Centre for Research Ethics & Bioethics (CRB)

Trust based consent looks promising

2015-06-02

Finding a model for informed consent that protects the integrity and interests of participants, future patients and researchers isn't easy. Recently, a group in Milano tested a trust based consent that I think looks promising.

The European Institute of Oncology (IEO) in Milano has designed and tested a new information and consent procedure for its tissue bank, the IEO Biobank and Biomolecular Resource Infrastructure (IBBRI).

This new model of trust-based consent is a modified version of broad consent that has proven successful both for information to participants and for providing a useful resource for important research. The participants are informed that this participation pact concerns only and exclusively the collection and the use of biological materials, current and future medical records for research purposes, including the use of information that is generated by the research. They are informed that the biospecimens will be used for future, not yet specified research and about the different measures that are taken to protect data against unauthorised use.

This pact for research represents a promising approach for biobank systems. 97.2 % of the participants accepted on this basis the use of identifiable data for broad and future purposes. The model shows how trust can be maintained without having to go at lengthy and burdensome procedures for re-consent by using a broad consent in this way.

Having followed the discussions on informed consent for the better part of my career, I think this looks like a promising solution to the dilemma of weighing the interests of future patients, research participants and research.

The full article was recently accepted in Bioethics: Sanchini V, Bonizzi G, Disalvatore D, Monturano M, Pece S, Viale G, Di Fiore PP, Boniolo G, A trust-based pact in research practice. From theory to practice (In press). Virginia Sanchini will also present this trust-based model during the HandsOn: Biobanks Conference in Milano at the Ethics Round Table Discussion on 30th July, 10.am.

Mats G. Hansson

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