HIPAA Authorization (Health Information Privacy Rights)

Transcription

1 ALBANY MEDICAL CENTER ALBANY, NY PERMISSION TO TAKE PART IN A HUMAN RESEARCH STUDY AND HIPAA Authorization (Health Information Privacy Rights) Title of research study: Prospective Database Multidisciplinary Approach to Improve Care for Pelvic Pain (3960) Principal Investigator: Dr. Elise De, M.D. Site: Albany Medical Center, Community Care Physicians Study-related phone numbers: (518) or (518) You are being asked to take part in a research study because you have pelvic pain. If you are a parent or legal guardian of a child who may take part in this study, permission from you is required. The assent (agreement) of your child may also be required. When we say you in this consent form, we mean you or your child. What you should know about a research study We give you this consent form so that you can read about the purpose, risks and possible benefits of taking part in this research study. Please review it carefully. The main goal of regular medical care is to help each patient. The main goal of a research study is to learn things to help future patients. We cannot promise that this research study will help you. Just like regular medical care, your taking part in this research study can result in harmful effects that may be minor. Someone will explain this research study to you. Feel free to ask all the questions you want before you make a decision. A research study is something you volunteer for. Whether or not you take part in this research study is up to you. You have the right to choose not to take part in the research study. Also if you agree to take part now, you can change your mind later on. Whatever you decide it will not affect your access to health care, treatment and services not related to the research. Page 1 of 8

2 1 - Why is this research study being done and what is its purpose? Pelvic pain has many possible causes. Often it is difficult to find the cause and patients need to try a few doctors before the cause is identified. This can lead to a delay in diagnosis, resulting in prolonged pain, anxiety, and sometimes a worsening of the original problem. The reason we are doing this study is to find the best ways for providers who specialize in pelvic organs, nerves, and bones, to diagnose and treat the causes of pelvic pain. We want to find out if coordinating the providers, who take care of different parts of the pelvis, will lead to a quicker diagnosis and improve the quality of care. This study will use standard questionnaires and calendar data to track your progress as you receive care. The information from these surveys will help us track how well patients do with treatment in a coordinated care system of pelvic health experts and help identify what treatments were helpful for which diagnosis. 2 - Who is doing the research study? Dr. Elise De, M.D. is in charge of this research study. We expect about 500 patients per year to participate at Albany Medical Center and Community Care Physicians for 10 years (5000 total). Your participation will last about 12 months. 3 - What can you expect if you take part in this research study? When a patient is referred to a provider because of pelvic pain, it is normal for the patient to be asked to fill out some forms and to have her/his medical records sent to the doctor before the visit. Some of these standard forms are several pages long. This information is very important for the provider to have before the appointment so that he or she can focus on you (and not the paperwork). For all patients who will be seen in our system for a new visit for pelvic pain, there is a medical history form and 5 questionnaires that need completion prior the first encounter. The questionnaires are: 2 pain questionnaires A questionnaire about bowel and bladder symptoms An anxiety/depression questionnaire A survey that asks your views on your health These questionnaires will be repeated at 3, 12, and 60 months as part of your clinical care. One short questionnaire about pain will be repeated at 1 week after your first contact with our program. The information from these questionnaires will be added to your medical record whether or not you participate in the research side of the program, as they will be used to track your health progress.. You can return this information by mail in a pre-addressed stamped envelope, in person, by secure , or by fax. The study nurse may phone or you to remind you. The schedule for filling out the health questionnaires is: 1 week after signing the consent, you will receive a phone call and be asked to complete a 1-page pain survey. This form takes about 5 minutes to complete. You will have a 3- and 12-month follow-up contact with the study nurse to follow up 7 pages of questions. The forms can be returned by pre-addressed stamped envelope, in Page 2 of 8

3 person, by secure , or by fax. The forms will take about 30 minutes each time. These questionnaires are: A survey to find out how you are feeling overall and what has been done for you (Patient Global Assessment, Diagnoses, and Interventions) Three pain scales Questionnaire about bowel and bladder symptoms An anxiety/depression questionnaire A survey that asks your views on your health The information on these questionnaires will be added to your medical record under your name. Your provider will use the information to understand your progress, and which step to take next with your care. If you agree to be in the study and sign the consent form, the study participation involves the use of your health information to learn more about pelvic pain. The information will be pulled into a password-protected, de-identified, research data base; WITHOUT YOUR NAME ASSOCIATED, in order to study all our pelvic pain patients as a group. 4 - What are the risks and possible discomforts? Answering some of the questions on the forms may cause you to feel embarrassed, or may cause you to feel stressed. There is the possible risk of loss of confidentiality (privacy) of the study data, which we minimize to the best of our ability. Your questionnaire information will be stored in your secure patient clinical chart for your clinical care. When your information is extracted to be part of the research database, your name will be removed, and linked only to a de-identified, password-protected number. All data will be stored in a password-protected computer drive on the Albany Medical Center Network. The database will only be accessible to members of the research team. 5 - What are the possible benefits? We cannot guarantee that you will receive any benefits from participating in this study. The additional information you provide on the surveys may help your doctor take care of you. You may appreciate seeing the change in the study scores as symptoms improve. It is hoped that patients who have pelvic pain in the future will benefit from what is learned from this study. 6 - If you do not want to take part in the research study, are there other choices? You are free to choose not to participate in the research study. If you choose not to take part in the study, you will be treated according to the usual practice of your provider. 7 - If you have any questions or problems, whom can you call? If you have any questions about the research study now or later, please call Barb Smith, Nurse Navigator, at (518) If you think you have been injured by the research, you should call Dr. Elise De or the Urological Institute of Northeastern New York at (518) during normal business hours, or (518) during the evening or weekends. If you cannot reach Barb Smith or Page 3 of 8

