Back to Basics: Informed Consent
Thanks for joining! Today we’re taking it back to the basics for a refresher on Informed Consent in the tissue banking industry for living donors. Informed consent is a foundational principle in medical ethics and legal compliance, especially within the domain of tissue banking. As tissue banks handle human biological tissue products for transplantation, research, education, and therapy, the process of obtaining informed consent ensures that donors or their representatives are fully aware of the purpose, risks, and implications of tissue donation. Let’s learn more as we explore the concept of informed consent from the perspective of tissue banking, address regulatory frameworks, and discuss the necessity and importance of informed consent.
What is informed consent? Informed consent refers to the process by which an individual voluntarily agrees to participate in a medical procedure, research, or donation after receiving comprehensive information about the risks, benefits, and alternatives. It involves communicating the intended use of donated tissues, potential outcomes, confidentiality protections, and the donor’s right to withdraw consent at any stage prior to tissue recovery/acquisition. Informed consent as defined by the American Association of Tissue Banks (AATB) [1] is, “Permission given by a living donor or client depositor who is presented with a description of the scope, use and any risks or benefits to her or him of the proposed donation, and who has been given the opportunity to ask questions and receive accurate answers. A living donor who gives her or his informed consent to donation shall sign a record of the informed consent”. The Food and Drug Administration (FDA) regulates tissue banking under Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), 21 CFR Part 1271, and includes principles related to informed consent with record-keeping and periodic audits to ensure compliance [2].
Informed consent must disclose and provide a clear explanation of the purpose, procedures, risks, and benefits, including the opportunity to ask questions and seek clarification. It also ensures that the donor or their representative understands the information provided and comprehends how their tissues will be used, including potential research applications, transplantation, and disposal procedures. Their decision to donate must be free from coercion or undue influence and be voluntary. Proper recording and documentation of the consent process includes donor information, signatures, dates, and witnesses as applicable, on a consent record.
Why is informed consent required?
Informed consent is rooted in legal, ethical, and practical considerations.
Legally it protects organizations and healthcare professionals from liability and ensures compliance with national and international regulations.
Ethically it respects donor autonomy and upholds the principle of self-determination/informed decision-making. It protects the rights and dignity of donors.
Practically it fosters trust between donors, recipients, and institutions, thereby enhancing transparency and accountability in tissue banking practices.
When are witnesses required? Witnesses are sometimes necessary during the informed consent process, particularly in situations where the donor is unable to sign the consent form (e.g., due to physical incapacity, illiteracy, language barriers, etc.) or when the consent is provided verbally. Regulatory guidelines from the FDA, state, or other applicable standard bodies, recommend the presence of a witness to attest to the voluntary nature and accuracy of consent, especially in cases involving vulnerable populations or when legal representatives are involved.
Informed consent is a critical component of tissue banking, mandated by regulatory authorities and upheld as an ethical imperative. Best practices include clear communication, thorough documentation, and adherence to evolving regulatory standards, with the involvement of witnesses when necessary to uphold the integrity of the consent process. It safeguards donor rights, promotes trust and transparency, and ensures legal compliance. While the process may introduce administrative challenges, the benefits of transparency, accountability, and donor protection far outweigh the drawbacks and is essential to uphold the highest ethical standards in tissue acquisition and use.
Have questions about the informed consent process? Reach out to us here!
See you next time!
References
[1] American Association of Tissue Banks, Standards for Tissue Banking, 15th Edition, - https://www.aatb.org/standards
[2] https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271