP study?
What are the benefits of my participation in the study?
Why is this research important?
What will I be asked to do?
Why is the consent form so long?
Will I get paid extra for participating in this part of the study?
What will be done with the saliva sample?
What will happen then with the genetic data?
How long will you store the DNA?
If I agree to DNA storage, what other tests might be done?
Privacy and Security
Is long-term DNA storage safe?
Will I have the right to remove my genetic profile from the database at some later time?
Who will be the guardian of the DNA? of the genetic data?
Who will do the genetic analysis?
Will anyone else be given access to the DNA?
Does this include lawyers, insurance companies and law enforcement agencies?
If insurance companies or employers obtained my genetic information in some other manner, can this genetic information be used against me in the workplace or with my insurance?
What will you do to make sure my interview and genetic samples and data remain private?
Genes and Genetic Research
What is a gene?
What is DNA?
How many genes are there in the body?
I thought you had to get DNA from blood. Can you get it from spit, too?
What is “genotyping”? What’s a “genetic marker”?
Why collect information about genes?
Could the genes measured in SSDP tell me if I am going to get a disease later on?
Can I get a copy of the results or the genotype?
Is there a gene for smoking? Or a gene for alcohol problems?
What genes will be examined?
Is there something odd about these genes that I should be concerned about?
Could you clone me?
Could my DNA get mixed up with someone else’s?
What if I have questions?
What is different (and similar) about this phase of the SSDP study?
For many years SSDP has looked at experiences in families, schools and communities that affect child, adolescent and young adult development. As you move through adulthood, we know that your health is an increasingly important aspect of your life. Researchers agree that health is due in some part to our genes and some part to what we experience, so we will collect genetic as well as environmental information from people who participate.
What are the benefits of my participation in the study?
Your involvement will help researchers better understand how a person’s genes and experiences and surroundings are related to health conditions. Our findings will help us develop new ideas about how past and current life experiences and genes relate to both good health and to health problems that many adults face
Why is this research important?
Scientists have identified all of the genes in the human body. More than 20,000 of them! But many questions remain about which genes are related to health outcomes, how genes work, and why they seem to have different effects on our health and behavior under different circumstances. We need to know more about when and how different versions of our genes are affected by our environment because our surroundings and experiences (such as how much stress we experience, what kind of relationships we have with friends and family members) can have a big influence on our health. By studying the relationships between genes and environment, we may learn how to improve treatments for health problems. In fact, we may discover ways in which families and communities actually protect us from developing health problems in the first place!The upcoming interview will be much shorter than you are accustomed to. If you agree to participate, we will ask you to do an interview, a health assessment and a saliva collection. In the interview, we will ask about how active your lifestyle is, and we will take some general bio-measures like height, weight and blood pressure. Since smoking and drinking and other drug use are also related to health, we will ask questions about these things in your life as well. Genetic material is stored in nearly every cell in your body, so we will be able to get a sample of your genetic information from cheek cells in your saliva. The saliva sample is very easy: spit less than half a teaspoon into a tube! No blood. No needles. That’s it! The whole visit should last under an hour.
Why is the consent form so long?
DNA research can be a sensitive matter both for public participants and the scientists conducting the research. We want to protect your privacy, and we want you to be fully aware of the use, purpose, and methods of conducting research with your DNA. The consent forms serve as tools to communicate the goals of the project and the methods employed, as well as a way for you to acknowledge your understanding.
Will I get paid extra for participating in this part of the study?
You will be compensated $50 for participating and completing this short interview and bio-assessment.
What will be done with the saliva sample?
Your saliva sample in the tube (called an “Oragene kit”) will be labeled with a bar-coded identification number rather than your name. It will be express delivered to the laboratory of our collaborators at the Institute for Behavioral Genetics at the University of Colorado, Boulder. A portion of each sample will be sent to the Mayo Clinic in Minnesota where researchers will genotype approximately one million genetic markers, called “Single Nucleotide Polymorphisms,” or SNPs (“snips”). For more explanation about genes and genetic markers, see below.
