1. Please complete the highlighted in yellow sections of the Research Consent form and the HIPAA Authorization form;

Transcription

1 1. Please complete the highlighted in yellow sections of the Research Consent form and the HIPAA Authorization form; 2. Mail all documents to the following address: Dr. Michele Marcus Emory University Claudia Nance Rollins Building Mailstop: BB 1518 Clifton Road NE Atlanta, GA 30322

2 Title: PBB Registry Health Research Emory University PBB Registry Health Research Consent Form Blood Draw Principal Investigator: Michele Marcus, Ph.D. Introduction: In 1973, the Michigan Chemical Company accidentally shipped PBB to the Farm Bureau instead of a nutritional supplement. PBB was mixed into livestock feed and eaten by cattle, pigs, and chickens. Contaminated milk, beef, and other farm products were sold throughout the state, and those who ate or drank these products were exposed to PBB. Researchers at Emory University are investigating the long term effects of PBB exposure. To test exposure levels, your blood can be drawn and analyzed for PBB. Emory University will cover all of the costs unless you have your blood drawn at an independent laboratory. In that case, Emory will pay for shipping and PBB testing, but you will need to cover the cost of having your blood collected. Emory investigators will follow up with you to provide your blood results and information for interpretation. What is involved? You are being asked to take part in a research study. You will be asked to give a small sample of blood (three tubes each containing 10cc for a total of 2 tablespoons) collected from a vein in your arm. The entire procedure should take only about 10 minutes. For more information on the blood draw, you can contact Dr. Michele Marcus, the lead scientist for this study, at (404) or mmarcus@emory.edu. What will happen to my sample? Your blood sample will be identified by a unique number that does not include any of your personal information. Your personal information will be stored separately in a secure electronic file. The results of the PBB testing will become part of your PBB Registry record. The data collected from your blood sample will only be used for the purposes of health research. Your sample will be stored in a secured laboratory for as long as it is useful, unless you ask us to destroy it sooner. The remaining sample may be tested further for hormone levels, genes, and other chemicals as they relate to the health effects of long-term PBB exposure. You may request that your sample be destroyed at any time, simply by contacting Dr. Michele Marcus, the lead scientist for this study, at (404) or mmarcus@emory.edu. Are there any risks? Collecting blood from a vein in the arm is a standard medical procedure. Sometimes there may be some discomfort or bruising. There is also a risk of faintness, dizziness or lightheadedness with drawing blood. In the unlikely event that you are injured as a result of this procedure, Emory University has not set aside funds to pay for care or to compensate you. For more information concerning potential risks, you can contact Dr. 1 Version date: 01/14/2013

3 Michele Marcus, the lead scientist for this study, at (404) or Are there any benefits? It may be useful for you and your doctor to be aware of your PBB levels. Some of the health effects of PBB exposure may take many years to develop and will only be found by continued research. The study findings can help you and your doctor decide if you need more frequent tests for certain conditions. Although your participation in this blood analysis may not directly help you or your relatives, the results may help us understand more about the length of time that PBB stays in the body and whether there are long term health consequences. What about results? The results of the testing of the PBB level in your blood will be made available to you and you and will become part of your PBB Registry record. The results will be reported when the lead scientist is confident of the accuracy and interpretation of those results. What about my confidentiality? All information about you will be kept private to the fullest extent allowable by law. Your blood sample will be identified by a study ID number and not your name. Your name and any information that might identify you will not appear when we present or publish the results of this study. Each sponsor and participating institution has procedures to insure that research is conducted in a safe and ethical manner. Research review committees at this study's sponsor (The National Institutes of Health), at the Centers for Disease Control and Prevention, and at Emory University may review information regarding your participation in this study. To further help protect your privacy, we have obtained a Certificate of Confidentiality from the National Institutes of Health. Emory will use this Certificate to legally refuse to disclose information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if there is a court subpoena. The Certificate does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then Emory may not use the Certificate to withhold that information. The Certificate also does not prevent Emory from releasing information: to state public health offices about certain infectious diseases to law officials if child abuse has taken place to prevent immediate harm to you or others Research Information Will Not Go Into an Emory Medical Record: If you are or have been an Emory Healthcare patient, you have an Emory Healthcare medical record. If you are not and have never been an Emory Healthcare patient, you do not have an Emory Medical Record. 2 Version date: 01/14/2013

