A trial of consent procedures for future research with clinically derived biological samples

Abstract

BACKGROUND: The aims of this study were to determine which consent procedure patients prefer for use of stored tissue for research purposes and what the effects of consent procedures on actual consenting behaviour are. METHODS: We offered 264 cancer patients three different consent procedures: 'one-time general consent' (asked written informed consent), 'opt-out plus' (had the opportunity to opt out by a form), or the standard hospital procedure (control group). The two intervention groups received a specific leaflet about research with residual tissue and verbal information. The control group only received a general hospital leaflet including opt-out information, which is the procedure currently in use. Subsequently, all patients received a questionnaire to examine their preferences for consent procedures. RESULTS: In all, 99% of patients consented to research with their residual tissue. In the 'one-time consent' group 85% sent back their consent form. Patients preferred 'opt-out plus' (43%) above 'one-time consent' (34%) or 'opt-out' (16%), whereas 8% indicated that they did not need to receive information about research with residual tissues or be given the opportunity to make a choice. CONCLUSIONS: The 'opt-out plus' procedure, which places fewer demands on administrative resources than 'one-time consent', can also address the information needs of patients.

La recherche biomédicale à l’ère des tumorothèques

“…Cette brève revue de la littérature souligne la vision positive de la recherche biomédicale [15,23,24]. Avec le développe-ment de tumorothèques virtuelles collaboratives, un nombre suffisant d'échantillons à analyser semble assuré mais un taux de consentement insuffisant peut entraîner une sélection non représentative des échantillons disponibles [25].…”

“…En effet, seulement 35 % des patients participant à une biobanque constituée pour des recherches génétiques savaient que d'autres personnes que leurs soignants pouvaient accéder à leurs données médicales [20] et moins de la moitié (42 %) des patients de notre enquête avaient réalisé que leur consentement incluait une autorisation d'accès au dossier médical, alors que celle-ci était explicitement mentionnée dans le document écrit [4]. D'autres études ont montré que le transfert à l'étranger des prélèvements n'était pas jugé problématique [27], mais il y avait une certaine réticence à faire confiance aux chercheurs non académiques [28] et accepter la « vente » d'un échantillon soulevait de grandes difficultés [24]. Notre étude confirme ces résultats de manière très nette [4].…”

Consenting postpartum women for use of routinely collected biospecimens and/or future biospecimen collection

“…Marsolo et al (2012) found that more than 86 % of subjects consented to biobanking of residual biospecimens. In addition, Vermeulen et al (2009) found that 85 % opted to consent for use of tissue specimens from breast, prostate, and colorectal cancer surgery. Our study findings indicate that a high percentage of postpartum women also are willing to consent for use of their own and their neonates' residual biospecimens for medical research.…”

Connective tissue: Cancer patients’ attitudes towards medical research using excised (tumour) tissue

“…Patients cannot really control what is done with it. Legally, they have the right to opt-out but most have no knowledge of research with tissue and the option to opt-out (Vermeulen et al, 2009), but they are interested in what is done and with the results, because it is part of their extended body scheme (that is, internal awareness of the body and the relationship of body parts to one another). The tissue is an extension of the body by which the person takes part in research, and is connected to other patients and relatives yet to be born.…”