Healthcare Stem Cells Agreement

Healthcare Stem Cells Agreement

Patient Information

Patient Name:    Date of Birth:

Male    Female    Other / Prefer not to say

Insurance Information

Medical History

Collection, Processing and Storage

I authorize the collection of my stem cells and associated biological materials and medical information for the purposes described below. The procedure to obtain stem cells, if applicable, will be explained to me by authorized clinical personnel. I understand that no guarantee is made as to the suitability, quality, or future therapeutic efficacy of the stored material.

Storage Period: years. Patient understands that storage beyond the agreed period may be subject to additional fees and that disposal procedures are described below.

Risks, Benefits and Alternatives

I acknowledge that the collection and processing of stem cells and related procedures involve risks, which may include infection, bleeding, pain, and other complications as explained by clinical staff. I understand potential benefits include availability of biological material for future therapeutic use, but no promise of successful treatment is made. Reasonable alternatives have been explained to me.

I acknowledge receipt of verbal and/or written information concerning risks, benefits, and alternatives and confirm that I have had the opportunity to ask questions and to have them answered to my satisfaction.

Consent for Use and Disclosure

By initialing and checking the options below I provide specific consents regarding the use, disclosure, and disposition of my stem cells and associated data.

I consent to collection, processing and long-term storage of my stem cells for potential future autologous or allogeneic clinical use.

I consent to the use of my de-identified stem cells and associated data for research purposes, subject to institutional review and applicable law.

I consent to use of my material in research that may lead to commercial products. I understand I will not receive financial compensation from commercialization of products derived from my donated material.

I consent to sharing of my identifiable health information associated with the sample with treating clinicians and authorized laboratories as necessary for clinical care.

I consent to sharing of de-identified data and/or samples with external research collaborators consistent with applicable privacy protections.

HIPAA Authorization and Privacy Acknowledgment

I authorize the release of my protected health information (PHI) to the storage facility, processing laboratories, and authorized clinical personnel for the purposes of collection, processing, storage, clinical use, treatment coordination, and permitted research activities. I understand that my PHI may be used and disclosed as described herein and that I may revoke this authorization in writing at any time, except to the extent that action has already been taken in reliance on it.

Authorization Expiration Date:

Right to Withdraw and Disposition

I understand I may withdraw this authorization at any time by submitting a written request to the storage facility; withdrawal will not affect disclosures made prior to the facility's receipt of the revocation. Upon termination of storage or at the end of the storage period, I authorize the following disposition (select one):

Return unused material to the treating facility for clinical use

Release de-identified material for research

Dispose of material in accordance with facility policies

Fees, Liability, and Indemnification

I acknowledge and accept responsibility for any fees associated with collection, initial processing, and scheduled storage charges. Financial responsibility is designated as:

I acknowledge that the storage provider and affiliated personnel will use reasonable care in handling, processing, and storing material, but no warranty is made regarding viability or fitness of samples for future use. To the fullest extent permitted by law, I agree to release, indemnify, and hold harmless the storage provider, its agents, and clinicians from claims arising from storage, processing, or authorized use of my donated material except for willful misconduct or gross negligence.

Legal Terms

This Agreement constitutes the full and exclusive statement of the terms between the patient and the storage provider concerning the matters herein. Any amendment must be in writing and signed by the patient and an authorized representative of the storage provider. This Agreement is governed by the laws of the state in which the collection facility is located, without regard to conflict of laws principles.

If any provision of this Agreement is found invalid, illegal, or unenforceable, the remaining provisions shall remain in full force and effect.

Acknowledgment and Certification

I certify that I am the patient named in this Agreement or the legally authorized representative of the patient, that I am at least 18 years of age (unless otherwise permitted by law), and that I have read and understand this Agreement. I have had the opportunity to ask questions and have received satisfactory answers.

Patient initials acknowledging understanding of each key term and consent category:

Collection & Storage:    Research Use:

Commercialization:    HIPAA Authorization:

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