4 The researchers will review the results of the blood analysis only for the research. The researchers will not be looking at the results of these tests and procedures to make decisions about your personal health or treatment. Will there be any costs or payments? If you don t have an opportunity to have your blood drawn by Emory researchers, and have it drawn by a local laboratory, the laboratory will charge you for the blood draw. The cost of the blood draw will be determined by the local laboratory. Emory University will cover the cost of the sample shipping and blood analysis. What are my options? Participation in this blood test is voluntary. You are free not to have your blood tested. Some of your blood sample may remain after the blood test for PBB exposure is completed and may be used for future research, unless you request to have the remaining blood destroyed. Should you wish to withdraw your blood sample once you have already donated samples, simply notify Dr. Michele Marcus, the lead scientist for this study, at (404) or mmarcus@emory.edu. Who should I call if I have questions? Contact Dr. Michele Marcus at : if you have any questions about this study or your part in it, if you feel you have had a research-related injury if you have questions, concerns or complaints about the research Contact the Emory Institutional Review Board at or or irb@emory.edu: if you have questions about your rights as a research participant. if you have questions, concerns or complaints about the research. You may also let the IRB know about your experience as a research participant through our Research Participant Survey at You may request or download additional copies of this consent form ( Your signature below indicates that you consent to having your blood drawn for research on the health effects of PBB exposure. At your request, a copy of this signed form can be mailed to you. Contact us at or PBBRegistry@emory.edu Date Signature of Study Participant 3 Version date: 01/14/2013

5 Printed Name of Study Participant Date of Birth: / / Sex: Male Female What is your current mailing address? Address: City: State: Zip: At what telephone numbers can you be reached? Primary ( ) - Secondary ( ) - What is your address? Signature of Person Obtaining Authorization Date 4 Version date: 01/14/2013

6 Emory University Research Subject HIPAA Authorization to Use or Disclose Health Information that Identifies You for a Research Study Title: PBB Registry Health Research Principal Investigator: Michele Marcus MPH PhD Sponsor: National Institute of Environmental Health Sciences, National Institutes of Health Introduction The privacy of your health information is important to us. We call your health information that identifies you, your protected health information or PHI. To protect your PHI, we will follow federal and state privacy laws, including the Health Insurance Portability and Accountability Act (HIPAA). We refer to all of these laws in this form as the Privacy Rules. This form explains how we will use your PHI for this study. Please read this form carefully and if you agree with it, sign it at the end. Description of Research Study In 1973, the Michigan Chemical Company accidentally shipped PBB to the Farm Bureau instead of a nutritional supplement. PBB was mixed into livestock feed and eaten by cattle, pigs, and chickens. Contaminated milk, beef, and other farm products were sold throughout the state, and those who ate or drank these products were exposed to PBB. Researchers at Emory University are investigating the long term effects of PBB exposure. To test exposure levels, your blood can be drawn and analyzed for PBB. PHI That Will Be Used/Disclosed The PHI that we may use or disclose (share) for this research study includes: Blood Test Results Purposes for Which Your PHI Will Be Used If you sign this form, you give us your permission to use your PHI for the conduct and oversight of this research study. People That Will Use or Disclose Your PHI and Purpose of Use/Disclosure Different people and groups will use and disclose your PHI. They will do this only in connection with the research study. The following persons or groups may use and/or disclose your PHI: The Principal Investigator and the research staff. The Principal Investigator may use other people and groups to help conduct the study. These people and groups will use your PHI to do this work. The National Institute of Health is the sponsor of this Research. The Sponsor may use and disclose your PHI to make sure the research is done correctly. They may also use your PHI to collect and analyze the results of the research. The Sponsor may have other people and groups help conduct, oversee, and analyze the study. These people or groups will use your PHI. The following groups may also use and disclose your PHI. They will do this to make sure the research is done correctly and safely. The groups are: o the Emory University Institutional Review Board Page 1 of 3 Version Date: 04/10/2012 IRB Form:

