A. INTRODUCTION
We are inviting you to take part in a research study. Research is a way of gaining new knowledge. A person who participates in a research study is called a "participant." This research study is evaluating the mutation patterns in patients with myelodysplastic syndromes (MDS) who were exposed to Agent Orange during US Military service. You are being asked to participate because you are at risk of developing MDS, you have had MDS in the past or you have MDS now.
It is expected that about 120 people will take part in this research study.
This study is funded by a grant from the Aplastic Anemia & MDS International Foundation (AA&MDS IF).
This research consent form explains why this research study is being done, what is involved in participating, the possible risks and benefits of the study, alternatives to participation, and your rights as a participant. The decision to participate is yours. If you decide to participate, please sign and date at the end of the form. We will give you a copy so that you can refer to it while you are involved in this research study.
If you decide to participate in this research study, certain questions will be asked of you or certain tests will be taken to see if you are eligible to be in the research study. These tests are called screening tests. The research study has certain requirements that must be met. If the screening tests show that you can be in the research study, you will be able to start on the study intervention.
If the tests show that you cannot be in the research study, you will not be able to participate in this research study. We encourage you to take some time to think this over and to discuss it with other people and to ask questions now and at any time in the future.
B. WHY IS THIS RESEARCH STUDY BEING DONE?
A research study is an effort to learn more about a problem or to answer questions. Genetic research seeks to understand the role that variations in genes play in disease. The main purpose of this study is to better understand the DNA mutation patterns in the blood cells of participants with MDS among U.S. Military service personnel who were presumed to have been exposed to Agent Orange while serving during the Vietnam Conflict (1962-1975). Our proposed genetic study will examine the tissue of 120 Veterans diagnosed with MDS who were exposed to Agent Orange, its contaminants, and associated solvents during the Vietnam War-era. In analyzing participant blood and saliva tissue samples; our objective is to better understand a potential contribution of Agent Orange to the risk for the acquisition of MDS and other bone marrow failure syndromes.
C. WHAT OTHER OPTIONS ARE THERE?
Taking part in this research study is voluntary. Instead of being in this research
study, you may continue to obtain your clinical care without participating in the
study. Your decision not to participate will not affect your clinical care in any way.
D. WHAT IS INVOLVED IN THE RESEARCH STUDY?
Before the research starts: After signing this consent form, you will be asked to answer some screening questions to find out if you are eligible to be in the research study. If you decide to participate, you will be invited to fill out an online survey questionnaire to assess your perceived level of service-related Agent Orange exposure (in addition to demographics and MDS-related clinical history). We anticipate filling out the questionnaires will take approximately 10 to 15 minutes. If these tests show that you are eligible, you will be invited to participate in the research study. If you do not meet the eligibility criteria, you will not be able to participate.
After the screening procedures confirm that you are eligible to participate in the research study: In addition to the online questionnaire, eligible patients will be asked to provide a one-time blood and saliva sample. You will be sent a sample collection kit via the mail, and will be instructed to bring this kit with you to your next regularly scheduled medical appointment. There, a licensed provider will assist you in collecting the serum (blood) and saliva samples, which will then be shipped back to our labs for testing via a prepaid envelope included in the original kit. We anticipate that having your provider collect these samples will take less than 5-minutes.
Aside from administering the above procedures, we will not contact you after you have completed the study unless you express interest in being contacted with updates and results. All of the collected information will be stored in secure databases.
E. HOW LONG WILL I BE IN THIS RESEARCH STUDY?
Your samples will be stored for subsequent analysis by the research team. You can stop participating in the research study at any time by requesting that your sample and survey results be destroyed. If you decide to stop participating it will not affect your care in any way.
If you choose to participate, peripheral blood specimens will be collected from you with a sample kit that will be provided by the study. Using this kit, blood may be drawn at any medical facility convenient to you, and shipped to the Benjamin L. Ebert Laboratory ("Ebert Lab") at Brigham & Women's Hospital in Boston, Massachusetts (http://ebertlab.bwh.harvard.edu/) for examination. Sequencing of blood cells and saliva will be performed, which may include whole exome, whole genome, sub-exome, and whole transcriptome sequencing. Frozen tissue will be stored in freezers at DFCI, including secure freezers at DFCI's Harbor Campus site. Blood samples will be stored in designated and secure facilities at DFCI. Materials derived from these samples, such as DNA and RNA, may be stored similarly. Sequencing data will also be stored securely. Specimens collected from patients registered at DFCI, The Ebert Lab, or other facilities are the property of those hospitals and will remain at those institutions even if the staff members who obtained the specimens or worked on the study leave.
The research Investigator may decide to take you off the research study for reasons such as:
• It is considered to be in your best interest;
• The study procedures are found to be unsafe or ineffective;
• There is any problem with following study procedures;
• There are any problems with research funding;
• Or for any other reason.
