CCHHS Institutional Review Board, HektoenBuildingSte. 333, 627 S. Wood, (312)864-4821 Fax (312)864-9210
Informed Consent Template - Sample
This template indicates the basic sections to be covered in your consent in upright bold letters. Language in italics is “help” and gives you more information about the nature of each section. Language in“quotes” is an example of the way in which you may offer this information. Do not include quotation marks in your consent. Sample language is written for situations that occur frequently in research. Please READ the language and be sure that it is TRUE for your study.
Use Letterhead for first page. Number pages, Use font of at least 12 pt. Aim for 7th grade reading level.Provide a 2” x 23/4” space for an Approval stamp on each page. This consent does NOT include HIPAA authorization. A separate authorization is required.
Title of Study
Names and affiliation of Investigators should be listed beneath the title.
“You are being invited to participate in a research study.
This description of the study is called an ‘informed consent.’ After you learn about the study, you will decide whether or not you want to participate. You may take this description home and discuss it with your family or friends to help you decide. There may be words or ideas you do not understand. Please askquestions. Participation is voluntary. Whetheryou join the study or not, your medical provider will continue to care for you as before.”
Purpose of this Research
“This study seeks to answer the question:----- ”Describe the research question as clearly as possible. You may want to begin with what is already known. For example:“Study drug is helpful in treating xyz… This study is asking ‘Is the study drug also able to extend life or the quality of life of patients with ABC health condition.”
Indicate how many participants will take part in the study at County and in total.
What to expect
The description should include the duration of the study. Indicate how many visits will take place and how long each visit will last.
“This is the care you will be getting for your condition, whether you participate in this research or not:”
List any tests and/or procedures. You do not have to go into detail repeating information that will be covered in a ‘consent to treat.’ The idea is to differentiate the research activities from the routine clinical care procedures.
“These are the additionalresearch procedures or medications that you will have if you join this study:”
List all tests and procedures. Indicate how much time is involved. A chart of what takes place at each visit may be helpful especially if the same procedures take place repeatedly.
“These are the procedures or medications that you would or might get as part of your normal care for your condition, that you will not get if you join the study:”
“These are the risks to you from your regular care for your condition:”
Provide risks of care that would be experienced even if patient did not participate in the research.
“These are the additional risks to you that may arise from joining this study:”
List risks including inconveniences using lay language. It is helpful to indicate how frequently they occur (what percentage of patients). If the significance of the side effect is not clear, you should explain it. Distinguish between routine care and research where appropriate.
“Your research records will be kept private. The CCHHS (name collaborating Institutions if relevant) study team will have access to these records. In addition, your records may be reviewed by the study sponsor, xyz, regulatory agencies such as the Food and Drug Administration (include only if this is the case)and the Cook County Health & Hospitals System Institutional Review Board (IRB) or as required by law. The IRB is a panel whose job is to review the ethics of research.”
If you are releasing PHI to an outside coordinating center, say this and get permission.
“Researchers at Stroger will send partsof your medical record by a secure encrypted method to the xyz group which is located in (state). The information from your records will be given a code number before it is sent. Only the Stroger research team will have the key to link your code number to your name.(Say this only if it is true, correct it if it is not accurate). If the xyz group releases your data to anyone else, the recipient will not have any identifiers either, only the code number. A separate HIPAA authorization describes this in more detail.”
If the data do not includeany of the 18 HIPAA identifiers, this is not necessary.
List possible benefits. Do not include compensation for expenses in benefits. If there are none, indicate that there are no direct benefits to the participant but that this study may help to improve treatment in the future e.g. “Although we do not know whether the study drug will be effective, this research will help us to treat patients with your condition in the future”
Alternative to participation
Briefly describe treatment options. If this is not a therapeutic study indicate that the alternative is to choose not to participate. Indicate that if new information or treatments become available which may affect the decision to participate, you will notify the subject. And then you must do this.This includes information about newly approved treatments for the participant’s condition.
Costs and compensation
Describe how the research is paid. You may include something like “Your regular care that is not part of this research will be paid for in the way in which your care at Stroger is normally paid.” If subjects are being reimbursed,you must include this,for example, “You will be receive ($30) for each study visit to help pay for travel and child care expenses”
Injuries or complications
”In the unlikely event of a research related injury, you will receive medical care but the care will be paid for in the same way in which your routine care is paid for at County. There is no special fund to pay for injuries.”
“In the unlikely event of a research related injury, you will receive medical care which will be paid for by the sponsor. The sponsor will pay only for medical expenses and will not pay for lost wages or other non-medical costs.”
