Human Whole-Eye Donation for Research-Optimizing Clinical Trial Informed Consent

• Published in: JAMA ophthalmology Vol. 142; no. 5; p. 476
• Main Author: Bramstedt, Katrina A
• Format: Journal Article
• Language: English
• Published: United States 01.05.2024
• Subjects: Biomedical Research; Clinical Trials as Topic; Eye; Humans; Informed Consent; Tissue and Organ Procurement; Tissue Donors - supply & distribution
• ISSN: 2168-6173
• DOI: 10.1001/jamaophthalmol.2024.0203

Posthumous whole-eye (globe) donations for research lack a mechanism that reinvolves the existing ophthalmic research team of the donor unless there is a preplanned donor directive. Disconnection between the deceased and their research team equates to lost opportunities for the research team to have a longitudinal view of the eyes that have been involved in their research. To use the clinical trial informed consent process to create a posthumous research donation opportunity that directs the donation to the currently affiliated research team of the donors (preserving the longitudinal research experience). Current globe donation pathways were reviewed. Additionally, published advice from the fields of ophthalmology, brain banking, and implantable medical devices were used as reference points. Globe donation represents a small but valuable type of ocular donation. Globe donation for research purposes is useful for investigators performing total human eye allotransplantation clinical trials, as well as for ophthalmic drug or device researchers. Results suggest that those performing invasive eye research should include the option of posthumous globe donation in their study protocols and informed consent forms to facilitate more opportunities for the generation of scientific knowledge. The longitudinal perspective can be valuable especially for eyes that have received long-term treatment with an investigational drug or device. This article poses a research-informed consent framework for posthumous globe donation.