Healthcare Study Release Form

HEALTHCARE STUDY RELEASE FORM

This Healthcare Study Release Form documents the voluntary agreement of the Participant to participate in the research study described below, and authorizes the release and use of specified protected health information and related materials by the named healthcare providers and study personnel. By signing this form the Participant acknowledges having received information about the study, the risks and benefits, and the privacy protections described herein, and agrees to the release provisions subject to the limitations stated.

Participant Information

Date of Birth:     Gender:

Insurance Information

Medical History (Relevant)

Study Information

Study Title:

Principal Investigator:

Expected Start Date:     Expected End Date:

Risks, Benefits, and Alternatives

The Participant has been informed of the reasonably foreseeable risks, discomforts, and possible adverse events associated with participation in this study, which may include clinical risks specific to the procedures described above. The Participant has been informed of potential benefits, if any, and that direct medical benefit is not guaranteed. Alternatives to participation, including standard care options, have been explained.

I acknowledge that the risks and benefits have been explained to me and that I have had the opportunity to ask questions: I acknowledge

Authorization to Release Protected Health Information

I authorize the release of my protected health information (PHI) and other study-related materials as indicated below to the Principal Investigator, study staff, sponsor representatives, and regulatory authorities for purposes of conducting the study, data analysis, monitoring, and regulatory compliance. This authorization includes information created before, on, and after the date of this authorization unless limited below.

Types of information to be released (check all that apply):

Medical records and clinic notes    Laboratory results    Imaging and radiology reports

Pathology reports    Genetic test results    Audio/video recordings and photographs

De-identified data for future research or secondary analysis    Permission to re-contact me for follow-up or future studies

I understand that information released pursuant to this authorization may be subject to re-disclosure by the recipient and may no longer be protected by privacy laws. I authorize re-disclosure for research, regulatory, or publication purposes provided identifiers are removed when required.

Privacy, Confidentiality, and HIPAA Acknowledgment

Study records that include my personal health information will be kept confidential to the extent required by law. Reasonable safeguards will be used to protect the confidentiality of data. The Participant acknowledges receipt of a privacy notice describing permitted uses and disclosures of protected health information related to this study.

I acknowledge that I have been provided information regarding privacy protections and uses of my health information for research purposes.

Withdrawal and Revocation

Participation is voluntary. I may withdraw my consent and stop participating at any time. If I revoke this authorization, I understand that the revocation will not apply to information already used or disclosed in reliance on this authorization prior to the date the revocation is received, and that withdrawal may affect my ability to continue in the study.

To revoke this authorization, I must provide written notice to the Principal Investigator at the contact information below:

Compensation and Costs

Will the participant receive compensation or reimbursement for participation?   Yes    No

Release of Claims and Indemnification

In consideration of being permitted to participate in the Study, and to the fullest extent permitted by applicable law, the Participant releases and discharges the Institution, its employees, agents, investigators, sponsors, and contractors from any and all claims, liabilities, losses, or damages arising directly from the Participant’s participation in the Study, except for claims arising from the gross negligence or willful misconduct of those released parties. This release does not limit the Participant’s right to seek medical care for injury.

Certifications and Participant Acknowledgment

I certify that I am the person named above, that I have read and understand this Healthcare Study Release Form (or it has been read to me), that my questions have been answered to my satisfaction, and that I voluntarily agree to the terms set forth herein. I understand that signing this form does not waive any of my legal rights except as expressly set forth above.

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