Surgical Research Study Participation Agreement

Study Information

Study Title: [Insert Study Title] Principal Investigator: [Insert Name], MD Institution: [Insert Institution Name] IRB Protocol Number: [Insert Number]

Purpose and Procedures

I, [Patient Name], understand that I am being asked to participate in a research study involving surgical procedures. I acknowledge that:

• The purpose of this study is to [Insert Study Purpose]
• The study will involve [Insert Procedure Details]
• My participation will last approximately [Insert Duration]
• I will need to attend [Insert Number] follow-up visits

Risks and Benefits

Potential Risks:

• Standard surgical risks including infection, bleeding, and anesthesia-related complications
• Study-specific risks: [List Study-Specific Risks]
• Additional procedures that may be necessary

Potential Benefits:

• [List Potential Direct Benefits]
• Contribution to medical knowledge
• [Other Benefits]

Financial Considerations

• Study-related costs covered: [List Covered Items]
• Patient responsibility: [List Patient Financial Responsibilities]
• Compensation (if any): [Insert Details]

Confidentiality

I understand that:

• My medical information will be kept confidential
• Data will be de-identified for research purposes
• Access to my information is restricted to authorized study personnel

Voluntary Participation

I acknowledge that:

• My participation is entirely voluntary
• I may withdraw at any time without affecting my medical care
• I will receive a copy of this signed agreement

Signatures

Patient Name: _________________ Signature: ____________________ Date: ________________________

Investigator Name: _____________ Signature: ____________________ Date: ________________________

Witness Name: ________________ Signature: ____________________ Date: ________________________