Healthcare Studies Form

HEALTHCARE STUDIES FORM

Study Title:    Protocol ID:

Principal Investigator:    Study Site:

Patient Information

Insurance Information

Medical History

Tobacco use:    Alcohol use:

Study Description and Consent Information

I have been provided a description of the investigational procedures, purpose, expected duration, and the approximate number and frequency of visits associated with participation in this study. The study procedures include:

I understand the reasonably foreseeable risks, discomforts, and possible adverse events associated with participation, as well as the reasonably expected benefits, if any. I understand that not all risks can be anticipated and that I should report any new or worsening symptoms to the research team.

Participation is voluntary. I may withdraw from the study at any time without penalty, and without loss of benefits to which I am otherwise entitled. My decision to withdraw will not affect my ability to receive medical care at this facility except where procedures require continued monitoring.

By initialing the boxes below I acknowledge receipt and understanding of these core elements:

I acknowledge that I received and understand the study information, including risks and potential benefits.

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

I have been informed of alternative procedures or courses of treatment that may be available to me.

Use and Disclosure of Health Information (HIPAA Authorization)

I authorize the release of my protected health information (PHI) necessary for the purposes of this study to the sponsor, regulatory authorities, and their designees. PHI that may be disclosed includes medical history, laboratory results, and study-related assessments.

This authorization permits use and disclosure of my PHI for research, oversight, auditing, and regulatory compliance. I understand that once my PHI is disclosed to entities outside the study team, it may no longer be protected by privacy rules and could be subject to re-disclosure.

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

I understand I may revoke this authorization in writing at any time by delivering a signed, dated written statement to the research team, except to the extent that action has already been taken in reliance on this authorization.

Compensation, Costs, and Injury

I have been informed about any compensation or remuneration for participation, and any anticipated costs for tests, procedures, or treatment related to study participation. I understand the procedures for reporting research-related injury and the contact information provided for questions about injury or compensation.

Certification and Consent

By signing below, I certify that I am the patient named on this form or the legally authorized representative of the patient. I have read (or had read to me) the information provided in this form, my questions have been answered to my satisfaction, and I voluntarily agree to participate in this study and to the release and use of my health information as described above.

I further certify that I have been given a copy of this signed form for my records.

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