Measurements of DNA Repair in Human Peripheral Blood Cells

Principal Investigator: Sylvain Costes, Ph.D.
24 Hour Phone: (510) 982-6703

 

Background

One of Exogen Biotechnology’s missions is to make meaningful scientific contributions by enabling its customers to participate directly in health research. Exogen Biotechnology asks each of its customers to privately participate in this research. Exogen Biotechnology seeks your voluntary participation in My-DNA-Health, an ongoing research study conducted by Exogen Biotechnology.

 

Purpose of the Study

DNA damage and DNA repair kinetics are suspected to impact cancer risks and can be critical determinants of responsiveness to medical procedures involving radiation and chemotherapy. In addition, these cellular processes may be an important hallmark of general cellular health in adult humans. At Exogen Biotechnology we aim to gather information to test these ideas and to establish the variation of DNA damage and repair processes in human populations. The My-DNA-Health study specifically aims to:

 

  • Determine the range of variance for the amount of DNA breaks in human populations
  • Determine the normal variance of DNA repair kinetics in human populations
  • Understand how DNA breaks at the cellular level is linked with external factors (environmental exposure, medical exposure, diets, sports, activity…)
  • Determine whether DNA repair kinetics are linked to inherited factors.

 

My-DNA-Health refers to research aimed at publication in peer-reviewed journals and research funded by the federal government. You have the right to know about the procedures, risks, hazards, discomforts, and possible benefits of this study to help you in making an informed decision about whether or not you want to participate.  Once you understand the study and agree to take part, you will be asked to sign this consent form.  You will be given a copy of the consent form to take with you for your records.

This document explains:

  • How you can participate

 

  • How your data will be used

 

  • How we protect your data and keep it private

 

  • The benefits and risks of participation

 

  • No Medical Advice

 

  • Your options and how to withdraw

 

  • Who to contact if you have questions

 

 

1. What am I agreeing to if I consent?

Giving consent by checking the appropriate box below means that you agree to let Exogen Biotechnology investigators use your Phenotypic & Self-Reported Information for My-DNA-Health research, as described above.

“Phenotypic & Self-Reported Information” refers to:

  • Your phenotypic data (a score of your cellular DNA damage and/or repair kinetics)
  • Information you enter into surveys and forms
  • Information you enter via features labeled with the My-DNA-Health research logo
  • Data you authorize us to use anonymously for research
  • Your age, ethnicity, and general health

 

Self-Reported Information includes any information you submitted prior to giving consent. If you have elected to have your blood sample stored, we may also use the results of further analysis of your sample in My-DNA-Health research. To protect your privacy, your Phenotypic & Self-Reported Information does not include identifying Registration Information you provided when you purchased the MyDNABreaks® kit, MyDNARepair® kit, or created an account (such as name, address, email address, user ID, password, or credit card information).

A description of this clinical trial will not be available on the http://www.ClinicalTrials.gov website.

2. How do I participate?

Participation consists of (1) allowing Exogen Biotechnology investigators to use your Phenotypic & Self-Reported Information for research, and (2) entering data about yourself into My-DNA-Health features on the Exogen Biotechnology website. These features include surveys, individual questions, and other features where you enter information. If you do not feel comfortable providing a piece of information, you may choose not to answer that question. You may choose to take all, some, or none of the surveys.

The My-DNA-Health study is ongoing: new surveys and features may be added to My-DNA-Health on a continuing basis. If new surveys or features are added, you may receive an email update or see an announcement when you sign in to your account. We might invite you to participate in a specific study if your Phenotypic & Self-Reported Information matches the area of interest.

Your participation in this research project is completely voluntary.

If you are concerned about the use of previously submitted Self-Reported Information in research, you should carefully consider whether you want to give consent for your data to be used in research.

3. How will my data be used in My-DNA-Health research?

Your Phenotypic & Self-Reported Information may be used to discover links between existing medical conditions, the development of diseases and the amount of DNA breaks, links between character traits, lifestyle habits and the amount of DNA breaks; or to evaluate how individuals alter behavior in response to cellular health information. Discoveries made as a result of this research could be used to understand the basic causes of disease, develop drugs or other treatments and/or lifestyle interventions, or predict a person’s risk of disease. The topics to be studied span a wide range of traits, conditions and lifestyle habits, from common to rare. The topics include simple traits such as age or weight, serious diseases such as cancer, Alzheimer’s disease or diabetes, and other lifestyle habits such as medical exposure to X-rays, diet or physical activity.

This study may cover potentially sensitive topics such as illicit drug use or other illegal behavior. When Exogen Biotechnology conducts studies on these topics, you will be provided additional information to help you decide whether you want to participate in research on these topics.

