[UIC Form Version 2.1, dated 12/17/2012]
You are being asked to be a subject in a research study. The study will involve [Add a brief description of study procedures (i.e. blood draw, use of existing pathology sample) - please refer to the expedited review categories found in the Initial Review Form for minimal risk procedures.] in [number and type of subjects (i.e. healthy adult volunteers or individuals with a certain diagnosis) at UIC(or JBVAMC). If a multi-site study, add the total number of subjects anticipated and the projected number of research sites. (e.g., In the entire study, there may be X subjects at X sites) Before you decide whether to participate, you should know what the study is about, the possible risks and benefits, and what you will have to do in this study. Your participation in this study is voluntary. Your decision whether or not to participate will not affect your current or future relationship with the University. If you decide to participate, you are free to withdraw at any time without affecting that relationship. Please read this form and ask any questions you may have; if you decide to take part in the study, you will be asked to sign this form to verify that choice.
Who is doing the research, and why is it being done?
The research is being conducted by [name of Principal Investigator] in the [Department or Section name] at the University of Illinois at Chicago (UIC). The study is funded by [add sponsor/funding source]. The purpose of the study is [add statement of study purpose].
What procedures are involved?
[Describe the procedures chronologically using lay language, short sentences and short paragraphs. Define and explain medical and scientific terms in ordinary language (for example, describing the amount of blood to be drawn in terms of teaspoons or tablespoons). Specify length of time for participation in each procedure, frequency of procedures, location of the procedures to be done, etc. If applicable, include a statement about the use of medical records in the research (i.e. “We will also need to record your name and medical record number in order to get information from your medical record about your health and any recent medications or illnesses. Because we need access to your health information for this research, we will not be able to include you in this study if you choose not to allow us to access your medical records.”)]
How long will you be in the study?
[Include a statement of the duration of participation.]
What about the potential risks and discomforts, and benefits from this study?
[Explain the risks including the likelihood, severity, and reversibility, if applicable, of each risk.]
[Include a statement describing any benefits to the subject that may be reasonably expected from the research. If there are no direct benefit to subjects, state that here. Payment for participation is not, in and of itself, a direct benefit of the research. Include a statement that knowledge may be gained from the research that may help others in the future. (Sample: “You will not directly benefit by participating in this study, but others in the future may benefit from what we learn.”)]
[The following two paragraphsare onlyrequired for research involving genetic testing.]
There is a Federal law called the Genetic Information Nondiscrimination Act (GINA). In general, this law makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. However, it does not protect you against discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. GINA also does not protect you against discrimination if you have already been diagnosed with the genetic disease being tested.
There is a risk that someone could get access to the genetic information we have stored about you. Genetic testing can create information about a subjects’ and their families’ personal health risks and can cause or increase anxiety, and/or interfere with your ability to get insurance or a job, and can even lead to discrimination. Patterns of genetic variation also can be used by law enforcement agencies to identify a person or his/her blood relatives. There are laws against this kind of misuse, but they may not give full protection. There may be other unforeseen privacy risks. We believe the chance these things will happen is very small, but we cannot make guarantees. Your privacy and the confidentiality of your data are very important to us and we will make every effort to protect them. These efforts are described in the section below called “What about privacy and confidentiality?”.
Will you be compensated or reimbursed for your participation in this research?
[Add amount and type of compensation or reimbursed, if any, and how and when compensation or reimbursement will be received (i.e. mailed check or cash after study visit). If there is more than one visit in the study, then the schedule for payment should be outlined (x visits at x dollars per visit, for a total of x), and include the payment schedule for subjects who do not complete all of the visits. ]
What about privacy and confidentiality?
Researchers will store information gathered about you [describe specific plan for storing research data (i.e. in locked file cabinets in a locked office)], but there is a possible loss of confidentiality since absolute confidentiality cannot be guaranteed. You should know that in any research publications and scientific meetings coming from the research, you will not be identified individually.
By signing this form, you are also authorizing or allowing access to your medical record, and the disclosure of your health information to [add Principal Investigator (if applicable, “and his/her research team”) and others who may have access, such as the sponsor] for the purposes of this research. The health information includes all information created and/or collected during the research as described within this form [or any health information in your medical record, if applicable] and specifically includes[list all PHI including demographic information (i.e. name, age, race), the results of physical exams, blood tests, x-rays and other diagnostic and medical procedures, as well as medical history].
