Adult-to-adult living donor liver transplantation (ALDLT) has been increasingly utilized in the US since 1998 in response to the dramatic shortage of liver grafts.1 Many transplant clinicians, ethicists, and policy-makers are concerned about the ethics of subjecting living liver donors (LDs) to serious health risks because they will experience no direct medical benefits and little is known about long-term liver donor outcomes. Ethical questions remain about whether the current informed consent process adequately informs LDs about ALDLT, maintains their autonomy, and assures their voluntary consent. Studies report that LDs do not comprehend the information disclosed to them about ALDLT and have unmet information needs and unmet expectations. LDs also report feeling undue pressure to donate since patients in need of a liver transplant have no alternative to transplantation other than certain death. In order for surgeons to ethically proceed with transplant surgery, there must be evidence that LDs understand the information about the ALDLT process and have made an autonomous decision to undergo the associated risks. However, current practice does not entail any formal assessment of a donor's comprehension and no tools exist to formally assess the adequacy of informed consent in this or any other clinical contexts. Measuring individual donor's comprehension of information provided in the informed consent process could help to optimize the ethical practice of obtaining informed consent for LDs and prevent unnecessary harm through surgery. The objective of this study is to develop and pilot test a new Evaluation of Donor Informed Consent Tool (EDICT), to assess individual donor comprehension during the ALDLT informed consent process. The study will adapt the tool that Joffe used to assess comprehension in informed consent for clinical research. Qualitative and quantitative methods, including consent form review and interviews and surveys with bioethicists, clinicians, and liver donors will be used to empirically validate the adapted tool.
The specific aims are to: (1) Develop a brief tool to measure potential liver donors'actual (objective) and perceived (subjective) comprehension in informed consent for ALDLT;and (2) Pilot-test EDICT among liver donor candidates. EDICT will be valuable for identifying comprehension problems of LDs during the ALDLT informed consent process. EDICT is innovative in its ability to identify individual donor deficits in comprehension and prompt further targeted donor-clinician communications to improve the ALDLT informed consent process. EDICT may also benefit transplant centers by providing assurances that the donation may ethically proceed. This proposal will heed transplant clinicians'call for empirical research to ensure that living liver donors provide adequate informed consent for ALDLT, to guide LDLT programs in offering ethically sound clinical practice, and to inform standards for informed consent for ALDLT. Reducing transplant clinicians'concerns by providing an ethically optimal informed consent process should promote and expand living liver donor programs and help save lives.
The objective of this study is to develop a new tool (Evaluation of Donor Informed Consent Tool (EDICT)) that measures living liver donor candidates'comprehension in the informed consent process for adult-to-adult living donor liver transplantation. This tool will help to improve the informed consent process for living liver donation by identifying living donors'comprehension deficits and prompting targeted donor-clinician communication. Promoting an ethically optimal informed consent process will help to provide assurances to transplant clinicians that the donation may ethically proceed, promote living liver donor programs, and help save lives.