Legal frame work
Eye tissues for transplant are almost invariably derived from cadaveric donors; therefore, discussions regarding consent for donation are usually undertaken with the next of kin of a deceased person. Donation of eye tissue cannot proceed unless legal authority to remove tissue is established under the relevant Central and State legislation and regulations. Details of this authority shall be documented in the Standard Operating Procedures (SOP) Manual. In most instances, this authority is obtained by the receiving of informed consent from the potential donor, the donor’s next-of-kin, or authorization by a Designated Officer or Forensic Expert (when they are legally in possession of the body). Obtaining of legal consent prior to eye tissue retrieval is mandatory.
Consent shall be obtained in writing (by a signed Consent Form), as determined by local or national legislation (including, but not limited to 1994 THOA Act, 1995 THOA Rules, and 2014 THOA Rules). In all cases, documentation of the consent shall be made and the consent retained as part of the donor records. A Consent Form shall be maintained in the donor’s medical records at the retrieving facility and a copy retained for inclusion in the donor record at the Eye Bank. Information contained on the Consent Form should follow the requirements of the local, State, or National health authority and shall be defined in the Standard Operating Procedures (SOP) Manual. The exact procedure for obtaining consent will also follow the legal requirement and should be defined in the SOP manual