Ethical, Legal, and Social Issues Substudy in Relation to the Genotype-Tissue Expression Project

The Genotype Tissue Expression Project (GTEx) is a partnership between multiple NIH agencies and funded by the Common Fund. Families who agreed to donation of organs and tissues for transplantation were asked to authorize the collection of additional tissues for GTEx by participating Organ Procurement Organizations (OPO). Donated tissues are placed in a National Cancer Institute biobank, and the donor's genome and medical record information analyzed and released to researchers through NIH's database of Genotypes and Phenotypes (dbGaP). The tissues and information will be kept in the biobank indefinitely and cell lines may be developed from the donated skin and blood.

An ethical, legal and social issues (ELSI) sub-study examines the issues surrounding risks to privacy and breach of confidentiality to family decision makers (FDM) as well as FDM perspectives on the return of findings to donor families. The ELSI sub-study assessed the authorization process and make suggestions for its improvement. Semi-structured interviews were completed with families who decided to donate to GTEx as well as those who refused to donate to the project. Tissue requesters (TR) who make the GTEx approaches for participating OPOs, were also asked to complete an online survey for each approach they completed for GTEx.

The study builds on this research team's extensive work in organ and tissue donation and the work currently being conducting during the ELSI pilot of the GTEx project. Specifically, the investigators propose to examine the impact of stress and complex information on donor families' decision-making to inform the consent process; understand how variations in requesters, consent approaches, and the characteristics of family decision makers affect understanding, recall of and willingness to donate tissues for research; consider the ethical and legal issues of the request and consent process; and, test a novel intervention designed to train tissue requesters to employ effective communication techniques when making requests for tissue. The overall goal is to develop a set of recommendations that will maximize the likelihood that family decision makers (FDM) make informed donation decisions under stressful circumstances. The specific aims of the ELSI GTEx study are:

This study will build on this research team's extensive work in organ and tissue donation and the work they are currently conducting during the ELSI pilot of the GTEx project. Specifically, the investigators propose to examine the impact of stress and complex information on the decision making of donor families to inform the consent process, understand how variations in requesters, consent approaches, and the characteristics of family decision makers affect understanding and recall of and willingness to donate tissues for research, consider the ethical and legal issues of the request and consent process, and test an intervention to train tissue requesters to employ effective communication techniques when making requests for tissue. The overall goal is to develop a set of recommendations that will maximize the likelihood that family decision makers (FDM) make informed donation decisions under stressful circumstances. The specific aims of the ELSI GTEx study are:

1. Identify elements of nonverbal and relational communication impacting FDM knowledge, recall and GTEx decision making. Using the methods and procedures of the pilot study, the investigators will conduct an observational study of the GTEx request process to understand the communication-related variables impacting FDM knowledge, recall and decision making. In addition, a subsample of audiotapes will be obtained from tissue-only donors whose consent conversations are conducted by telephone and are audiotaped. This will provide information about the important nonverbal and relational elements of communication on the outcome variables.