What will happen then with the genetic data?
These data will then be returned to us for analysis. With your saliva sample and prior interview responses, SSDP researchers and their collaborators will be searching for and studying genetic markers for associations between our genes and our environment in affecting physical and mental health in adulthood. The genetic analysis will be done by the SSDP research team at the University of Washington and their collaborators at the Institute for Behavioral Genetics at the University of Colorado in Boulder. The coded information, or data, will be put in a database whose access is controlled by SSDP investigators only. That means that your data will be used for research purposes only, and only researchers who are working directly with us will have access to it. Given our commitment and legal obligation to safeguard your rights and privacy as a study participant, we believe strongly that this is currently the safest, most ethical approach. At some point in the future we may seek to place these data in a national archive at the National Institutes of Health, however, we will not do this without first gaining your consent.
How long will you store the DNA?
We will securely store the DNA using de-identified code numbers (not your name) indefinitely at the University of Colorado in Boulder, Institute for Behavioral Genetics laboratory.
If I agree to DNA storage, what other tests might be done?
The technology and knowledge related to genetics is changing very rapidly, so SSDP investigators do not know at this point what specific analyses would be available and important to do in the future. However, all future analyses will be consistent with the overall goal of SSDP: To understand how biological, social, and environmental factors affect health over the lifespan. We expect that genetic markers related to obesity, cardiovascular disease, and addiction, for example, might be studied. This rapid change in what we know and what we can do is why storage of DNA samples is so important, and so valuable to our future understanding of population health. However, we will not analyze the data for purposes other than those described for the present study, without first obtaining your consent for the new analyses.
Is long-term DNA storage safe?
Yes! The SSDP study is known for its strong security procedures. Your name or other identifying information will never be associated with genetic data. SSDP investigators and a human subjects protection committee will review and control all future testing, to ensure that it is appropriate and secure.
Will I have the right to remove my genetic profile from the database at some later time?
Yes. If you decide that you want your data deleted from the database, you will have the opportunity to do so by contacting the PI, Karl G. Hill, in writing with your request at
Dr. Karl G. Hill
Social Development Research Group
9725 3rd Ave NE, Suite 401
Seattle, Washington 98115
Who will be the guardian of the DNA? of the genetic data?
DNA samples consist of the DNA from the saliva. These samples are kept under lock and key by our collaborators at the University of Colorado in Boulder. The genetic data are the results of genotyping (see below, What is “genotyping”?), and these data are kept securely at the University of Washington.
Who will do the genetic analysis?
The genetic analysis will be done jointly by our research team at the University of Washington, and by our collaborators at the University of Colorado in Boulder.
Will anyone else be given access to the DNA?
No. Your data will be used for research purposes only, and only researchers who are working directly with us will have access to it. Given our commitment and legal obligation to safeguard your rights and privacy as a study participant, we believe strongly that this is currently the safest, most ethical approach. At some point in the future we may seek to place these data in a national archive at the National Institutes of Health, however, we will not do this without first gaining your consent.
Does this include lawyers, insurance companies and law enforcement agencies?
Yes it does. No one outside of the research team will have access to the DNA samples.
No. A new law, the Genetic Information Nondiscrimination Act of 2008 (Pub.L. 110-233, 122 Stat. 881, enacted May 21, 2008, GINA), is an Act of Congress in the United States designed to prohibit the improper use of genetic information in health insurance and employment. The Act prohibits group health plans and health insurers from denying coverage to a healthy individual or charging that person higher premiums based solely on a genetic predisposition to developing a disease in the future. The legislation also bars employers from using individuals' genetic information when making hiring, firing, job placement, or promotion decisions.
What will you do to make sure my interview and genetic samples and data remain private?
