Healthcare Research Study Consent Form

Healthcare Research Study Consent Form

Study Identification

Study Title:

Participant Information

Date of Birth:     Gender:

Phone:     Email:

Emergency Contact

Relationship:     Phone:

Insurance Information (If applicable)

Policy Number:     Group Number:

Medical History

Study Procedure, Risks and Benefits

Purpose: The purpose of this research study is to collect clinical and/or behavioral data to evaluate the safety and effectiveness of the described intervention. The principal investigator will explain the specific aims verbally and in writing.

Procedures: Participation involves the following procedures: clinical assessments, collection of biological samples, study-specific imaging or monitoring, questionnaires, and follow-up visits as described in the study protocol. The estimated total time commitment is described in the study materials provided to you.

Risks: Participation may involve risks including, but not limited to, physical discomfort, allergic reaction, breach of confidentiality, psychological distress, and other risks described in the study information sheet. Unforeseen risks may occur.

Potential Benefits: You may receive no direct medical benefit from participation. Information gained may contribute to scientific knowledge and may benefit future patients.

Alternatives, Compensation, and Costs

Alternatives: Participation is voluntary. You may choose not to participate or to withdraw at any time. Your decision will not affect your access to standard medical care or your relationship with the treating clinicians.

Confidentiality and HIPAA Authorization

Confidentiality: Reasonable efforts will be made to keep your records confidential. Study data will be stored in secure systems and access limited to authorized study personnel. Identifiable information may be removed and replaced with a code for data analysis.

HIPAA Authorization: I authorize the use and disclosure of my protected health information (PHI) as necessary for this research study and related monitoring, auditing, regulatory compliance, and publication in de-identified form.

I authorize the use and disclosure of PHI for the purposes described above.

Expiration: This authorization will expire on:    or upon completion of the study procedures, whichever occurs first.

Participant Affirmations

By checking the following boxes and signing below, I affirm that I have read and understand the information provided, had the opportunity to ask questions, and that these questions were answered to my satisfaction.

I understand the purpose and procedures of the study.

I understand the risks and possible discomforts.

I understand that participation is voluntary and I may withdraw at any time without penalty.

Questions and Contacts

If you have questions about the study, contact the principal investigator:

Phone:     Email:

Consent and Authorization

I have read (or someone has read to me) the information in this form. I have been given the opportunity to ask questions and all questions have been answered to my satisfaction. I voluntarily agree to participate in this research study and authorize the use of my health information as described above.

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