4 Dr. De, you may call the Albany Medical College Office of Research Affairs at (518) You may also call this number if you have complaints about this research study, you believe you are not being treated fairly, or you have questions about your rights as a research subject. 8 - What information will be kept private? Our best efforts will be made to keep your personal information, including research study and medical records, private. However, we cannot guarantee privacy. Organizations that may inspect and copy your private information include the Department of Health and Human Services, the New York State Department of Health, Albany Medical Center, Community Care Physicians, and The Urological Institute of Northeastern New York. You will be identified as a research subject for medical records. Representatives of Albany Medical Center, Community Care Physicians, and The Urological Institute of Northeastern New York will have access to your private health information. Authorization (Permission) to Use and Disclose Information for Research Purposes Federal regulations give you certain rights related to your health information. The study doctor must get your authorization (permission) to use or give out any health information that might identify you. If you have questions about your privacy rights, please call the AMC Research Privacy Officer at (518) What information about you may be used and given to others? If you choose to be in this study, the study doctor, his/her study team including any new members of the study team in the future, and others who need it will have information about your past or present health care condition, or treatment, that identifies or can be used to identify you. This information is called protected health information or just health information for short. Health information includes both your medical information and information such as your address, where you work, your date of birth, and other similar personal information. Your health information can be in different forms: Written information such as what is in your medical chart, or the record of your study visits Electronic information which is information stored in computer systems, such as billing data Verbal information such as in phone calls made as part of this research study Information obtained during this research about - Physical exams - Other test results such as urodynamics and cough tests - Diaries and questionnaires Records about any medication, treatment, or procedure you underwent Who will be able to use your health information and give it to others? Information about your health may be used and given to others to carry out the research study by the study doctor and staff. They might see the research information during and after the study. Page 4 of 8

5 Who will be able to get your health information and use it? Information about you and your health that might identify you may be given to: The Albany Medical Center Institutional Review Board (IRB) The Department of Health and Human Services (DHHS) Will you be able to see your research records? You will be allowed access to your research records. Why are others able to get your information and for what purpose or purposes will the information be used? Information about you and your health that might identify you may be reviewed by a group of people called the Institutional Review Board (IRB). The IRB is responsible for protecting your rights and welfare and is not involved in the conduct of the clinical study. The information may be given to individuals approved by the IRB to carry out the research study. The information may also be used to meet the reporting requirements of governmental agencies. The results of this research may be published in scientific journals or presented at medical meetings, but your identity will not be disclosed for those purposes. When and how can you cancel your permission? You may cancel your permission for us to use and disclose your health information at any time. You do this by sending written notice stating you wish to cancel your permission. Send this to the study doctor. If you cancel your permission, you will not be able to continue being in this study. When you cancel your permission, no new health information, which might identify you, will be gathered after that date. Information gathered prior to your cancellation of permission may still be used and given to others. This would be done to account for your withdrawal. When will the research end and when will your health information no longer be used? This permission will remain in effect until the end of the research study. What if you don t want to give your permission to be included in the research and don t want anyone to give out and use your health information? If you do not give us permission and sign the permission (authorization) form, you will not be able to be in this research. You can give us permission to use and give out the health information listed above for the purposes described above by signing this permission (authorization) form. 9 - Can your taking part in the research end early? You may decide not to continue in the research study at any time and it will not affect your access to health care, treatment and services not related to the research. Dr. De can remove you from the Page 5 of 8

6 research study without your approval. Possible reasons for removal include not following the doctor s advice about treatment or not coming to follow up visits. We will tell you about any new information that may affect your health, welfare, or choice to stay in the research What else do you need to know? We will give you a signed and dated copy of this form. Page 6 of 8

7 DO NOT SIGN LATER THAN EXPIRATION DATE OR IF THERE IS NO EXPIRATION DATE ALBANY MEDICAL CENTER PERMISSION OF RESEARCH SUBJECT AND HIPAA AUTHORIZATION Approval of research subject: Consent obtained by: Witness: Title A witness is required when the subject cannot read and the consent document was read to the subject. The sponsor may also require a witness. Page 7 of 8

8 DO NOT SIGN LATER THAN EXPIRATION DATE OR IF THERE IS NO EXPIRATION DATE ALBANY MEDICAL CENTER PERMISSION OF RESEARCH SUBJECT S PARENT(S) OF MINOR OR LEGAL GUARDIAN(S) OF PERSON AND HIPAA AUTHORIZATION To be completed by Principal Investigator/designated member of research team: Check here if second parent of minor or legal guardian is deceased, unknown, incompetent, or not reasonably available. Check here if only one parent of minor has legal responsibility for the care and custody of the child. To be completed by IRB Office: Check here if permission of second parent of minor or legal guardian is not required by the IRB. Check here if assent is not required by the IRB because the subject is not capable of assent. Check here if assent is not required by the IRB because the research holds out prospect of direct benefit that is important to the health and well-being of the subject and is available only in the context of research. Check here if assent is not required because the requirement for assent was waived by the IRB. Subject information: Approval of parent of minor or legal guardian: Relationship Parent of minor Legal Guardian Approval of parent of minor or legal guardian: Relationship Parent of minor Consent obtained by: Witness: Legal Guardian Title A witness is required when the parent of minor or legal guardian cannot read and the consent document was read to the subject. The sponsor may also require a witness. Page 8 of 8