Study Title:
Subject Informed Consent Document
TITLE OF RESEARCH STUDY
NOTE: Use the Instruction Sheet for each section as it contains required language that may not be located within this template. Delete all red instructions before submitting this to the IRB.
Sponsor assigned number:
Grant assigned number:
Industry Contracts number:
Sponsor(s) name & address:
Investigator(s) name & address:
Site(s) where study is to be conducted:
Phone number for subjects to call for questions:
Introduction and Background Information
You are invited to participate in a research study. The study is being conducted by(principal investigator/faculty member and degree)and(name and degree/role, e.g., student, community agency). The study is sponsored by (list if the study is sponsored by an outside source) and the University of Louisville, Department of (give department name). The study will take place at (name of sites where study will be conducted). Approximately(give local number) subjects will be invited to participate.
Purpose
The purpose of this study is to(include a brief description of the scientific or scholarly purpose of the study. This description should be in lay terms, written so subjects reading at the Middle School level could understand the terms.
Procedures
In this study, you will be asked to(List the name and purpose of any questionnaires, surveys or other instruments the subject will be asked to complete. Include information in this paragraph about how long it should take the subject to complete the questionnaires or other procedures. Include total study length and session length. Include a statement that the subject may decline to answer any questions that may make them uncomfortable.)
Potential Risks
There are risks associated with(study procedure). The /Those risk(s) is/are (Describe any risk(s) that may occur in the study. Possible risks to subjects you may address are: physical, psychological, social, economic, and/or legal risks if they are a part of the research). There may be unforeseen risks. If there are no foreseeable risks, say“There are no foreseeable risks other than possible discomfort in answering personal questions.” <OR> If there are no foreseeable risks at all say"There are no foreseeable risks, although there may be unforeseen risks".
Benefits
The possible benefits of this study include (list any possible benefits for the subject or for humankind). The information collected may not benefit you directly. The information learned in this study may be helpful to others.
Payment
You will not be compensated for your time, inconvenience, or expenses while you are in this study.
<OR> (If the sentence above applies, remove the paragraph below. If below applies, remove sentence above.)
You will be paid by prepaid card (If another method of payment must be used it must be approved by the Controller’s Office (852-6273)for your time, inconvenience, or expenses while you are in this study. (If subjects will be compensated, state how much. Explain how payments to study subjects are pro-rated and distributed equally, if appropriate, or distributed according to time commitment and potential discomfort for each visit.) (The following sentences must be in the consent if subjects are paid.) Because you will be paid to be in this study the [University of Louisville and/or the sponsor (select the appropriate one or both if both will pay)] may collect your name, address, social security number, and keep records of how much you are paid. You may or may not be sent a Form 1099 by the University. This will only happen if you are paid $600 or more in one year by the University. This will not include payments you may receive as reimbursement, for example mileage reimbursement. We are required by the Internal Revenue Service to collect this information and you may need to report the payment as income on your taxes. You can still be in the study even if you don’t want to be paid.
Confidentiality
Total privacy cannot be guaranteed. We will protect your privacy to the extent permitted by law. If the results from this study are published, your name will not be made public. Once your information leaves our institution, we cannot promise that others will keep it private.
Your information may be shared with the following:
•The sponsor (name the sponsor) and others hired by the sponsor to oversee the research
•Organizations that provide funding at any time for the conduct of the research.
•The University of Louisville Institutional Review Board, Human Subjects Protection Program Office, Privacy Office, others involved in research administration and compliance at the University, and others contracted by the University for ensuring human subjects safety or research compliance
•The local research team
•Researchers at other sites participating in the study (if applicable)
•People who are responsible for research, compliance and HIPAA oversight at the institutions where the research is conducted
•People responsible for billing, sending and receiving payments related to your participation in the study
•Government agencies, such as:
- Office for Human Research Protections
- Office of Civil Rights
•Others (please specify)
OR:Your identity as a subject in this study and the information you provide may be released and published(only to be used if the subject agrees that the information may be made public).