4. How do you keep my data protected and private (whether or not I consent)?

Exogen Biotechnology uses a range of physical, technical, and administrative procedures to protect the privacy of your personal information, your health data, and your survey responses. These measures are in place for My-DNA-Health participants and all other users of MyDNABreaks® or MyDNARepair®. A key protection is that My-DNA-Health investigators do not have access to personally identifying Registration Information (such as name, address, email address, user ID, password, or credit card information). Your results and submitted health information will be given an anonymous numerical code that will be separate from your identifying information. Other measures for protecting your privacy are described in more detail in the Exogen Biotechnology Privacy Statement.

 

Exogen Biotechnology may collaborate on research with external parties. As outlined in the Privacy Statement, external parties will only have access to pooled data stripped of identifying information, with the following exceptions:

  • Exogen Biotechnology may release your individual-level data to a third party if we ask for, and receive your explicit authorization to do so.
  • Exogen Biotechnology’s partners or service providers (e.g. mailing services) may process and/or store your information in order to provide you with Exogen Biotechnology’s services.
  • Researchers invited by Exogen Biotechnology to conduct research may access your individual-level Phenotypic & Self-Reported Information (but not your name or contact information) for the purpose of scientific research. They may access the data only onsite at Exogen Biotechnology’s offices, only if they agree to abide by Exogen Biotechnology’s access rules and guidelines, and only if they are supervised by Exogen Biotechnology employees.
  • If we are required to do so by law, Exogen Biotechnology may release the individual-level information.
  • The Institutional Review Board and government officials responsible for monitoring this study may inspect the study records.

 

5. What are the benefits and risks of participating?

Benefits:

Information collected in this research study may be useful in the future clinical care of patients and may help doctors learn more about types of treatments that are most effective and lowest risk for an individual with a given DNA-repair profile. One of Exogen Biotechnology’s missions is to make meaningful scientific contributions by enabling its customers to participate directly in medical research. At Exogen Biotechnology we are committed to research that will lead to personalized and more effective healthcare practice.

You may also have the opportunity to acquire one or more of the following, in return for some level of participation in the research:

  • Comparison of your personal survey responses to those of all responders.
  • Electronic, graphical “badges” that signify you have contributed to one or more research projects
  • Monetary or cash equivalents such as discounts on future Exogen Biotechnology service purchases (up to a value of $30 per half hour of expected time).

 

Exogen Biotechnology may develop intellectual property, including but not limited to patents, copyrights and trademarks, and/or commercialize products or services, directly or indirectly, based on the results of this study, and in such cases you will not receive any compensation.

Unanticipated medical information:  During the course of this study, it is possible that we will learn unexpected information about your health or genetic background.  If this information is thought to be important to your health care, we will notify you. At your request we will explain the results to you, and with your permission, to your personal physician. We can then help you decide whether you want to send blood to confirm the test to a licensed clinical laboratory.  Otherwise, it is our policy not to reveal unexpected information resulting from these studies.

Risks and/or Discomforts:

  • Some survey questions may make you or your family members uncomfortable.
  • Although the risks and discomforts associated with a blood test are very low, you might be at risk for excessive bleeding, fainting, or feeling light-headed, hematoma (blood accumulating under the skin) or infection (a slight risk any time the skin is broken). While the possibility of this happening is very low, you should still be aware of the possibility. Drawing blood from your arm may cause discomfort or lightheadedness. It also may result in bruising or soreness for a few days. In rare instances, an infection can result. If you feel discomfort or other symptoms, tell the person drawing your blood immediately.
  • Exogen Biotechnology may advise you to have a follow up with your doctor after reviewing the results of your blood test. As a result, you may learn about health conditions and problems or potential health problems that you were not aware of before your participation in Exogen Biotechnology’s services. You may experience stress, anxiety, or emotional or physical discomfort when you learn about health problems or potential health problems. In addition, you could have a disease or condition even though your test results are in the normal range. You could have test results outside the normal range and still not have a disease or condition. Results outside the normal range, though, could lead to additional cost or discomfort if your physician orders follow-up tests.
  • There may also be additional risks to participation that are currently unforeseeable.
  • Recommendations regarding diet, exercise and lifestyle provided to you by Exogen Biotechnology as a result of our blood sample analysis may or may not be beneficial to you and may cause or exacerbate certain medical problems. You are following these recommendations at your own risk. If at any time during the follow-up period you feel unwell or ill you should seek medical help immediately and discontinue Exogen Biotechnology’s recommendations.
  • Despite encoded non-identifying storage of your phenotypic data, survey responses, and/or personally identifying information could potentially be stolen. While no entity can provide a 100% assurance against data theft, Exogen Biotechnology will continue to use state-of-the-art policies and procedures to minimize the possibility of compromising data anonymity, loss, or theft.
  • When Exogen Biotechnology investigators publish results from this study, your Phenotypic & Self-Reported Information may be included within pooled summaries that are made public. No identification of your individual-level data or your personal information will be included and results will be presented as anonymous human populations.
  • As with any online service, Exogen Biotechnology cannot control the security of your self-assigned account password. We strongly encourage all users to retain security of their personal account access and will routinely monitor accounts for suspicious activity.
  • There may be additional risks to participation that are currently unforeseeable.