SSDP has always worked to protect privacy to the greatest extent possible. Your answers, measurements, and test results will be held in strict privacy by the SSDP project staff and not given to unauthorized persons. Extensive security procedures are in place to make sure that your answers are not linked to your name. For example, in most cases the interview is conducted by trained interviewers using a laptop computer at the time of interview administration. Code-numbers instead of names are used at the time of the interview. Data are uploaded to a central database on a secure server (housed at the project office) via the Internet as soon as possible after each interview. Laptops are password protected, and, in the event they should be stolen, can be remotely wiped clean of all data. Once all data for an interview wave are received, they are cleaned and stripped of any identifiers by the project data manager. If the interview is conducted on paper, a bar-coded version of the interview is used that does not include names, and these data are entered into the laptop at SDRG, and the remaining procedures are followed. If portions of the interview are conducted on the web, respondents will be assigned a unique, random interval user id that will prevent unauthorized access to the survey, and enable researchers to identify the data without any personal identifiers being included with the data. All data will be encrypted using 128 bit SSL (Secure Sockets Layer) encryption. A SSL certificate will be registered and installed on the SDRG web server. This certificate allows the server and the client (the respondent's computer) to establish an encrypted connection. An encrypted SSL connection requires all information sent between a client and a server to be encrypted by the sending software and decrypted by the receiving software, thus providing a high degree of confidentiality. This provides assurance to the respondent that he or she is using a secure site and provides assurance to the researchers that the data has not been altered en route from the respondent. The survey does not store the login ID as a cookie. If a respondent fills out part of the survey on one computer and then switches to another for the rest, nothing will be left behind on the first computer.
Once the encrypted data are transferred to the server, it will continue to be protected from unauthorized access as it will be stored in a password protected SQL Server database behind a secure firewall. SQL Server also provides significant security features and has been certified under the U.S. government's C2-level security certification - the highest level of security available in the industry.
When the saliva is collected, the tube of saliva will be coded with a separate biologic specimen identification number. The link file that connects all identification numbers and personal access codes to participants will be stored in a locked facility and managed by SSDP management. Only the Principal Investigator and the data manager (a member of the research staff) will have access to the participant’s identifiable data. None of the collaborating labs will have any identifying information. After the biologic specimen collection is complete, the interviewer will ship the sample to the Institute for Behavioral Genetics Laboratory using trackable shipping methods.
The saliva sample and the DNA extracted from it will be kept frozen in secure facilities at the Institute for Behavioral Genetics, University of Colorado at Boulder in the laboratory of our Co-Investigators, Drs. Matthew McQueen & Andrew Smolen. Samples will be identified only by a separate laboratory ID that will be generated upon receipt in the laboratory. In all genotyping operations, only the laboratory ID will be used to identify the samples, and no one associated with the laboratory will have access to any personal information.
Confidentiality of interview and genetic data is protected in many ways. Our workplace suite is secured with locked, individual password-access doors. Our network is secured through a firewall. Individual computers are password protected. In addition, data are protected by the use of non-identifying codes on all data collection instruments and computer storage. Master lists of participants and identifying information are kept separate from survey data in locked files. Raw data with non-identifying codes are kept either in locked cabinets in our data storage area or archived in central storage. We have obtained a Certificate of Confidentiality (No. 02-148) to protect existing data and will be vigilant in preventing accidental disclosure of data; the certificate will be renewed for this new study.
A gene is a section of a person’s DNA that contains the code to create a specific protein in the body. The many different genes create many different proteins needed to make our bodies grow and work. The proteins do all the work (making and breaking down things) and form structures in the body (like cell membranes and nerve receptors). That’s how genes control how the body works and looks, by controlling which proteins get made and how well each protein works.
Many questions remain about how genes work and why they seem to have different effects on our health and behavior under different circumstances. We need to know more about when and how different versions of our genes are affected by our environment because our surroundings and experiences (such as how much stress we experience, what kind of relationships we have with friends and family members) can have a big influence on our health.
DNA is the chemical name for the molecule that carries a set of instructions for all living things. The molecule is made up of two strands that twist together to form a double helix shape, organized into packets of information called chromosomes. The chromosomes are contained in the nucleus of each cell. The section of a strand of DNA that contains the code to create a protein is called a gene. Each gene has a special sequence of code in the DNA, like a blueprint. The entire human DNA sequence contains about 23,000 genes.
