Informed Consent for Biomedical Device Trials

Study Title:

Principal Investigator:

Institution:

Contact Information:


Introduction

Purpose of the Study

Description of the Biomedical Device

Procedures

Potential Risks and Discomforts

Potential Benefits

Alternatives to Participation

Confidentiality

Voluntary Participation and Withdrawal

Compensation and Costs

Contact for Questions

Consent Statement

I have read and understood the information above. I have had the opportunity to ask questions and have received satisfactory answers. I voluntarily agree to participate in this study.

Participant Name:



Participant Signature:



Date:



Investigator/Person Obtaining Consent:



Date: