APPENDIX 7
Guidelines for issues to be addressed
when considering support for collections of human samples (3 August
1998—revised from 4 December 1997)
1. Legal issues
It is unclear under UK law whether it is possible
to own a sample of human tissue and if so, who would have rights
of ownership over the sample. Until the legal position regarding
samples has been resolved, it is recommended that in practice
the issues relating to the use and transfer of samples for specific
research purposes should be addressed by obtaining appropriate
consent.
2. Governance of access
The governance of the family collection should
be addressed at the time of funding; for example:
— Composition of steering group or
advisory group (this should usually include independent members;
funding agencies may also wish to be represented).
— Conditions of access (eg academic
research purposes, commercial use, ability to transfer resources
to third parties, return of data etc).
— Prioritisation and exclusivity of
access (eg is access open to all or prioritised by a steering
group—and on what basis?). Will groups involved in establishing
collections have preferential access?
— Distribution and maintenance of samples
will have substantial financial implications over the long term;
how will these be addressed and what mechanisms for cost-recovery
have been proposed?
3. Consent
Informed consent should be obtained, researchers
are asked to consider carefully the consent that is obtained at
the outset as this may reduce the need to seek reconsent at a
later date. The following issues should be addressed in obtaining
consent from patients:
— The nature and scope of the study;
this may be in general terms or relate to a specific study. The
information should be explicit about the circumstances in which
further consent will be requested.
— The scope of access to patient material
or information derived from the samples; potential commercial
access, access of researchers not directly associated with the
clinician or researcher who obtained the sample and whether material
will be archived or destroyed.
— Consequences of findings. The potential
for general or specific individual feedback should be explicit
in the information provided.
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