HIPAA Informed Consent Version 8

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HIPAA Informed Consent Version 8

  1. 1. Approved April 27, 2010 Date: April 27, 2010 Principal Investigator: Richard D. Moore Application No.: NA_00028824 Page 1 of 8 CombinedInformedConsent/Authorization October 2007 Version10 Site(s) of Research: Johns Hopkins Hospital HIV (Moore) Clinic Johns Hopkins Greenspring HIV Clinic Johns Hopkins 911 Broadway HIV Clinic Johns Hopkins County HIV Clinics RESEARCH PARTICIPANT INFORMED CONSENT AND PRIVACY AUTHORIZATION FORM Protocol Title: HIV DiseaseOutcomes in ClinicalPractice Application No.: NA_00028824 Sponsor: NIDA Principal Investigator: Richard D. Moore 1. What you should know about this study:  You are being asked to join a research study.  This consent form explains the research study and your part in the study.  Please read it carefully and take as much time as you need.  Please ask questions at any time about anything you do not understand.  You are a volunteer. If you join the study, you can change your mind later. You can decide not to take part or you can quit at any time. There will be no penalty or loss of benefits if you decide to quit the study.  During the study, we will tell you if we learn any new information that might affect whether you wish to continue to be in the study.  Ask your study doctor or the study team to explain any words or information in this informed consent that you do not understand. 2. Why is this researchbeing done? This research is being done to find out how the course of HIV infection changes over time, and how HIV treatment and other factors change the course of HIV. The medical care of people with HIV infection and AIDS has changed greatly and continues to change as new medicines become available. We would like to better understand how changes in medical care have affected the course of HIV infection in the patients who are followed in for HIV infection from the Johns Hopkins HIV Service. People with known HIV-infection who are in care in the Johns Hopkins HIV Service may join. We expect 7500 people to join the study. 3. What will happen if you join this study? Patient I.D. Plate
  2. 2. Approved April 27, 2010 Date: April 27, 2010 Principal Investigator: Richard D. Moore Application No.: NA_00028824 Page 2 of 8 CombinedInformedConsent/Authorization October 2007 Version10 If you agree to be in this study, we will collect information about the medical care that you have received. This research will not in any way change or have an effect on your medical care. Your care will continue to be completely up to your doctors. We will only collect information about your medical care after you receive that care. This is an observational study. This means that we will only observe, or record, information about your medical care after you have gotten that care. After you give us your consent, there is nothing else that you have to do for this study. The following information will be collected:  Symptoms that you have or that may occur  Any illnesses that you have or that may occur  Age, sex, race/ethnicity, and how you were infected with HIV  Medicines you receive from your doctor and filling of prescribed medicines at the pharmacy  Laboratory values, procedure results such as radiology and pathology (like biopsy results)  Cigarette smoking, alcohol use, and substance use  The use of and cost of your medical care  Vital statistics and disease registries Our research staff will get this information from your Johns Hopkins medical records, from medical insurance records, from state and national vital statistics records, from state and national disease registries (such as a cancer registry) and from other Johns Hopkins research records if you join any IRB- approved research studies in the future. We will collect the information starting with your first visit to the HIV Clinic. We will continue to collect this information about your medical care into the future. The information we collect is entered into a computer, and is kept in a confidential database. Analysis of this information is paid for by the National Institutes of Health, other federal agencies and, at times, by private companies (such as drug companies). Only those people directly involved in the research will handle your information. Your information will always be grouped with the information from other Clinic patients when analyzed, and you will not be identified individually in any analysis. 4. What are the risks or discomforts of the study? We believe there is very little risk to you. The only risk would be that someone not involved with this study would see your medical information. We believe this is very unlikely because of safeguards we have put into place. 5. Are there benefits to being in the study? There is no direct benefit to you for participating in this study. If you take part in this study, you may help others in the future who are infected with HIV because we will be able to better understand the way the HIV infection is changing in clinical practice over time. 6. What are your options if you do not want to be in the study? You do not have to join this study. If you do not join, your care at Johns Hopkins will not be affected. Joining this study is not required for you to receive treatment for HIV. You do not have to join this study. If you do not join, your medical care will not be affected. 7. Will it costyou anything to be in this study? No
