Ethical Issues in Tissue Banking for Research: A Brief Review of Existing Organizational Policies

Abstract

Based on a general review of international, representative tissue banking policies that were described in the medical, ethics, and legal literature, this paper reviews the range of standards, both conceptually and in existing regulations, relevant to four main factors: (1) commercialization, (2) confidentiality, (3) informed consent, and (4) quality of research. These four factors were selected as reflective of some of the major ethical considerations that arise in the conduct of tissue banking research. The authors emphasize that any policy or ethical guidelines designed to regulate tissue bank research should address all four factors. Whenever this sort of research is conducted between several institutions or several countries, the paper suggests that the relevant entities work collaboratively to harmonize their standards.

The Ethics of Research Biobanking: A Critical Review of the Literature

“…But despite the heterogeneity of the problems debated, informed consent once more became a key element of the "solutions" considered when contemplating the "biobank problem" and the consent requirement was entrenched in law already in 1994 (Godard et al, 2003). The plethora of new laws and circulars, nationally and internationally, has caused considerable confusion and has given rise to a call for harmonization of the consent requirement (Bauer et al, 2004;Clayton, 2005 ;Kapp, 2006;Morente and Alonso, 2005). But as pointed out by Maschke and Murrey, it is rarely debated who should be invited to do the harmonization, whether harmonization is indeed feasible, and in whose interest such harmonization would be (Maschke and Murray, 2004).…”

Size matters: the ethical, legal, and social issues surrounding large-scale genetic biobank initiatives

“…The question appears to be what to harmonize and how. 39 Maschke and Murray, however, have challenged the very notion of 'harmonization': 40 while a seamless legal web is a laudable objective, they argue that the harmonization paradigm rests on a set of assumptions in need of further contemplation. First, will it be good for all stakeholders?…”

Review Paper: Human Tissues for Discovery Biomarker Pharmaceutical Research: The Experience of the Indiana University Simon Cancer Center—Lilly Research Labs Tissue/Fluid BioBank

“…After the FDA began to regulate tissue banking, many states wrote additional regulations. 2,9 In the mid 1990s, the National Institutes of Health and Centers for Disease Control convened workshops to examine consent for genetic research on both DNA and tissue. The resulting report recommends restriction of access to archival clinical specimens for molecular genetic research, including frozen blood, frozen tissue samples, stored DNA, and paraffin-embedded tissue blocks.…”