Project Description

You (you equals you/your child) are being asked to take part in a research study that is looking at ways to improve the way hospitals work and provide care to patients. You are being asked to be in this study because you are a patient at ________________, where this study is taking place.  You will be observed for the duration of your hospitalization.We will write down where you go in the hospital and how long you stay there.We will also write down who gives you medical care and what they do to you.

Up to _____ local subjects will be enrolled in this research study.

Procedures

If you agree to take part in this study, your care will not be changed in any way.We will ask you to only read and sign this consent form.  From this point on, we will observe your movements throughout the hospital until you are discharged and not ask anything else of you.The information collected that could identify you as a patient will be kept in our records until October 2004. Patients have been selected to participate in this study if they are admitted to the hospital or visit the emergency room at _____________ from ________ through ________ 2004.

Discomforts and Risks

The study may include risks that are unknown at this time.

Benefits

This study is designed for the researcher to learn more about ways to improve hospital care.  This study is not designed to treat any illness or to improve your health. 

Study Sponsor

The sponsor for this study is the _________________________________________________________.

Cost to Subject

There is no cost to you for participating in this study. There are no procedures or drugs required by the study. All of the costs associated with your hospital stay will be billed to you or your insurance, just as they would without participation in this study. You will not be paid for participation in this study.

Voluntary Participation and Study Withdrawal

Taking part in this study is voluntary.You have the right to choose not to take part in this study.  If you do not take part in the study, your doctor will still take care of you.You will not lose any benefits or medical care to which you are entitled.If you choose to take part, you have the right to stop at any time.  If there are any new findings during the study that may affect whether you want to continue to take part, you will be told about them.The study doctor may decide to stop your participation without your permission, if he or she thinks that being in the study may cause you harm, or for any other reason.  Also the sponsor may stop the study at any time.

Invitation for Questions

The researcher carrying out this study is __________________. You may ask any questions you have now. If you have questions later, you may call ____________ at  (___)___-____. You will be given a copy of this form to keep.

If you have questions regarding your rights as a research subject, please call the Institutional Review Board office at (___)___-____.

Confidentiality

We will try to keep your research records confidential, but it cannot be guaranteed.  Records that identify you (including your medical records) and the consent form signed by you, may be looked at by the following people:

• Federal agencies that oversee human subject research.
• Institutional Review Board.
• The investigator and research team for this study.
• The sponsor or an agent for the sponsor.
• Regulatory officials from the institution where the research is being conducted, to ensure compliance with policies or monitor the safety of the study.

The results of this research may be presented at meetings or in published articles.However, your name will be kept private. You will also be asked to sign a separate authorization form. This form will explain who will have access to your protected health information.

Injury and Compensation

You should inform your care provider(s) if you decide to participate in this research study. If you have questions about injury related to the research, you may call ______________ at (___)___-____ and/or your private physician. ________________ should be informed about any injury you experience while you take part in this study.  If you are hurt by this research, we will provide medical care if you want it, but you will have to pay for the care that is needed.

AUTHORIZATION:

I have read this paper about the study or it was read to me. I understand the possible risk and benefits of this study.I know that being in this study is voluntary.I choose to be (or to have my child) in this study.  I know I can stop being in this study and I (my child) will still get the usual medical care.I will get a copy of this consent form. Initial all the previous pages of consent form.

Signature: ________________________________________________________ 

Print Name (subject) ____________________  Date ___________

Signature: ________________________________________________________ 

Print Name (legally authorized rep./proxy) ____________________  Date ___________

Consent form explained by: __________________________________________ 

Print Name _________________  Date ___________

Investigator ______________________________ Date ______________