  3. 3. Approved April 27, 2010 Date: April 27, 2010 Principal Investigator: Richard D. Moore Application No.: NA_00028824 Page 3 of 8 CombinedInformedConsent/Authorization October 2007 Version10
  4. 4. Approved April 27, 2010 Date: April 27, 2010 Principal Investigator: Richard D. Moore Application No.: NA_00028824 Page 4 of 8 CombinedInformedConsent/Authorization October 2007 Version10 8. Will you be paid if you join this study? No 9. Can you leave the study early? You can agree to be in the study now and change your mind later.  If you wish to stop, please tell us right away.  Leaving this study early will not stop you from getting regular medical care.  If you leave the study early, Johns Hopkins may use or give out your health information that it already has if the information is needed for this study or any follow-up activities. 10. Why might we take you out of the study early? You may be taken out of the study if:  Staying in the study would be harmful.  The study is cancelled.  There may be other reasons to take you out of the study that we do not know at this time. 11. How will your privacy be protected? Johns Hopkins has rules to protect information about you. Federal and state laws also protect your privacy. This part of the consent form tells you what information about you may be collected in this study and who might see or use it. Generally, only people on the research team will know that you are in the research study and will see your information. However, there are a few exceptions that are listed later in this section of the consent form. The people working on the study will collect information about you. This includes things learned from the procedures described in this consent form. They may collect other information including your name, address, date of birth, and other details. The research team will need to see your information. Sometimes other people at Johns Hopkins may see or give out your information. These include people who review the research studies, their staff, lawyers, or other Johns Hopkins staff. People outside of Johns Hopkins may need to see your information for this study. Examples include government groups (such as the Food and Drug Administration), safety monitors, other hospitals in the study and companies that sponsor the study. We cannot do this study without your permission to use and give out your information. You do not have to give us this permission. If you do not, then you may not join this study. We will use and disclose your information only as described in this form and in our Notice of Privacy Practices; however, people outside Hopkins who receive your information may not be covered by this promise. We try to make sure that everyone who needs to see your information keeps it confidential – but we cannot guarantee this.
  5. 5. Approved April 27, 2010 Date: April 27, 2010 Principal Investigator: Richard D. Moore Application No.: NA_00028824 Page 5 of 8 CombinedInformedConsent/Authorization October 2007 Version10 The use of your information has no time limit. You can cancel your permission to use and disclose your information at any time by calling the Johns Hopkins Medicine IRB at 410-955-3008 or by sending a letter to: Office of Human Subjects Research 1620 McElderry Street Reed Hall, Suite B130 Baltimore, MD 21205-1911 Your cancellation would not affect information already collected in this study. 12. Will the study require any of your other health care providers to share your health information with the researchers ofthis study? As a part of this study, the researchers will ask to see your health care records from your health care providers. 13. What if there is a Certificate of Confidentiality for this study? NIDA has given a Certificate of Confidentiality for this study. This document protects the study data. It also protects your privacy from federal, state, or local court or public agency action. The research team will not give out study information about you to a court or public agency without your consent. Still, we may disclose identifying information about you if, for example, you need medical help. We may also disclose identifiable information about you as described in Section 11 of this form or in other cases. For example, the government may see your information if it audits us, and the research team will voluntarily comply with Maryland disclosure laws and will tell the local or state authorities:  if they suspect abuse or neglect of a child or dependent adult;  if certain diseases are present; and  if the team learns that you plan to harm someone. In this case,  the team also may warn the person who is at risk. This Certificate does not mean the government approves or disapproves of this research project. 14. What treatment costs will be paid if you are injured in this study? Johns Hopkins does not have a program to pay you if you are hurt or have other bad results from being in the study. However, medical care at Johns Hopkins is open to you as it is to all sick or injured people.  If you have health insurance: The costs for any treatment or hospital care you receive as the result of a study-related injury will be billed to your health insurer. Any costs that are not paid for by your health insurer will be billed to you.  If you do not have health insurance: You will be billed for the costs of any treatment or hospital care you receive as the result of a study-related injury.