Click here for additional informationI thought you had to get DNA from blood. Can you get it from spit, too?
All of a person’s genes are present in the DNA in every cell of the body (except red blood cells). Some studies require blood to get the DNA from white blood cells, but for the work we are proposing, the DNA from cheek cells in your saliva will do just fine.
What is “genotyping”? What’s a “genetic marker”?
Genotyping is the term used for determining the sequence of chemical codes in a person’s DNA to see which particular variations of the basic human genes they have. These variations of human genes are tracked by differences at specific points in the gene called “genetic markers”.
Why collect information about genes?
Knowledge about how genes and life experiences work together to make us who we are has the potential to change our understanding of physical and mental health. We are particularly interested in health problems that occur in conjunction with alcohol, tobacco and other drug use. By studying a genetic sample along with information about attitudes and beliefs, interpersonal relationships, and home and health behaviors we may be able to answer questions about how certain experiences and environments can increase our chances of staying healthy.
Could the genes measured in SSDP tell me if I am going to get a disease later on?
No. These are not diagnostic tests. Some traits like blood type are caused by a single gene. Most diseases that are caused by a single gene, like sickle cell anemia, are very rare. Our study of 800 people from a normal community is too small to study single gene diseases, and we are not testing for them. Instead, we are studying factors that affect general human health and behavior.
Human health and behavior are influenced by many genes working in combination with many life experiences. Genetic work in SSDP will help us understand what combinations of genes and experiences may ultimately contribute to better health. But this knowledge will be on a population level -- that is, summarized over many people, not on an individual level. So, these tests will not provide information about your individual health.
Can I get a copy of the results or the genotype?
No. You cannot get individual results from this study. Neither can your family or your physician, nor can your insurance company or anyone else except a qualified researcher see results. No results of this DNA research will be used to make any medical decision or judgment about you or any member of your family. Similarly, by using your sample in this study, we cannot determine paternity or immediate family relationships.
Is there a gene for smoking? Or a gene for alcohol problems?
No. Tobacco and alcohol use problems are what are called complex traits where many genes (each with a small effect) combined make a person more or less likely to have smoking or drinking problems. Even then, researchers believe that whether these genes influence smoking or drinking depends a great deal upon the environment we experience as children and adults. This is what we hope to understand in the long run in this study.
Currently, we are only collecting and processing the DNA, and not examining any genes. We anticipate receiving funding for a follow-up grant to study how genes and environment predict health outcomes. That study will likely take a broad approach, looking at small variations in genes taken from all over the whole genome, or set of genes in human cells. This type of study is sometimes called a “Genome Wide Association Study.” There are some gene-systems that have been found to be related to problems with tobacco and alcohol use, depression and other health outcomes, and we will pay particular attention to these genes to see if early findings in other studies continue to hold true in SSDP.
Is there something odd about these genes that I should be concerned about?
No. We are interested only in the normal range of genes in a population. None of these can be considered disease genes at all. For example, genes control a person’s height. Both tall people and short people are normal, but the genes that control height are likely to differ between tall and short people. Similarly, mellow and excitable people are both normal, yet they likely have different genes that influence these traits. These are the kind of behavior genes we plan to study.
No. Human cloning is illegal and no one has ever been cloned. As much as you might sometimes wish there were two of you, we can neither clone you from your DNA sample, nor would we want to do so (or permit anyone else to do so).
Could my DNA get mixed up with someone else’s?
No. The samples are tracked through a strictly managed bar-coded system that keeps each sample uniquely labeled.
Please call us toll free (1-866-820-3163) at SDRG with any questions you may have. Holly Santos (the SSDP Field Director), Dr. Karl Hill (the Principal Investigator), or Dr. Jennifer Bailey (the Project Director) can answer specific questions about the SSDP study.