Conflict of Interest
This study involves a conflict of interest because (Select one of the following three options. Delete the remaining options and instructions prior to submission.)(1) the institution, (2) the investigator or (3) the institution and investigator) will be compensated for your participation in it. Please ask the investigator how (Select one of the following three options. Delete the remaining options and instructions prior to submission.This selection should agree with your previous choice.)(1) the institution, (2) the investigator or (3) the institution and investigator will benefit by your participation in the study.
Security
Your information will be kept private by
Describe what methods will be used to ensure that the data collected is secured (e.g., locked in a file cabinet, kept in a secured area, or kept in a password protected computer).
Voluntary Participation
Taking part in this study is voluntary. You may choose not to take part at all. If you decide to be in this study you may stop taking part at any time. If you decide not to be in this study or if you stop taking part at any time, you will not lose any benefits for which you may qualify.
You will be told about any changes that may affect your decision to continue in the study. (if appropriate)
U.S. Department of Education (DOE) Funded Studies(The following is required for all studies conducted in a public school system-you may delete this entire section if research isn’t conducted in the public school system.)
Because this study is funded by the U.S. DOE or this school system receives funding from the DOE, we are required to tell you the following information.
In addition to the surveys or questions we may ask you and your child to complete or answer, we want to collect the following information about your child from your child’s school records: [list information to be collected from records] [add this sentence if you are obtaining information from a child’s records held by the school system and delete these instructions. If no information is obtained from school records, delete the entire sentence and the instructions]
The information we collect from the education or study records of you or your child may only be used to meet the purposes of the study as stated in this consent. We will conduct this study in a manner that does not allow identification of you or your child by anyone other than study team members or others who may have a legitimate reason to know. All instructional materials or survey instruments used for the research, including teachers' manuals, films, tapes, or other supplementary instructional material used in connection with this study, are available for you to see before the study begins if you ask to see it. If you want to see any of this information, please contact [name of contact, phone number] and they will give you a date and time where it will be available for you to review. Once we have completed this study, we are required by the U.S. Department of Education to destroy or return to the school system all personally identifiable information when no longer needed for the purposes of the study. We expect this study to last for [time period] and we will destroy or return the information to the school system by [date-ensure that you give yourself adequate time to finish the data collection and de-identify the data. If you must maintain identified data to complete your analysis, you date estimate should be adequate to all for the analysis of this data.]
Contact Persons
If you have any questions, concerns, or complaints about the research study, please contact
Research Subject’s Rights
If you have any questions about your rights as a research subject, you may call the Human Subjects Protection Program Office at (502) 852-5188. You may discuss any questions about your rights as a research subject, in private, with a member of the Institutional Review Board (IRB). You may also call this number if you have other questions about the research, and you cannot reach the study doctor, or want to talk to someone else. The IRB is an independent committee made up of people from the University community, staff of the institutions, as well as people from the community not connected with these institutions. The IRB has approved the participation of human subjects in this research study.
Concerns and Complaints
If you have concerns or complaints about the research or research staff and you do not wish to give your name, you may call the toll free number 1-877-852-1167. This is a 24 hour hot line answered by people who do not work at the University of Louisville.
Acknowledgment and Signatures
This informed consent document is not a contract. This document tells you what will happen during the study if you choose to take part. Your signature indicates that this study has been explained to you, that your questions have been answered, and that you agree to take part in the study. You are not giving up any legal rights to which you are entitled by signing this informed consent document. You will be given a copy of this consent form to keep for your records.
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Subject Name (Please Print)Signature of Subject Date Signed
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Printed Name of Legally Signature of Legally Date Signed
Authorized Representative (if applicable) Authorized Representative
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Authority of Legally Authorized Representative to act on behalf of Subject
*Authority to act on behalf of another includes, but is not limited to parent, guardian, or durable power of attorney for health care.
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Printed Name of PersonExplaining Consent FormSignature of Person Explaining Date Signed
Consent Form (if other than the Investigator)
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Printed Name of InvestigatorSignature of InvestigatorDate Signed
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List of Investigators:Phone Numbers:
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