None of the surveys or other procedures used by the investigators in the My-DNA-Health study is invasive or experimental. The procedures involved do not involve more than the minimal risks described above, and no compensation or treatment is available if injury occurs as a result of participation.

6. No medical Advice

The information provided by Exogen Biotechnology are for purposes of improving your wellness only and are not intended to provide medical advice, diagnosis, or treatment. You should seek the advice of a physician or other qualified health provider with whom you have a doctor-patient relationship if you have questions regarding any medical or psychiatric condition or if you are experiencing any symptoms of or believe you may have any medical or psychiatric condition, regardless of any information contained within Exogen Biotechnology. You should not ignore professional medical advice or delay in seeking it because of Exogen Biotechnology data. Furthermore, you should not interpret your Exogen Biotechnology data or any other communications from Exogen Biotechnology as recommending any specific treatment plan, product or course of action. You should always consult your physician or other qualified health provider before starting any new treatment or stopping any treatment that has been prescribed for you by your physician or other qualified health provider.

PLEASE CALL YOUR DOCTOR OR 911 IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL OR PSYCHIATRIC EMERGENCY.

7. Do I have any alternatives? Can I withdraw from this study?

Your alternative is not to participate in the My-DNA-Health research study. If you do not give consent to participate at this time, you will be offered other opportunities to give consent, for example, if you take a My-DNA-Health survey on the website. Even if you do give consent to participate in this study, you may still choose not to take My-DNA-Health surveys or use other My-DNA-Health features. If you choose not to give consent for My-DNA-Health research, your Phenotypic & Self-Reported Information may still be used for other purposes, as described in our Privacy Statement.

 

At any time, you may choose to withdraw all or some of your Phenotypic & Self-Reported Information from My-DNA-Health research by changing your consent status by sending a written request to the Human Protections Administrator at hpa@exogenbio.com. You will still be allowed full access to MyDNABreaks® or MyDNARepair®, but Exogen Biotechnology will prevent the requested information from being used in new My-DNA-Health research occurring after 30 days from receipt of your request. Any research on your data that has been performed or published prior to this date will cannot be reversed or withdrawn. Your Phenotypic & Self-Reported Information may still be used for other purposes as described in the Exogen Biotechnology Privacy Statement. Choosing not to give consent or withdrawing from My-DNA-Health will not affect your access to your Phenotypic Information, to MyDNABreaks®, or MyDNARepair®.

 

You may also discontinue participation by closing your MyDNABreaks® or MyDNARepair account, as described in the Terms of Service. Requests for account closure must be made in writing to Exogen Biotechnology’s business address or via Customer Care. In addition, the My-DNA-Health study may be terminated without your consent. In the following cases, Exogen Biotechnology will maintain your Phenotypic & Self-Reported Information according to the terms of our Privacy Statement.

  1. Transfer of ownership. If Exogen Biotechnology undergoes a business transition such as an acquisition or merger, the My-DNA-Health research study may be terminated. In such a case, your information would remain subject to the promises made in any pre-existing Privacy Statement.
  2. Termination of service. Exogen Biotechnology may terminate your access to MyDNABreaks® or MyDNARepair® for any of the five reasons described in the Terms of Service: if a) you have breached the Terms of Service, b) Exogen Biotechnology is required to do so by law, c) the partner with whom Exogen Biotechnology offered MyDNABreaks® or MyDNARepair® to you has terminated its relationship with Exogen Biotechnology or ceased to offer the service to you, d) Exogen Biotechnology is no longer providing MyDNABreaks® or MyDNARepair® to customers in the country in which you are resident or from which you use the service, or e) MyDNABreaks® or MyDNARepair® is, in Exogen Biotechnology’s opinion, no longer commercially viable. If your access to MyDNABreaks® or MyDNARepair® is terminated for any of the above reasons, your participation in the My-DNA-Health research study may also be terminated.

 

8. Who do I contact if I have questions?

If you have general questions about Exogen Biotechnology’s service, please contact Exogen Biotechnology Customer Care.

If you have any questions or concerns about the study, if you suffer a research-related injury, or if you have a question about subjects’ rights, please contact the following:

Exogen Biotechnology Human Protections Administrator

Email: hpa@exogenbio.com

Phone: 510-230-3195

Address: 628 Stannage av., Albany, CA 94706

If you have any questions or concerns about research that you do not wish to discuss with Exogen Biotechnology, you may contact the following independent, impartial research review board:

Biomed IRB

P.O. Box 600870

San Diego, CA 92160-0870

Email: mailbox@biomedirb.com

Fax: 619-282-9998

Phone: 619-282-9997