F. WHAT ARE THE RISKS OR DISCOMFORTS OF THE RESEARCH STUDY?
Potential Risks: With any study, there are always concerns regarding the confidentiality of personal information. While we will take measures to protect the privacy and security of all your personal information, we cannot guarantee complete confidentiality. All study data will be kept in a secure, password-protected area, only accessible to the study team. The confidentiality of each participant will be rigorously maintained using existing DFCI standards. Data access will be guided by institutional SOPs. HIPAA and state/federal government regulations for protecting patient privacy and security will be strictly observed. No patient or subject identifiable information will be given to third parties, including family members, unless that subject has given written or witnessed consent to do so. The results of research studies may be published but subjects will not be identified in any publication.
While it is possible that public knowledge of a participant's genetic factors could lead to problems with health insurance, life insurance, or employment, the confidentiality of participant identities will be strictly preserved under this study, minimizing such risks in this context. Furthermore, protections afforded under the Genetic Information Nondiscrimination Act (GINA) will generally prohibit discrimination based on genetic information in connection with health coverage and employment. These protections apply to genetic research obtained as part of any study regardless of when it was conducted. However, GINA's provisions prohibiting such discrimination in employment do not apply to employers with fewer than 15 employees. Similarly, GINA's provisions do not prohibit discrimination based on genetic information by providers of life insurance, disability insurance, or long-term care insurance.
Potential Discomforts: There are small risks associated with obtaining a sample of blood, as you may experience slight pain and swelling at the site of the blood draw. There are no known risks and side effects related to saliva collection. There is also a small possibility that when filling out the Agent Orange exposure questionnaire, you may become upset thinking about your service history or your diagnosis. Please note that when filling out the surveys you may stop filling out the questionnaires if you decide you no longer want to participate in the study. You are welcome to contact the research team with any questions or concerns you may have.
G. WHAT ARE THE BENEFITS OF THE RESEARCH STUDY?
It is important to understand that this is not a clinical study being done to benefit you directly. There is no therapy administered as part of this study. Therefore, taking part in this research study may not directly benefit you. However, the information gained from your participation may generate important information which could help future patients with MDS and individuals at high risk of developing those diseases.
H. CAN I STOP BEING IN THE RESEARCH STUDY AND WHAT ARE MY RIGHTS?
• You have the right to choose not to sign the consent associated with this study. If you decide not to sign, you cannot participate in this research study;
• If you choose to not participate, or if you withdraw from this research study, your decision will not affect your present or future care and will not cause any penalty or loss of benefits to which you are otherwise entitled;
• You can stop being in the research study at any time. Leaving the research study will not affect your medical care. You can still get your medical care from your hospital or physician;
• You have the right to withdraw your permission for the research doctors and participating DF/HCC entities to use or share your protected health information. We will not be able to withdraw all the information that already has been used or shared with others to carry out related activities such as oversight, or that is needed to ensure quality of the study. To withdraw your permission, you must do so in writing by contacting the researcher listed below.
You have the right to request access to your protected health information that is used or shared during this research and that is related to your treatment or payment for your treatment, but you may access this information only after the study is completed. To request this information, please contact the researcher listed below.
I. WHAT ARE THE COSTS?
We do not anticipate that you will incur any additional costs as a direct result of your participation in this study. All equipment and materials necessary for the completion of this study will be provided free of cost. You will not be charged for shipping and handling. These kits will be sent free of charge to the address you provided on the questionnaire upon registration. We ask that you bring these kits to your next regularly scheduled medical appointment with your oncologist to reduce inconvenience and avoid incurring any unexpected or additional costs. The completed kits can be mailed back to our laboratory in Boston, MA using the pre-paid return envelope included in the kit. Please note that this study is not responsible for covering the costs of the medical appointment itself, or of charges for blood draws done as part of routine clinical care. We anticipate that participating medical staff will assist you in collecting the saliva and serum samples free of charge. However, please ask the investigator and/or your doctor about any concerns or insurance problems. You or your insurance company will, however, be charged for any other portion of your care, including blood draws that are considered standard of care. You may be responsible for co-payments and deductibles that are standard for your insurance coverage.
The National Cancer Institute provides an online resource to help people participating in cancer clinical trials understand which services their insurance company is required by law to pay. This can be found at the website below.
http://www.cancer.gov or 1-800-4-CANCER (1-800-422-6237)
J. WHAT HAPPENS IF I AM INJURED OR BECOME SICK BECAUSE I TOOK PART IN THIS RESEARCH STUDY?
If you think you have been injured as a result of taking part in this research study, tell the person in charge of this research study as soon as possible. The research doctor's name and phone number are listed in this consent form. Your treating hospital will offer you the care needed to treat injuries directly resulting from taking part in this research. These treatments will be billed to your insurance company. You will be responsible for deductibles and co-payments. There are no plans to pay you or give you other compensation for the injury. There are no plans for Dana-Farber Cancer Institute to pay you or give you other compensation for the injury. You do not give up your legal rights by signing the consent form.
