Healthcare Biobank Consent Form

HEALTHCARE BIOBANK CONSENT FORM

This form documents voluntary informed consent for collection, storage, and future research use of biological specimens and associated health information by the biobank. Patient Name: Date of Birth: Gender:

Contact and Demographic Information

Insurance Information

Medical History (for research use)

Authorization and Consent

I authorize collection of biological specimens (which may include blood, saliva, tissue, and derivatives) and access to my health information for research purposes. I understand that specimens and data may be stored indefinitely and used for current and future research studies, including genetic and genomic analyses, epidemiologic studies, and development of diagnostics or therapeutics. I consent to the use of my specimens and associated data under the terms set forth below.

Scope of Use

Specimens and data may be shared with qualified researchers within the institution and with external collaborators, including non-profit and for-profit entities. Shared materials will typically be coded or de-identified; however, re-identification may be possible. I acknowledge that my specimens and data may contribute to publications, patent filings, and commercial products, and I will not receive financial compensation from such activities.

Optional Permissions (check boxes)

I permit re-contact for additional studies or to obtain updated health information. I consent to genetic and genomic sequencing of my specimens. I consent to sharing de-identified specimens/data with commercial entities for research and development. I wish to be notified of clinically actionable findings, if identified, consistent with the biobank policy.

Risks, Benefits, and Confidentiality

Risks: Potential risks include physical discomfort from specimen collection and loss of privacy if data are improperly disclosed. Although measures will be taken to protect confidentiality, absolute confidentiality cannot be guaranteed. Genetic information may have implications for family members.

Benefits: There may be no direct benefit to me. Potential benefits include contributions to scientific knowledge and development of future diagnostics and treatments.

Confidentiality protections include coded identifiers, restricted access, data security safeguards, and limited metadata shared with researchers. Identifiable information will only be disclosed as required by law or with separate authorization.

Withdrawal of Consent

I understand that I may withdraw consent at any time by contacting the biobank contact listed below. Withdrawal will be effective upon receipt of written notice. Specimens and data already distributed to researchers or incorporated into analyses or products cannot practically be retrieved; however, no further use or distribution will occur after withdrawal.

Compensation and Costs

There is no monetary compensation for donating specimens. Research related procedures that are not part of standard care will not be billed to my insurance without my separate authorization. The biobank does not assume liability for research-related injury beyond applicable laws and institutional policies.

HIPAA Authorization Acknowledgment

I authorize the use and disclosure of my protected health information, as necessary to carry out the research described above. I understand that information disclosed pursuant to this authorization may be subject to re-disclosure by recipients and may no longer be protected by law.

Contact for Questions or Withdrawal

Acknowledgment and Certification

By signing below I certify that I have read and received an explanation of the information in this form, had the opportunity to ask questions, and voluntarily agree to donate specimens and permit their use as described. I understand that I may revoke this authorization at any time by written notice to the biobank contact named above, subject to the limitations described in this form.

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