A Toolkit for Redesign in Health Care: Final Report: Form E. Patient/Family Focus Group Consent Form

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A Toolkit for Redesign in Health Care: Final Report

Form E. Patient/Family Focus Group Consent Form

Project Description

You (you equals you/your child) are being asked to take part in a research study of improving the way hospitals work and provide care to patients. You are being asked to be in this study because you or a family member was a patient in the hospital at ________________, where this study is taking place. You will be part of a group of ______ people. The other members of the group were also selected because they or their family member were in the hospital at _______________. Each member of the group will be asked about their and/or their family member's hospital experience. You will be asked for ways you think this experience could have been improved. You will also be asked about the parts of your hospital experience that you thought were good.

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

Procedures

If you agree to take part in this study, we will ask you to read and sign this consent form. You will also be asked to participate in a focus group that will take place at _____________ sometime during February 2004 through October 2004. This focus group will meet once, for 2-3 hours, to discuss your or your family's hospital experience at __________________.

Discomfortsand Risks

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

Benefits

This study is designed for the researcher to learn more about improving 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. You will be paid $_____ for your participation in this study. If you arrive late or leave the focus group session before it has been completed, you will not be paid for your participation.

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. The investigator may withdraw you from the study if your participation in the focus group is having a negative effect on the other participants of if you arrive to the focus group session late or leave the session early.

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 _________________. You will be given a copy of this form to keep.

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 in this study. I know I can stop being in this study and I will still get the usual medical care. I will get a copy of thisconsent form. (Initial all the previous pages of the consent form).