Consent form
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Informed Consent Document |
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TITLE OF RESEARCH: Investigation of the Epidemiology if Lemierre’s Disease
IRB PROTOCOL: X100329023
INVESTIGATOR: Dr. Robert Centor
SPONSOR: UAB Huntsville Regional Medical Campus
For Children/Minors (persons under 19 years of age) participating in this study, the term You addresses both the participant ("you") and the parent or legally authorized representative ("your child").
Explanation of Procedures
We are asking you to take part in a research study. This research study will help define the current natural history of Lemierre’s disease. In particular it will focus on the duration of symptoms prior to hospitalization, length of stay, and cost of care. Anyone with a history of Lemierre’s disease is eligible for the study.
If you enter the study you will need to participate in a 30-60 minute interview about your experience with Lemierre’s Syndrome and provide your medical records that pertain to Lemierre’s Syndrome. The study plans to enroll 100 participants.
Risks and Discomforts
Patients (or family) will voluntarily tell the story of their illness. The only possible discomfort that we can imagine is psychological, but since they are volunteers, we suspect that those with severe psychological aversion will avoid the study. The participants will be asked to send past medical records in resulting in a potential loss of confidentiality. All documents will be kept in a locked office during the study and properly disposed of upon completion of the study.
Benefits
You may not benefit directly from taking part in this study. However, this study may help us better understand Lemierre’s disease
Alternatives
The study will not involve any direct patient care. At any time the participant can choose not to participate in the study
Confidentiality
Information obtained about you for this study will be kept private to the extent allowed by law. However, research information that identifies you may be shared with the UAB Institutional Review Board (IRB) and others who are responsible for ensuring compliance with laws and regulations related to research, and the Office for Human Research Protections (OHRP).The results of the research may be published for scientific purposes. These results could include your survey results and symptoms. However, your identity will not be given out.
Refusal or Withdrawal without Penalty
Your taking part in this study is your choice. There will be no penalty if you decide not to be in the study. If you decide not to be in the study, you will not lose any benefits you are otherwise owed. You are free to withdraw from this research study at any time. Your choice to leave the study will not affect your relationship with this institution. However, you should return to see the study doctor for safety reasons so you can be referred for follow-up care.
Cost of Participation
There will be no cost to you from taking part in this study. The costs of your standard medical care will be billed to you and/or your insurance company in the usual manner.
Payment for Participation in Research
You will not be paid for participating in this study.
Questions
If you have any questions, concerns, or complaints about the research please contact Dr. English. He will be glad to answer any of your questions. Dr. English’s number is 256-551-4412.
If you have questions about your rights as a research participant, or concerns or complaints about the research, you may contact Ms. Sheila Moore. Ms. Moore is the Director of the Office of the Institutional Review Board for Human Use (OIRB). Ms. Moore may be reached at (205) 934-3789 or 1-800-822-8816. If calling the toll-free number, press the option for “all other calls” or for an operator/attendant and ask for extension 4-3789. Regular hours for the Office of the IRB are 8:00 a.m. to 5:00 p.m. CT, Monday through Friday. You may also call this number in the event the research staff cannot be reached or you wish to talk to someone else.
Legal Rights
You are not waiving any of your legal rights by signing this informed consent document.
Signatures
Your signature below indicates that you agree to participate in this study. You will receive a copy of this signed document.
Signature of Participant Date
Signature of investigator or other person obtaining consent Date
Signature of Witness Date
Signature of Investigator reviewing consent document Date
Assent of Child
(name of child/minor) has agreed to participate in research titled Investigation of Sore Throat Pain and its relation to Sore Throat Symptoms
Signature Of Child Date
OR
Waiver of Assent
The assent of ______________________________ (name of child/minor) was waived because of:
Psychological state of the child ________
Signature of Parent or Date
Legally Authorized Representative
University of Alabama at Birmingham
AUTHORIZATION FOR USE/DISCLOSURE OF HEALTH INFORMATION
FOR RESEARCH
What is the purpose of this form? You are being asked to sign this form so that UAB may use and release your health information for research. Participation in research is voluntary. If you choose to participate in the research, you must sign this form so that your health information may be used for the research.
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Participant Name: |
UAB IRB Protocol Number: X100329023 |
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Research Protocol: Investigation of the Epidemiology if Lemierre’s Disease |
Principal Investigator:Robert Centor |
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Sponsor: UAB Huntsville Regional Medical Campus |
What health information do the researchers want to use? All medical information and personal identifiers, including past, present, and future history, examinations, laboratory results, imaging studies and reports, and treatments of whatever kind related to or collected for use in the research protocol.
Why do the researchers want my health information? The researchers want to use your health information as part of the research protocol listed above and described to you in the Informed Consent document.
Who will disclose, use and/or receive my health information? The physicians, nurses and staff working on the research protocol (whether at UAB or elsewhere); other operating units of UAB, HSF, UAB Highlands, The Children’s Hospital of Alabama, Callahan Eye Foundation Hospital and the Jefferson County Department of Public Health, as necessary for their operations; the IRB and its staff; the sponsor of the research and its employees; and outside regulatory agencies, such as the Food and Drug Administration.
How will my health information be protected once it is given to others? Your health information that is given to the study sponsor will remain private to the extent possible, even though the study sponsor is not required to follow the federal privacy laws. However, once your information is given to other organizations that are not required to follow federal privacy laws, we cannot assure that the information will remain protected.
How long will this Authorization last? Your authorization for the uses and disclosures described in this Authorization does not have an expiration date.
Can I cancel the Authorization? You may cancel this Authorization at any time by notifying the Director of the IRB, in writing, referencing the Research Protocol and IRB Protocol Number. If you cancel this Authorization, the study doctor and staff will not use any new health information for research. However, researchers may continue to use the health information that was provided before you cancelled your authorization.
Can I see my health information? You have a right to request to see your health information. However, to ensure the scientific integrity of the research, you will not be able to review the research information until after the research protocol has been completed.
Signature of participant: Date:
or participant's legally authorized representative: Date:
Printed Name of participant’s representative:
Relationship to the participant:
