The University of Michigan Health System (UMHS), Ann Arbor, Michigan  
INFORMED CONSENT OF A SUBJECT 
PARTICIPATING IN A RESEARCH STUDY
(Version April 1998)

1.  GENERAL INFORMATION
The Institutional Review Board for Human Subject Research at the University of Michigan Medical School (IRBMED) reviewed this research project from the standpoint of the protection of human research subjects.  The IRBMED found the project to be in compliance with the regulations of the United States Government and of the University of Michigan.  

1.1	This version of the consent document was prepared on:  
1999/09/16
1.2	This version of the consent document was approved by the IRBMED on:  
1999/09/23
1.3	This project’s approval by the IRBMED will expire on: 
2000/09/23
1.4	The archive number assigned by the IRBMED to this project is:  
1999-476  
1.5	Names of the investigators responsible for this project: 
Milton P. Huang, MD
Norman E. Alessi, MD
Klaus-Peter Beier, Dr.-Ing.
1.6	The title of this research project is:
Estimating height in a virtual building
1.7	The protocol number assigned to this study is:  
Enter any identifier codes, particularly those implemented by industry sponsors.  
1.8	This research is funded by:  
Department of Psychiatry
2.  INFORMATION ON THE RESEARCH STUDY  
2.1	What is the purpose of this research study?  
This research project seeks to determine different personality traits that affect how a person judges height in a virtual environment.  We hope to get height estimates from a variety of people with different personality characteristics and see if particular personality types have a tendency to judge height incorrectly.  We hope that this may teach us something about how people with these personality characteristics react when “reality” is changed in virtual reality, which in turn may help us understand who changes the most when faced with virtual reality based treatments for psychological difficulties.
2.2	Who can take part in this study?  
Anyone who can see a projected image can participate in this experiment.  We will be recruiting different student classes, aiming for a total of eighty participants, although we will include anyone who is interested.
2.3	Why should I consider joining this study as a research subject?
This experiment will help us learn something about how different people react to virtual reality.  It will give you an opportunity to experience virtual reality and learn about how you react to it.  It will also give you some information about your own personality characteristics.
2.4	Do I have to become a subject in this study?  If I joined the study, can I change my mind and drop out before it ends?  
Your becoming a subject in this study is entirely by your own free choice.  You may also drop out of the study by your own free will, after having agreed to become a subject.  You may refuse to enroll in the study, or drop out of the study at any time without any penalty; by doing so, you will not lose any benefits that you may be entitled to.
2.5	What exactly will be done to me, and what kinds of treatments or procedures will I receive, if I agree to be a research subject in this study?
You will first answer a questionnaire that will assess various personality characteristics we are interested in including how much you avoid heights or how you visualize.  You will then enter a CAVE virtual environment, which involves putting on a pair of 3D-glasses.  In the environment, we will take you to different floors of a virtual building and have you estimate your apparent height above the ground.  We will also have you estimate apparent height from platforms suspended above the ground.  After this procedure, we will have you fill out another questionnaire about your experience.
2.6	What kinds of harm can I experience in this study, and what will the investigators do to reduce the chances of harm?  
•	If you have a fear of heights, this procedure may make you anxious or uncomfortable.  The full procedure will involve less than one minute of looking down, and you will be able to stop at any time.  Just like watching a movie may be frightening, you should be able to stop and suffer few ongoing effects.
•	If you have a tendency to suffer motion sickness, you may experience this as part of using the virtual environment. You will not have to actually experience any apparent motion during our experiment, which will reduce this likelihood.  You can also close your eyes or stop at any time you wish.
2.7	What will the investigators do to make sure that the information they will collect on me will not get in wrong hands?  
We shall put the information collected about you during the study into a research record.  This research record will not show your name, but will have codes entered in it, that will allow the information to be linked to you.  However, we shall keep your research record confidential, to the extent provided by federal, state and local law.  We shall not allow anyone to see your record, other than people who have a right to see it.  You will not be identified in any reports on this study.
2.8	What kinds of benefit can I expect personally from taking part in this study?
Many people find a virtual reality experience to be interesting and engaging.  You will learn something about how you react to a virtual environment.  You may also learn something about some of your own personality characteristics.
2.9	What kinds of benefit to others can come out of this study? 
This research should provide information about how different people with different personality characteristics respond to virtual environments.  Since we immerse people in virtual environments for educational, instructional, and therapeutic purposes, this information may help design more effective virtual environments as well as select people who will benefit more from virtual training than other traditional methods.
2.10	What will the investigators do, if I get injured in the study?  
If you experience any discomfort or injury that may be related to the study, please contact Dr. Milton P. Huang, MD.  1500 E. Medical Center Dr. Box 0390, Ann Arbor, MI, 48109-0390; telephone 734-936-8707.  Should you get physically injured as a result of research-related treatments or procedures, the University of Michigan will provide first-aid medical treatment.  Additional medical treatment will be provided, if the University determines that it is responsible to provide such treatment.  However, the University does not provide compensation to a person injured while taking part as a subject in research.  We will not be providing continued psychiatric treatment for anxiety generated by this study as we expect such effects to be short term and no greater than that which is experienced in daily activities such as watching a movie or television.
2.11	Will I get paid for taking part in this study?  
No
2.12	Will I or my health insurance company be charged for any of the costs of this study?  
This study is being funded by the University of Michigan Department of Psychiatry.  There should be no financial burden for you or for your health insurance carrier.  
2.13	Once I start in this study as a subject, what do I do if I want to find out more about the study, or to complain about the way I get treated? 
If new information is obtained during the course of this research, which may indicate that the risks of harm to subjects have increased significantly, the investigators will let you know, so that you may reconsider your willingness to stay as a subject in the study.  To find out more about any aspect of this study, including your rights as a subject, you may contact the persons whose names, addresses and telephone numbers appear below: 
Dr. Milton Huang.  1500 E. Medical Center Dr. Box 0390, Ann Arbor, MI, 48109-0390;  telephone 734-763-2015
If you have any questions or concerns about your rights as a research subject, or any grievance, you may also contact the Office of Patient-Staff Relations, L5003 Women’s Hospital, University of Michigan Medical Center, Ann Arbor, Michigan 48109-0275; telephone 734 763 5456.

