Application) Despite the fact that tissue donation has greater public health implication and potentially affects many more donor families and recipients than solid organ donation, little research has been done on the consent process. Donated tissues provide heart valve replacements, skin grafts, and replacement of amputated bone in cancer patients. They are used in prosthetic surgery, treatment of facial wasting, and many other procedures. It is estimated that tens of thousands of patients are eligible to donate tissues. Nonetheless, most requests for tissue donation are refused (consent rates are no higher than 35%). Most importantly, recent controversies have raised questions about how requests are made for tissue donations. This 4-year study will directly examine the tissue request process used by Tissue Bank staff. We will assess the determinants of families? willingness to donate tissues, their informational needs, and the adequacy of consent practices. A sample of 1,400 tissue-eligible family decision makers and their tissue staff requesters will be recruited over a 30- month period. Cases will be randomly selected from a national sample from 13 tissue banks of families who made decisions about donating a family member?s tissue. This study will collect data from three sources: 1)donor-eligible patients? families; 2) requesters directly involved in asking for consent to tissue donation; 3) audiotaped recordings of the request for tissue donation. This study will be the first to comprehensively examine consent to tissue donation.
