• Tuck Wai Chan, Sandra Mackey, and Desley Gail Hegney.
• Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. dprctw@nus.edu.sg
• Int J Evid Based Healthc. 2012 Mar 1;10(1):9-26.

AimThis review aimed to critically appraise, synthesise and present the best available evidence related to the experiences of patients who have donated their residual biological samples and the impact of this experience on the type of consent given for future research use of these tissues.MethodThe three-step search strategy aimed to find both published and unpublished studies published in English between 1990 and 2010 in electronic databases (PubMed, CINAHL, Scopus, Embase, PsycINFO, Mednar, PROQUEST). Using the standardised data extraction tool from the Joanna Briggs Institute, the Qualitative Assessment and Review Instrument, 131 findings were extracted from the 18 papers included in this review. These findings generated 19 categories and four synthesised findings.ResultsThe synthesised findings generated were related to the different stages of the handling of leftover tissue. The first synthesised finding: patient consent to the use of leftover tissue is a complex interaction between many factors and not solely driven by perceptions of benefits to self or others, relates to the collection of the leftover tissue - the initial consent process. The second synthesised finding: healthcare institutions and regulatory authorities must provide clear and transparent safeguards and controls, and communicate these to the patient prior to the consenting process, outlines the issues affecting consent during the processing and storage of the tissues in biobanks or research institutions. The third synthesised finding: views on ownership and rights to the further use of the leftover tissue varies between individual patients and influences their willingness to consent to further use, demonstrates the concerns relating to the safeguards on the collection and storage of leftover tissue. The fourth synthesised finding: patients have opposing views on the use of their leftover tissue for commercial purposes, reflecting the differing community beliefs around using leftover tissue for research which may provide a commercial benefit to some, but not all, the community.ConclusionFor leftover tissues to be used, patients must clearly understand: the type of consent they are providing (opt in or opt out); the parameters for the future research use of their leftover tissues; the safeguards put into place to protect the individual and the donated tissue from unethical use; and the commercial implications of their consent.Implications For PracticeThis review provides information on patient's experiences on the collection, storage, distribution and future use of leftover tissue. These preferences need to be understood when designing a prospective model of consent regimen which respects patient's confidentiality and wishes. The information in this review is especially important for policy-makers designing a prospective model of consent regimen for the use of existing and previously collected biological samples with no consent taken.Implications For ResearchFurther research is needed to ascertain what factors specifically influence patient's willingness to consent for the use of leftover tissue. Factors for further exploration include the effects of culture, religion and age. Additionally, further research is required to inform the development of specific consent regimes for the use of leftover tissue for commercial, stem cell and genetic research.© 2012 The Authors. International Journal of Evidence-Based Healthcare © 2012 The Joanna Briggs Institute.

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