Timing of consent for the research use of surgically removed tissue

Is Postoperative Consenting Acceptable?

Authors


  • The authors are all pathologists and/or scientists who are actively involved the practice of biobanking. They represent many different countries including the US, Canada, the UK, Spain, and Singapore and all are members of a biobanking association called the International Society for Biological and Environmental Repositories (ISBER). The consensus of opinion in this article is the result of a productive listserv discussion followed by additional E-mail correspondence, in which all the authors played an active role. The following ISBER members also made valuable contributions to the listserv discussion: Lisa Devereux, Carolyn Compton, Regina Gandour-Edwards, Mark Elliott, Lisa Miranda, Sharon Terry, Theresa Chow, Peter Geary, Ed Levine, Kathy Sexton, and Yaffa Rubinstein.

Abstract

Consent by patients to perform surgery (‘surgical consent’) and consent for the research use of residual tissue (‘research consent’) are desirable to respect individual autonomy and human dignity. In the past, documentation of these consents has been conveniently obtained before surgery by the same person using the same form. More recently, however, ethical concerns have forced a separation between the 2 consents so that they are now often obtained by different people using different forms, thus raising the possibility of obtaining the research consent postoperatively. The current study seeks to clarify the issues and explain why a postoperative informed consent process has distinct advantages in certain circumstances.

Ancillary