2.14	If I decide not to become a subject in this study, what may happen to me, or what other choices do I have if I need treatment? 
There should be no negative consequences from non-participation.  If a subject does request treatment for anxiety problems, we will facilitate referrals to the University of Michigan Anxiety Disorders Clinic.

3.  DOCUMENTATION OF CONSENT
3.1	Who gets to keep this document, once I sign it?  
One copy of this document will be kept together with the investigators’ research records on this study.  A second copy will be given to the subject to keep.  
3.2	Research subject’s statement of consent to participate in this study  
I have read the information given above.  The investigators personally discussed with me and told me more about the study, and answered my questions.  I understand the meaning of this information.  I am aware that, like in any research, the investigators cannot always predict what may happen or possibly go wrong.  I have been given sufficient time to consider if I should join this study.  I hereby consent by my own free choice to take part in the study as a research subject.
3.3	Research subject’s identity, and the identity and dated signatures of the subject and/or legal representative of the subject, affirming that consent was given  
The information shown below identifying the subject should be entered in the designated spaces at the time of execution of the consent document.  
Subject’s Name:		
Subject’s Birth Date:		
Subject’s student ID number:		

Consenting Signature of the Subject:  		Date:  		
3.4	Investigators’ confirming statement  
I have given this research subject information on the study, which in my opinion is accurate and sufficient for the subject to understand fully the nature, risks and benefits of the study, and the rights of a research subject.  There has been no coercion or undue influence.  I have witnessed the signing of this document by the subject.  

Investigator’s Name:		

Investigator’s Signature:			Date:		

	Investigator copy. IRB 1999-476, version 9/23/1999

3.  DOCUMENTATION OF CONSENT
3.1	Who gets to keep this document, once I sign it?  
One copy of this document will be kept together with the investigators’ research records on this study.  A second copy will be given to the subject to keep.  
3.2	Research subject’s statement of consent to participate in this study  
I have read the information given above.  The investigators personally discussed with me and told me more about the study, and answered my questions.  I understand the meaning of this information.  I am aware that, like in any research, the investigators cannot always predict what may happen or possibly go wrong.  I have been given sufficient time to consider if I should join this study.  I hereby consent by my own free choice to take part in the study as a research subject.
3.3	Research subject’s identity, and the identity and dated signatures of the subject and/or legal representative of the subject, affirming that consent was given  
The information shown below identifying the subject should be entered in the designated spaces at the time of execution of the consent document.  
Subject’s Name:		
Subject’s Birth Date:		
Subject’s student ID number:		

Consenting Signature of the Subject:  		Date:  		
3.4	Investigators’ confirming statement  
I have given this research subject information on the study, which in my opinion is accurate and sufficient for the subject to understand fully the nature, risks and benefits of the study, and the rights of a research subject.  There has been no coercion or undue influence.  I have witnessed the signing of this document by the subject.  

Investigator’s Name:		

Investigator’s Signature:			Date: