This paper argues against considering incidental fndings as potential benefts of research when assessing the social value of proposed research, determining the appropriateness of a study's risk/beneft ratio, and identifying and disclosing the risks and benefts of participation during informed consent. The possibility of generating IFs should be disclosed during informed consent as neither a risk nor beneft, but as a possible outcome collateral to participation. Whether specifc IFs will be disclosed when identifed is a separate question whose answer is (...) material to determining whether IFs constitute a risk or a potential indirect beneft of participation. Finally, three types of IF should be distinguished and treated diferently during informed consent: those that will be routinely generated , those that can reasonably be characterized in terms of their nature and frequency of generation , and those of unpredictable nature and frequency that can be characterized only in general terms. Research protocols should provide a rationale for sharing or not sharing IFs of these three types with participants. Regulatory review of such plans should not, however, be confused with regarding IFs as potential benefts when assessing the study's risk/beneft ratio or merit. (shrink)

The cornea was the first human solid tissue to be transplanted successfully, and is now a common procedure in ophthalmic surgery. The grafts come from deceased donors. Corneal therapies are now being developed that rely on tissue from living-related donors. This presents new ethical challenges for ophthalmic surgeons, who have hitherto been somewhat insulated from debates in transplantation and donation ethics. This paper provides the first overview of the ethical considerations generated by ocular tissue donation from living donors and suggests (...) how these might be addressed in practice. These are discussed in the context of a novel treatment for corneal limbal stem cell deficiency. This involves limbal cell grafts which are transplanted, either directly or after ex vivo expansion, onto recipient stem cell-deficient eyes. Where only one eye is diseased, the unaffected eye can be used as a source of graft tissue. Bilateral disease requires an allogenic donation, preferably from a genetically related living donor. While numerous papers have dealt with the theory, surgical approaches and clinical outcomes of limbal stem cell therapies, none has addressed the ethical dimensions of this form of tissue donation. (shrink)