IRB Protocol Number:

IRB Approval Date

Southwest Minnesota State University
Institutional Review Board
Informed Consent Statement

Title of Project:			[Insert Title of Study]

Principal Investigator:	[Insert Name, Title, Building/Office, Marshall, MN 56258, (area code) phone, email address]

Other Investigators:		[Insert Name(s), Title(s), Building/Office/Institution]

What is the reason for doing this study:
You are being asked to take part in this study because… [Explain the purpose of your study.] 
 
What you will do if you choose to be in this study:
As a subject in this study, you will be asked to come to… [Indicate location]

Your part in this study will last for [indicate time involvement] and will involve [indicate the expected duration of participation] visits.

As a subject in this study you will be asked to… [Explain study procedures in chronological order, and indicate whether any procedures/products are experimental (i.e. not FDA approved). If there are many procedures, please consider a table to summarize this information rather than paragraph form.]

What are some of the risks and discomforts that may happen to people who are in this study?
Taking part in this study involves… [Example: no physical risk to you beyond those experienced in everyday life…or…the following risks…or…procedures that may make you feel emotionally uncomfortable.] Southwest State Minnesota University is not responsible for recommending, providing or reimbursing participants for counseling and other mental health services as a result of your participation in this study.

Benefits    
[Example:  You will receive no direct benefit from participating in this study, but you may learn more about yourself by participating…or…The possible benefits to you include…or…You may help researchers better understand…]

Compensation [Example: You will receive no compensation for participating in this research…or…Upon successful completion of every part of this research, you will receive $10.00…or…You will receive 3 extra credit points for your SMSU 001 course.]

Extra Costs to Participate  [This section is not required unless this project involves costs to be covered by the subject, e.g. travel to and from test site, room and board, materials, etc.]

Injury or Illness [This section is not required unless this project involves more than minimal risk.]  Southwest Minnesota State University or its designees will not be responsible for providing medical treatment or financial compensation if you are injured or become ill as a result of participating in this research project. This does not waive any of your legal rights nor release any claim you might have based on gross negligence.

Confidentiality  The project's research records may be reviewed by [collaborating institutions, external funding agency, Food and Drug Administration (if FDA regulated), Office for Human Research Protections (if funded by Department of Health and Human Services or Federal Grants and by departments at Southwest Minnesota State University responsible for regulatory and research oversight.] The project’s research records are also governed by the Minnesota Data Practices Act, Minnesota Statutes Chapter 13.  Safeguards to ensure your confidentiality will include [insert statement regarding presentation of data in research and secure storage of data.]

Voluntary Nature of Participation
You do not have to participate in this research project.  If you agree to participate you can withdraw your participation at any time without penalty.     

Contact Information:
If you have any questions about this research project, you can contact [insert PI name and phone number plus any additional research personnel that participants may need to contact and their contact information.  If more than one person is listed, please indicate the first point of contact]. If you have concerns about the treatment of research participants, you can contact the Institutional Review Board at Southwest Minnesota State University by phone or email.  The phone number to call is (xxx) xxx-xxxx.  The email address is xxx@smsu.edu. Refer to the IRB Website for the chair’s number and phone number to insert here.

Documentation of Informed Consent
I have had the opportunity to read this consent form and to have the research study explained.  I have had the opportunity to ask questions about the research project and my questions have been answered.  I am prepared to participate in the research project described above.  I will receive a copy of this consent form after I sign it.  

__________________________________________                           _________________________
              Participant’s Signature                                                                                  Date
__________________________________________                          
              Participant’s Name
__________________________________________                          ___________________________
              Researcher’s Signature                                                                                  Date
__________________________________________                          
              Researcher’s Name

For subjects unable to give consent or for minors, permission to participate is given by the following authorized subject representative:

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              Authorized Representative’s Signature                                                      Date
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              Authorized Representative’s Name                                           parent, spouse, legal guardian