And, in either case
“You are not being asked to give up your legal rights by agreeing to these conditions”
Leaving the study
“You may leave this studyat any time. In order to make sure that you understand the consequences of leaving the study and your options, the study doctor may want to discuss your decision to leave the study with you, but the decision to leave is yours alone. Your study doctor may remove you from the study for a variety of reasons (including a determination that the study is not what is best for you or instructions from the study sponsor to do so).”
“If you leave the study without withdrawing your permission to continue to collect and/or use of your medical information, your medical information may continue to be used for this research. If you wish to stop researchers from using your medical information, you must say so in writing. How to withdraw your permission to use your medical information is described in the HIPAA authorization.”
People you may call
“If you have questions about this research study, call Dr. Cook at (123) 456-7890”(Name and number- use a number that can be reached. The IRB may test this number)
“If you feel you a suffered a research injury, call name and number” – (use a number that can be reached. The IRB may test this number).
“If you have questions about your rights as a research subject, call the Cook County Health & Hospitals System Institutional Review Board at 312 864-4821 during regular business hours. You may leave a message. Your call will be treated confidentially “
“I have explained all aspects of this research and have answered the participant’s questions.”
Person Obtaining Consent Date
Signature Person Obtaining Consent Date
“I have had my questions answered, I understand that my participation is voluntary and I agree to participate in this study”
Signature of Participant Date
“In this study tissue samples will be stored for additional research. You may agree to having your (left over) tissue used for (re-word appropriately)
Research on your condition, Initial if OK ______
Research on other conditions. Initial if OK ______
Research that identifies genetic characteristics that may make a person prone to disease or responsive to treatment. Initial if OK ______
Results from these additionally studies would not benefit you in anyway. The information will not be put in your medical record or shared with your provider. The tissue sample that is sent to a central repository will be identified by a code rather than your name or medical record number, however, this code number could be linked back to your name.”
“I agree to participate in the tissue study.”
Signature of Participant Date
Affidavit of Interpreter
If the subject does not understand English, the subject should still sign the English consent however the Interpreter should sign the affidavit.
“I have translated this consent for the subject and have translated his/her questions to the investigator and have translated the answers back to the subject.”
Printed Name of Interpreter
Signature of Interpreter
“I understand that choosing to participate inthis study will not help my status in judicial system in any way and refusing to participate will not be held against me. This study will not affect my sentence, parole or prison conditions.”
“As described above,you should not be come pregnant during this study. If you do become pregnant during this study, you will no longer be given the study drug. Your pregnancy will be cared for through another department, however with your permission, your pregnancy and baby will be followed by the research study”
“Completing the survey questionnaire will take aboutn minutes. The survey will not contain your name but the code number will be linked to you. (if true). The questions are about xyz. Answering them may make you feel (sad, uncomfortable –if true). You may skip any question you do not want to answer.”
“Confidentiality in focus groups depends on the participants. You will not use your name in the group. Participants will be reminded not to repeat anything in the group but there is no way to be sure that they will follow this direction or that you may not know someone in the group.”
Typically minors under 7 do not assent. (However, except in the case of therapeutic studies, their resistance excludes them from participation). Minors between 7 and 13 should sign a simplified version of the consent. Minors over 13 may sign the consent on a line for assent because the languagein the general consent should be at a 7th grade level. The consent for parents and guardian should use appropriate pronouns such as “your child”. “You/your child” is almost never acceptable. When minors turn 18, they must be re-consented.
Wards of the state
In general, the IRB approves only 45CFR46.404, or 405 research. In the rare case in which 406 research is approved, Wards of the State are not to be included.
A legally authorized representative may consent for persons who may not be able to consent due tomental retardation, extreme pain or anesthesia, or mental illness (mental illness does not automatically preclude the ability to consent).If a legal representative is used, language should be appropriate (“Your family member”)
New information relevant to choosing to participate
Where appropriate, promise to keep the subject informed about new developments that might affect the decision to participate. The promise must then be kept.
Persons to help locate subject lost to follow-up
If you wish to identify contacts to locate lost subjects, you must have permission. You must tell the subject how the person will be contacted and exactly what you will tell that person. Remember that mentioning the hospital or jail, may not be desirable and may cause alarm.
“We would like the names and contact information of a friend or relative you say we may contact, if we are do not know how to find you. If we cannot contact you, we will try contacting the person (by phone, letter say how) and say:
‘This is Mr. X from the Healthy-Walks project. Mr. Smith gave us your name to help locate him when he joined our program last year. Do you know how we can contact Mr. Smith’?
If it ok with you to try to locate you in this way, please provide the information requested below
Name of contact ______
Address if contact______
Phone number of contact______
Relationship to contact______”
CCHHS Institutional Review BoardInformed Consent Template,2014