K. WHAT ABOUT CONFIDENTIALITY?
We will take measures to protect the privacy and security of all your personal information, but we cannot guarantee complete confidentiality of study data. The results of this research study may be published. You will not be identified in publications without your permission. If participation in this protocol involves providing a specimen of your tissue, please know that if the investigator leaves the institution, the research and the tissue might remain at the DF/HCC or might be transferred to another institution.
L. Whom do I contact if I have questions about the research study?
If you have questions about the study, please contact the Research Investigator or study staff as listed below:
Dana-Farber Cancer Institute
• David P. Steensma, MD | Principal Investigator: (617) 632-3712
david_steensma@dfci.harvard.edu
• Maxwell P. Teschke| Research Assistant: (617) 582-7396
maxwellp_teschke@dfci.harvard.edu
For questions about your rights as a research participant, please contact a representative of the Office for Human Research Studies at DFCI (617) 632-3029. This can include questions about your participation in the study, concerns about the study, a research related injury, or if you feel/felt under pressure to enroll or to continue to participate in this research study.
M. PRIVACY OF PROTECTED HEALTH INFORMATION
Federal law requires Dana-Farber/Harvard Cancer Center (DF/HCC) and its affiliated research doctors, health care providers, and physician network to protect the privacy of information that identifies you and relates to your past, present, and future physical and mental health conditions ("protected health information"). If you enroll in this research study, your "protected health information" will be used and shared with others as explained below.
1. What protected health information about me will be used or shared with others during this research?
• Existing medical records, including mental health records.
• New health information created from study-related tests, procedures, visits, and/or questionnaires.
2. Why will protected information about me be used or shared with others?
The main reasons include the following:
• To conduct and oversee the research described earlier in this form;
• To ensure the research meets legal, institutional, and accreditation requirements;
• To conduct public health activities (including reporting of adverse events or situations where you or others may be at risk of harm); and
• To provide the study sponsor with information arising from an adverse event or other event that relates to the safety or toxicity of the drug for the purpose of this or other research relating the study drug and its use in cancer; and,
• Other reasons may include for treatment, payment, or health care operations. For example, some medical information produced by this research study may become part of your hospital medical record because the information may be necessary for your medical care. (You will also be given a notice for use and sharing of protected health information.)
3. Who will use or share protected health information about me?
• DF/HCC and its affiliated research doctors and entities participating in the research will use and share your protected health information. In addition, other DF/HCC offices that deal with research oversight, billing or quality assurance will be able to use and share your protected health information.
4. With whom outside of DF/HCC may my protected health information be shared?
While all reasonable efforts will be made to protect the confidentiality of your protected health information, it may also be shared with the following entities:
• Outside individuals or entities that have a need to access this information to perform functions relating to the conduct of this research such as analysis by outside laboratories on behalf of DF/HCC and its affiliates (for example, data storage companies, insurers, or legal advisors).
• The sponsor(s) of the study, its subcontractors, and its agent(s): the Aplastic Anemia & MDS International Foundation (AA&MDS IF).
• Other research doctors and medical centers participating in this research, if applicable.
• Federal and state agencies (for example, the Department of Health and Human Services, the Food and Drug Administration, the National Institutes of Health, and/or the Office for Human Research Protections), or other domestic or foreign government bodies if required by law and/or necessary for oversight purposes. A qualified representative of the FDA and the National Cancer Institute may review your medical records.
• Hospital accrediting agencies.
• A data safety monitoring board organized to oversee this research, if applicable.
Some who may receive your protected health information may not have to satisfy the privacy rules and requirements. They, in fact, may share your information with others without your permission.
5. For how long will protected health information about me be used or shared with others?
• There is no scheduled date at which your protected health information that is being used or shared for this research will be destroyed, because research is an ongoing process.
6. Statement of privacy rights:
• You have the right to withdraw your permission for the research doctors and participating DF/HCC entities to use or share your protected health information. We will not be able to withdraw all the information that already has been used or shared with others to carry out related activities such as oversight, or that is needed to ensure quality of the study. To withdraw your permission, you must do so in writing by contacting the researcher listed above in Section L.
• You have the right to request access to your protected health information that is used or shared during this research and that is related to your treatment or payment for your treatment, but you may access this information only after the study is completed. To request this information, please contact the researcher listed above in Section L.
Q. DOCUMENTATION OF CONSENT
My signature below indicates:
• I have had enough time to read the consent and think about participating in this study;
• I have had all of my questions answered to my satisfaction;
• I am willing to participate in this study;
• I have been told that my participation is voluntary and I can withdraw at any time