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Consent
Form
University of St. Thomas
[Insert Title of Study]
[Insert IRB log number when assigned]
I am conducting a study about [insert general statement about the study]. I invite you to participate in this research. You were selected as a possible participant because [explain how subject was identified]. Please read this form and ask any questions you may have before agreeing to be in the study.
This study is being conducted by: [Indicate name of researcher, student status and name of advisor, if applicable, Department affiliation].
Background Information:
The purpose of this study is: [Explain research question and purpose in clear, lay language. You may also wish to explain the benefits of this research to people other than the subject]
Procedures:
If you agree to be in this study, I will ask you to do the following things: [Explain all tasks and procedures; subjects should be told about assignment to study groups, length of time for participation, frequency of procedures, audio taping, etc.]
Risks and Benefits of Being in the Study:
The study has several risks. First [], Second, [] [Risk must be explained, including the likelihood of the risk and provisions made to minimize the risk.]
The direct benefits you for participating are: [If no benefit, state that fact here. Explain only direct benefits to the subject]
You will receive payment: [] [Include payment or reimbursement information here. If subjects receive class points or some other token, include that information here. Explain when disbursement will occur and conditions of payment.]
Compensation:
[If there is a physically invasive procedure, or an exercise component of this research, where there is even a slight risk of injury the following statement must be included in the consent form.]
In the event that this research activity results in an injury, treatment will be available, including first aid, emergency treatment and follow-up care as needed. Payment for any such treatment must be provided by you or your third party payor if any (such as health insurance, Medicare, etc.).
[Omit this section if there is no risk involved in the study objective.]
Confidentiality:
The records of this study will be kept confidential [or anonymous]. In any sort of report I publish, I will not include information that will make it possible to identify you in any way. Research records will be kept in a locked file [where?] ; I am the only person who [state if anyone else] will have access to the records. [Explain if data will be used for educational purposes, and when data will be destroyed.] [Explain other steps to keep data confidential, such as storing the data in a separate place from any lists of names of subjects].
Voluntary Nature of the Study:
Your participation in this study is entirely voluntary. Your decision whether or not to participate will not affect your current or future relations with any cooperating institutions or the University of St. Thomas. If you decide to participate, you are free to withdraw at any time without penalty. Should you decide to withdraw, data collected about you [state whether or not you will use their data]
Contacts and Questions
My name is [insert researcher’s name]. You may ask any questions you have now. If you have questions later, you may contact me at [telephone number]. [If the researcher is a student, include advisor’s name and telephone number here.] You may also contact the University of St. Thomas Institutional Review Board at 651-962-4869 with any questions or concerns.
You will be given a copy of this form to keep for your records.
Statement of Consent:
I have read the above information. My questions have been answered to my satisfaction. I consent to participate in the study. [include any additional permission here (eg., audiotaping).]
______________________________ _________________
Signature of Study Participant Date
______________________________ _________________
Signature of Parent or Guardian Date
(If applicable)
______________________________ _________________
Signature of Researcher Date