Healthcare Biobank Addendum

HEALTHCARE BIOBANK ADDENDUM

This Biobank Addendum supplements and modifies any prior consent given by the individual identified below for clinical care or participation in research. It documents authorization for the collection, storage, use, and disclosure of biological specimens and associated health information for biomedical research and related uses as described herein.

Patient Identification

Patient Name:

Medical Record Number:

Date of Birth: Month Day Year

Address:

Phone:     Email:

Addendum Effective Date

Effective Date of this Addendum: Month Day Year

Description of Materials and Data

Authorized Uses

By signing below, Patient authorizes the Biobank and approved investigators to store, process, analyze, and share the specimens and associated medical information for current and future biomedical research, including genetic, genomic, biochemical, and other laboratory analyses. Authorized uses include sharing with external research collaborators, transfer to other institutions or commercial entities for research or development, and creation of derived materials and data.

Privacy, De-identification, and Data Sharing

Specimens and data may be coded or de-identified before sharing. The Biobank will maintain a linkage key when necessary for approved research; however, re-identification by recipients is prohibited except as required by law or permitted by agreement. The Biobank and recipients may use or disclose data for research, regulatory, quality assurance, and commercial development. There is no guarantee that research results will be private.

I acknowledge that my specimens or data may be used for research that could lead to commercial products. I understand I will not receive financial compensation for discoveries, inventions, or commercial development arising from the use of my specimens or data.

Genetic Testing and Return of Results

Genetic analyses may be performed on specimens. The Biobank's policy on return of individual research results is as follows; please select your preference.

Return clinically actionable results to me if validated: Yes No

Risks, Benefits, and No Guarantee of Direct Benefit

Potential risks include loss of privacy, uninsurable information, or psychological distress from research findings. There is no guarantee of direct clinical benefit to the Patient. Biobank and investigators will take reasonable measures to protect privacy, but absolute confidentiality cannot be guaranteed.

Duration, Withdrawal, and Disposition

This authorization remains in effect until the Patient withdraws consent in writing or until the specified expiration date below, whichever occurs first. Withdrawal will not affect research or products developed prior to receipt of withdrawal notice.

Expiration Date (if not perpetual): Month Day Year

If withdrawn, specimens already distributed to approved investigators may not be retrievable; the Biobank will make reasonable efforts to destroy remaining specimens and discontinue use of identifiable data. Please indicate your preference regarding destruction of samples upon withdrawal:

Destroy remaining specimens upon withdrawal: Yes No

Authorization, Acknowledgement, and HIPAA

I acknowledge that I have read and understand this Biobank Addendum. I understand the nature and purpose of the Biobank's activities, the potential uses of my specimens and data, and the risks described herein. I authorize the collection, storage, use, and disclosure of my specimens and protected health information as described in this Addendum. This authorization includes any disclosures necessary to accomplish the research uses described, including disclosures to outside investigators and commercial entities.

I understand that I may refuse to sign this Addendum and that refusal will not affect my ability to receive medical care. I understand I may revoke this authorization at any time by providing written notice to the Biobank contact listed below, subject to the limitations described above.

I authorize the Biobank to use and disclose my protected health information for the purposes described. I understand that once information is disclosed under this authorization it may no longer be protected by privacy law.

I acknowledge receipt of the privacy practices applicable to research and Biobank operations: I ACKNOWLEDGE

Biobank Contact for Questions and Withdrawal

Special Authorizations and Signatures of Representative

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