7 o o o o the Emory University Office of Research Compliance the Office for Human Subjects Research Protections and NIH research monitors and reviewers data and safety monitoring boards We will use or disclose your PHI when we are required to do so by law. This includes laws that require us to report child abuse or elder abuse or a court ordered subpoena. Revoking Your Authorization You do not have to sign this form. Even if you do, at any time later on you may revoke (take back) your permission. If you want to do this, you must contact: Dr. Michele Marcus, Lead Scientist Phone: PBBregistry@emory.edu Emory University Rollins School of Public Health Claudia Nance Rollins Building Mailstop: BB 1518 Clifton Road Atlanta, GA After that point, the researchers would not collect any more of your PHI. But they may use or pass along the information you already gave them so they can follow the law, protect your safety, or make sure the research was done properly. If you have any questions about this, please ask. Other Items You Should Know You do not have to sign this form. If you do not sign, you may not participate in the research study. We will not put your signed informed consent form for the research study and your signed HIPAA Authorization form into any medical record that you may have with Emory Healthcare facilities. During the study you will generally not have access to records related to the research study. This is to preserve the integrity of the research. You may have access to these records when the study is complete. These records may include research related PHI your health care providers use to make decisions about your care. If necessary for your care, this information may be available to your doctor before the end of the study. Expiration Date Your permission to use and disclose your PHI will expire. The expiration will be at the end of the research study and any required record-keeping period. Contacts If you have any questions regarding the study, you may call Dr. Michele Marcus at If you have any questions about the study, or your rights as a study subject, you may Page 2 of 3 Version Date: 04/10/2012 IRB Form:

8 contact the Emory University Institutional Review Board at or , by at Authorization Signature of Study Participant Date Time Printed Name of Study Subject Signature of Person Obtaining Authorization Date Time Printed Name of Person Obtaining Authorization Date Time Page 3 of 3 Version Date: 04/10/2012 IRB Form:

9 Michigan PBB Registry Members Blood Draw Instructions Background Information It has been almost four decades since livestock feed in Michigan was contaminated with polybrominated biphenyl (PBB), a fire-retardant chemical that can mimic estrogen, is stored in the fat, and takes many years to be eliminated from the body. PBB can also be transferred from a mother to her children in the womb and through breast milk. If you would like to know your current PBB levels, Emory University will cover the cost of the laboratory blood test for Registry members. Please have your blood collected and shipped to Emory following the instructions below. Emory will send you the results of this blood test, which will take several months. Blood Draw Instructions 1) Call to request a pre-printed shipping label: (toll free) The shipping label will be mailed to you, so please plan accordingly. 2) Sign both the enclosed Research Consent form and HIPAA Authorization form. 3) Mail signed forms: Juandalyn Coffen Emory University Claudia Nance Rollins Building Mailstop: BB 1518 Clifton Road NE Atlanta, GA ) Go to a local laboratory or your physician with the attached instruction sheet: For Lab Use Only: Instructions for Blood Sample Collection and Shipping. 5) When you call your provider to schedule your blood draw, please confirm that the provider has the correct tubes available: Serum Separator Vacutainer and EDTA Vacutainer tubes. Emory Laboratory Contact If you have questions about the sample collection procedure or shipping instructions, please contact: Juandalyn Coffen Toll Free: pbbregistry@emory.edu

10 Michigan PBB Registry For Lab Use Only: Instructions for Blood Sample Collection and Shipping Sample Collection & Shipping on Mondays, Tuesdays, or Wednesdays ONLY 1. Using standard blood collection procedures, fill one 10 cc (10 ml) Serum Separator Vacutainer tube (ex: BD product #367981) with blood from the median cubital vein. Invert tubes at least 5-6 times to mix. Take all care and precaution to avoid dust contamination of the collection area. 2. Fill two 10cc (10 ml) EDTA Vacutainer tubes (ex: BD product #366643) with blood. Invert tubes at least 5-6 times to mix. Take all care and precaution to avoid dust contamination of the collection area. 3. Record the following information on the blood tube labels: name of registry member, date and time of the blood draw, initials of the person drawing the blood, and any additional notes. 4. Place each labeled Vacutainer tube in a clean zip top bag. 5. Please complete the information in the box below and include this form with the shipment. ONLY SHIP ON MONDAYS, TUESDAYS, OR WEDNESDAYS!!! 6. Ship blood samples on wet ice (e.g., ice packs) and this completed form via overnight express using the provided, preprinted shipping label. Sample Information: To be completed at time of blood draw Registry Member s name: Collection date: Collection time: Name of the person doing the collection: Lab/Clinic Name: Lab/Clinic Phone Number: Lab notes: Emory Laboratory Contact Juandalyn Coffen Toll Free: pbbregistry@emory.edu