Obtaining ‘fresh’ consent for genetic research with biological samples archived 10 years ago Eric Vermeulen, Marjanka K. Schmidt, Neil K. Aaronson, Marianne Kuenen, Flora E. van Leeuwen * Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands ARTICLE INFO Article history: Received 20 June 2008 Received in revised form 11 November 2008 Accepted 19 November 2008 Available online 14 February 2009 Keywords: Research on stored biological samples Breast cancer Fresh consent Consent procedure Genetic research Commercial research ABSTRACT Objective: To obtain consent from breast cancer survivors to use residual tissue for a study on carriership of germ line mutations in the BRCA 1 and 2 genes. To investigate which con- sent regimen patients prefer for research with archived tissue. Participants: One hundred and thirty-two patients surgically treated for breast cancer between 1995 and 1997 in the Netherlands Cancer Institute were mailed a consent form and a questionnaire. Results: A consent form was obtained from 90%; 3% withheld consent for the use of archived tissue. A completed questionnaire was returned by 84%. ‘One-time general consent’ was considered to be the best procedure for consenting to research with stored tissue by 56%, 23% favoured the current ‘opt-out’ procedure; 21% did not know or had no preference. Conclusion: Obtaining fresh consent for genetic research with stored tissue is possible at the cost of time and effort. Most patients give consent for research with residual tissue. Ó 2008 Published by Elsevier Ltd. 1. Introduction Human tissue stored after clinical procedures is an exceed- ingly important resource for medical research. 1,2 Consent for use of stored tissue for research purposes can be obtained in a variety of ways, and there is on-going discussion about which procedure complies best with patients’ wishes while also being feasible. Some argue that implied consent with the opportunity to opt-out is sufficient. 2–5 Others claim that explicit ‘one-time general’ (for all future research) consent should be asked. 6,7 An alternative is ‘one-time specific con- sent’ with opportunities to have more control over future uses of tissue. 8,9 Patients can also be asked for fresh consent at the start of research, a procedure of which thus far only Furness and Nicholson 10 have reported. European national legal systems differ as to whether it is required to obtain fresh consent for the use of residual coded tissues in scientific research. 11 Genomic studies could have consequences for the individuals or families if data are re- leased. 12–14 The recent ‘Draft Guidelines for Human Biobanks and Genetic Research Databases’ of the OECD 15 only apply to tissue banks established for research purposes, thereby miss- ing the vast potential resource of stored residual tissue. Ask- ing consent for the use of these collections in biobank research would mean re-contact and fresh consent. In the Netherlands, anonimised samples obtained during medical treatment may, according to the Dutch Act on the Medical Treatment Contract, 11,16 be used in medical research if the patient has not objected to this ‘secondary use’. Active consent for the use of such materials is not required and the 0959-8049/$ - see front matter Ó 2008 Published by Elsevier Ltd. doi:10.1016/j.ejca.2008.11.022 * Corresponding author: Tel.: +31 20 512 2480; fax: +31 20 512 2322. E-mail address: f.v.leeuwen@nki.nl (F.E. van Leeuwen). EUROPEAN JOURNAL OF CANCER 45 (2009) 1168 – 1174 available at www.sciencedirect.com journal homepage: www.ejconline.com