title: TuBaFrost 3: regulatory and ethical issues on the exchange of residual tissue for research across Europe.
abstract: The regulatory regimes for research with residual tissue and accompanying data differ widely between countries in the European Union (EU): from specific consent to opt-out or even no consent at all. This could greatly hamper research where the exchange of tissue and accompanying data has become the gold standard, like in TubaFrost. Instead of adhering to international guidelines, which have a democratic deficit, or an attempt for a new set of possible harmonising rules, TubaFrost chose to create a coordinating rule: if tissue may legitimately be used for a certain kind of research in the country where it was taken and under whose jurisdiction the patient falls, it may also be used for such research in the country where it is sent to in the context of a scientific program even if in that other country other regulations would apply for research with residual tissue taken from patients under their jurisdiction. This coordinating rule has a sound basis in EU law in general and will solve the problems related to diverging national regulatory regimes in the case of cross national research with residual tissue.
authors.affiliation: Medlaw Consult, P.O. Box 11500, 2502 AM Den Haag, The Netherlands. tissueresearch@medlaw.nl <tissueresearch@medlaw.nl>
authors.forename: E-B
authors.initials: EB
authors.lastname: van Veen
authors.forename: P H J
authors.initials: PH
authors.lastname: Riegman
authors.forename: W N M
authors.initials: WN
authors.lastname: Dinjens
authors.forename: K H
authors.initials: KH
authors.lastname: Lam
authors.forename: M H A
authors.initials: MH
authors.lastname: Oomen
authors.forename: A
authors.initials: A
authors.lastname: Spatz
authors.forename: R
authors.initials: R
authors.lastname: Mager
authors.forename: C
authors.initials: C
authors.lastname: Ratcliffe
authors.forename: K
authors.initials: K
authors.lastname: Knox
authors.forename: D
authors.initials: D
authors.lastname: Kerr
authors.forename: B
authors.initials: B
authors.lastname: van Damme
authors.forename: M
authors.initials: M
authors.lastname: van de Vijver
authors.forename: H
authors.initials: H
authors.lastname: van Boven
authors.forename: M M
authors.initials: MM
authors.lastname: Morente
authors.forename: S
authors.initials: S
authors.lastname: Alonso
authors.forename: D
authors.initials: D
authors.lastname: Kerjaschki
authors.forename: J
authors.initials: J
authors.lastname: Pammer
authors.forename: J A
authors.initials: JA
authors.lastname: Lopez-Guerrero
authors.forename: A
authors.initials: A
authors.lastname: Llombart Bosch
authors.forename: A
authors.initials: A
authors.lastname: Carbone
authors.forename: A
authors.initials: A
authors.lastname: Gloghini
authors.forename: I
authors.initials: I
authors.lastname: Teodorovic
authors.forename: M
authors.initials: M
authors.lastname: Isabelle
authors.forename: A
authors.initials: A
authors.lastname: Passioukov
authors.forename: S
authors.initials: S
authors.lastname: Lejeune
authors.forename: P
authors.initials: P
authors.lastname: Therasse
authors.forename: J W
authors.initials: JW
authors.lastname: Oosterhuis
mesh_terms: D032984:Ethics, Research; D005060:Europe; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence*; D006801:Humans; D007373:Interinstitutional Relations; D007400:Interprofessional Relations / Q000941:ethics; D009369:Neoplasms; D013048:Specimen Handling; D014015:Tissue Banks / Q000941:ethics / Q000331:legislation & jurisprudence*