After information about you is given to anyone outside of the study, it may be re-disclosed and may no longer be protected by federal privacy laws.
This permission to access your medical records has no expiration date, but you may withdraw your permission for the use of your health information for this study at any time by sending a letter to the following person: [add name and address of Principal Investigator]. If you cancel this authorization the researchers may still use and disclose the health information they have already obtained as necessary to maintain the integrity and reliability of the research and to report any adverse (bad) effects that may have happened to you.
[Add if applicable: “Because you will receive money for participating, your name, address, and social security number may be provided to the University’s business office for tax reporting purposes”]There are University, state and federal agencies and officials who ensure the protection of human subjects in research, and they might access your records in line with their official duties or as required by law.
Who should you contact if you have questions?
The researcher conducting this study is [add name of Principal Investigator]. You may ask any questions you have now. If you have questions later, you may contact the researcher at: [Add phone number].
What are your rights as a research subject?
If you feel you have not been treated according to the descriptions in this form, or you have any questions about your rights as a research subject, you may call the Office for the Protection of Research Subjects (OPRS) at 312-996-1711 (local) or 1-866-789-6215 (toll-free) or e-mail OPRS at .
If you have any questions or concerns regarding your privacy rights under HIPAA, you should contact the UIC Privacy Officer at (312) 996-2271.
Right to Refuse to Sign this Consent/Authorization
[Use this language when PHI is required for the research.] You do not have to sign this Consent/Authorization form. However, because your health information is required for research participation, if you decide not to sign this form, it will only mean you cannot take part in this research. Not signing this form will not affect your non-research related treatment, payment or enrollment in any health plans or your eligibility for other medical benefits.
[If the use of PHI is optional to participating in the research, then different language must be used and separate consent and authorization documents must be used allowing the subjects the option of participating in the research, but not allowing access to the PHI. See the regular HIPAA authorization template.]
Signature of Subject
You have read (or someone has read to you) the above information. You have discussed the procedures, risks and benefits of the study with the researchers. You have been given an opportunity to ask questions and your questions have been answered to your satisfaction. You agree to participate in this research. You will be given a copy of this signed form for your information and to keep for your records. The original copy will be stored in the research file [if applicable, add “and a copy may be placed in the University of Illinois Medical Center medical record”].
SignatureDate
Printed Name
I have discussed the above research study, including the purpose, procedures, risks, and benefits, with the subject. I encouraged questions and answered all questions that were asked. The subject is aware that he/she does not have to participate in the research and may later withdraw their Authorization.
Signature of Person obtaining consentDatePrinted Name
(Same as Subject’s)
[If the authorization will be signed by someone other than the subject, then additional signature lines need to be added along with a description of the relationship between the signer and the subject; see printout of HIPAA drop-in language for consents on the OPRS website: ]
If you have not already received a copy of the Notice of Privacy Practices, you should ask for one.
[Required, if applicable to the research]
[If someone other than the subject will be providing authorization for the subject, the following signatures/information must be added to the signature area of the combined consent/authorization form instead of the parent guardian signature lines used for the consent template in order to meet both the consent and HIPAA regulations.]
______
Signature of Parent / Guardian orDate (must be same as Subject’s)
Legally Authorized Representative of
Subject
Printed name of Parent / Guardian or
Legally Authorized Representative of
Subject
Describe relationship to subject including the legal authority this individual has to act on behalf of the subject. (Check one below)
Parent
Medical Power of attorney/representative
Legal guardian
Health care surrogate
Other; specify ______
______
______
[OPTIONAL --- If all subjects will be physically able to provide consent/authorization, the witness signature section is not needed for authorization. A witness’ signature is only required under HIPAA when the research subject is physically unable, for any reason, to sign the authorization document. The witness is attesting that the research subject is providing authorization in some manner other than signing the document. If you do not anticipate any subjects in this condition, then delete the witness lines. However, if a witness signature is required for the consent process for a different reason (i.e. witness to subject signing consent document, witness to consent process), there should be a statement above the signature line indicating what the witness is attesting to with their signature.]
Signature of WitnessDate (must be same as Subject’s)
Printed name of Witness
Describe why a witness signature is required and the relationship to the Subject.
______
______
______
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