CONSENT TO PARTICIPATE IN A RESEARCH STUDY

HIC # 10807

 

What is an Informed Consent?

 

You are being asked to take part in a clinical research study.  Before you can make an informed decision whether to participate, you should understand the possible risks and benefits associated with this study.  This process is known as informed consent.  This consent form will provide you with the information about this study and your rights so that you can make an informed decision.  No guarantees or assurances can be made regarding the results of this study. 

 

This consent form may contain words or information you do not understand. Dr. Scott Strayer or Marit Kington, the research study coordinator, who is familiar with the study, will explain anything that you do not clearly understand.  Please ask as many questions as you need to make sure that you understand this study and why you are being asked to participate. 

 

Introduction

 

We invite you to participate in a study of handheld computer usage. The purpose of this study is to gather information about how residents and physicians use their handheld computers on a weekly basis.  Up to 212 participants will be enrolled in this study at UVA, as well as other locations in the region. You are being asked to participate in this study because we are interested in knowing about your handheld computer use and the types of activities for which it is used.  Even if you do not use a handheld computer, we are still interested in your responses and opinions regarding handheld computers.

 

Exclusions

 

All persons receiving an invitation are asked to participate in the survey.  Your participation is entirely voluntary.

 

Investigational Procedures

 

If you choose to participate in this study, you will be asked to respond to a few short questions about your handheld computer use.  The survey containing these questions is entirely internet-based, meaning that you will receive an email invitation with a link that will direct you to the survey web site.  Once you submit your answers to the survey, they will not be available for you to change.  You will not be able to access or view the answers to your survey once you submit them.  The survey should only take 10 minutes of your time. Once you have finished responding to the questions the survey will be over.

 

Risks

 

Research studies often involve some risks.  There are risks of this study that are minimal and we do not anticipate any risks to you.  Your responses will be kept confidential and only available to the study investigators.  In addition, it is possible in any experiment that side effects, which are not now known, could occur.  Precautions will be taken to prevent harmful side effects. You should contact Dr. Scott Strayer or Marit Kington if you think you are having side effects related to the study.

 

Benefits

 

There is no benefit to you for participating in this study.

 

Alternatives to Participating in This Study

 

The only alternative is not to participate.

 

Privacy of Records

 

Any survey information and study materials including the consent form you sign may be inspected by the investigator of this study, and his/her research staff in order to conduct this study. These individuals, or UVA on their behalf, may also release your study information, this consent form and the information about you created by this study to individuals and agencies responsible for the oversight of this study. Other persons who would have access to the study records include federal, state and local agencies having oversight over this research, for example, the United States Department of Health and Human Services; and the University of Virginia Human Investigation Committee (HIC) members or designates.  The HIC is a special committee at the University of Virginia that reviews all medical research studies involving human participants. This release is required so they may check to see if this study is being properly performed.   If you electronically agree to this form, you have given us permission to release study information to these other people.  There is no expiration date to this permission.  Because of the need to release information to these parties, absolute confidentiality cannot be guaranteed.  There is the potential that the information released to The National Cancer Institute or a governmental agency may be released again and would no longer be protected by privacy laws. The results of this research may be presented at meetings or in publications; however, your identity will not be disclosed.

 

If you do decide to withdraw from the study and end this agreement, please notify Dr. Scott Strayer through email, or in writing to The University of Virginia Health System, Department of Family Medicine, PO Box 800729, Charlottesville, VA 22908-0729.  Please note that any information already obtained will continue to be used.  No additional withdrawal procedures are necessary.

 

Payment

 

You will receive no payment for participating in this study.

 

Financial Costs of the Research

 

There are no financial costs to you for participating in this research study.

 

Compensation in Case of Injury

 

In the event you suffer injury directly resulting from the research, no financial compensation for lost wages, disability, or discomfort is available.  Treatment for an injury directly resulting from the research procedure that is not covered by your insurance will be provided free of charge at the University of Virginia.  If you have any questions concerning financial compensation for injuries caused by the experiment, you should talk to. Dr. Scott Strayer at (434) 982-3294.  You do not waive any liability rights for personal injury by signing this form.

 

Right to Refuse to Participate or to Withdraw Early From the Study

 

Participation in this study is entirely voluntary. The University of Virginia cannot require you to participate in this study and sign this authorization in order for you to receive health care, except for the treatment directly related to this research study. You may choose not to participate or you may enter the study and withdraw at any time.  There is no penalty for withdrawing.  Neither your decision to participate in this study nor your decision to stop and withdraw from the study after you have decided to participate will affect your health care in any other way. Of course, we will tell you anything we learn during the study that may help you decide whether to continue participating, or that is important to your overall health. 

 

You may be withdrawn from the study without your permission at any time by the investigator conducting this study.  Some situations in which this might occur are if you do not follow the instructions given to you or if the investigator feels your safety is at risk if you continue in the study.

Contact Information

 

If you have any questions about this study, please ask Marit Kington at (434) 982-1756 or Dr. Scott Strayer at (434) 982-3294.

 

If you have any questions regarding research participants' rights, please contact the Human Investigation Committee staff at the University of Virginia, at (434) 924-2620.

 

Conclusion

 

I HAVE READ, OR HAD READ TO ME, THE ABOVE INFORMATION BEFORE ELECTRONICALLY AGREEING TO THIS CONSENT FORM.