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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, name of advisor, if applicable, Department affiliation].
Background Information:
The purpose of this study is: [Insert text from questions 9a and 9c from the IRB application here. 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: [Insert text from question 8e from the IRB application here. Be sure to state specifically what the subjects will be doing, including the they will be performing any tasks. If not included in question 9e, 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, [] [Insert text from questions 13a and 13b from the IRB application here. Be sure to include the likelihood of the risk and provisions made to minimize the risk.]
The direct benefits you will receive for participating are: [Insert text from question 13d here. Explain only direct benefits to the subject]
Compensation:
You will receive payment: [] [Insert text from question 11d from the IRB application here. Explain when disbursement will occur and conditions of payment. Omit this section if neither payment nor cost is involved.]
[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 payer 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. In any sort of report I publish, I will not include information that will make it possible to identify you in any way. The types of records I will create include [List each type of record they have (recordings, transcripts, master list, computer records) and explain what will happen to each item (where it will be stored, who will have access, when it will be destroyed). If tape recordings or videotapes are made, explain who will have access, and when they will be erased. Use text from question 12 from the IRB application as applicable.]
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 agencies or institutions] or the University of St. Thomas. If you decide to participate, you are free to withdraw at any time up to and until [state a specific date or time in the study]. Should you decide to withdraw data collected about you [state whether or not you will use their data. You are also free to skip any questions I may ask [state if and where there are any exceptions to this rule and include a rationale for these exceptions in your IRB application (question 9e)].
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 651-962-5341 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. I am at least 18 years of age. [If additional permissions are needed (e.g. audio or video recording, accessing private student or medical records), include these here.]
______________________________ ________________
Signature of Study Participant Date
______________________________________
Print Name of Study Participant
______________________________ ________________
Signature of Parent or Guardian Date
(If applicable)
______________________________ ________________
Signature of Researcher Date