Research involving storage and use of human tissue: how did the Human Tissue Act 2004 affect decisions by research ethics committees?

Background: Little is known about the types of issues research ethics committees (RECs) raise in their letters about research involving the storage and use of human tissue. Aims: To classify the issues that appear to trouble RECs and to identify how the implementation of the Human Tissue (HT) Act in September 2006 might have affected REC decisions. Methods: 100 letters relating to applications about research use of human tissue were randomly selected from the National Research Ethics Service database, of which half were issued before the implementation of the HT Act and half post-implementation. Ethical issues raised by RECs were classified with a coding scheme developed using ethnographic content analysis. Results: Many letters raised issues about informed consent, including specific concerns about the information to be provided to participants about the taking, using and storing of their tissue samples. However, RECs appeared to be less likely to raise concerns about informed consent to use or store tissue after the HT Act, and there was some evidence that RECs were more comfortable allowing archived tissue samples to be used without additional patient consent after the HT Act than before. Conclusions: In the wake of the HT Act, RECs do not appear to be more cautious about approving research to use or store tissue without consent when responding to applications for ethical approval. The HT Act has provided clarity and authority to RECs and may indeed facilitate the process of gaining ethical approval for tissue-based research.