  6. 6. Approved April 27, 2010 Date: April 27, 2010 Principal Investigator: Richard D. Moore Application No.: NA_00028824 Page 6 of 8 CombinedInformedConsent/Authorization October 2007 Version10 15. What other things should you know about this researchstudy? a. What is the Institutional Review Board (IRB) and how does it protect you? The Johns Hopkins Medicine IRB is made up of:  Doctors  Nurses  Ethicists  Non-scientists  and people from the local community. The IRB reviews human research studies. It protects the rights and welfare of the people taking part in those studies. You may contact the IRB if you have questions about your rights as a participant or if you think you have not been treated fairly. The IRB office number is 410-955-3008. You may also call this number for other concerns or questions about the research. b. What do you do if you have questions about the study? Call the principal investigator, Dr. Richard Moore at (410) 955-2144. If you cannot reach the principal investigator or wish to talk to someone else, call the IRB office at 410-955-3008. c. What should you do if you are injured or ill as a result of being in this study? Call Dr. Richard Moore at (410) 955-2144, if you have an urgent medical problem related to your taking part in this study. Call the principal investigator, Dr. Richard Moore, at (410) 955-2144, if you think you are injured or ill because of this study. Medical care at Johns Hopkins is open to you as it is to all sick or injured people. Johns Hopkins does not have a program to pay you if you are hurt or have other bad results from being in the study. The costs for any treatment or hospital care would be charged to you or your insurance company. d. What happens to Data that are collected in the study? Scientists at Johns Hopkins work to find the causes and cures of disease. The data collected from you during this study are important to both this study and to future research. If you join this study:  Johns Hopkins and/or its outside partners in this research will own these data.  Scientists may study, test and use this material in this study.  Scientists may study, test and use this material in future research only with your consent or with the approval of a special review board.  If this material is used to create a product or idea, the scientists and Johns Hopkins will own that product or idea.  You will not receive any financial benefit from the creation, use or sale of that product or idea.
  7. 7. Approved April 27, 2010 Date: April 27, 2010 Principal Investigator: Richard D. Moore Application No.: NA_00028824 Page 7 of 8 CombinedInformedConsent/Authorization October 2007 Version10 e. What are the Organizations that are part of Johns Hopkins? Johns Hopkins includes the following:  The Johns Hopkins University  The Johns Hopkins Hospital  Johns Hopkins Bayview Medical Center  Howard County General Hospital  Johns Hopkins Community Physicians.
  8. 8. Approved April 27, 2010 Date: April 27, 2010 Principal Investigator: Richard D. Moore Application No.: NA_00028824 Page 8 of 8 CombinedInformedConsent/Authorization October 2007 Version10 16. What does your signature on this consentform mean? Your signature on this form means that:  you understand the information given to you in this form  you accept the provisions in the form  you agree to join the study You will not give up any legal rights by signing this consent form. WE WILL GIVE YOU A COPY OF THIS SIGNED AND DATED CONSENTFORM __________________________________________________________________________________________________________________________ Signature of Participant Date _________________________________________________________________________________________ Signature of Person Obtaining Consent Date NOTE:A COPYOF THE SIGNED, DATED CONSENT FORM MUST BE KEPT BYTHE PRINCIPAL INVESTIGATOR; A COPYMUST BE GIVEN TO THE PARTICIPANT; AND, IF APPROPRIATE A COPYOF THE CONSENT FORM MUST BEPLACEDIN THE PARTICIPANT ‘S MEDICAL RECORD. FOR OFFICE USE ONLY: STUDY APPROVED FOR ENROLLMENTOF: X_ Adults Only __ Adults andChildren __ ChildrenOnly

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