Timing of Consent for the Research Use of Surgically Removed Tissue Is Postoperative Consenting Acceptable

Consent by patients to perform surgery (‘surgical consent’) and consent for the research use of residual tissue (‘research consent’) is desirable to respect individual autonomy and human dignity. The need to obtain this research consent lies at the heart of ethical research involving human tissues, but it should be noted that in some jurisdictions and under certain circumstances, it is possible for researchers to obtain a ‘‘waiver of research consent.’’ This may occur if an Institutional Ethics Review Board (IRB) determines that the research use is of minimal risk and it is impractical to obtain the research consent. 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. This raises the possibility of obtaining the research consent postoperatively. Unfortunately, there have been uncertainties regarding this relatively new practice, and this has slowed down its widespread implementation. The current study seeks to clarify the issues and explain why a postoperative informed consent process has distinct advantages in certain circumstances. The points presented herein are based on a listserv discussion among members of the International Society for Biological and Environmental Repositories (ISBER).