Abstract

This study examined how research conducted at several federally funded institutions designated as Clinical Research Centers or Specialized Programs of Research Excellence addressed the issues of consent, control over biological materials, confidentiality, and disclosure of results in protocols and consent forms for genetic research with stored biological materials. Although a majority of the documents reviewed addressed most of the issues raised in the research ethics literature, topics identified in the literature that were missing include the return of research results, the right to withdraw from research involving biological materials, and the consent of children when they become legal adults. If typical, these findings suggest greater educational efforts may be needed to prompt investigators and IRBs to consider these and other issues that were either not addressed in the protocols or consent forms or were addressed inadequately